Blood Banking

Blood samples

Photo by Graham Colm

A new blood collection set has received 510(k) clearance from the US Food and Drug Administration as well as the CE mark, which means it can be marketed within the European Economic Area.

The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is engineered to minimize patient discomfort during blood collection.

The set uses proprietary needle technology—Pentapoint™ Comfort and RightGauge™ Ultra-Thin Wall technology.

According to the manufacturer, BD, this technology can reduce penetration forces without compromising tube fill times or sample quality.

Research has shown that PentaPoint™ Comfort 5-bevel needle technology helps reduce the chance of a painful injection by creating a flatter, thinner surface to help penetrate the skin with significantly greater ease.¹

When combined with RightGauge™ technology, which increases the needle’s inner diameter and enables clinicians to select a smaller gauge needle without sacrificing sample quality and blood flow, the BD Vacutainer® UltraTouch™ Push Button Blood Collection Set has been shown to reduce penetration forces by up to 32% when compared to another blood collection set.²

“The ability to use smaller gauge needles should also help clinicians access veins more successfully,” said Ana K. Stankovic, MD, PhD, worldwide vice president of Medical Affairs for BD Life Sciences – Preanalytical Systems and Global Health.

“This could prove especially valuable in patient populations—such as oncology, geriatric, and pediatric—that often have difficult or fragile veins.”

Dr Stankovic also noted that clinicians may be reluctant to use smaller gauge needles for fear of increasing hemolysis as the blood passes slowly through the narrow cannula.

“With BD Vacutainer® UltraTouch™ Push Button Blood Collection Sets, clinicians can select the gauge that is most appropriate for their patients, without compromising sample quality, testing accuracy, and their own efficiency,” she said.

1. Hirsch LJ, et al. Journal of Diabetes Science and Technology. 2012, 6(2):328-35.

2. 2015 BD bench testing versus BD Vacutainer® Push Button Blood Collection Sets.

Blood samples

Photo by Graham Colm

A new blood collection set has received 510(k) clearance from the US Food and Drug Administration as well as the CE mark, which means it can be marketed within the European Economic Area.

The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is engineered to minimize patient discomfort during blood collection.

The set uses proprietary needle technology—Pentapoint™ Comfort and RightGauge™ Ultra-Thin Wall technology.

According to the manufacturer, BD, this technology can reduce penetration forces without compromising tube fill times or sample quality.

Research has shown that PentaPoint™ Comfort 5-bevel needle technology helps reduce the chance of a painful injection by creating a flatter, thinner surface to help penetrate the skin with significantly greater ease.¹

When combined with RightGauge™ technology, which increases the needle’s inner diameter and enables clinicians to select a smaller gauge needle without sacrificing sample quality and blood flow, the BD Vacutainer® UltraTouch™ Push Button Blood Collection Set has been shown to reduce penetration forces by up to 32% when compared to another blood collection set.²

“The ability to use smaller gauge needles should also help clinicians access veins more successfully,” said Ana K. Stankovic, MD, PhD, worldwide vice president of Medical Affairs for BD Life Sciences – Preanalytical Systems and Global Health.

“This could prove especially valuable in patient populations—such as oncology, geriatric, and pediatric—that often have difficult or fragile veins.”

Dr Stankovic also noted that clinicians may be reluctant to use smaller gauge needles for fear of increasing hemolysis as the blood passes slowly through the narrow cannula.

“With BD Vacutainer® UltraTouch™ Push Button Blood Collection Sets, clinicians can select the gauge that is most appropriate for their patients, without compromising sample quality, testing accuracy, and their own efficiency,” she said.

1. Hirsch LJ, et al. Journal of Diabetes Science and Technology. 2012, 6(2):328-35.

2. 2015 BD bench testing versus BD Vacutainer® Push Button Blood Collection Sets.

Blood samples

Photo by Graham Colm

A new blood collection set has received 510(k) clearance from the US Food and Drug Administration as well as the CE mark, which means it can be marketed within the European Economic Area.

The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is engineered to minimize patient discomfort during blood collection.

The set uses proprietary needle technology—Pentapoint™ Comfort and RightGauge™ Ultra-Thin Wall technology.

According to the manufacturer, BD, this technology can reduce penetration forces without compromising tube fill times or sample quality.

Research has shown that PentaPoint™ Comfort 5-bevel needle technology helps reduce the chance of a painful injection by creating a flatter, thinner surface to help penetrate the skin with significantly greater ease.¹

When combined with RightGauge™ technology, which increases the needle’s inner diameter and enables clinicians to select a smaller gauge needle without sacrificing sample quality and blood flow, the BD Vacutainer® UltraTouch™ Push Button Blood Collection Set has been shown to reduce penetration forces by up to 32% when compared to another blood collection set.²

“The ability to use smaller gauge needles should also help clinicians access veins more successfully,” said Ana K. Stankovic, MD, PhD, worldwide vice president of Medical Affairs for BD Life Sciences – Preanalytical Systems and Global Health.

“This could prove especially valuable in patient populations—such as oncology, geriatric, and pediatric—that often have difficult or fragile veins.”

Dr Stankovic also noted that clinicians may be reluctant to use smaller gauge needles for fear of increasing hemolysis as the blood passes slowly through the narrow cannula.

“With BD Vacutainer® UltraTouch™ Push Button Blood Collection Sets, clinicians can select the gauge that is most appropriate for their patients, without compromising sample quality, testing accuracy, and their own efficiency,” she said.

1. Hirsch LJ, et al. Journal of Diabetes Science and Technology. 2012, 6(2):328-35.

2. 2015 BD bench testing versus BD Vacutainer® Push Button Blood Collection Sets.

Blood for transfusion

Photo courtesy of UAB Hospital

The US Food and Drug Administration (FDA) has issued a new guidance recommending the deferral of blood donors who have been to areas with active Zika virus transmission, may have been exposed to the virus, or have had a confirmed Zika virus infection.

In areas of the US without active Zika virus transmission, the FDA recommends that donors at risk for Zika virus infection be deferred for 4 weeks.

Individuals considered to be at risk include those who have had symptoms suggestive of Zika virus infection during the past 4 weeks, those who have had sexual contact with a person who has traveled to or resided in an area with active Zika virus transmission during the prior 3 months, and those who have traveled to areas with active transmission of Zika virus during the past 4 weeks.

In areas of the US with active Zika virus transmission (at present, the Commonwealth of Puerto Rico, the US Virgin Islands, and American Samoa), the FDA recommends that whole blood and blood components for transfusion be obtained from areas of the US without active transmission.

Blood establishments may continue collecting and preparing platelets and plasma if an FDA-approved pathogen-reduction device is used.

The FDA’s guidance also recommends that blood establishments update donor education materials with information about the signs and symptoms of Zika virus and ask potentially affected donors to refrain from giving blood.

“Based on the best available evidence, we believe the new recommendations will help reduce the risk of collecting blood and blood components from donors who may be infected with the Zika virus,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

There have been no reports to date of Zika virus entering the US blood supply. However, the risk of blood transmission is considered likely based on the most current scientific evidence of how Zika virus and similar viruses (flaviviruses) are spread and recent reports of transfusion-associated infection outside the US.

Furthermore, about 4 out of 5 people infected with Zika virus do not become symptomatic. For these reasons, the FDA is recommending that blood establishments defer blood donations in accordance with the new guidance.

The FDA also intends to issue a guidance that will address appropriate donor deferral measures for human cells, tissues, and cellular and tissue-based products, given recent reports of sexual transmission of the Zika virus.

In addition, the FDA is prioritizing the development of blood screening and diagnostic tests that may be useful for identifying the Zika virus, preparing to evaluate the safety and efficacy of investigational vaccines and therapeutics that might be developed, and reviewing technology that may help suppress populations of mosquitoes that can spread the virus.

Blood for transfusion

Photo courtesy of UAB Hospital

The US Food and Drug Administration (FDA) has issued a new guidance recommending the deferral of blood donors who have been to areas with active Zika virus transmission, may have been exposed to the virus, or have had a confirmed Zika virus infection.

In areas of the US without active Zika virus transmission, the FDA recommends that donors at risk for Zika virus infection be deferred for 4 weeks.

Individuals considered to be at risk include those who have had symptoms suggestive of Zika virus infection during the past 4 weeks, those who have had sexual contact with a person who has traveled to or resided in an area with active Zika virus transmission during the prior 3 months, and those who have traveled to areas with active transmission of Zika virus during the past 4 weeks.

In areas of the US with active Zika virus transmission (at present, the Commonwealth of Puerto Rico, the US Virgin Islands, and American Samoa), the FDA recommends that whole blood and blood components for transfusion be obtained from areas of the US without active transmission.

Blood establishments may continue collecting and preparing platelets and plasma if an FDA-approved pathogen-reduction device is used.

The FDA’s guidance also recommends that blood establishments update donor education materials with information about the signs and symptoms of Zika virus and ask potentially affected donors to refrain from giving blood.

“Based on the best available evidence, we believe the new recommendations will help reduce the risk of collecting blood and blood components from donors who may be infected with the Zika virus,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

There have been no reports to date of Zika virus entering the US blood supply. However, the risk of blood transmission is considered likely based on the most current scientific evidence of how Zika virus and similar viruses (flaviviruses) are spread and recent reports of transfusion-associated infection outside the US.

Furthermore, about 4 out of 5 people infected with Zika virus do not become symptomatic. For these reasons, the FDA is recommending that blood establishments defer blood donations in accordance with the new guidance.

The FDA also intends to issue a guidance that will address appropriate donor deferral measures for human cells, tissues, and cellular and tissue-based products, given recent reports of sexual transmission of the Zika virus.

In addition, the FDA is prioritizing the development of blood screening and diagnostic tests that may be useful for identifying the Zika virus, preparing to evaluate the safety and efficacy of investigational vaccines and therapeutics that might be developed, and reviewing technology that may help suppress populations of mosquitoes that can spread the virus.

Blood for transfusion

Photo courtesy of UAB Hospital

The US Food and Drug Administration (FDA) has issued a new guidance recommending the deferral of blood donors who have been to areas with active Zika virus transmission, may have been exposed to the virus, or have had a confirmed Zika virus infection.

In areas of the US without active Zika virus transmission, the FDA recommends that donors at risk for Zika virus infection be deferred for 4 weeks.

Individuals considered to be at risk include those who have had symptoms suggestive of Zika virus infection during the past 4 weeks, those who have had sexual contact with a person who has traveled to or resided in an area with active Zika virus transmission during the prior 3 months, and those who have traveled to areas with active transmission of Zika virus during the past 4 weeks.

In areas of the US with active Zika virus transmission (at present, the Commonwealth of Puerto Rico, the US Virgin Islands, and American Samoa), the FDA recommends that whole blood and blood components for transfusion be obtained from areas of the US without active transmission.

Blood establishments may continue collecting and preparing platelets and plasma if an FDA-approved pathogen-reduction device is used.

The FDA’s guidance also recommends that blood establishments update donor education materials with information about the signs and symptoms of Zika virus and ask potentially affected donors to refrain from giving blood.

“Based on the best available evidence, we believe the new recommendations will help reduce the risk of collecting blood and blood components from donors who may be infected with the Zika virus,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

There have been no reports to date of Zika virus entering the US blood supply. However, the risk of blood transmission is considered likely based on the most current scientific evidence of how Zika virus and similar viruses (flaviviruses) are spread and recent reports of transfusion-associated infection outside the US.

Furthermore, about 4 out of 5 people infected with Zika virus do not become symptomatic. For these reasons, the FDA is recommending that blood establishments defer blood donations in accordance with the new guidance.

The FDA also intends to issue a guidance that will address appropriate donor deferral measures for human cells, tissues, and cellular and tissue-based products, given recent reports of sexual transmission of the Zika virus.

In addition, the FDA is prioritizing the development of blood screening and diagnostic tests that may be useful for identifying the Zika virus, preparing to evaluate the safety and efficacy of investigational vaccines and therapeutics that might be developed, and reviewing technology that may help suppress populations of mosquitoes that can spread the virus.

Blood for transfusion

Photo courtesy of UAB Hospital

A new study suggests that as few as 2% of patients with life-threatening bleeding after serious injury receive optimal blood transfusion therapy in England and Wales.

Researchers estimate that nearly 5000 trauma patients sustain a major hemorrhage in England and Wales each year, and one-third of those patients die.

The current study, published in the British Journal of Surgery, highlights how delays in transfusions may contribute to this death rate.

“The rapid and consistent delivery of blood, plasma, platelets, and other clotting products to trauma patients is essential to maintain clotting during hemorrhage and has been shown to halve mortality,” said study author Karim Brohi, MBBS, of Queen Mary University of London in the UK.

“However, we found that only 2% of patients with massive hemorrhage received the optimal type of blood transfusion for their resuscitation. There is a clear opportunity for clinicians to improve the delivery of blood and clotting products during resuscitation for major hemorrhage.”

Dr Brohi and his colleagues analyzed 442 patients treated at 22 hospitals in England and Wales. The patients had experienced major hemorrhage as a result of injuries and received at least 4 units of packed red blood cells (PRBCs) in the first 24 hours of admission.

The patients’ median age was 38 (range, 24-54), and 74% were men. Thirty-three percent of patients (n=146) had massive hemorrhage.

Mortality from bleeding tended to occur early in these patients. Twenty-seven percent of patients (n=117) died in hospital—18% (n=79) within the first 24 hours. The 30-day mortality rate was about 27% (n=119), and 33% of evaluable patients had died at 1 year (127/383).

All 442 patients received PRBCs. The median number of PRBC units transfused within 24 hours was 7 (range, 5-11), and the median number of PRBC units given in 30 days was 9 (range, 6-15).

The average time to transfusion of PRBCs was longer than expected, at 41 minutes (range, 1-122).

Similarly, the researchers found the administration of blood components such as plasma and platelets to be significantly delayed, occurring, on average, 2 to 3 hours after admission.

Three-quarters of patients (n=330) received fresh-frozen plasma (FFP). The median number of FFP units given within 24 hours was 4 (range, 0-7), and the time to first FFP transfusion was 87 minutes (range, 42.5-229).

About 45% of patients (n=197) received platelets. The median dose was 0 (range, 0-1), and the time to first platelet transfusion was 146 minutes (range, 72.5-364).

About 28% of patients (n=122) received cryoprecipitate. The median dose was 0 (range, 0-1), and the time to first cryoprecipitate infusion was 179.5 minutes (range, 84.5-333.5).

“The rapid delivery of the right mix of blood components in an emergency environment is extremely challenging,” Dr Brohi said.

“Some transfusion components have to be thawed and, at present, aren’t always available for the patient quickly enough. More research is also needed into techniques and devices to control bleeding earlier, even at the scene of injury.”

The researchers noted that this study had its limitations, such as incomplete data for some patients.

Blood for transfusion

Photo courtesy of UAB Hospital

A new study suggests that as few as 2% of patients with life-threatening bleeding after serious injury receive optimal blood transfusion therapy in England and Wales.

Researchers estimate that nearly 5000 trauma patients sustain a major hemorrhage in England and Wales each year, and one-third of those patients die.

The current study, published in the British Journal of Surgery, highlights how delays in transfusions may contribute to this death rate.

“The rapid and consistent delivery of blood, plasma, platelets, and other clotting products to trauma patients is essential to maintain clotting during hemorrhage and has been shown to halve mortality,” said study author Karim Brohi, MBBS, of Queen Mary University of London in the UK.

“However, we found that only 2% of patients with massive hemorrhage received the optimal type of blood transfusion for their resuscitation. There is a clear opportunity for clinicians to improve the delivery of blood and clotting products during resuscitation for major hemorrhage.”

Dr Brohi and his colleagues analyzed 442 patients treated at 22 hospitals in England and Wales. The patients had experienced major hemorrhage as a result of injuries and received at least 4 units of packed red blood cells (PRBCs) in the first 24 hours of admission.

The patients’ median age was 38 (range, 24-54), and 74% were men. Thirty-three percent of patients (n=146) had massive hemorrhage.

Mortality from bleeding tended to occur early in these patients. Twenty-seven percent of patients (n=117) died in hospital—18% (n=79) within the first 24 hours. The 30-day mortality rate was about 27% (n=119), and 33% of evaluable patients had died at 1 year (127/383).

All 442 patients received PRBCs. The median number of PRBC units transfused within 24 hours was 7 (range, 5-11), and the median number of PRBC units given in 30 days was 9 (range, 6-15).

The average time to transfusion of PRBCs was longer than expected, at 41 minutes (range, 1-122).

Similarly, the researchers found the administration of blood components such as plasma and platelets to be significantly delayed, occurring, on average, 2 to 3 hours after admission.

Three-quarters of patients (n=330) received fresh-frozen plasma (FFP). The median number of FFP units given within 24 hours was 4 (range, 0-7), and the time to first FFP transfusion was 87 minutes (range, 42.5-229).

About 45% of patients (n=197) received platelets. The median dose was 0 (range, 0-1), and the time to first platelet transfusion was 146 minutes (range, 72.5-364).

About 28% of patients (n=122) received cryoprecipitate. The median dose was 0 (range, 0-1), and the time to first cryoprecipitate infusion was 179.5 minutes (range, 84.5-333.5).

“The rapid delivery of the right mix of blood components in an emergency environment is extremely challenging,” Dr Brohi said.

