Evaluation of Production Lots of a Rapid Point-of-Care Lateral Flow Serological Test Intended for Identification of IgM and IgG against the N-Terminal Part of the Spike Protein (S1) of SARS-CoV-2
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Abstract
The potential of rapid point-of-care (POC) tests has been subject of doubt due to an eventual risk of production errors. The aim was therefore to evaluate the two separate production lots of a commercial POC lateral flow test, intended for the detection of IgM and IgG against the SARS-CoV-2 spike protein (S1). Control samples consisted of serum from individuals with confirmed SARS-CoV-2 infection and pre-COVID-19 negative sera gathered from a biobank. The presence of anti-S1 IgM/IgG in the sera was verified by an in-house Luminex-based serological assay (COVID-19 SIA). One hundred samples were verified as positive for anti-S1 IgG and 74 for anti-S1 IgM. Two hundred samples were verified as negative for anti-S1 IgM/IgG. For the two lots of the POC-test, the sensitivities were 93.2% and 87.8% for IgM and 93.0% and 100% for IgG. The specificities were 100% for IgM and 99.5% for IgG. The positive predictive value was 100% for IgM and 98.9% and 99.0% for IgG. The negative predictive value was 97.6% and 95.7% for IgM, and 96.6% and 100% for IgG. The evaluated POC-test is suitable to assess anti-SARS-CoV-2 S1 IgM and IgG, as a measure of previous virus exposure on an individual level. The external validation of separate lots of rapid POC-tests is encouraged to ensure high sensitivity before market introduction.
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SciScore for 10.1101/2020.08.27.20182923: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: They were all used with informed consent according to the Swedish Biobank law, which allows anonymized diagnostic patient samples to be used for purposes similar to those of the original sampling. Randomization Negative controls constituted of serum from babies (6-12 months old) and randomly selected blood donor sera from the Uppsala Academic Hospital from individuals, without any known history of SARS-CoV-2 infection/COVID-19 and before the COVID-19 pandemic (i.e. collected 2018). Blinding Test results were blinded to the assessors of the index test, as well as to the assessors of the reference standard. Power Analysis not detected. Sex as a biological … SciScore for 10.1101/2020.08.27.20182923: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: They were all used with informed consent according to the Swedish Biobank law, which allows anonymized diagnostic patient samples to be used for purposes similar to those of the original sampling. Randomization Negative controls constituted of serum from babies (6-12 months old) and randomly selected blood donor sera from the Uppsala Academic Hospital from individuals, without any known history of SARS-CoV-2 infection/COVID-19 and before the COVID-19 pandemic (i.e. collected 2018). Blinding Test results were blinded to the assessors of the index test, as well as to the assessors of the reference standard. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Analyses were performed with STATA v13.1 (StataCorp, Texas, USA). STATAsuggested: (Stata, RRID:SCR_012763)StataCorpsuggested: (Stata, RRID:SCR_012763)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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.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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