Centre issues fresh guidelines for blood transfusion services

Convalescent plasma therapy to treat the coronavirus disease (Covid-19) received boost on Tuesday when the Union health ministry revised blood transfusion guidelines

Convalescent plasma therapy to treat the coronavirus disease (Covid-19) received boost on Tuesday when the Union health ministry revised blood transfusion guidelines to include the collection of convalescent plasma under the clinical trials protocol from people who have recovered from infection by the Sars-CoV-2 virus.

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“Systems should be in place to enable re-entry of cured Covid-19 patients as donors for convalescent plasma for treatment of Covid-19 patients. The treatment of Covid-19 patients using plasma therapy is under clinical trial and currently no evidence of the efficacy of the convalescent plasma as a treatment modality for Sars-Cov-2 is established… the use of convalescent plasma for routine treatment of Covid-19 patients is not recommended at present…,” say the revised health ministry guidelines.

The Indian Red Cross Society (IRCS) is working to create a database of potential convalescent plasma donors for hospitals treating Covid-19 patients.

“We are creating a list of eligible convalescent plasma donors that we pass on to hospitals. You have to extensively counsel these people as these were sick patients who are sometimes not very comfortable with the idea of going back to a hospital even if it is to donate plasma. We find not many recovered patients approaching us directly, so we are dependent on hospitals to provide us the list as we don’t have a hospital of our own,” said Dr Vanshree Singh, director (blood bank), IRCS.

The revised guidelines do not recommend testing of donated blood and blood components for Covid-19 or going in for more advanced pathogen reduction techniques, citing reasons such as financial impracticality and lack of enough evidence to support transmission of the virus though blood transfusion.

“Testing of the blood supply for Covid-19 is not recommended in light of the risk of transfusion transmission being theoretical or lack of demonstrated infectivity of the Covid-19 virus in blood collected from asymptomatic persons. Routine practices of infectious disease testing for transfusion transmissible infections should not be changed,” the guidelines said.

“Pathogen Reduction Technologies (PRT) require significant logistical and financial investment. PRT for whole blood is less widely available and studies of inactivation of coronavirus in whole blood are lacking. Introduction of PRT for the COvid-19 virus would not be cost-effective or proportionate and is not recommended,” the guidelines added.

The document has cited studies that say respiratory viruses are not known to transmit through blood transfusion.

“No cases of transfusion-transmission were ever reported for the other two corona viruses that emerged during the past two decades (SARS and MERS-CoV). Virus detection in blood has only happened in symptomatic patients with Covid-19 to date. American Association of Blood Blanks, USFDA (US Food and Drug Administration) and CDC (Centers for Disease Control and Prevention in the US) are not recommending any additional action by blood collection establishments at this time because there are no data or precedent suggesting risk of transfusion-transmission for Covid-19… According to the USFDA, there have been no reported or suspected cases of transfusion-transmitted Covid-19,” experts said in the guideline document.

Having said that, the government has asked blood banks to screen donors thoroughly for Covid-related symptoms, and discard or recall the donated blood if there was even slightest suspicion of Covid-19. The donors will have to wait for at least 28 days before they will again be eligible for donation.

People who cannot donate blood are laboratory confirmed cases of Covid-19, irrespective of clinical signs and symptoms; contacts of a lab positive case or those with travel history to a country where community transmission of the disease has been established.

“The blood samples collected from a donor, who turns out to be Covid positive, or is unconfirmed case or even a close contact of a laboratory positive case within 28 days of donation, will be discarded. All known positive cases cannot donate for 28 days after the end of 7 day home isolation post discharge or when symptoms subside, or travel to a Covid-19 affected country,” the guidelines say.

Dr RN Makroo, president, Indian Society of Transfusion Medicine, said thorough screening is good enough. “For regular donors thorough screening of history of the person is good enough. You cannot conduct blood test or PRT which is not just super expensive but also does not happen anywhere in India. We must strengthen screening of our regular donors, that’s the solution. The new guidelines are pretty comprehensive and should be followed,” said Dr Makroo.

“The government guidelines say 28 days of deferral, but we go by six weeks to be cautious,” said Dr Singh from IRCS.