Impact of serological and PCR testing requirements on the selection of COVID-19 convalescent plasma donors.

BACKGROUND: 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.

Improving Adherence to Care Recommendations Using a Community Health Worker (CHW) Intervention with the Pediatric Medical Home.

While CHW interventions improve health outcomes, evidence identifying specific domains of CHW-delivered support resulting in positive outcomes is limited. Our goals were to identify domains of CHW-delivered support that assist families with adhering to recommended pediatric care; and, to identify predictors of successful completion of an enriched medical home intervention (EMHI) using trained CHWs making home visits to provide health education and support positive health behaviors. We performed a prospective descriptive study of 88 families participating in a protocol-based EMHI. Completers (N = 46) finished the program with mutual agreement that the family can independently adhere to recommended clinical care. Non-completers (N = 42) were lost to follow-up or dropped out of the program before reaching this milestone. Using Grounded Theory, two trained coders evaluated CHW tasks recorded in an electronic database and classified these tasks across 17 domains. We assessed predictors of EMHI completion using logistic regression. The 88 EMHI participants were primarily <24 months of age (80 %), Hispanic (56 %), and Medicaid enrollees (67 %). Hispanic families (OR = 2.76, p = 0.04) and those with self-reported program goals to 'facilitate family's creation of a system to keep track of child's medical information' (OR = 3.11, p = 0.02) or a 'newborn-specific goal' (OR = 3.21, p = 0.04), such as feeding and safety tips, were more likely to complete the EMHI compared to their counterparts. The most consistent CHW tasks were supporting medical appointments, medication maintenance, and providing health education. CHW interventions designed to improve health behavior outcomes of 'at-risk' families, including Medicaid enrollees, may benefit from support in goal-setting and strategies to systematically manage their child's medical care.