“Some transfusion components have to be thawed and, at present, aren’t always available for the patient quickly enough. More research is also needed into techniques and devices to control bleeding earlier, even at the scene of injury.”

The researchers noted that this study had its limitations, such as incomplete data for some patients.

Blood for transfusion

Photo courtesy of UAB Hospital

A new study suggests that as few as 2% of patients with life-threatening bleeding after serious injury receive optimal blood transfusion therapy in England and Wales.

Researchers estimate that nearly 5000 trauma patients sustain a major hemorrhage in England and Wales each year, and one-third of those patients die.

The current study, published in the British Journal of Surgery, highlights how delays in transfusions may contribute to this death rate.

“The rapid and consistent delivery of blood, plasma, platelets, and other clotting products to trauma patients is essential to maintain clotting during hemorrhage and has been shown to halve mortality,” said study author Karim Brohi, MBBS, of Queen Mary University of London in the UK.

“However, we found that only 2% of patients with massive hemorrhage received the optimal type of blood transfusion for their resuscitation. There is a clear opportunity for clinicians to improve the delivery of blood and clotting products during resuscitation for major hemorrhage.”

Dr Brohi and his colleagues analyzed 442 patients treated at 22 hospitals in England and Wales. The patients had experienced major hemorrhage as a result of injuries and received at least 4 units of packed red blood cells (PRBCs) in the first 24 hours of admission.

The patients’ median age was 38 (range, 24-54), and 74% were men. Thirty-three percent of patients (n=146) had massive hemorrhage.

Mortality from bleeding tended to occur early in these patients. Twenty-seven percent of patients (n=117) died in hospital—18% (n=79) within the first 24 hours. The 30-day mortality rate was about 27% (n=119), and 33% of evaluable patients had died at 1 year (127/383).

All 442 patients received PRBCs. The median number of PRBC units transfused within 24 hours was 7 (range, 5-11), and the median number of PRBC units given in 30 days was 9 (range, 6-15).

The average time to transfusion of PRBCs was longer than expected, at 41 minutes (range, 1-122).

Similarly, the researchers found the administration of blood components such as plasma and platelets to be significantly delayed, occurring, on average, 2 to 3 hours after admission.

Three-quarters of patients (n=330) received fresh-frozen plasma (FFP). The median number of FFP units given within 24 hours was 4 (range, 0-7), and the time to first FFP transfusion was 87 minutes (range, 42.5-229).

About 45% of patients (n=197) received platelets. The median dose was 0 (range, 0-1), and the time to first platelet transfusion was 146 minutes (range, 72.5-364).

About 28% of patients (n=122) received cryoprecipitate. The median dose was 0 (range, 0-1), and the time to first cryoprecipitate infusion was 179.5 minutes (range, 84.5-333.5).

“The rapid delivery of the right mix of blood components in an emergency environment is extremely challenging,” Dr Brohi said.

“Some transfusion components have to be thawed and, at present, aren’t always available for the patient quickly enough. More research is also needed into techniques and devices to control bleeding earlier, even at the scene of injury.”

The researchers noted that this study had its limitations, such as incomplete data for some patients.

Blood donation

Photo by Marja Helander

Health officials in Campinas, Brazil, have reported 2 cases of the Zika virus that were likely transmitted through blood transfusions.

The officials said both transfusions occurred last year, but transmission of the virus wasn’t confirmed until recently.

A liver transplant recipient appeared to have contracted Zika through a transfusion in March 2015, and a gunshot victim appeared to have contracted the virus after multiple transfusions in April 2015.

Doctors originally thought the gunshot victim had dengue fever, so his blood was not tested for the Zika virus until January 28. The man later died of his wounds.

The liver transplant recipient did not show any symptoms of Zika infection, but testing confirmed that both he and his blood donor had the virus.

Protecting the world’s blood supply

Even before these cases of Zika transmission were reported, countries around the world were implementing blood donor deferral policies in attempts to protect the blood supply.

The US Food and Drug Administration is still reviewing its blood donation policy with regard to the virus, but the American Red Cross and AABB have recommended donor self-deferral.

Both organizations said people should refrain from donating blood for 28 days if they have visited Mexico, the Caribbean, Central America, or South America in the past 4 weeks.

NHS Blood and Transplant has also implemented a 28-day deferral period for potential blood donors in England and North Wales who have travelled to countries where the Zika virus is endemic.

A spokesperson for NHS Blood and Transplant said travel to most Zika-endemic countries already brings a blood donation deferral period of at least 28 days. So the agency doesn’t expect the new deferral policy to have a significant impact on the number of people who can donate following travel abroad.

Canadian Blood Services has said that anyone who has travelled outside of Canada, the continental US, and Europe will be temporarily ineligible to give blood for 3 weeks (21 days). This policy has been implemented across the country.

The 21-day waiting period also applies to cord blood and stem cell donors who have travelled to affected areas. Héma-Québec (Quebec’s blood operator) is implementing the same change.

Canadian Blood Services said the new deferral policy will reduce the number of people available to donate in the coming months and therefore urged Canadians to donate before they travel. The agency also urged new and current donors who have not recently travelled outside of Canada, the continental US, and Europe to book an appointment to donate.

Hong Kong’s Red Cross Blood Transfusion Service has begun screening potential blood donors. Anyone who has resided in or visited any countries affected by the Zika virus is screened and deferred for blood donation for at least 28 days from the date he or she departed from the affected country.

South Korea’s health authorities have implemented a 30-day deferral period for potential donors who have visited Zika-endemic areas.

The Australian Red Cross Blood Service said it already defers potential blood donors who have travelled to countries with mosquito-borne viruses that are a transfusion-transmission risk, such as dengue and malaria. So all countries affected by Zika outbreaks are already covered by temporary travel deferrals in Australia.

However, the organization said it will continue to monitor the countries impacted by the virus and will make any adjustments to deferrals as required.

Blood donation

Photo by Marja Helander

Health officials in Campinas, Brazil, have reported 2 cases of the Zika virus that were likely transmitted through blood transfusions.

The officials said both transfusions occurred last year, but transmission of the virus wasn’t confirmed until recently.

A liver transplant recipient appeared to have contracted Zika through a transfusion in March 2015, and a gunshot victim appeared to have contracted the virus after multiple transfusions in April 2015.

Doctors originally thought the gunshot victim had dengue fever, so his blood was not tested for the Zika virus until January 28. The man later died of his wounds.

The liver transplant recipient did not show any symptoms of Zika infection, but testing confirmed that both he and his blood donor had the virus.

Protecting the world’s blood supply

Even before these cases of Zika transmission were reported, countries around the world were implementing blood donor deferral policies in attempts to protect the blood supply.

The US Food and Drug Administration is still reviewing its blood donation policy with regard to the virus, but the American Red Cross and AABB have recommended donor self-deferral.

Both organizations said people should refrain from donating blood for 28 days if they have visited Mexico, the Caribbean, Central America, or South America in the past 4 weeks.

NHS Blood and Transplant has also implemented a 28-day deferral period for potential blood donors in England and North Wales who have travelled to countries where the Zika virus is endemic.

A spokesperson for NHS Blood and Transplant said travel to most Zika-endemic countries already brings a blood donation deferral period of at least 28 days. So the agency doesn’t expect the new deferral policy to have a significant impact on the number of people who can donate following travel abroad.

Canadian Blood Services has said that anyone who has travelled outside of Canada, the continental US, and Europe will be temporarily ineligible to give blood for 3 weeks (21 days). This policy has been implemented across the country.

The 21-day waiting period also applies to cord blood and stem cell donors who have travelled to affected areas. Héma-Québec (Quebec’s blood operator) is implementing the same change.

Canadian Blood Services said the new deferral policy will reduce the number of people available to donate in the coming months and therefore urged Canadians to donate before they travel. The agency also urged new and current donors who have not recently travelled outside of Canada, the continental US, and Europe to book an appointment to donate.

Hong Kong’s Red Cross Blood Transfusion Service has begun screening potential blood donors. Anyone who has resided in or visited any countries affected by the Zika virus is screened and deferred for blood donation for at least 28 days from the date he or she departed from the affected country.

South Korea’s health authorities have implemented a 30-day deferral period for potential donors who have visited Zika-endemic areas.

The Australian Red Cross Blood Service said it already defers potential blood donors who have travelled to countries with mosquito-borne viruses that are a transfusion-transmission risk, such as dengue and malaria. So all countries affected by Zika outbreaks are already covered by temporary travel deferrals in Australia.

However, the organization said it will continue to monitor the countries impacted by the virus and will make any adjustments to deferrals as required.

Blood donation

Photo by Marja Helander

Health officials in Campinas, Brazil, have reported 2 cases of the Zika virus that were likely transmitted through blood transfusions.

The officials said both transfusions occurred last year, but transmission of the virus wasn’t confirmed until recently.

