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Real-time PCR-based SARS-CoV-2 detection in Canadian laboratories
Jason J LeBlanc1, Jonathan B Gubbay2, Yan Li3
1Division of Microbiology, Department of Pathology and Laboratory Medicine, Nova Scotia Health Authority (NSHA), Room 404B, MacKenzie Building, 5788 University Avenue, Halifax, Nova Scotia B3H 1V8, Canada; Departments of Pathology, Medicine, and Microbiology and Immunology, Dalhousie University, Halifax, Nova Scotia, Canada.
This study found that laboratory-developed tests (LDTs) for detecting SARS-CoV-2 showed analytical sensitivities comparable to commercial real-time RT-PCR assays. These findings support the reliability of LDTs for COVID-19 diagnosis in Canadian laboratories.
Area of Science:
- Virology
- Clinical Diagnostics
- Public Health
Background:
- The COVID-19 pandemic necessitated rapid and accurate diagnostic testing for SARS-CoV-2.
- Hospital and public health laboratories rely on various testing methods for disease detection.
Purpose of the Study:
- To compare the analytical sensitivity of laboratory-developed tests (LDTs) against commercially available real-time RT-PCR assays for SARS-CoV-2 detection.
- To evaluate the performance of diagnostic tests used in Canadian healthcare settings.
Main Methods:
- Comparison of analytical sensitivities of SARS-CoV-2 detection assays.
- Inclusion of laboratory-developed tests (LDTs) from Canadian hospital and public health laboratories.
- Evaluation of commercially available real-time RT-PCR assays.
Main Results:
- Analytical sensitivities of LDTs were found to be equivalent to most commercially available methods.
- The study assessed the performance of various SARS-CoV-2 diagnostic tests.
Conclusions:
- Laboratory-developed tests (LDTs) demonstrate comparable analytical sensitivity to commercial assays for SARS-CoV-2 detection.
- These findings support the use of LDTs in Canadian laboratories for reliable COVID-19 diagnosis.
