AI Article Synopsis
- An evaluation of 12 commercially available lateral flow assays (LFAs) for detecting antibodies to SARS-CoV-2 was conducted to assess their performance beyond manufacturer reports.
- The study included sera from 100 SARS-CoV-2 positive participants and 105 negative samples, revealing sensitivity rates ranging from 21.2% to 79% for various antibodies, with specific tests showing improved sensitivity after 21 days past symptom onset.
- The findings highlight significant variability in sensitivity and specificity among the LFAs, emphasizing the importance of independent evaluations to ensure accurate diagnostic decisions related to antibody status.
Article Abstract
Background: There are an abundance of commercially available lateral flow assays (LFAs) that detect antibodies to SARS-CoV-2. Whilst these are usually evaluated by the manufacturer, externally performed diagnostic accuracy studies to assess performance are essential. Herein we present an evaluation of 12 LFAs.
Methods: Sera from 100 SARS-CoV-2 reverse-transcriptase polymerase chain reaction (RT-PCR) positive participants were recruited through the FASTER study. A total of 105 pre-pandemic sera from participants with other infections were included as negative samples.
Results: At presentation sensitivity against RT-PCR ranged from 37.4 to 79% for IgM/IgG, 30.3-74% for IgG, and 21.2-67% for IgM. Sensitivity for IgM/IgG improved ≥ 21 days post symptom onset for 10/12 tests. Specificity ranged from 74.3 to 99.1% for IgM/IgG, 82.9-100% for IgG, and 75.2-98% for IgM. Compared to the EuroImmun IgG enzyme-linked immunosorbent assay (ELISA), sensitivity and specificity ranged from 44.6 to 95.4% and 85.4-100%, respectively.
Conclusion: There are many LFAs available with varied sensitivity and specificity. Understanding the diagnostic accuracy of these tests will be vital as we come to rely more on the antibody status of a person moving forward, and as such manufacturer-independent evaluations are crucial.
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Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8664720 | PMC |
| http://dx.doi.org/10.1016/j.jinf.2021.12.007 | DOI Listing |
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