학술논문
Evaluation of the Access Bio CareStart rapid SARS-CoV-2 antigen test in asymptomatic individuals tested at a community mass-testing program in Western Massachusetts.
Document Type
Article
Author
Suliman, Sara; Matias, Wilfredo R.; Fulcher, Isabel R.; Molano, Francisco J.; Collins, Shannon; Uceta, Elizabeth; Zhu, Jack; Paxton, Ryan M.; Gonsalves, Sean F.; Harden, Maegan V.; Fisher, Marissa; Meldrim, Jim; Gabriel, Stacey; Franke, Molly F.; Hung, Deborah T.; Smole, Sandra C.; Madoff, Lawrence C.; Ivers, Louise C.
Source
Subject
*SARS-CoV-2
*ANTIGEN analysis
*REVERSE transcriptase polymerase chain reaction
*COVID-19 testing
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Language
ISSN
2045-2322
Abstract
Point-of-care antigen-detecting rapid diagnostic tests (RDTs) to detect Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) represent a scalable tool for surveillance of active SARS-CoV-2 infections in the population. Data on the performance of these tests in real-world community settings are paramount to guide their implementation to combat the COVID-19 pandemic. We evaluated the performance characteristics of the CareStart COVID-19 Antigen test (CareStart) in a community testing site in Holyoke, Massachusetts. We compared CareStart to a SARS-CoV-2 reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) reference, both using anterior nasal swab samples. We calculated the sensitivity, specificity, and the expected positive and negative predictive values at different SARS-CoV-2 prevalence estimates. We performed 666 total tests on 591 unique individuals. 573 (86%) were asymptomatic. There were 52 positive tests by RT-qPCR. The sensitivity of CareStart was 49.0% (95% Confidence Interval (CI) 34.8–63.4) and specificity was 99.5% (95% CI 98.5–99.9). Among positive RT-qPCR tests, the median cycle threshold (Ct) was significantly lower in samples that tested positive on CareStart. Using a Ct ≤ 30 as a benchmark for positivity increased the sensitivity of the test to 64.9% (95% CI 47.5–79.8). Our study shows that CareStart has a high specificity and moderate sensitivity. The utility of RDTs, such as CareStart, in mass implementation should prioritize use cases in which a higher specificity is more important, such as triage tests to rule-in active infections in community surveillance programs. [ABSTRACT FROM AUTHOR]