A liver transplant recipient appeared to have contracted Zika through a transfusion in March 2015, and a gunshot victim appeared to have contracted the virus after multiple transfusions in April 2015.

Doctors originally thought the gunshot victim had dengue fever, so his blood was not tested for the Zika virus until January 28. The man later died of his wounds.

The liver transplant recipient did not show any symptoms of Zika infection, but testing confirmed that both he and his blood donor had the virus.

Protecting the world’s blood supply

Even before these cases of Zika transmission were reported, countries around the world were implementing blood donor deferral policies in attempts to protect the blood supply.

The US Food and Drug Administration is still reviewing its blood donation policy with regard to the virus, but the American Red Cross and AABB have recommended donor self-deferral.

Both organizations said people should refrain from donating blood for 28 days if they have visited Mexico, the Caribbean, Central America, or South America in the past 4 weeks.

NHS Blood and Transplant has also implemented a 28-day deferral period for potential blood donors in England and North Wales who have travelled to countries where the Zika virus is endemic.

A spokesperson for NHS Blood and Transplant said travel to most Zika-endemic countries already brings a blood donation deferral period of at least 28 days. So the agency doesn’t expect the new deferral policy to have a significant impact on the number of people who can donate following travel abroad.

Canadian Blood Services has said that anyone who has travelled outside of Canada, the continental US, and Europe will be temporarily ineligible to give blood for 3 weeks (21 days). This policy has been implemented across the country.

The 21-day waiting period also applies to cord blood and stem cell donors who have travelled to affected areas. Héma-Québec (Quebec’s blood operator) is implementing the same change.

Canadian Blood Services said the new deferral policy will reduce the number of people available to donate in the coming months and therefore urged Canadians to donate before they travel. The agency also urged new and current donors who have not recently travelled outside of Canada, the continental US, and Europe to book an appointment to donate.

Hong Kong’s Red Cross Blood Transfusion Service has begun screening potential blood donors. Anyone who has resided in or visited any countries affected by the Zika virus is screened and deferred for blood donation for at least 28 days from the date he or she departed from the affected country.

South Korea’s health authorities have implemented a 30-day deferral period for potential donors who have visited Zika-endemic areas.

The Australian Red Cross Blood Service said it already defers potential blood donors who have travelled to countries with mosquito-borne viruses that are a transfusion-transmission risk, such as dengue and malaria. So all countries affected by Zika outbreaks are already covered by temporary travel deferrals in Australia.

However, the organization said it will continue to monitor the countries impacted by the virus and will make any adjustments to deferrals as required.

Researcher in the lab

Photo by Daniel Sone

The European Hematology Association (EHA) has created a “roadmap” for hematology research in Europe.

This guidance document summarizes the current status of basic, translational, and clinical hematology research and identifies areas of unmet scientific and medical need in Europe.

It is intended to help European and national policy makers, funding agencies, charities, research institutes, and researchers make decisions on initiating, funding, or developing research.

The guidance, “The European Hematology Association Roadmap for European Hematology Research: A Consensus Document,” is published in this month’s issue of haematologica.

“For the first time, hematologists in Europe came together to develop a roadmap to guide hematology research in Europe” said Andreas Engert, MD, chair of the EHA Research Roadmap Task Force.

“Hematology in Europe has achieved a lot, but the discipline must focus and collaborate to be efficient and remain successful in improving patient outcomes. The roadmap does just that and will determine the research agenda in Europe in the coming years.”

Roughly 300 experts from more than 20 countries—including clinicians, basic researchers, and patients—contributed to the roadmap. Stakeholders such as national hematology societies, patient organizations, hematology trial groups, and other European organizations were consulted to comment on the final draft version.

The final roadmap has 9 sections: normal hematopoiesis, malignant lymphoid and myeloid diseases, anemias and related diseases, platelet disorders, blood coagulation and hemostatic disorders, transfusion medicine, infections in hematology, and hematopoietic stem cell transplantation.

The roadmap lists priorities and needs in these areas, including the need for targeted therapies based on genomic profiling and chemical biology, the need to eradicate minimal residual disease, and the need for treatments that are better tolerated by elderly patients.

“Now’s the time for Europe to pay attention,” said Ulrich Jäger, MD, chair of the EHA European Affairs Committee.

“With an aging population, the slow recovery from the financial and Euro crises, costly medical breakthroughs and innovations—quite a few of which involve hematology researchers—Europe faces increased health expenditures while budgets are limited.”

“Policy makers are rightfully cautious when spending the taxpayers’ money. So it is our responsibility to provide the policy makers with the information and evidence they need to decide where their support impacts knowledge and health most efficiently, to the benefit of patients and society. The Research Roadmap delivers on that. Now, it is up to the policy makers in the EU to deliver too.”

Researcher in the lab

Photo by Daniel Sone

The European Hematology Association (EHA) has created a “roadmap” for hematology research in Europe.

This guidance document summarizes the current status of basic, translational, and clinical hematology research and identifies areas of unmet scientific and medical need in Europe.

It is intended to help European and national policy makers, funding agencies, charities, research institutes, and researchers make decisions on initiating, funding, or developing research.

The guidance, “The European Hematology Association Roadmap for European Hematology Research: A Consensus Document,” is published in this month’s issue of haematologica.

“For the first time, hematologists in Europe came together to develop a roadmap to guide hematology research in Europe” said Andreas Engert, MD, chair of the EHA Research Roadmap Task Force.

“Hematology in Europe has achieved a lot, but the discipline must focus and collaborate to be efficient and remain successful in improving patient outcomes. The roadmap does just that and will determine the research agenda in Europe in the coming years.”

Roughly 300 experts from more than 20 countries—including clinicians, basic researchers, and patients—contributed to the roadmap. Stakeholders such as national hematology societies, patient organizations, hematology trial groups, and other European organizations were consulted to comment on the final draft version.

The final roadmap has 9 sections: normal hematopoiesis, malignant lymphoid and myeloid diseases, anemias and related diseases, platelet disorders, blood coagulation and hemostatic disorders, transfusion medicine, infections in hematology, and hematopoietic stem cell transplantation.

The roadmap lists priorities and needs in these areas, including the need for targeted therapies based on genomic profiling and chemical biology, the need to eradicate minimal residual disease, and the need for treatments that are better tolerated by elderly patients.

“Now’s the time for Europe to pay attention,” said Ulrich Jäger, MD, chair of the EHA European Affairs Committee.

“With an aging population, the slow recovery from the financial and Euro crises, costly medical breakthroughs and innovations—quite a few of which involve hematology researchers—Europe faces increased health expenditures while budgets are limited.”

“Policy makers are rightfully cautious when spending the taxpayers’ money. So it is our responsibility to provide the policy makers with the information and evidence they need to decide where their support impacts knowledge and health most efficiently, to the benefit of patients and society. The Research Roadmap delivers on that. Now, it is up to the policy makers in the EU to deliver too.”

Researcher in the lab

Photo by Daniel Sone

The European Hematology Association (EHA) has created a “roadmap” for hematology research in Europe.

This guidance document summarizes the current status of basic, translational, and clinical hematology research and identifies areas of unmet scientific and medical need in Europe.

It is intended to help European and national policy makers, funding agencies, charities, research institutes, and researchers make decisions on initiating, funding, or developing research.

The guidance, “The European Hematology Association Roadmap for European Hematology Research: A Consensus Document,” is published in this month’s issue of haematologica.

“For the first time, hematologists in Europe came together to develop a roadmap to guide hematology research in Europe” said Andreas Engert, MD, chair of the EHA Research Roadmap Task Force.

“Hematology in Europe has achieved a lot, but the discipline must focus and collaborate to be efficient and remain successful in improving patient outcomes. The roadmap does just that and will determine the research agenda in Europe in the coming years.”

Roughly 300 experts from more than 20 countries—including clinicians, basic researchers, and patients—contributed to the roadmap. Stakeholders such as national hematology societies, patient organizations, hematology trial groups, and other European organizations were consulted to comment on the final draft version.

The final roadmap has 9 sections: normal hematopoiesis, malignant lymphoid and myeloid diseases, anemias and related diseases, platelet disorders, blood coagulation and hemostatic disorders, transfusion medicine, infections in hematology, and hematopoietic stem cell transplantation.

The roadmap lists priorities and needs in these areas, including the need for targeted therapies based on genomic profiling and chemical biology, the need to eradicate minimal residual disease, and the need for treatments that are better tolerated by elderly patients.

“Now’s the time for Europe to pay attention,” said Ulrich Jäger, MD, chair of the EHA European Affairs Committee.

“With an aging population, the slow recovery from the financial and Euro crises, costly medical breakthroughs and innovations—quite a few of which involve hematology researchers—Europe faces increased health expenditures while budgets are limited.”

