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IFCC Interim Guidelines on Molecular Testing of SARS-CoV-2 Infection.
Mary Kathryn Bohn1, Nicasio Mancini2, Tze Ping Loh3
1Paediatric Laboratory Medicine, The Hospital for Sick Children, and Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
Clinical Chemistry and Laboratory Medicine
|October 7, 2020
Summary
Molecular testing is crucial for diagnosing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and managing coronavirus disease 2019 (COVID-19). This guidance aids clinical laboratories in selecting, verifying, and interpreting these vital diagnostic assays.
Area of Science:
- Clinical diagnostics
- Infectious disease management
- Laboratory medicine
Background:
- Molecular testing for SARS-CoV-2 has been essential for pandemic response, including case identification and contact tracing.
- Clinical laboratories faced challenges in rapidly verifying new tests and scaling up capacity during the COVID-19 pandemic.
- Ongoing global health threats necessitate continued laboratory expertise in managing molecular diagnostics.
Purpose of the Study:
- To provide interim guidance for clinical laboratories on molecular testing for SARS-CoV-2.
- To address challenges in assay selection, verification, and interpretation.
- To support evidence-based decision-making in laboratory medicine during the pandemic.
Main Methods:
- Development of interim guidance by the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on COVID-19.
- Focus on clinical indications, target populations, assay selection, verification, and interpretation.
- Evidence-based recommendations for practical laboratory application.
Main Results:
- The guidance covers critical aspects of molecular testing for SARS-CoV-2.
- It addresses practical challenges faced by clinical laboratories worldwide.
- It emphasizes the importance of laboratory medicine in pandemic response.
Conclusions:
- The IFCC provides essential interim guidance for molecular testing of SARS-CoV-2.
- These recommendations aim to assist clinical laboratories in navigating diagnostic challenges.
- Laboratory medicine plays a pivotal role in the global response to infectious disease threats.
