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Clinical Performance of a Lateral Flow SARS-CoV-2 Total Antibody Assay.
- Source :
- Journal of Applied Laboratory Medicine; Jul2022, Vol. 7 Issue 4, p827-833, 7p
- Publication Year :
- 2022
-
Abstract
- Background: Serological assays for SARS-CoV-2 are important tools for diagnosis in patients with negative RT-PCR testing, pediatric patients with multisystem inflammatory syndrome, and serosurveillance studies. However, lateral flow-based serological assays have previously demonstrated poor analytical and clinical performance, limiting their utility. Methods: We assessed the ADEXUSDx COVID-19 lateral flow assay for agreement with diagnostic RT-PCR testing using 120 specimens from RT-PCR–positive patients, 77 specimens from symptomatic RT-PCR–negative patients, and 47 specimens obtained prepandemic. Specimens collected <14 days from symptom onset in RT-PCR–positive patients were compared relative to the Abbott SARS-CoV-2 IgG assay. Results: The ADEXUSDx COVID-19 Test yielded an overall positive percent agreement (PPA) of 92.5% (95%CI 85.8 to 96.3) and negative percent agreement of 99.2% (95% CI 94.9–100.0) relative to RT-PCR and in prepandemic specimens. Relative to days from symptom onset, the PPA after 13 days was 100% (95% CI 94.2–100); from 7 to 13 days, 89.7 (95% CI 71.5–97.2); and from 0 to 7 days, 53.8 (95% CI 26.1–79.6). The overall agreement between the Abbott and ADEXUSDx assays was 80.9%. Twenty-five specimens were positive by both assays, 9 specimens were negative by both assays, and 8 specimens were positive by only the ADEXUSDx assay. Conclusions: We demonstrate high PPA and negative percent agreement of the ADEXUSDx COVID-19 assay and diagnostic testing by RT-PCR, with PPA approximately 90% by 7 days following symptom onset. The use of waived testing for antibodies to SARS-CoV-2 with high sensitivity and specificity provide a further tool for combatting the COVID-19 pandemic. [ABSTRACT FROM AUTHOR]
- Subjects :
- MULTISYSTEM inflammatory syndrome in children
SARS-CoV-2
COVID-19 testing
Subjects
Details
- Language :
- English
- ISSN :
- 24757241
- Volume :
- 7
- Issue :
- 4
- Database :
- Complementary Index
- Journal :
- Journal of Applied Laboratory Medicine
- Publication Type :
- Academic Journal
- Accession number :
- 158440684
- Full Text :
- https://doi.org/10.1093/jalm/jfac003