“Policy makers are rightfully cautious when spending the taxpayers’ money. So it is our responsibility to provide the policy makers with the information and evidence they need to decide where their support impacts knowledge and health most efficiently, to the benefit of patients and society. The Research Roadmap delivers on that. Now, it is up to the policy makers in the EU to deliver too.”

Blood donation

The continued spread of the Zika virus has raised concerns about transmission via blood transfusion.

So organizations in the US are asking people who have visited Zika outbreak zones to defer their plans to donate blood.

The US Food and Drug Administration is currently reviewing its blood donation policy with regard to the virus, but the American Red Cross and AABB are recommending donor self-deferral.

Both organizations said people should refrain from donating blood for 28 days if they have visited Mexico, the Caribbean, Central America, or South America in the past 4 weeks.

AABB said blood collection facilities should implement self-deferral, but blood-center-documented donor deferral is not required.

AABB has also recommended that donors who don’t defer call the blood collection facility if they travelled to Zika outbreak areas or other tropical areas and develop an unexplained illness that includes 2 or more symptoms common to Zika, dengue, and chikungunya virus infection in the 14 days after they donate blood.

In addition, blood collection facilities should recall nontransfused products if an infected donor reports experiencing 2 or more such symptoms.

And if a blood collection facility receives a post-donation report of a confirmed case of Zika, the facility should recall any in-date products collected in the 14 days before the onset of symptoms and defer the donor for 28 days after the symptoms are resolved.

About the virus

Zika is a flavivirus transmitted by Aedes mosquitoes. The virus was first described in Africa, but it began to cause epidemics in the Pacific in 2007. In 2015, Zika was found in Brazil, and local transmission has since been reported in more than 20 countries and territories in the Western Hemisphere.

When symptomatic, Zika infection typically causes a mild illness characterized by fever, myalgia, rash, retro-orbital pain, and prostration. However, asymptomatic infection occurs in about 80% of Zika-infected individuals.

Microcephaly has been linked to the ongoing Zika epidemic in Brazil, although the connection has not been confirmed. It has been suggested that microcephaly may be a result of maternal transmission of the Zika virus to the fetus.

During the French Polynesian outbreak of Zika virus that occurred in 2013, there was a 20-fold increase in the number of individuals diagnosed with Guillain-Barré syndrome.

It is not clear what risk the Zika virus poses to the blood supply, but the potential for transfusion transmission was suggested during the French Polynesian outbreak.

The maximum duration of viremia is thought to be less than 28 days, which is why AABB and American Red Cross are recommending a 28-day deferral period for blood donors who may have the virus.

Blood donation

The continued spread of the Zika virus has raised concerns about transmission via blood transfusion.

So organizations in the US are asking people who have visited Zika outbreak zones to defer their plans to donate blood.

The US Food and Drug Administration is currently reviewing its blood donation policy with regard to the virus, but the American Red Cross and AABB are recommending donor self-deferral.

Both organizations said people should refrain from donating blood for 28 days if they have visited Mexico, the Caribbean, Central America, or South America in the past 4 weeks.

AABB said blood collection facilities should implement self-deferral, but blood-center-documented donor deferral is not required.

AABB has also recommended that donors who don’t defer call the blood collection facility if they travelled to Zika outbreak areas or other tropical areas and develop an unexplained illness that includes 2 or more symptoms common to Zika, dengue, and chikungunya virus infection in the 14 days after they donate blood.

In addition, blood collection facilities should recall nontransfused products if an infected donor reports experiencing 2 or more such symptoms.

And if a blood collection facility receives a post-donation report of a confirmed case of Zika, the facility should recall any in-date products collected in the 14 days before the onset of symptoms and defer the donor for 28 days after the symptoms are resolved.

About the virus

Zika is a flavivirus transmitted by Aedes mosquitoes. The virus was first described in Africa, but it began to cause epidemics in the Pacific in 2007. In 2015, Zika was found in Brazil, and local transmission has since been reported in more than 20 countries and territories in the Western Hemisphere.

When symptomatic, Zika infection typically causes a mild illness characterized by fever, myalgia, rash, retro-orbital pain, and prostration. However, asymptomatic infection occurs in about 80% of Zika-infected individuals.

Microcephaly has been linked to the ongoing Zika epidemic in Brazil, although the connection has not been confirmed. It has been suggested that microcephaly may be a result of maternal transmission of the Zika virus to the fetus.

During the French Polynesian outbreak of Zika virus that occurred in 2013, there was a 20-fold increase in the number of individuals diagnosed with Guillain-Barré syndrome.

It is not clear what risk the Zika virus poses to the blood supply, but the potential for transfusion transmission was suggested during the French Polynesian outbreak.

The maximum duration of viremia is thought to be less than 28 days, which is why AABB and American Red Cross are recommending a 28-day deferral period for blood donors who may have the virus.

Blood donation

The continued spread of the Zika virus has raised concerns about transmission via blood transfusion.

So organizations in the US are asking people who have visited Zika outbreak zones to defer their plans to donate blood.

The US Food and Drug Administration is currently reviewing its blood donation policy with regard to the virus, but the American Red Cross and AABB are recommending donor self-deferral.

Both organizations said people should refrain from donating blood for 28 days if they have visited Mexico, the Caribbean, Central America, or South America in the past 4 weeks.

AABB said blood collection facilities should implement self-deferral, but blood-center-documented donor deferral is not required.

AABB has also recommended that donors who don’t defer call the blood collection facility if they travelled to Zika outbreak areas or other tropical areas and develop an unexplained illness that includes 2 or more symptoms common to Zika, dengue, and chikungunya virus infection in the 14 days after they donate blood.

In addition, blood collection facilities should recall nontransfused products if an infected donor reports experiencing 2 or more such symptoms.

And if a blood collection facility receives a post-donation report of a confirmed case of Zika, the facility should recall any in-date products collected in the 14 days before the onset of symptoms and defer the donor for 28 days after the symptoms are resolved.

About the virus

Zika is a flavivirus transmitted by Aedes mosquitoes. The virus was first described in Africa, but it began to cause epidemics in the Pacific in 2007. In 2015, Zika was found in Brazil, and local transmission has since been reported in more than 20 countries and territories in the Western Hemisphere.

When symptomatic, Zika infection typically causes a mild illness characterized by fever, myalgia, rash, retro-orbital pain, and prostration. However, asymptomatic infection occurs in about 80% of Zika-infected individuals.

Microcephaly has been linked to the ongoing Zika epidemic in Brazil, although the connection has not been confirmed. It has been suggested that microcephaly may be a result of maternal transmission of the Zika virus to the fetus.

During the French Polynesian outbreak of Zika virus that occurred in 2013, there was a 20-fold increase in the number of individuals diagnosed with Guillain-Barré syndrome.

It is not clear what risk the Zika virus poses to the blood supply, but the potential for transfusion transmission was suggested during the French Polynesian outbreak.

The maximum duration of viremia is thought to be less than 28 days, which is why AABB and American Red Cross are recommending a 28-day deferral period for blood donors who may have the virus.

Blood sample collection

Photo by Juan D. Alfonso

NHS Blood and Transplant (NHSBT) has announced an initiative to provide more detailed blood-group typing for patients with hemoglobinopathies, with the goal of enabling better-matched and potentially safer transfusions.

The typing will detect Rh variant blood groups, which need to be considered when planning transfusions.

Previously, typing to this level was only possible through reference laboratories using complex genotyping methods.

NHSBT is offering the testing at no extra cost to hospitals in England until the end of June 2016.

The initiative involves routinely testing for the RHD and RHCE variants most commonly found in patients with hemoglobinopathies. NHSBT will also test genes for the blood groups K, k, Kpa, Kpb, Jsa, Jsb, Jka, Jkb, Fya, Fyb, Fy (GATA), M, N, S, s, U, Doa, and Dob.

Unlike older methods, this testing can be performed in patients who have recently received blood.

NHSBT said this initiative will enable the creation of a database of genotyped blood details for patients with hemoglobinopathies.

Extended blood type information and fast access to the database could potentially enable safer blood transfusions for these patients, who may need numerous transfusions during their lifetime and may move between hospitals.

NHSBT said it has received more than 2500 blood samples thus far. The results are processed centrally by NHSBT at the International Blood Group Reference Laboratory in Filton and are securely stored.

Patients’ test results will be accessible to the teams involved in the patients’ care.

“Patients taking part can now potentially receive more finely matched blood if we know not just their blood group but whether they have a variant Rh type,” said Sara Trompeter, MB ChB, a consultant hematologist for NHSBT.

“And there will also be greater safety and likelihood of getting matched blood in an emergency, as their records will be held centrally and can be accessed by blood banks in local hospitals. We would urge all patients with hemoglobin disorders such as sickle cell disease or thalassemia to speak to their medical or nursing team about providing a blood sample to NHS Blood and Transplant via their local transfusion laboratories to be genotyped.”

