Variation across population subgroups of COVID-19 antibody testing performance
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Abstract
Understanding variations in the performance of serological tests for SARS-CoV-2 across varying demographics is relevant to clinical interpretations and public policy derived from their results. Appropriate use of serological assays to detect anti-SARS-CoV-2 antibodies requires estimation of their accuracy over large populations and an understanding of the variance in performance over time and across demographic groups. In this manuscript we focus on anti-SARS-CoV-2 IgG, IgA, and IgM antibody tests approved under emergency use authorizations and determine the recall of the serological tests compared to RT-PCR tests by Logical Observation Identifiers Names and Codes (LOINCs). Variability in test performance was further examined over time and by demographics. The recall of the most common IgG assay (LOINC 94563-4) was 91.2% (95% CI: 90.5%, 91.9%). IgA (LOINC 94562-6) and IgM (94564-2) assays performed significantly worse than IgG assays with estimated recall rates of 20.6% and 27.3%, respectively. A statistically significant difference in recall ( p = 0.019) was observed across sex with a higher recall in males than females, 92.1% and 90.4%, respectively. Recall also differed significantly by age group, with higher recall in those over 45 compared to those under 45, 92.9% and 88.0%, respectively ( p < 0.001). While race was unavailable for the majority of the individuals, a significant difference was observed between recall in White individuals and Black individuals ( p = 0.007) and White individuals and Hispanic individuals ( p = 0.001). The estimates of recall were 89.3%, 95.9%, and 94.2% for White, Black, and Hispanic individuals respectively.
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SciScore for 10.1101/2020.09.14.20191833: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: This study was reviewed and deemed exempt by the institutional review board of UnitedHealth Group. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not 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:4.1 Limitations: This study has many of the limitations of retrospective observational studies, not least of which is how the patients …
SciScore for 10.1101/2020.09.14.20191833: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: This study was reviewed and deemed exempt by the institutional review board of UnitedHealth Group. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not 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:4.1 Limitations: This study has many of the limitations of retrospective observational studies, not least of which is how the patients were ascertained. This outpatient testing data is skewed since individuals who receive these tests are generally healthier and have relatively fewer comorbid conditions than the general population. Biases are especially likely in the earliest stage of the pandemic when the supply of tests was limited and testing was frequently reserved for those deemed most likely to be infected. The high number of asymptomatic infections is another consideration for understanding the tested population, as those without symptoms may have been less likely to seek out or be given a test. In fact, some reports show a lower peak antibody level response in these patients [4]. Also, using the RT-PCR test as a gold standard means that this study does not include the serology of those patients who had a false negative RT-PCR test, which may be substantial given reports of poor sensitivity [27,28]. Nonetheless, the recall rates we report here do reflect much of current practice relative to positive RT-PCR assays, and the subpopulation seropositivity recall differences are therefore of interest to policy-making and clinical practice.
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.
- Thank you for including a protocol registration statement.
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