Comparison of commercial assays and laboratory developed tests for detection of SARS-CoV-2

Kerry Dust; Adam Hedley; Kim Nichol; Derek Stein; Heather Adam; James A Karlowsky; Jared Bullard; Paul Van Caeseele; David C Alexander

doi:10.1016/j.jviromet.2020.113970

Comparison of commercial assays and laboratory developed tests for detection of SARS-CoV-2

J Virol Methods. 2020 Nov:285:113970. doi: 10.1016/j.jviromet.2020.113970. Epub 2020 Sep 10.

Authors

Kerry Dust¹, Adam Hedley¹, Kim Nichol², Derek Stein¹, Heather Adam³, James A Karlowsky³, Jared Bullard⁴, Paul Van Caeseele⁴, David C Alexander⁵

Affiliations

¹ Cadham Provincial Laboratory, Manitoba Health, Winnipeg, Manitoba, Canada.
² Diagnostic Services, Shared Health, Winnipeg, Manitoba, Canada.
³ Diagnostic Services, Shared Health, Winnipeg, Manitoba, Canada; Department of Medical Microbiology & Infectious Diseases, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
⁴ Cadham Provincial Laboratory, Manitoba Health, Winnipeg, Manitoba, Canada; Department of Medical Microbiology & Infectious Diseases, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada; Department of Pediatrics & Child Health, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
⁵ Cadham Provincial Laboratory, Manitoba Health, Winnipeg, Manitoba, Canada; Department of Medical Microbiology & Infectious Diseases, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada. Electronic address: David.Alexander@gov.mb.ca.

Abstract

The global COVID-19 pandemic has led to the rapid development of tests for detection of SARS-CoV-2. Studies are required to assess the relative performance of different assays. Here, we compared the performance of two commercial assays, the cobas® SARS-CoV-2 (Roche Diagnostics) and Xpert® Xpress SARS-CoV-2 (Cepheid®) tests, and a laboratory developed RT-PCR test adapted for use on the Hologic® Panther Fusion® (Hologic®) instrument as well as Bio-Rad and QIAGEN real-time PCR detection systems. Performance characteristics for each test were determined by testing clinical specimens and reference material. All assays detect the pan-Sarbecovirus E (envelope structural protein) gene plus a SARS-CoV-2-specific target. The limit of detection for the E gene target varied from ∼2 copies/reaction to >30 copies/reaction. Due to assay-specific differences in sample processing and nucleic acid extraction, the overall analytical sensitivity ranged from 24 copies/mL specimen to 574 copies/mL specimen. Despite these differences, there was 100 % agreement between the commercial and laboratory developed tests. No false-negative or false-positive SARS-CoV-2 results were observed and there was no cross-reactivity with common respiratory viruses, including endemic coronaviruses.

Keywords: COVID-19; Clinical virology; Molecular diagnostics; SARS-CoV-2.

Publication types

Comparative Study
Research Support, Non-U.S. Gov't

MeSH terms

Betacoronavirus* / genetics
Betacoronavirus* / immunology
COVID-19
COVID-19 Testing
COVID-19 Vaccines
Clinical Laboratory Techniques* / methods
Clinical Laboratory Techniques* / standards
Coronavirus Infections / diagnosis*
Coronavirus Infections / virology*
Humans
Molecular Diagnostic Techniques* / methods
Molecular Diagnostic Techniques* / standards
Pandemics
Pneumonia, Viral / diagnosis*
Pneumonia, Viral / virology*
Reagent Kits, Diagnostic* / standards
SARS-CoV-2
Sensitivity and Specificity

Substances

COVID-19 Vaccines
Covid-19 aAPC vaccine
Reagent Kits, Diagnostic