Evaluation of the commercially available LightMix® Modular E-gene kit using clinical and proficiency testing specimens for SARS-CoV-2 detection
Date
2020Author
Chik-Yan Yip, Cyril
Sridhar, Siddharth
Kim-Wai Cheng, Andrew
Leung, Kit-Hang
Kwan-Yue Choi, Garnet
Hon-Kwan Chen, Jonathan
Wing-Shan Poon, Rosana
Chan, Kwok-Hung
Ka-Lun Wu, Alan
Shuk-Ying Chan, Helen
Ka-Yee Chau, Sandy
Wai-Hin Chung, Tom
Kai-Wang To, Kelvin
Tak-Yin Tsang, Owen
Fan-Ngai Hung, Ivan
Chi-Chung Cheng, Vincent
Yuen, Kwok- Yung
Fuk-Woo Chan, Jasper
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Abstract
Background: 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.
Objective: To evaluate the performance characteristics of the LightMix® E-gene kit in comparison with wellvalidated in-house developed COVID-19 RT-PCR assays.
Study design: 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.
Results: 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-house
assays showed excellent correlation. Reproducibility of the Cp values was satisfactory with intra- and inter-assay
coefficient of variation values < 5%. Importantly, the LightMix® E-gene kit, when used as a stand-alone assay,
was equally sensitive as testing algorithms using multiple COVID-19 RT-PCR assays.
Conclusions: The LightMix® E-gene kit is a rapid and sensitive assay for SARS-CoV-2 detection. It has fewer
verification requirements compared to laboratory-developed tests.
Palabras clave
LightMix E-gene; SARS-CoV-2; COVID-19; Diagnostic; Evaluation; PCRLink to resource
https://doi.org/10.1016/j.jcv.2020.104476Collections
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