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.

Keywords: COVID-19; Europe; PCR; SARS-CoV-2; commercial nucleotide production; contamination; coronavirus disease; coronaviruses; delayed laboratory response; molecular diagnostics; primers; probes; respiratory infections; severe acute respiratory syndrome coronavirus 2; viruses; zoonoses.

Figure

Timeline and extent of product and molecular diagnostic contamination issues in 10 laboratories in Europe during delayed laboratory response to COVID-19. A) Contamination status of commercially ordered primers and probes for molecular detection of SARS-CoV-2 based on Corman et al. (2). Red vertical dotted line indicates starting date of laboratories in Europe receiving contaminated commercial primers and probes. The letters a–h are unique identifiers for the 8 companies that produced the materials. B) Timeline of simultaneous hallmark events in the SARS-CoV-2 outbreak. C) Delay of implementation of SARS-CoV-2 diagnostic test in laboratories and delay of national or regional roll-out schemes per laboratory. Laboratories that indicated no delay had access to noncontaminated material from previous orders or cooperated with another laboratory. COVID-19, coronavirus disease; E, envelope; EVAg, European Virus Archive Global; GISAID, Global Initiative on Sharing All Influenza Data (http://gisaid.org); ID, identification; PHEIC, public health emergency of international concern; SARS-CoV, severe acute respiratory syndrome coronavirus; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; WHO, World Health Organization.