Additional information on this initiative can be found at www.nhsbt.nhs.uk/extendedbloodgrouptesting.

Blood sample collection

Photo by Juan D. Alfonso

NHS Blood and Transplant (NHSBT) has announced an initiative to provide more detailed blood-group typing for patients with hemoglobinopathies, with the goal of enabling better-matched and potentially safer transfusions.

The typing will detect Rh variant blood groups, which need to be considered when planning transfusions.

Previously, typing to this level was only possible through reference laboratories using complex genotyping methods.

NHSBT is offering the testing at no extra cost to hospitals in England until the end of June 2016.

The initiative involves routinely testing for the RHD and RHCE variants most commonly found in patients with hemoglobinopathies. NHSBT will also test genes for the blood groups K, k, Kpa, Kpb, Jsa, Jsb, Jka, Jkb, Fya, Fyb, Fy (GATA), M, N, S, s, U, Doa, and Dob.

Unlike older methods, this testing can be performed in patients who have recently received blood.

NHSBT said this initiative will enable the creation of a database of genotyped blood details for patients with hemoglobinopathies.

Extended blood type information and fast access to the database could potentially enable safer blood transfusions for these patients, who may need numerous transfusions during their lifetime and may move between hospitals.

NHSBT said it has received more than 2500 blood samples thus far. The results are processed centrally by NHSBT at the International Blood Group Reference Laboratory in Filton and are securely stored.

Patients’ test results will be accessible to the teams involved in the patients’ care.

“Patients taking part can now potentially receive more finely matched blood if we know not just their blood group but whether they have a variant Rh type,” said Sara Trompeter, MB ChB, a consultant hematologist for NHSBT.

“And there will also be greater safety and likelihood of getting matched blood in an emergency, as their records will be held centrally and can be accessed by blood banks in local hospitals. We would urge all patients with hemoglobin disorders such as sickle cell disease or thalassemia to speak to their medical or nursing team about providing a blood sample to NHS Blood and Transplant via their local transfusion laboratories to be genotyped.”

Additional information on this initiative can be found at www.nhsbt.nhs.uk/extendedbloodgrouptesting.

Blood sample collection

Photo by Juan D. Alfonso

NHS Blood and Transplant (NHSBT) has announced an initiative to provide more detailed blood-group typing for patients with hemoglobinopathies, with the goal of enabling better-matched and potentially safer transfusions.

The typing will detect Rh variant blood groups, which need to be considered when planning transfusions.

Previously, typing to this level was only possible through reference laboratories using complex genotyping methods.

NHSBT is offering the testing at no extra cost to hospitals in England until the end of June 2016.

The initiative involves routinely testing for the RHD and RHCE variants most commonly found in patients with hemoglobinopathies. NHSBT will also test genes for the blood groups K, k, Kpa, Kpb, Jsa, Jsb, Jka, Jkb, Fya, Fyb, Fy (GATA), M, N, S, s, U, Doa, and Dob.

Unlike older methods, this testing can be performed in patients who have recently received blood.

NHSBT said this initiative will enable the creation of a database of genotyped blood details for patients with hemoglobinopathies.

Extended blood type information and fast access to the database could potentially enable safer blood transfusions for these patients, who may need numerous transfusions during their lifetime and may move between hospitals.

NHSBT said it has received more than 2500 blood samples thus far. The results are processed centrally by NHSBT at the International Blood Group Reference Laboratory in Filton and are securely stored.

Patients’ test results will be accessible to the teams involved in the patients’ care.

“Patients taking part can now potentially receive more finely matched blood if we know not just their blood group but whether they have a variant Rh type,” said Sara Trompeter, MB ChB, a consultant hematologist for NHSBT.

“And there will also be greater safety and likelihood of getting matched blood in an emergency, as their records will be held centrally and can be accessed by blood banks in local hospitals. We would urge all patients with hemoglobin disorders such as sickle cell disease or thalassemia to speak to their medical or nursing team about providing a blood sample to NHS Blood and Transplant via their local transfusion laboratories to be genotyped.”

Additional information on this initiative can be found at www.nhsbt.nhs.uk/extendedbloodgrouptesting.

Bags and vials of blood

Photo by Daniel Gay

Researchers have discovered a bloodborne virus, known as human pegivirus 2 (HPgV-2), in patients with hepatitis C virus (HCV).

The team identified 8 complete strains of HPgV-2 and noted that the virus was only found in patients who tested positive for HCV RNA. However, it’s not clear if HPgV-2 causes hepatitis.

Charles Chiu, MD, PhD, of the University of California San Francisco, and his colleagues described their discovery of HPgV-2 in PLOS Pathogens.

The team identified the virus by sequencing plasma from an HCV-infected patient with multiple bloodborne exposures who died from sepsis of unknown etiology.

They said HPgV-2 is “highly divergent,” sharing less than 32% amino acid identity with its nearest relatives, rodent and bat pegiviruses.

After their initial discovery, the researchers screened an additional 2440 plasma samples and found 11 HPgV-2 RNA-positive samples.

All 12 HPgV-2 RNA-positive cases were found in patients who tested positive for HCV RNA, including 2 patients who were also infected with HIV.

The researchers performed longitudinal sampling in 2 patients and found that active HPgV-2 infection can persist in blood for at least 7 weeks, despite the presence of virus-specific antibodies.

The team also identified 1 patient with HPgV-2 and HCV RNA who was seronegative for both viruses. They said this suggests a high likelihood of simultaneous acquisition of HCV and HPgV-2 infection from an acute co-transmission event.

“Based on our findings, our team used the genetic makeup of the virus to develop both a molecular test for detecting it in the bloodstream and an antibody test for determining an immune response to the virus,” said John Hackett Jr, PhD, of Abbott Laboratories, Inc. in Abbott Park, Illinois.

“Our next step is to explore whether this new virus can cause disease, and if so, work with blood banks to continue to help safeguard the world’s blood supply against these types of new viruses. Research such as this is ultimately focused on unlocking new technologies that hold the potential for significant improvements to the practice of healthcare.”

Bags and vials of blood

Photo by Daniel Gay

Researchers have discovered a bloodborne virus, known as human pegivirus 2 (HPgV-2), in patients with hepatitis C virus (HCV).

The team identified 8 complete strains of HPgV-2 and noted that the virus was only found in patients who tested positive for HCV RNA. However, it’s not clear if HPgV-2 causes hepatitis.

Charles Chiu, MD, PhD, of the University of California San Francisco, and his colleagues described their discovery of HPgV-2 in PLOS Pathogens.

The team identified the virus by sequencing plasma from an HCV-infected patient with multiple bloodborne exposures who died from sepsis of unknown etiology.

They said HPgV-2 is “highly divergent,” sharing less than 32% amino acid identity with its nearest relatives, rodent and bat pegiviruses.

After their initial discovery, the researchers screened an additional 2440 plasma samples and found 11 HPgV-2 RNA-positive samples.

All 12 HPgV-2 RNA-positive cases were found in patients who tested positive for HCV RNA, including 2 patients who were also infected with HIV.

The researchers performed longitudinal sampling in 2 patients and found that active HPgV-2 infection can persist in blood for at least 7 weeks, despite the presence of virus-specific antibodies.

The team also identified 1 patient with HPgV-2 and HCV RNA who was seronegative for both viruses. They said this suggests a high likelihood of simultaneous acquisition of HCV and HPgV-2 infection from an acute co-transmission event.

“Based on our findings, our team used the genetic makeup of the virus to develop both a molecular test for detecting it in the bloodstream and an antibody test for determining an immune response to the virus,” said John Hackett Jr, PhD, of Abbott Laboratories, Inc. in Abbott Park, Illinois.

“Our next step is to explore whether this new virus can cause disease, and if so, work with blood banks to continue to help safeguard the world’s blood supply against these types of new viruses. Research such as this is ultimately focused on unlocking new technologies that hold the potential for significant improvements to the practice of healthcare.”

Bags and vials of blood

Photo by Daniel Gay

Researchers have discovered a bloodborne virus, known as human pegivirus 2 (HPgV-2), in patients with hepatitis C virus (HCV).

The team identified 8 complete strains of HPgV-2 and noted that the virus was only found in patients who tested positive for HCV RNA. However, it’s not clear if HPgV-2 causes hepatitis.

Charles Chiu, MD, PhD, of the University of California San Francisco, and his colleagues described their discovery of HPgV-2 in PLOS Pathogens.

The team identified the virus by sequencing plasma from an HCV-infected patient with multiple bloodborne exposures who died from sepsis of unknown etiology.

They said HPgV-2 is “highly divergent,” sharing less than 32% amino acid identity with its nearest relatives, rodent and bat pegiviruses.

