2020
DOI: 10.3201/eid2608.201843
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Delayed Laboratory Response to COVID-19 Caused by Molecular Diagnostic Contamination

Abstract: The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) created an exceptional situation in which numerous laboratories in Europe simultaneously implemented SARS-CoV-2 diagnostics. These laboratories reported in February 2020 that commercial primer and probe batches for SARS-CoV-2 detection were contaminated with synthetic control material, causing delays of regional testing roll-out in various countries.

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Cited by 56 publications
(45 citation statements)
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“…As previously reported [ 19 ], we identified probable primer contamination using N2 US CDC and E Charité, which prevented us from further evaluating their sensitivity and specificity. Except for these two assays, no false-positive results were observed when testing a wide range of respiratory viruses, a result consistent with previous studies [ 5 , 6 , 10 , 11 , 13 , 14 ].…”
Section: Discussionmentioning
confidence: 99%
“…As previously reported [ 19 ], we identified probable primer contamination using N2 US CDC and E Charité, which prevented us from further evaluating their sensitivity and specificity. Except for these two assays, no false-positive results were observed when testing a wide range of respiratory viruses, a result consistent with previous studies [ 5 , 6 , 10 , 11 , 13 , 14 ].…”
Section: Discussionmentioning
confidence: 99%
“…All primers should be ordered with HPLC purification, which ensures the yield and avoids cross contamination from other SARS-CoV-2-related synthesis projects being run on the same equipment at the oligo synthesis facilities (which can lead to false positives). This is particularly a problem during a pandemic where these facilities are handling many oligo synthesis orders focused on the same pathogen14 . It is also recommended that you communicate with the primer synthesis company to inform them that primers are intended for use with a SARS-CoV-2 screening test.…”
mentioning
confidence: 99%
“…The addition to the EVA catalog of lyophilized primers, probes, and positive controls for the molecular detection of COVID-19 has played a major role to help laboratories in Europe prepare for detection of cases. A large part of the delay in establishing diagnostic capacities can be attributed to multiple contamination incidents at the production sites of industrial distributors of primers and probes, 18 and this EVA product was a timely solution to that problem. Especially at these early stages of the viral emergence, giving access to reference material is mandatory as there is no economic market meeting these needs.…”
Section: Discussionmentioning
confidence: 99%