Impact of serological and PCR testing requirements on the selection of COVID-19 convalescent plasma donors
Convalescent plasma is undergoing randomized trials as a potential therapeutic option for COVID-19 infection. Little empirical evidence exists regarding the determination of donor eligibility and experiences with donor selection.
STUDY DESIGN AND METHODS:This prospective study was conducted at a tertiary care hospital in New York to select plasma donors for a randomized, double-blind, controlled convalescent plasma trial. Clearance for donation required successful completion of an online questionnaire and an in-person screening visit, which included (a) completion of a Donor Health Questionnaire (DHQ), (b) Immunoglobulin G (IgG) antibody testing using an immunochromatographic anti- severe acute respiratory coronavirus 2 (SARS-CoV-2) test, (c) Polymerase chain reaction (PCR) testing if <28 days from symptom resolution, and (d) routine blood bank testing.
RESULTS:After receiving 3093 online questionnaires, 521 individuals presented for in-person screening visits, with 40.1% (n = 209) fully qualifying. Subjects (n = 312) failed to progress due to the following reasons: disqualifying answer from DHQ (n = 30, 9.6%), insufficient antibodies (n = 198, 63.5%), persistent positive PCR tests (n = 14, 4.5%), and blood donation testing labs (n = 70, 22.4%). Importantly, 24.6% and 11.1% of potential donors who reported having PCR-diagnosed infection had low or undetectable SARS-CoV-2 antibody levels, respectively. Surprisingly, 62.9% (56/89) of subjects had positive PCR tests 14-27 days after symptom resolution, with 13 individuals continuing to be PCR positive after 27 days.
CONCLUSION:It is feasible for a single site to fully qualify a large number of convalescent plasma donors in a short period of time. Among otherwise qualified convalescent plasma donors, we found high rates of low or undetectable antibody levels and many individuals with persistently positive PCR tests.
KEYWORDS: | blood component preparations; donors; immunology (other than RBC serology) |
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MESH HEADINGS: | Adult; Blood Donors; COVID-19; COVID-19 Nucleic Acid Testing; COVID-19 Serological Testing; Convalescence; Donor Selection; Female; Humans; Male; Middle Aged; Reverse Transcriptase Polymerase Chain Reaction |
Study Design: | Randomised Controlled Trial |
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Language: | eng |
Credits: | Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine |