key: cord-0682554-ctbf47dy
authors: Demuth, Sabrina; Damaschek, Sarah; Schildgen, Oliver; Schildgen, Verena
title: Low sensitivity of SARS-CoV-2 Rapid antigen self-tests under laboratory conditions
date: 2021-07-13
journal: New Microbes New Infect
DOI: 10.1016/j.nmni.2021.100916
sha: 93610ee6c21e9b13abdeaae2a43f319d35950132
doc_id: 682554
cord_uid: ctbf47dy

SARS-CoV-2-antigen-testing for has be proposed as “game-changing” tools to interrupt infection chains. Thereby European strategies focused on two pillar, namely rapid antigen tests conducted by health care experts and/or trained personal, and so called-self tests. Here evidence is provided that these assay have a weak performance even under laboratory conditions.

Abstract 9 SARS-CoV-2-antigen-testing for has be proposed as "game-changing" tools to interrupt infection 10 chains. Thereby European strategies focused on two pillar, namely rapid antigen tests conducted by 11 health care experts and/or trained personal, and so called-self tests. Here evidence is provided that 12 these assay have a weak performance even under laboratory conditions. 13 14 Brief Report 15

With the broad usage of rapid antigen tests (RAT) as part of the German national SARS-CoV-2 test 16 strategy the question on their reliability arises. Thereby, it should be noted that different application 17 types ranging from RATs performed in official test centers by qualified medical stuff to supervised 18 usage of RATs in schools and enterprises up to RATs carried out privately are implemented. Having 19 reported a debatable performance of various professional RATs (1), which was independently 20 confirmed (2-5), we evaluated the performance of three assays (Novel Coronavirus (COVID-19) 21

Antigen Test Kit (Colloidal Gold) (Lyher, Hangzhou, Zhejiang, People's Republic of China), the SARS-22

CoV-2 Rapid Antigen Test (Roche, Mannheim, Germany), and the Clinitest Rapid Covid-19 Antigen 23

Test (Siemens, Cologne, Germany) that received the official approval for self-testing in Germany. 24

All lateral flow tests were performed strictly following the manufacturer's recommendations. The 25 read out was also done as recommended by the manufacturers and done by trained laboratory staff. 26

In order to address this issue a cohort of 40 SARS-CoV-2 positive throat washes, three cell-culture 27 derived round-robin-trial specimens, and 10 SARS-CoV-2 RNA negative controls were tested. 28

Two independent observers analysed the lateral flow assays within the permitted time slot and 29 recorded their results. The overall agreement among the observers was 100%. 30

The specimens were collected during the screening of hospital staff members. The throat washes 31

were performed with sterile 10 ml NaCl solution (0.9%) at a 30 second gargling interval (6). RT-PCR 32 was performed using the dual-target Real-Star SARS-CoV-2 assay according to the manufacturer's 33 protocol. The entire sampling procedure was supervised by trained medical staff members from and 34 Table 1 103 -NC-3   ---PCR-NC-4  ---PCR-NC-5  ---PCR-NC-6  ---PCR-NC-7  ---PCR-NC-8  ---PCR-NC-9 ---PCR-NC-10 ---104 

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