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Molecular diagnostic assays for COVID-19: an overview
Parham Habibzadeh1, Mohammad Mofatteh2, Mohammad Silawi1
1Persian BayanGene Research and Training Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Critical Reviews in Clinical Laboratory Sciences
|February 17, 2021
Summary
Rapid and accurate COVID-19 diagnostic assays are crucial. This review covers molecular methods like RT-PCR and emerging technologies, offering insights for future pandemic preparedness.
Area of Science:
- Infectious Diseases
- Molecular Diagnostics
- Biotechnology
Background:
- The COVID-19 pandemic underscored the critical need for swift and precise diagnostic tools.
- Numerous molecular diagnostic assays have been developed and validated globally to meet this demand.
Purpose of the Study:
- To review the technical and clinical applications of various molecular diagnostic assays for COVID-19.
- To explore promising alternative molecular methods beyond RT-PCR.
- To provide recommendations for implementing these technologies in future outbreaks.
Main Methods:
- Review of current literature on COVID-19 molecular diagnostic assays.
- Analysis of reverse transcription polymerase chain reaction (RT-PCR) as the primary method.
- Evaluation of alternative molecular techniques including CRISPR-based assays, isothermal amplification, digital PCR, microarrays, and next-generation sequencing (NGS).
Main Results:
- Reverse transcription polymerase chain reaction (RT-PCR) remains the most utilized method for SARS-CoV-2 RNA detection.
- Emerging molecular technologies such as CRISPR, isothermal amplification, digital PCR, microarrays, and NGS show significant promise as alternatives.
- Various assays are approved, while others are undergoing clinical validation.
Conclusions:
- Molecular diagnostic assays are essential for managing the COVID-19 pandemic.
- A range of molecular methods, from established RT-PCR to novel techniques, are available for SARS-CoV-2 detection.
- Strategic implementation of these diagnostic technologies is vital for future infectious disease outbreak response.

