tetano
Editor, Senior Moderator
Sci Rep
. 2022 Dec 9;12(1):21338.
doi: 10.1038/s41598-022-25266-3.
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
Sara Suliman[SUP] #[/SUP][SUP] 1 2 [/SUP], Wilfredo R Matias[SUP] #[/SUP][SUP] 3 4 [/SUP], Isabel R Fulcher[SUP] 5 6 [/SUP], Francisco J Molano[SUP] 4 7 [/SUP], Shannon Collins[SUP] 4 [/SUP], Elizabeth Uceta[SUP] 4 [/SUP], Jack Zhu[SUP] 4 [/SUP], Ryan M Paxton[SUP] 8 [/SUP], Sean F Gonsalves[SUP] 8 [/SUP], Maegan V Harden[SUP] 9 [/SUP], Marissa Fisher[SUP] 9 [/SUP], Jim Meldrim[SUP] 9 [/SUP], Stacey Gabriel[SUP] 9 [/SUP], Molly F Franke[SUP] 5 [/SUP], Deborah T Hung[SUP] 9 [/SUP], Sandra C Smole[SUP] 10 [/SUP], Lawrence C Madoff[SUP] 10 [/SUP], Louise C Ivers[SUP] 3 4 5 11 [/SUP]
Affiliations
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.
. 2022 Dec 9;12(1):21338.
doi: 10.1038/s41598-022-25266-3.
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
Sara Suliman[SUP] #[/SUP][SUP] 1 2 [/SUP], Wilfredo R Matias[SUP] #[/SUP][SUP] 3 4 [/SUP], Isabel R Fulcher[SUP] 5 6 [/SUP], Francisco J Molano[SUP] 4 7 [/SUP], Shannon Collins[SUP] 4 [/SUP], Elizabeth Uceta[SUP] 4 [/SUP], Jack Zhu[SUP] 4 [/SUP], Ryan M Paxton[SUP] 8 [/SUP], Sean F Gonsalves[SUP] 8 [/SUP], Maegan V Harden[SUP] 9 [/SUP], Marissa Fisher[SUP] 9 [/SUP], Jim Meldrim[SUP] 9 [/SUP], Stacey Gabriel[SUP] 9 [/SUP], Molly F Franke[SUP] 5 [/SUP], Deborah T Hung[SUP] 9 [/SUP], Sandra C Smole[SUP] 10 [/SUP], Lawrence C Madoff[SUP] 10 [/SUP], Louise C Ivers[SUP] 3 4 5 11 [/SUP]
Affiliations
- PMID: 36494424
- DOI: 10.1038/s41598-022-25266-3
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.