Tags

Type your tag names separated by a space and hit enter

Comparison of commercial assays and laboratory developed tests for detection of SARS-CoV-2.
J Virol Methods. 2020 11; 285:113970.JV

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.

Authors+Show Affiliations

Cadham Provincial Laboratory, Manitoba Health, Winnipeg, Manitoba, Canada.Cadham Provincial Laboratory, Manitoba Health, Winnipeg, Manitoba, Canada.Diagnostic Services, Shared Health, Winnipeg, Manitoba, Canada.Cadham Provincial Laboratory, Manitoba Health, Winnipeg, Manitoba, Canada.Diagnostic Services, Shared Health, Winnipeg, Manitoba, Canada; Department of Medical Microbiology & Infectious Diseases, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.Diagnostic Services, Shared Health, Winnipeg, Manitoba, Canada; Department of Medical Microbiology & Infectious Diseases, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.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.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.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.

Pub Type(s)

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

Language

eng

PubMed ID

32920028

Citation

Dust, Kerry, et al. "Comparison of Commercial Assays and Laboratory Developed Tests for Detection of SARS-CoV-2." Journal of Virological Methods, vol. 285, 2020, p. 113970.
Dust K, Hedley A, Nichol K, et al. Comparison of commercial assays and laboratory developed tests for detection of SARS-CoV-2. J Virol Methods. 2020;285:113970.
Dust, K., Hedley, A., Nichol, K., Stein, D., Adam, H., Karlowsky, J. A., Bullard, J., Van Caeseele, P., & Alexander, D. C. (2020). Comparison of commercial assays and laboratory developed tests for detection of SARS-CoV-2. Journal of Virological Methods, 285, 113970. https://doi.org/10.1016/j.jviromet.2020.113970
Dust K, et al. Comparison of Commercial Assays and Laboratory Developed Tests for Detection of SARS-CoV-2. J Virol Methods. 2020;285:113970. PubMed PMID: 32920028.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of commercial assays and laboratory developed tests for detection of SARS-CoV-2. AU - Dust,Kerry, AU - Hedley,Adam, AU - Nichol,Kim, AU - Stein,Derek, AU - Adam,Heather, AU - Karlowsky,James A, AU - Bullard,Jared, AU - Van Caeseele,Paul, AU - Alexander,David C, Y1 - 2020/09/10/ PY - 2020/06/05/received PY - 2020/08/18/revised PY - 2020/09/08/accepted PY - 2020/9/14/pubmed PY - 2020/10/21/medline PY - 2020/9/13/entrez KW - COVID-19 KW - Clinical virology KW - Molecular diagnostics KW - SARS-CoV-2 SP - 113970 EP - 113970 JF - Journal of virological methods JO - J Virol Methods VL - 285 N2 - 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. SN - 1879-0984 UR - https://www.unboundmedicine.com/medline/citation/32920028/Comparison_of_commercial_assays_and_laboratory_developed_tests_for_detection_of_SARS_CoV_2_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0166-0934(20)30222-6 DB - PRIME DP - Unbound Medicine ER -