Assessing the performance of a serological point-of-care test in measuring detectable antibodies against SARS-CoV-2
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Abstract
This study investigated the performance of a rapid point-of-care antibody test, the BioMedomics COVID-19 IgM/IgG Rapid Test, in comparison with a high-quality, validated, laboratory-based platform, the Roche Elecsys Anti-SARS-CoV-2 assay. Serological testing was conducted on 709 individuals. Concordance metrics were estimated. Logistic regression was used to assess associations with seropositivity. SARS-CoV-2 seroprevalence was 63.5% (450/709; 95% CI 59.8%-67.0%) using the BioMedomics assay and 71.9% (510/709; 95% CI 68.5%-75.2%) using the Elecsys assay. There were 60 discordant results between the two assays, all of which were seropositive in the Elecsys assay, but seronegative in the BioMedomics assay. Overall, positive, and negative percent agreements between the two assays were 91.5% (95% CI 89.2%-93.5%), 88.2% (95% CI 85.1%-90.9%), and 100% (95% CI 98.2%-100%), respectively, with a Cohen’s kappa of 0.81 (95% CI 0.78–0.84). Excluding specimens with lower (Elecsys) antibody titers, the agreement improved with overall, positive, and negative percent concordance of 94.4% (95% CI 92.3%-96.1%), 91.8% (95% CI 88.8%-94.3%), and 100% (95% CI 98.2%-100%), respectively, and a Cohen’s kappa of 0.88 (95% CI 0.85–0.90). Logistic regression confirmed better agreement with higher antibody titers. The BioMedomics COVID-19 IgM/IgG Rapid Test demonstrated good performance in measuring detectable antibodies against SARS-CoV-2, supporting the utility of such rapid point-of-care serological testing to guide the public health responses and vaccine prioritization.
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SciScore for 10.1101/2021.02.04.21251126: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Research methods were approved by the ethics review boards at Hamad Medical Center Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources Qualitative anti-SARS-CoV-2 results were generated following the manufacturer’s instructions (reactive for optical density (proxy for antibody titer [15]) cutoff index ≥1.0 vs. non-reactive for cutoff index <1.0) [13]. anti-SARS-CoV-2suggested: NoneSoftware and Algorithms Sentences Resources Analyses were performed using Microsoft Excel and IBM-SPSS version 26.0. Microsoft Excelsuggested: (Microsoft Excel, RRID:SCR_016137)SciScore for 10.1101/2021.02.04.21251126: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Research methods were approved by the ethics review boards at Hamad Medical Center Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources Qualitative anti-SARS-CoV-2 results were generated following the manufacturer’s instructions (reactive for optical density (proxy for antibody titer [15]) cutoff index ≥1.0 vs. non-reactive for cutoff index <1.0) [13]. anti-SARS-CoV-2suggested: NoneSoftware and Algorithms Sentences Resources Analyses were performed using Microsoft Excel and IBM-SPSS version 26.0. Microsoft Excelsuggested: (Microsoft Excel, RRID:SCR_016137)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:This study has a limitation. The performance of the rapid assay was compared to a laboratory-based assay, the Roche Elecsys Anti SARS-CoV-2 platform (and to PCR testing), but not to a gold standard test of seropositivity, as such a test was not available. Having so said, the Elecsys assay is one of the most extensively used and investigated commercial platforms, having a specificity ≥99.8% [13–15] and a sensitivity ≥89% [3, 12, 15]. Therefore, it is not likely that this limitation could have affected the findings. In conclusion, the BioMedomics rapid point-of-care test demonstrated excellent performance in measuring detectable antibodies against SARS-CoV-2, with better performance for specimens with higher antibody titers, demonstrating the utility of such assays in mass expansion of serological testing to guide public health responses and possible vaccine prioritization.
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 scite Reference Check: We found no unreliable references.
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