After their initial discovery, the researchers screened an additional 2440 plasma samples and found 11 HPgV-2 RNA-positive samples.

All 12 HPgV-2 RNA-positive cases were found in patients who tested positive for HCV RNA, including 2 patients who were also infected with HIV.

The researchers performed longitudinal sampling in 2 patients and found that active HPgV-2 infection can persist in blood for at least 7 weeks, despite the presence of virus-specific antibodies.

The team also identified 1 patient with HPgV-2 and HCV RNA who was seronegative for both viruses. They said this suggests a high likelihood of simultaneous acquisition of HCV and HPgV-2 infection from an acute co-transmission event.

“Based on our findings, our team used the genetic makeup of the virus to develop both a molecular test for detecting it in the bloodstream and an antibody test for determining an immune response to the virus,” said John Hackett Jr, PhD, of Abbott Laboratories, Inc. in Abbott Park, Illinois.

“Our next step is to explore whether this new virus can cause disease, and if so, work with blood banks to continue to help safeguard the world’s blood supply against these types of new viruses. Research such as this is ultimately focused on unlocking new technologies that hold the potential for significant improvements to the practice of healthcare.”

Blood donation

Photo by Михаило Јовановић

The US Food and Drug Administration (FDA) has issued a final guidance outlining updated blood donor deferral recommendations.

As part of the guidance, the FDA is changing its recommendation that men who have sex with men (MSM) be indefinitely deferred from donating blood—a policy that has been in place for approximately 30 years.

Now, the agency is recommending that MSMs be deferred for 12 months since their last sexual contact with another man.

The FDA’s guidance also reflects a change in the rationale for deferring potential blood donors with hemophilia or related clotting disorders who have received clotting factor concentrates.

The FDA recommends that blood establishments make corresponding revisions to donor educational materials, donor history questionnaires, and accompanying materials, as well as donor requalification and product management procedures.

MSM deferral

The FDA said its recommendation regarding MSM blood donors reflects the most current scientific evidence and will help ensure continued safety of the blood supply by reducing the risk of human immunodeficiency virus (HIV) transmission by blood and blood products.

The agency also said this recommendation better aligns the deferral period for MSMs with the deferral period for other men and women at increased risk for HIV infection, such as those who had a recent blood transfusion or those who have been accidentally exposed to the blood of another individual.

Before issuing this guidance, the FDA reviewed its policies regarding HIV transmission through blood products to determine appropriate changes based on the most recent scientific evidence. The agency examined a variety of studies, epidemiologic data, and shared experiences from other countries that have made recent MSM deferral policy changes.

“In reviewing our policies to help reduce the risk of HIV transmission through blood products, we rigorously examined several alternative options, including individual risk assessment,” said Peter Marks, MD, PhD, deputy director of the FDA’s Center for Biologics Evaluation and Research.

“Ultimately, the 12-month deferral window is supported by the best available scientific evidence, at this point in time, relevant to the US population. We will continue to actively conduct research in this area and further revise our policies as new data emerge.”

Several countries, including the UK and Australia, currently have 12-month deferral policies for MSM blood donors.

During the change in Australia from an indefinite blood donor deferral policy for MSMs to a 12-month deferral, studies evaluating over 8 million units of donated blood were performed using a national blood surveillance system. These studies (CR Seed et al, Transfusion 2010; TTA Lucky et al, Transfusion 2014) show no change in risk to the blood supply with use of the 12-month deferral.

A study conducted in the UK produced similar results, although it also suggested that 3 in 10 MSMs don’t comply with the 12-month deferral policy.

And a study conducted in Canada, which recently shortened its MSM deferral period to 5 years, showed no change in risk to the blood supply with the 5-year deferral as compared to indefinite deferral. Based on these results, Canadian regulators are considering changing to a 12-month deferral period as well.

Patients with clotting disorders

The FDA’s new guidance also reflects a change in the rationale for deferring patients with hemophilia or related clotting disorders who have received clotting factor concentrates. Previously, potential donors with hemophilia or related clotting disorders were deferred due to the increased risk of HIV transmission to potential recipients.

Based on new scientific evidence, these potential donors are still deferred, but not due to the risk of HIV transmission—instead, for their own protection due to potential harm from large needles used during the donation process.

FDA policies and actions

Throughout the process of updating blood donor deferral policies over the past several years, the FDA has worked with other government agencies, considered input from external advisory committees, reviewed comments from stakeholders to its May 2015 draft guidance, and examined the most recent available scientific evidence to support the current policy revision.

The FDA has also implemented a nationally representative safety monitoring system for the blood supply with assistance from the National Heart, Lung and Blood Institute at the National Institutes of Health. This system will provide information to help inform future actions the FDA may take on blood donor policies.

The FDA said it will continue to reevaluate and update its blood donor deferral policies as new scientific information becomes available.

Blood donation

Photo by Михаило Јовановић

The US Food and Drug Administration (FDA) has issued a final guidance outlining updated blood donor deferral recommendations.

As part of the guidance, the FDA is changing its recommendation that men who have sex with men (MSM) be indefinitely deferred from donating blood—a policy that has been in place for approximately 30 years.

Now, the agency is recommending that MSMs be deferred for 12 months since their last sexual contact with another man.

The FDA’s guidance also reflects a change in the rationale for deferring potential blood donors with hemophilia or related clotting disorders who have received clotting factor concentrates.

The FDA recommends that blood establishments make corresponding revisions to donor educational materials, donor history questionnaires, and accompanying materials, as well as donor requalification and product management procedures.

MSM deferral

The FDA said its recommendation regarding MSM blood donors reflects the most current scientific evidence and will help ensure continued safety of the blood supply by reducing the risk of human immunodeficiency virus (HIV) transmission by blood and blood products.

The agency also said this recommendation better aligns the deferral period for MSMs with the deferral period for other men and women at increased risk for HIV infection, such as those who had a recent blood transfusion or those who have been accidentally exposed to the blood of another individual.

Before issuing this guidance, the FDA reviewed its policies regarding HIV transmission through blood products to determine appropriate changes based on the most recent scientific evidence. The agency examined a variety of studies, epidemiologic data, and shared experiences from other countries that have made recent MSM deferral policy changes.

“In reviewing our policies to help reduce the risk of HIV transmission through blood products, we rigorously examined several alternative options, including individual risk assessment,” said Peter Marks, MD, PhD, deputy director of the FDA’s Center for Biologics Evaluation and Research.

“Ultimately, the 12-month deferral window is supported by the best available scientific evidence, at this point in time, relevant to the US population. We will continue to actively conduct research in this area and further revise our policies as new data emerge.”

Several countries, including the UK and Australia, currently have 12-month deferral policies for MSM blood donors.

During the change in Australia from an indefinite blood donor deferral policy for MSMs to a 12-month deferral, studies evaluating over 8 million units of donated blood were performed using a national blood surveillance system. These studies (CR Seed et al, Transfusion 2010; TTA Lucky et al, Transfusion 2014) show no change in risk to the blood supply with use of the 12-month deferral.

A study conducted in the UK produced similar results, although it also suggested that 3 in 10 MSMs don’t comply with the 12-month deferral policy.

And a study conducted in Canada, which recently shortened its MSM deferral period to 5 years, showed no change in risk to the blood supply with the 5-year deferral as compared to indefinite deferral. Based on these results, Canadian regulators are considering changing to a 12-month deferral period as well.

Patients with clotting disorders

The FDA’s new guidance also reflects a change in the rationale for deferring patients with hemophilia or related clotting disorders who have received clotting factor concentrates. Previously, potential donors with hemophilia or related clotting disorders were deferred due to the increased risk of HIV transmission to potential recipients.

Based on new scientific evidence, these potential donors are still deferred, but not due to the risk of HIV transmission—instead, for their own protection due to potential harm from large needles used during the donation process.

FDA policies and actions

Throughout the process of updating blood donor deferral policies over the past several years, the FDA has worked with other government agencies, considered input from external advisory committees, reviewed comments from stakeholders to its May 2015 draft guidance, and examined the most recent available scientific evidence to support the current policy revision.

The FDA has also implemented a nationally representative safety monitoring system for the blood supply with assistance from the National Heart, Lung and Blood Institute at the National Institutes of Health. This system will provide information to help inform future actions the FDA may take on blood donor policies.

The FDA said it will continue to reevaluate and update its blood donor deferral policies as new scientific information becomes available.

Blood donation

Photo by Михаило Јовановић

The US Food and Drug Administration (FDA) has issued a final guidance outlining updated blood donor deferral recommendations.

As part of the guidance, the FDA is changing its recommendation that men who have sex with men (MSM) be indefinitely deferred from donating blood—a policy that has been in place for approximately 30 years.

Now, the agency is recommending that MSMs be deferred for 12 months since their last sexual contact with another man.

