Performance Characteristics of a Rapid Severe Acute Respiratory Syndrome Coronavirus 2 Antigen Detection Assay at a Public Plaza Testing Site in San Francisco

Pilarowski, Genay; Lebel, Paul; Sunshine, Sara; Liu, Jamin; Crawford, Emily; Marquez, Carina; Rubio, Luis; Chamie, Gabriel; Martinez, Jackie; Peng, James; Black, Douglas; Wu, Wesley; Pak, John E.; Laurie, Matthew T.; Jones, Diane; Miller, Steve; Jacobo, Jon; Rojas, Susana; Rojas, Susy; Nakamura, Robert M.; Tulier-Laiwa, Valerie; Petersen, Maya; Havlir, Diane V.; DeRisi, Joseph L.

doi:10.1093/infdis/jiaa802

Cited by 123 publications

(117 citation statements)

References 14 publications

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“…Antigens were produced using previously described constructs. 22,23 Antigen concentrations used for COOH-bead coupling were as follows: S, 4 ug/mL; RBD, 2 ug/mL; and N, 3 ug/mL. Concentration values were calculated from the Luminex median fluorescent intensity (MFI) using a plate-specific standard curve consisting of serial dilutions of a pool of positive control samples.…”

Section: Methodsmentioning

confidence: 99%

SARS-CoV-2 antibody magnitude and detectability are driven by disease severity, timing, and assay

Peluso

Takahashi

Hakim

et al. 2021

Preprint

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Serosurveillance studies are critical for estimating SARS-CoV-2 transmission and immunity, but interpretation of results is currently limited by poorly defined variability in the performance of antibody assays to detect seroreactivity over time in individuals with different clinical presentations. We measured longitudinal antibody responses to SARS-CoV-2 in plasma samples from a diverse cohort of 128 individuals over 160 days using 14 binding and neutralization assays. For all assays, we found a consistent and strong effect of disease severity on antibody magnitude, with fever, cough, hospitalization, and oxygen requirement explaining much of this variation. We found that binding assays measuring responses to spike protein had consistently higher correlation with neutralization than those measuring responses to nucleocapsid, regardless of assay format and sample timing. However, assays varied substantially with respect to sensitivity during early convalescence and in time to seroreversion. Variations in sensitivity and durability were particularly dramatic for individuals with mild infection, who had consistently lower antibody titers and represent the majority of the infected population, with sensitivities often differing substantially from reported test characteristics (e.g., amongst commercial assays, sensitivity at 6 months ranged from 33% for ARCHITECT IgG to 98% for VITROS Total Ig). Thus, the ability to detect previous infection by SARS-CoV-2 is highly dependent on the severity of the initial infection, timing relative to infection, and the assay used. These findings have important implications for the design and interpretation of SARS-CoV-2 serosurveillance studies.

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Section: Methodsmentioning

confidence: 99%

SARS-CoV-2 antibody magnitude and detectability are driven by disease severity, timing, and assay

Peluso

Takahashi

Hakim

et al. 2021

Preprint

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“…That individuals with false negative results of the RAT had significantly higher Ct value corresponding to a lower viral load, indicate that individuals with false negative RATs are less infectious in general.The comparison of test results from oropharyngeal and nasopharyngeal swabs suggests a limitation.However, both methods are in accordance with CDC recommendations 2 . Even though RT-PCR is considered the gold standard for detection of SARS-CoV-2 infection, it is not flawless, and the choice of RT-PCR as reference and criteria for positive results have implications3,4 .…”

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confidence: 99%

Detection of SARS-CoV-2 infection by rapid antigen test in comparison with RT-PCR in a public setting

Jakobsen

Jensen

Todsen

et al. 2021

Preprint

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BackgroundRapid and accurate detection of SARS-CoV-2 infection is essential in limiting the spread of infection during the ongoing COVID-19 pandemic. The aim of this study was to determine the accuracy of the STANDARD Q COVID-19 Ag test (SD BIOSENSOR) by comparison with RT-PCR in a public setting.MethodIndividuals aged 18 years or older who had booked an appointment for a RT-PCR test on December 26-31, 2020 at a public test center in Copenhagen, Denmark, were invited to participate. An oropharyngeal swab was collected for RT-PCR analysis, immediately followed by a nasopharyngeal swab examined by the STANDARD Q COVID-19 Ag test (SD BIOSENSOR). Sensitivity, specificity, positive and negative predictive values of the antigen test were calculated with test results from RT-PCR as reference.ResultsOverall, 4697 individuals were included (female n=2456, 53.3%; mean age: 44.7 years, SD: 16.9 years); 196 individuals were tested twice or more. Among 4811 paired conclusive test results from the RT-PCR and antigen tests, 221 (4.6%) RT-PCR tests were positive. The overall sensitivity and specificity of the antigen test were 69.7% and 99.5%, the positive and negative predictive values were 87.0% and 98.5%. Ct values were significantly higher among individuals with false negative antigen tests compared to true positives.ConclusionThe sensitivity, specificity, and predictive values found indicate that the STANDARD Q COVID-19 Ag is a good supplement to RT-PCR testing.

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“…The first non-instrumented antigen test, the Abbott BinaxNOW COVID-19 Ag CARD, received FDA EUA approval in the United States on August 26, 2020 51 . While the sensitivity of RT-LAMP is broadly comparable to the Abbott BinaxNOW antigen test (reported as 1.6×10 4 - 4.3×10 4 vRNA copies; Ct 30.3-28.8), because the former is technically straightforward and can be used as a SARS-CoV-2 diagnostic at testing sites operating under a Clinical Laboratory Improvement Amendments (CLIA) waiver, it is likely a better choice for rapid turnaround, on-site testing in most circumstances 52 . However, even with the existence of antigen tests, RT-LAMP surveillance programs still have a place as part of a comprehensive SARS-CoV-2 risk mitigation strategy, especially in areas where access to antigen tests is limited.…”

Section: Discussionmentioning

confidence: 89%

Initial evaluation of a mobile SARS-CoV-2 RT-LAMP testing strategy

Newman

Ramuta

McLaughlin

et al. 2020

Preprint

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Performance Characteristics of a Rapid Severe Acute Respiratory Syndrome Coronavirus 2 Antigen Detection Assay at a Public Plaza Testing Site in San Francisco

Cited by 123 publications

References 14 publications

SARS-CoV-2 antibody magnitude and detectability are driven by disease severity, timing, and assay

SARS-CoV-2 antibody magnitude and detectability are driven by disease severity, timing, and assay

Detection of SARS-CoV-2 infection by rapid antigen test in comparison with RT-PCR in a public setting

Initial evaluation of a mobile SARS-CoV-2 RT-LAMP testing strategy

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