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Utility of Antigen-Based Rapid Diagnostic Test for Detection of SARS-CoV-2 Virus in Routine Hospital Settings.
Thakur, Preeti; Saxena, Sonal; Manchanda, Vikas; Rana, Neha; Goel, Ruchi; Arora, Ritu.
  • Thakur P; Department of Microbiology, Maulana Azad Medical College, New Delhi, India.
  • Saxena S; Department of Microbiology, Maulana Azad Medical College, New Delhi, India.
  • Manchanda V; Department of Microbiology, Maulana Azad Medical College, New Delhi, India.
  • Rana N; Department of Microbiology, Maulana Azad Medical College, New Delhi, India.
  • Goel R; Department of Ophthalmology, Guru Nanak Eye Center, New Delhi, India.
  • Arora R; Department of Ophthalmology, Guru Nanak Eye Center, New Delhi, India.
Lab Med ; 52(6): e154-e158, 2021 Nov 02.
Article in English | MEDLINE | ID: covidwho-1559980
ABSTRACT

OBJECTIVE:

This study aims to evaluate the performance of an antigen-based rapid diagnostic test (RDT) for the detection of the SARS-CoV-2 virus.

METHODS:

A cross-sectional study was conducted on 677 patients. Two nasopharyngeal swabs and 1 oropharyngeal swab were collected from patients. The RDT was performed onsite by a commercially available immune-chromatographic assay on the nasopharyngeal swab. The nasopharyngeal and oropharyngeal swabs were examined for SARS-CoV-2 RNA by real-time reverse-transcription quantitative polymerase chain reaction (RT-qPCR) assay.

RESULTS:

The overall sensitivity of the SARS-CoV-2 RDT was 34.5% and the specificity was 99.8%. The positive predictive value and negative predictive value of the test were 96.6% and 91.5%, respectively. The detection rate of RDT in RT-qPCR positive results was high (45%) for cycle threshold values <25.

CONCLUSION:

The utility of RDT is in diagnosing symptomatic patients and may not be particularly suited as a screening tool for patients with low viral load. The low sensitivity of RDT does not qualify its use as a single test in patients who test negative; RT-qPCR continues to be the gold standard test.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: RNA, Viral / Chromatography, Affinity / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antigens, Viral Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adolescent / Aged / Female / Humans / Male / Middle aged Language: English Journal: Lab Med Year: 2021 Document Type: Article Affiliation country: Labmed

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Full text: Available Collection: International databases Database: MEDLINE Main subject: RNA, Viral / Chromatography, Affinity / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antigens, Viral Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adolescent / Aged / Female / Humans / Male / Middle aged Language: English Journal: Lab Med Year: 2021 Document Type: Article Affiliation country: Labmed