Evaluation of the commercially available LightMix® Modular E-gene kit using clinical and proficiency testing specimens for SARS-CoV-2 detection

Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology
Cyril C Y YipJasper F W Chan

Abstract

Rapid and sensitive diagnostic assays for SARS-CoV-2 detection are required for prompt patient management and infection control. The analytical and clinical performances of LightMix® Modular SARS and Wuhan CoV E-gene kit, a widely used commercial assay for SARS-CoV-2 detection, have not been well studied. To evaluate the performance characteristics of the LightMix® E-gene kit in comparison with well-validated in-house developed COVID-19 RT-PCR assays. Serial dilutions of SARS-CoV-2 culture isolate extracts were used for analytical sensitivity evaluation. A total of 289 clinical specimens from 186 patients with suspected COVID-19 and 8 proficiency testing (PT) samples were used to evaluate the diagnostic performance of the LightMix® E-gene kit against in-house developed COVID-19-RdRp/Hel and COVID-19-N RT-PCR assays. The LightMix® E-gene kit had a limit of detection of 1.8 × 10-1 TCID50/mL, which was one log10 lower than those of the two in-house RT-PCR assays. The LightMix® E-gene kit (149/289 [51.6%]) had similar sensitivity as the in-house assays (144/289 [49.8%] for RdRp/Hel and 146/289 [50.5%] for N). All three assays gave correct results for all the PT samples. Cycle threshold (Cp) values of the LightMix® E-gene kit and in...Continue Reading

References

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Citations

Aug 14, 2020·International Journal of Molecular Sciences·Cyril Chik-Yan YipKelvin Kai-Wang To
Aug 26, 2020·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Kelvin Kai-Wang ToKwok-Yung Yuen
Feb 13, 2021·Euro Surveillance : Bulletin Européen Sur Les Maladies Transmissibles = European Communicable Disease Bulletin·Anne Carroll, Eleanor McNamara
Feb 2, 2021·Measurement : Journal of the International Measurement Confederation·Madeshwari EzhilanNoel Nesakumar
Apr 30, 2021·Infectious Diseases·Mehrab E HossainRobert J Commons
Jun 5, 2021·Journal of Virological Methods·William G DundonGiovanni Cattoli
Jul 30, 2021·Expert Review of Molecular Diagnostics·Nidhi ChauhanUtkarsh Jain
Aug 27, 2021·PloS One·Salvador Domènech-MontoliuAlberto Arnedo-Pena
Nov 5, 2020·Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases·Jonathan Daniel IpKelvin Kai-Wang To

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