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Chembio DPP COVID-19 IgM/IgG Serological Testing: Laboratory Validation, Guidelines, and Recommendations.
Clin Lab ; 66(11)2020 Nov 01.
Article in English | MEDLINE | ID: covidwho-922948
ABSTRACT

BACKGROUND:

On January 30, 2020, WHO declared COVID-19 a pandemic. In this article we describe our experience at Richmond University Medical Center with Chembio serological IgM, IgG testing.

METHODS:

In this prospective cohort study of patients and hospital employees, we utilized Chembio COVID-19 IgM/IgG serological testing in addition to Cepheid RT-PCR analysis.

RESULTS:

We evaluated the performance of Chembio serological test for IgM and IgG as an employee screening tool in a community hospital setting. The total number of currently asymptomatic employees screened was 1,866 from the Richmond University Medical Center. The non-exposed group included 1,253 (67.1%) employees with no significant clinical history and non-reactive IgM and IgG antibodies. The convalescent group included 255 (13.7%) of the employees with elevation of IgG only, 18 (1%) employees with past history of positive PCR and COVID-19 who currently have non-reactive IgM and IgG antibodies or demonstrate elevated IgG only, followed by 3 employees (< 1%) with no past clinical history who demonstrated reactive IgM and IgG antibodies and negative follow up by PCR. The reported 14.9% exposure/convalescent rate is lower than the reported 20% by the Department of Health and Governor Andrew Cuomo and may represent a better utilization of personal protective equipment, better hand washing techniques, and better disinfection procedures combined with strict social distancing.

CONCLUSIONS:

Chembio's performance is satisfactory; however, hospitals must design their own policies addressing who needs to be screened and who will interpret the results as well as constructing management algorithms for employees with no previous history and current double positive antibodies.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoglobulin G / Immunoglobulin M / Serologic Tests / Mass Screening / Clinical Laboratory Techniques Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Humans Language: English Journal subject: Laboratory Techniques and procedures Year: 2020 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoglobulin G / Immunoglobulin M / Serologic Tests / Mass Screening / Clinical Laboratory Techniques Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Humans Language: English Journal subject: Laboratory Techniques and procedures Year: 2020 Document Type: Article