Variable Performance in 6 Commercial SARS-CoV-2 Antibody Assays May Affect Convalescent Plasma and Seroprevalence Screening.

OBJECTIVES: Serologic detection of prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is needed for definition of convalescent plasma donors, for confounding SARS-CoV-2 presentation, and for seroprevalence studies. Reliable serologic assays with independent validation are required. METHODS: Six SARS-CoV-2 antibody assays from Beckman Coulter, Euroimmun (IgG, IgA), Roche, and Siemens (Centaur, Vista) were assessed for specificity (n = 184), sensitivity (n = 154), and seroconversion in a defined cohort with clinical correlates and molecular SARS-CoV-2 results. RESULTS: Assay specificity was 99% or greater for all assays except the Euroimmun IgA (95%). Sensitivity at more than 21 days from symptom onset was 84%, 95%, 72%, 98%, 67%, and 96% for Beckman Coulter, Centaur, Vista, Roche, Euroimmun IgA, and Euroimmun IgG, respectively. Average day of seroconversion was similar between assays (8-10 d), with 2 patients not producing nucleocapsid antibodies during hospitalization. CONCLUSIONS: SARS-CoV-2 nucleocapsid antibodies may be less reliably produced early in disease than spike protein antibodies. Assessment of convalescent plasma donors at more than 30 days from symptom onset and seroprevalence studies should use assays with defined sensitivity at time points of interest because not all assays detected antibodies reliably at more than 30 days.

Recognizing Laboratory Medicine's Collaborative Role in Identifying and Eliminating Health Disparities.

BACKGROUND: A health disparity is a health outcome that presents in a lesser or greater extent between populations. Health disparities in diseases are products of complex interactions between social, economic, and to a lesser extent, biological factors and can be mediated by structural racism and discriminatory policies. The objective of this review is to understand how both laboratorians and nonlaboratorians think about the relationship between laboratory medicine and health disparities and to highlight ways in which laboratory medicine can play a role in eliminating health disparities. CONTENT: We developed an electronic survey from which we selected the top responses reported by the 215 participants to frame a discussion around why laboratorians perceive health disparities exists, and how they can reduce health disparities. SUMMARY: We found that both laboratorians and nonlaboratorians feel that laboratory medicine can and should play a role in reducing health disparities using many tools already in use in the clinical laboratory. The skills of laboratory workers in data generation, the establishment of reference ranges, control over the presentation of laboratory results, generation of test menus, and the development of novel diagnostics may impact health disparities. Laboratorians' responses in our survey indicated that they felt that they could reduce health disparities by using laboratory data to proactively track in cooperation with healthcare providers individuals with chronic conditions to prevent acute events, ensuring gender and ethnic diversity in new clinical trials, including appropriate curriculum in laboratory medicine training, using equations and reference intervals based on physiological differences and participating in unconscious bias training.