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Identification of contagious SARS-CoV-2 infected individuals by Roche's Rapid Antigen Test.
Kessler, Harald H; Prüller, Florian; Hardt, Melina; Stelzl, Evelyn; Föderl-Höbenreich, Esther; Pailer, Sabine; Lueger, Andreas; Kreuzer, Philipp; Zatloukal, Kurt; Herrmann, Markus.
  • Kessler HH; Molecular Diagnostics Laboratory, Diagnostic and Research Institute of Hygiene,Microbiology, and Environmental Medicine, Medical University of Graz, Graz, Austria.
  • Prüller F; Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Graz, Austria.
  • Hardt M; Diagnostic- and Research Center for Molecular Biomedicine, Institute of Pathology, Medical University of Graz, Graz, Austria.
  • Stelzl E; Molecular Diagnostics Laboratory, Diagnostic and Research Institute of Hygiene,Microbiology, and Environmental Medicine, Medical University of Graz, Graz, Austria.
  • Föderl-Höbenreich E; Diagnostic- and Research Center for Molecular Biomedicine, Institute of Pathology, Medical University of Graz, Graz, Austria.
  • Pailer S; Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Graz, Austria.
  • Lueger A; Division of Emergency Medicine, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
  • Kreuzer P; Division of Emergency Medicine, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
  • Zatloukal K; Diagnostic- and Research Center for Molecular Biomedicine, Institute of Pathology, Medical University of Graz, Graz, Austria.
  • Herrmann M; Molecular Diagnostics Laboratory, Diagnostic and Research Institute of Hygiene,Microbiology, and Environmental Medicine, Medical University of Graz, Graz, Austria.
Clin Chem Lab Med ; 60(5): 778-785, 2022 04 26.
Article in English | MEDLINE | ID: covidwho-1731617
ABSTRACT

OBJECTIVES:

Rapid antigen tests (RAT) can provide valuable information on the presence or absence SARS-CoV-2 within 15 min without the need of a laboratory. The analytical and diagnostic characteristics of available RATs has led to the question whether they can safely distinguish between infectious and non-infectious patients in an acute care setting.

METHODS:

Three nasopharyngeal swabs for the analysis by RAT, reverse transcriptase real time polymerase chain reaction (RT-qPCR), and a cell culture based infection assay were collected from 67 patients that presented to the emergency department of the University Hospital of Graz (Austria). The first swab was used for on-site RAT testing in the emergency department using the Roche SARS-CoV-2 RAT. The second swab was sent to the central laboratory of the hospital for RT-qPCR with two independent methods (Cepheid Xpert® Xpress SARS-CoV-2 assay and Roche Cobas SARS-CoV-2 Test) and repeat RAT testing using the same commercial test. With the third swab a cell culture-based infection assay was performed.

RESULTS:

The RATs performed from independent samples showed substantial agreement (Cohen's-kappa 0.73, p<0.001). All patients with a positive RAT had positive RT-qPCR with cycle threshold (ct) values <25. Fifteen out of 55 RAT-negative samples were RT-qPCR positive with ct values between 25 and 40. The inoculation of cell cultures with RT-qPCR negative swabs and RT-qPCR positive swabs with ct values >25 did not induce cytopathic effects that were related to SARS-CoV-2. The infection assays from four RAT-negative patients showed cytopathic effects that were induced by other pathogens.

CONCLUSIONS:

The SARS-CoV-2 RAT from Roche Diagnostics is a valuable tool for managing symptomatic patients. RAT-negative patients may be regarded as non-contagious.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study Limits: Humans Language: English Journal: Clin Chem Lab Med Journal subject: Chemistry, Clinical / Laboratory Techniques and procedures Year: 2022 Document Type: Article Affiliation country: Cclm-2021-1276

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study Limits: Humans Language: English Journal: Clin Chem Lab Med Journal subject: Chemistry, Clinical / Laboratory Techniques and procedures Year: 2022 Document Type: Article Affiliation country: Cclm-2021-1276