Objective Independent assessment of SARS-CoV-2 antigen (COV2Ag) tests remains important as varying performance between assays is common. We assessed the performance of a new high-throughput COV2Ag test compared to SARS-CoV-2 nucleic acid amplification tests (NAAT). Methods A total of 347 nasopharyngeal samples collected from January to October 2021 were assessed by NAAT as part of standard-of-care testing (CDC LDT or GeneXpert System, Cepheid) and COV2Ag using the ADVIA Centaur CoV2Ag assay (Siemens Healthineers). Results Among NAAT positive specimens we found 82.4% agreement and in NAAT negative specimens we found 97.3% agreement (overall agreement 85.6%). In symptomatic persons, COV2Ag agreed with NAAT 90.0% (n = 291), and in asymptomatic persons, 62.5% (n = 56). Agreement between positive NAAT and COV2Ag increased at lower cycle threshold (Ct) values. Conclusion The COV2Ag assay exceeded the World Health Organization minimum performance requirements of ≥ 80% sensitivity and ≥ 97% specificity. The COV2Ag assay is helpful for large scale screening efforts due to high-throughput and reduced wait times.

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.

Background Children infected with SARS-CoV-2 are often asymptomatic or have only mild symptoms, leading to underestimation of disease prevalence in symptom-based testing strategies. Objectives This study sought to determine pediatric SARS-CoV-2 disease burden during local mitigation efforts by using antibody testing to compare seroprevalence estimates to cumulative PCR prevalence estimates. Study Design In this cross-sectional study, we collected 1142 strict phase and 1196 relaxed phase remnant blood specimens from patients less than 19-years-old in southwestern Pennsylvania (SWPA). Patients were excluded if their residential zip code was outside the region of interest, if they were under 6-months-old, or they had recently received antibody-modifying treatments. Demographic, encounter, and laboratory electronic medical record information was extracted. Samples were tested for SARS-CoV-2 spike protein IgG using an EUA ELISA, and PCR results were recorded from county health department data. Seroprevalence and Clopper-Pearson exact 95% confidence intervals were calculated. Results The observed seroprevalence of SARS-CoV-2 spike protein antibodies in children during strictest mitigation was 0.53% (95% CI 0.19, 1.14) and 0.92% (95% CI 0.46,1.64) during moderately relaxed. Strict and relaxed phase PCR-based prevalence were significantly higher, 2.87% (95% CI 1.95, 4.08) and 3.64 (95% CI 3.01, 4.38), respectively. Conclusions Estimates of pediatric seroprevalence were significantly lower than cumulative PCR prevalence estimates, and less than adult seroprevalence estimates, potentially due to biological, population, or sampling differences. Biological differences in pediatric immune responses to SARS-CoV-2 may make serosurvey interpretation challenging and these differences warrant further study.