Clinical Performance of a Lateral Flow SARS-CoV-2 Total Antibody Assay.
J Appl Lab Med
; 7(4): 827-833, 2022 06 30.
Article
in English
| MEDLINE | ID: covidwho-1746868
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.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
SARS-CoV-2
/
COVID-19
Type of study:
Diagnostic study
/
Prognostic study
Topics:
Long Covid
Limits:
Child
/
Humans
Language:
English
Journal:
J Appl Lab Med
Year:
2022
Document Type:
Article
Affiliation country:
Jalm
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