Performance Characteristics of the Abbott Architect SARS-CoV-2 IgG Assay and Seroprevalence in Boise, Idaho
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Abstract
Coronavirus disease 2019 (COVID-19), the novel respiratory illness caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is associated with severe morbidity and mortality. The rollout of diagnostic testing in the United States was slow, leading to numerous cases that were not tested for SARS-CoV-2 in February and March 2020 and necessitating the use of serological testing to determine past infections. Here, we evaluated the Abbott SARS-CoV-2 IgG test for detection of anti-SARS-CoV-2 IgG antibodies by testing 3 distinct patient populations.
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SciScore for 10.1101/2020.04.27.20082362: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: This work was approved under a consent waiver by the University of Washington IRB. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources IgG Testing: Serum samples were run on the Abbott Architect instrument using the Abbott SARS-CoV-2 IgG assay after FDA notification following manufacturer’s instructions. Abbottsuggested: (Abbott, RRID:SCR_010477)Partial AUC analysis and data visualization were performed using the R packages pROC, ggplot2, and cowplot (5, 6). ggplot2suggested: (ggplot2, RRID:SCR_014601)Results from OddPub: We did not …
SciScore for 10.1101/2020.04.27.20082362: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: This work was approved under a consent waiver by the University of Washington IRB. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources IgG Testing: Serum samples were run on the Abbott Architect instrument using the Abbott SARS-CoV-2 IgG assay after FDA notification following manufacturer’s instructions. Abbottsuggested: (Abbott, RRID:SCR_010477)Partial AUC analysis and data visualization were performed using the R packages pROC, ggplot2, and cowplot (5, 6). ggplot2suggested: (ggplot2, RRID:SCR_014601)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:Given limitations of clinical sensitivity of SARS-CoV-2 PCR testing for various sample types, IgG serology with an applied low threshold may be a useful adjunctive diagnostic for patients with negative PCR results who have been symptomatic for ≥ 7 days with a clinical presentation consistent with COVID-19 disease. In contrast, a higher threshold might be considered for PCR-negative asymptomatic patients for assessing previous undiagnosed infection. For laboratories reporting a single diagnostic result for both populations, it may be useful to report an inconclusive range corresponding to an OD ratio of roughly 0.8-1.5 with a recommendation for repeat testing to minimize false negative results associated with seroconversion. At this time, repeat serology may be preferable to a diagnostic algorithm using a secondary assay, as no specific confirmatory assay with sufficient sensitivity and specificity exists at this time. Our serological validation was chiefly limited by use of excess serum specimens from a mostly hospitalized population known to be very recently infected with SARS-CoV-2. This convenience sample meant that PCR and serology data were not available for each day since symptom onset, requiring us to censor follow-up days accordingly (e.g. days before if the first longitudinal serological result was positive or days afterward if the last serological result was negative). The majority of patients in this study were elderly individuals – 65.6% were older than 60 years o...
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.
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