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. 2021 May 31;13(6):1043.
doi: 10.3390/v13061043.

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

Tove Hoffman  1 , Linda Kolstad  1 , Bengt Rönnberg  1   2 , Åke Lundkvist  1
Affiliations

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

Tove Hoffman et al. Viruses. .

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.

Keywords: IgM/IgG; POC-test; S1; SARS-CoV-2; lateral flow; lot; specificity.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Flow diagram of sampling: IgG, immunoglobulin G; IgM, immunoglobulin M; MFI, median fluorescence intensity; COVID-19 SIA, Coronavirus disease 2019 suspension immunoassay; Pos, positive; Neg, negative.
Figure 2
Figure 2
Effect of prevalence on the positive and negative predictive values (PPV; NPV) for two production lots (A and B) of a commercial rapid lateral flow point-of-care test, using the values for sensitivity and specificity presented in Table 3. IgG, immunoglobulin G; IgM, immunoglobulin M; Sens, sensitivity; Spec, specificity.
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