Testing Frequency Matters: An Evaluation of the Diagnostic Performance of a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Rapid Antigen Test in US Correctional Facilities

  1. Margaret L Lind
  2. Olivia L Schultes
  3. Alexander J Robertson
  4. Amy J Houde
  5. Derek A T Cummings
  6. Albert I Ko
  7. Byron S Kennedy
  8. Robert P Richeson

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Abstract

Background

The Centers for Disease Control and Prevention recommends serial rapid antigen assay collection within congregate facilities. Although modeling and observational studies from communities and long-term care facilities have shown serial collection provides adequate sensitivity and specificity, the accuracy within correctional facilities remains unknown.

Methods

Using Connecticut Department of Correction data from 21 November 2020 to 15 June 2021, we estimated the accuracy of a rapid assay, BinaxNOW (Abbott), under 3 collection strategies: single test collection and serial collection of 2 and 3 tests separated by 1–4 days. The sensitivity and specificity of the first (including single), second, and third serially collected BinaxNOW tests were estimated relative to RT-PCRs collected ≤1 day of the BinaxNOW test. The accuracy metrics of the testing strategies were then estimated as the sum (sensitivity) and product (specificity) of tests in each strategy.

Results

Of the 13 112 residents who contributed ≥1 BinaxNOW test during the study period, 3825 contributed ≥1 RT-PCR paired BinaxNOW test. In relation to RT-PCR, the 3-rapid-antigen-test strategy had a sensitivity of 95.9% (95% CI: 93.6–97.5%) and specificity of 98.3% (95% CI: 96.7–99.1%). The sensitivities of the 2- and 1-rapid-antigen-test strategies were 88.8% and 66.8%, and the specificities were 98.5% and 99.4%, respectively. The sensitivity was higher among symptomatic residents and when RT-PCRs were collected before BinaxNOW tests.

Conclusions

We found serial antigen test collection resulted in high diagnostic accuracy. These findings support serial collection for outbreak investigation, screening, and when rapid detection is required (such as intakes or transfers).

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  1. Version published to 10.1093/cid/ciac450
  2. ScreenIT

    SciScore for 10.1101/2022.03.03.22271803: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsIRB: Quest Diagnostic facilities performed SARS-CoV-2 RT-PCR testing of nasopharnyngeal swab specimens and defined positive tests as having a cycle threshold value less than 40.[25] At the time rapid antigen test collection was implemented, the DOC oversaw 17 facilities with a resident census of around 10,000 residents (9,945 residents on July 1st, 2020).[26,27] The Yale University Institutional Review Board classified this study as public health surveillance.
    Sex as a biological variablenot detected.
    RandomizationWe propagated the uncertainty through the serial testing equations using posterior simulation of 1000 random draws of the GEE estimate.[
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Limitations and Strengths: Our study was subject to limitations typical of retrospective diagnostic validation analyses. First, race/ethnicity was missing for a large portion of the population and we were unable to test for differences in test accuracy by race. However, it is unlikely that race would impact the diagnostic accuracy of the rapid antigen test. Second, we relied on a reference outcome of RT-PCR positivity, which is an imperfect indicator of infection. In addition, in the absence of cycle threshold values, we were unable to tests the impact of viral load on rapid antigen test performance. Third, our accuracy estimates relied on collected test that may be biased towards department specific testing practices. However, we observed similar results when we selected the first, second, and third test of each series at random (eTable5). Finally, our study was conducted prior to the large Delta and Omicron waves of 2021. While the diagnostic accuracy of rapid antigen tests likely varies between the different variants, we believe the benefits of serial collection will hold. Our study had several strengths including our large sample of paired assays collected among a diverse population of Connecticut State correctional facility residents. This large sample allowed us to estimate and compare the diagnostic accuracy of three different collection strategies, including the three-test strategy employed by the Connecticut DOC. Our large sample also allowed us to examine characteri...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

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  3. Version published to 10.1101/2022.03.03.22271803 on medRxiv