Clinical performance of a semi-quantitative assay for SARS-CoV2 IgG and SARS-CoV2 IgM antibodies.
Clin Chim Acta
; 510: 790-795, 2020 Nov.
Article
in English
| MEDLINE | ID: covidwho-778568
ABSTRACT
BACKGROUND:
While the diagnosis of SARS-CoV-2 infection is primarily based on detection of viral RNA, the detection of SARS-CoV-2 antibodies is useful for assessing past prevalence of the disease, and in corroborating a current infection in challenging cases. Sensitive and specific immunoassays provide the ability to identify exposure to SARS-CoV-2, to determine seroconversion, to confirm eligibility for donation of convalescent plasma as well as play an essential part in epidemiological studies. We report on the validation of the Ansh Laboratories SARS-CoV-2 IgG and SARS-CoV-2 IgM ELISA immunoassays. These assays were evaluated for detection of anti-SARS-CoV-2 IgG and IgM antibodies for clinical use in our hospital as part of an orthogonal testing algorithm recommended by the CDC.METHODS:
Diagnostic specificity and sensitivity of the IgG and IgM ELISA assays were tested using samples confirmed to be negative or positive for COVID-19 by RT-PCR. We also evaluated precision, analytical interference, and cross-reactivity with known cases of infection with other viruses. Additionally, we validated concordance with molecular and other serological testing and evaluated seroconversion in our patient population.RESULTS:
The IgG and IgM ELISA assays showed acceptable precision, were robust to analytical interference and did not exhibit cross reactivity with specimens positive for common respiratory viruses. Both assays exhibited 95% agreement with a primary screening serological assay utilized at our institution as well as with a reference laboratory semi-quantitative method. Concordance with RT-PCR was excellent > 6 days after symptom onset (100%).CONCLUSIONS:
The Ansh SARS-CoV-2 ELISA assays have good analytical performance suitable for clinical use.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Immunoglobulin G
/
Immunoglobulin M
/
Enzyme-Linked Immunosorbent Assay
/
Betacoronavirus
Type of study:
Diagnostic study
/
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Limits:
Humans
Language:
English
Journal:
Clin Chim Acta
Year:
2020
Document Type:
Article
Affiliation country:
J.cca.2020.09.023
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