The FDA’s guidance also reflects a change in the rationale for deferring potential blood donors with hemophilia or related clotting disorders who have received clotting factor concentrates.

The FDA recommends that blood establishments make corresponding revisions to donor educational materials, donor history questionnaires, and accompanying materials, as well as donor requalification and product management procedures.

MSM deferral

The FDA said its recommendation regarding MSM blood donors reflects the most current scientific evidence and will help ensure continued safety of the blood supply by reducing the risk of human immunodeficiency virus (HIV) transmission by blood and blood products.

The agency also said this recommendation better aligns the deferral period for MSMs with the deferral period for other men and women at increased risk for HIV infection, such as those who had a recent blood transfusion or those who have been accidentally exposed to the blood of another individual.

Before issuing this guidance, the FDA reviewed its policies regarding HIV transmission through blood products to determine appropriate changes based on the most recent scientific evidence. The agency examined a variety of studies, epidemiologic data, and shared experiences from other countries that have made recent MSM deferral policy changes.

“In reviewing our policies to help reduce the risk of HIV transmission through blood products, we rigorously examined several alternative options, including individual risk assessment,” said Peter Marks, MD, PhD, deputy director of the FDA’s Center for Biologics Evaluation and Research.

“Ultimately, the 12-month deferral window is supported by the best available scientific evidence, at this point in time, relevant to the US population. We will continue to actively conduct research in this area and further revise our policies as new data emerge.”

Several countries, including the UK and Australia, currently have 12-month deferral policies for MSM blood donors.

During the change in Australia from an indefinite blood donor deferral policy for MSMs to a 12-month deferral, studies evaluating over 8 million units of donated blood were performed using a national blood surveillance system. These studies (CR Seed et al, Transfusion 2010; TTA Lucky et al, Transfusion 2014) show no change in risk to the blood supply with use of the 12-month deferral.

A study conducted in the UK produced similar results, although it also suggested that 3 in 10 MSMs don’t comply with the 12-month deferral policy.

And a study conducted in Canada, which recently shortened its MSM deferral period to 5 years, showed no change in risk to the blood supply with the 5-year deferral as compared to indefinite deferral. Based on these results, Canadian regulators are considering changing to a 12-month deferral period as well.

Patients with clotting disorders

The FDA’s new guidance also reflects a change in the rationale for deferring patients with hemophilia or related clotting disorders who have received clotting factor concentrates. Previously, potential donors with hemophilia or related clotting disorders were deferred due to the increased risk of HIV transmission to potential recipients.

Based on new scientific evidence, these potential donors are still deferred, but not due to the risk of HIV transmission—instead, for their own protection due to potential harm from large needles used during the donation process.

FDA policies and actions

Throughout the process of updating blood donor deferral policies over the past several years, the FDA has worked with other government agencies, considered input from external advisory committees, reviewed comments from stakeholders to its May 2015 draft guidance, and examined the most recent available scientific evidence to support the current policy revision.

The FDA has also implemented a nationally representative safety monitoring system for the blood supply with assistance from the National Heart, Lung and Blood Institute at the National Institutes of Health. This system will provide information to help inform future actions the FDA may take on blood donor policies.

The FDA said it will continue to reevaluate and update its blood donor deferral policies as new scientific information becomes available.

Drop of blood

Researchers say they have created a biosensor capable of counting blood cells electrically using only a drop of blood.

The microfluidic device can measure red blood cell, platelet, and white blood cell counts using as little as 11 µL of blood.

The device electrically counts the different types of blood cells based on their size and membrane properties.

To count leukocyte and its differentials, red blood cells are selectively lysed, and the remaining white blood cells are individually counted. Specific cells like neutrophils can be counted using multi-frequency analysis, which probes the membrane properties of the cells.

For red blood cells and platelets, 1 µL of whole blood is diluted with PBS on-chip, and the cells are counted electrically. The total time for measurement is under 20 minutes.

The researchers described this device in TECHNOLOGY.

“Our biosensor exhibits the potential to improve patient care in a spectrum of settings,” said Rashid Bashir, PhD, of the University of Illinois at Urbana-Champaign.

He noted that the device could be particularly useful in resource-limited settings where laboratory tests are often inaccessible due to costs, poor prevalence of laboratory facilities, and the difficulty of follow-up upon receiving results that take days to process.

“There exists a huge potential to translate our biosensor commercially for blood cell count applications,” added Umer Hassan, PhD, of the University of Illinois at Urbana-Champaign.

“The translation of our technology will result in minimal to no experience requirement for device operation. Even patients can perform the test at the comfort of their home and share the results with their primary care physicians via electronic means too.”

“The technology is scalable, and, in future, we plan to apply it to many other potential applications in the areas of animal diagnostics, blood transfusion analysis, ER/ICU applications, and blood cell counting for chemotherapy management,” Dr Bashir said.

The researchers are now working to further develop a portable prototype of the cell counter.

“The cartridges will be disposable and the size of a credit card,” Dr Umer said. “The base unit or the reader will be portable and possibly hand-held. Our technology has the potential to reduce the cost of the test to less than $10, as compared to $100 or more currently charged.”

Drop of blood

Researchers say they have created a biosensor capable of counting blood cells electrically using only a drop of blood.

The microfluidic device can measure red blood cell, platelet, and white blood cell counts using as little as 11 µL of blood.

The device electrically counts the different types of blood cells based on their size and membrane properties.

To count leukocyte and its differentials, red blood cells are selectively lysed, and the remaining white blood cells are individually counted. Specific cells like neutrophils can be counted using multi-frequency analysis, which probes the membrane properties of the cells.

For red blood cells and platelets, 1 µL of whole blood is diluted with PBS on-chip, and the cells are counted electrically. The total time for measurement is under 20 minutes.

The researchers described this device in TECHNOLOGY.

“Our biosensor exhibits the potential to improve patient care in a spectrum of settings,” said Rashid Bashir, PhD, of the University of Illinois at Urbana-Champaign.

He noted that the device could be particularly useful in resource-limited settings where laboratory tests are often inaccessible due to costs, poor prevalence of laboratory facilities, and the difficulty of follow-up upon receiving results that take days to process.

“There exists a huge potential to translate our biosensor commercially for blood cell count applications,” added Umer Hassan, PhD, of the University of Illinois at Urbana-Champaign.

“The translation of our technology will result in minimal to no experience requirement for device operation. Even patients can perform the test at the comfort of their home and share the results with their primary care physicians via electronic means too.”

“The technology is scalable, and, in future, we plan to apply it to many other potential applications in the areas of animal diagnostics, blood transfusion analysis, ER/ICU applications, and blood cell counting for chemotherapy management,” Dr Bashir said.

The researchers are now working to further develop a portable prototype of the cell counter.

“The cartridges will be disposable and the size of a credit card,” Dr Umer said. “The base unit or the reader will be portable and possibly hand-held. Our technology has the potential to reduce the cost of the test to less than $10, as compared to $100 or more currently charged.”

Drop of blood

Researchers say they have created a biosensor capable of counting blood cells electrically using only a drop of blood.

The microfluidic device can measure red blood cell, platelet, and white blood cell counts using as little as 11 µL of blood.

The device electrically counts the different types of blood cells based on their size and membrane properties.

To count leukocyte and its differentials, red blood cells are selectively lysed, and the remaining white blood cells are individually counted. Specific cells like neutrophils can be counted using multi-frequency analysis, which probes the membrane properties of the cells.

For red blood cells and platelets, 1 µL of whole blood is diluted with PBS on-chip, and the cells are counted electrically. The total time for measurement is under 20 minutes.

The researchers described this device in TECHNOLOGY.

“Our biosensor exhibits the potential to improve patient care in a spectrum of settings,” said Rashid Bashir, PhD, of the University of Illinois at Urbana-Champaign.

He noted that the device could be particularly useful in resource-limited settings where laboratory tests are often inaccessible due to costs, poor prevalence of laboratory facilities, and the difficulty of follow-up upon receiving results that take days to process.

“There exists a huge potential to translate our biosensor commercially for blood cell count applications,” added Umer Hassan, PhD, of the University of Illinois at Urbana-Champaign.

“The translation of our technology will result in minimal to no experience requirement for device operation. Even patients can perform the test at the comfort of their home and share the results with their primary care physicians via electronic means too.”

“The technology is scalable, and, in future, we plan to apply it to many other potential applications in the areas of animal diagnostics, blood transfusion analysis, ER/ICU applications, and blood cell counting for chemotherapy management,” Dr Bashir said.

The researchers are now working to further develop a portable prototype of the cell counter.

“The cartridges will be disposable and the size of a credit card,” Dr Umer said. “The base unit or the reader will be portable and possibly hand-held. Our technology has the potential to reduce the cost of the test to less than $10, as compared to $100 or more currently charged.”