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Even as convalescent plasma (CP) therapy has helped treat moderately/severely ill COVID-19 patients, blood banks in India are finding it extremely difficult to offer CP on a regular basis to hospitals for providing CP therapy to COVID-19 patients due to the unavailability of titration kits.
The issue of unavailability of titration kits has been raised by clinical experts, blood banks and blood transfusion specialists based on the premise that plasma IgG titer stipulated as per Indian Council of Medical Research (ICMR) guidelines of above 1:640 cannot be validated in Indian healthcare settings due to lack of testing kits for the same. There are no clinical studies either to suggest that the stipulated titer works out well for Indian patients based on peer-reviewed studies.
For off-label use of CP for treatment of COVID-19 patients, ICMR had issued guidelines on June 13, 2020 which stated that plasma IgG titer (against S-protein RBD) above 1:640 should be used for transfusion for the treatment.
Offering clarity on the issue, Dr Anand Deshpande, Blood Transfusion Specialist at Mumbai-based PD Hinduja Hospital and vice chairperson, Federation of Bombay Blood Banks (FBBB), said, “We are at the peak of pandemic in India. Considering the cost and availability of authoritative technology in India particularly in rural India and outside metropolitan cities, I strongly feel that CP collected from whole blood donation should also be allowed to be used in COVID-19 patients.”
He further explained, “For off-label use of plasma, the condition of titer of 1:640 is difficult to fulfill as the necessary kits are currently not available in India. So called indirect dilution or titration method is not validated and standardized. Hence, titer needs to be replaced as on today by a positive qualitative antibody test result. This will help a large number of blood banks to carry out the plasmapheresis procedure as well as encourage to collect plasma from whole blood for the needy patients.”
To make the plasma available consistently and in an affordable manner, it has been recommended that plasma can be extracted from whole blood through centrifuge method at most of the blood banks in the country at NBTC stipulated price ranging between Rs. 200 and Rs. 400.
COVID-19 patients requiring CP therapy are today charged a prohibitive cost of Rs. 11, 000 for CP as most of the blood banks don’t have plasmapheresis machines to extract CP as per ICMR approved CP therapy for COVID-19 patients.
There are close to only 60 plasma banks in the country and hospitals are struggling to get donors for CP therapy. A COVID-19 patient requires 400 ml of plasma and plasmapheresis gives 500 ml of plasma in one sitting while component separation centrifuge method from whole blood gives 200 ml in one sitting or session. As per ICMR guidelines, plasma collection should be done by centrifugal separation using apheresis machine or equipment at the healthcare facility.
Recently, key members of FBBB had a very productive meeting with Maharashtra Health Minister Rajesh Tope, subsequent to which Maharashtra Health Minister recommended to the Union Health Minister Dr Harsh Vardhan to remove the provision in ICMR guidelines of having a titer of 1:640 which is meant to assess the number of antibodies in the plasma donor who has recovered from COVID-19.
“We are extremely thankful to Maharashtra Health Minister Rajesh Topeji for his sensitivity and kind intervention to resolve these practical problems faced by blood banks. Given the crisis situation, Central Drugs Standard Control Organization (CDSCO) and Maharashtra Food and Drug Administration (FDA) have also been very proactive in fast tracking plasmapheresis licenses for blood banks to help optimise this therapy,” said Dr Abhijit Bopardikar, Joint Secretary, FBBB and Incharge, Mahatma Gandhi Seva Mandir Blood Bank, Bandra, Mumbai which is also currently actively involved in a CDSCO approved clinical trial using CP in association with Wockhardt Hospital.
Immunoglobulin G (IgG) is the most common antibody. It's in blood and other body fluids and protects against bacterial and viral infections. Plasma from coronavirus survivors contains antibodies which offer protection against the virus when transferred to infected patients. Any survivor aged 18 to 60, weighing at least 50 kg and who has completed 28 days after the completion of treatment or home isolation is eligible to donate blood plasma. Blood banks assess the eligibility of donors for blood donation and check their antibody status before they can donate. This process is completed in one to three hours and plasma can be collected the same day.
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