Comparative performance of COVID-19 serology testing.
Pract Lab Med
; 31: e00289, 2022 Aug.
Article
in English
| MEDLINE | ID: covidwho-2245828
ABSTRACT
Background:
The 2019 novel coronavirus infectious disease (COVID-19) pandemic resulted in a surge of assays aimed at detecting severe acute respiratory syndrome (SARS) - coronavirus (CoV) - 2 infection and prior exposure. Although both molecular and antigen testing have clearly defined uses, the utility of serology remains uncertain and is presently not recommended for assessing immunity.Methods:
We conducted a pragmatic, observational study evaluating four commercially available emergency use authorized laboratory-based COVID-19 serology assays (Assays A-D). Remnant samples from hospitalized, and non-hospitalized SARS-CoV-2 PCR positive patients, as well as vaccinated and unvaccinated individuals were collected and tested. Positive percent agreement (PPA) and negative percent agreement (NPA) were calculated. Antibody concentrations were compared across the platforms and populations.Results:
A total of 588 remnant samples derived from 500 patients were tested. PPA at 5-12 weeks post-PCR positive results for Assays A-D was 98.3, 97.4, 99.2, and 95.8% respectively. NPA was 100% across all platforms. Mean antibody concentrations at 2-4 weeks post-PCR positive result were significantly higher in hospitalized versus non-hospitalized patients, respectively, for Assay A (131.8 [101.7] vs. 95.6 [100.3] AU/mL, P < 0.001), B (61.7 [62.4] vs. 38.1 [40.5] AU/mL, P < 0.001), and C (157.6 [105.3] vs. 133.3 [100.7] AU/mL, P < 0.001). For individuals receiving two vaccine doses mean antibody concentrations were respectively 169.6 (104.4), 27.3 (50.8), 189.6 (120.9), 21.19 (13.1) AU/mL for Assays A-D.Conclusions:
Overall, PPA and NPA differed across the four assays. Assays A and C produced higher PPA and NPA and detected larger concentrations of antibodies following vaccination.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Type of study:
Experimental Studies
/
Observational study
/
Prognostic study
Topics:
Vaccines
Language:
English
Journal:
Pract Lab Med
Year:
2022
Document Type:
Article
Affiliation country:
J.plabm.2022.e00289
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