Cautionary Note on Contamination of Reagents Used for Molecular Detection of SARS-CoV-2

• Published in: Clinical chemistry (Baltimore, Md.) Vol. 66; no. 11; pp. 1369 - 1372
• Main Authors: Huggett, Jim F, Benes, Vladimir, Bustin, Stephen A, Garson, Jeremy A, Harris, Karthyn, Kammel, Martin, Kubista, Mikael, McHugh, Timothy D, Moran-Gilad, Jacob, Nolan, Tania, Pfaffl, Michael W, Salit, Marc, Shipley, Greg, Vallone, Peter M, Vandesompele, Jo, Wittwer, Carl, Zeichhardt, Heinz
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 01.11.2020
• Subjects: Contamination; Coronaviruses; COVID-19; COVID-19 - diagnosis; COVID-19 - virology; Diagnostic Errors; Genomes; Humans; Indicators and Reagents - chemistry; Laboratories; Limit of Detection; Medical diagnosis; Medicine; Nasopharynx - virology; Opinion; Pandemics; Pathogens; Reagents; Reverse Transcriptase Polymerase Chain Reaction; RNA, Viral - genetics; RNA, Viral - metabolism; SARS-CoV-2 - genetics; SARS-CoV-2 - isolation & purification; Severe acute respiratory syndrome coronavirus 2; Specimen Handling - standards; SARS-CoV-2; RT-qPCR; false positive; contamination; molecular diagnosis
• ISSN: 0009-9147; 1530-8561; 1530-8561
• DOI: 10.1093/clinchem/hvaa214

Reverse transcription (RT)-PCR, the principal diagnostic method applied in the world-wide struggle against COVID-19, is capable of detecting a single molecule of a viral genome. Correctly designed and practiced RT-PCR assays for SARS-CoV-2 should not cross react with similar but distinct viral pathogens, such as the coronaviruses associated with the common cold, and should perform with very high analytical sensitivity. This analytical performance is predicated on the ability of the method to detect the presence of the selected nucleic acid target, without detection of a false positive signal.