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Evaluation of the commercially available LightMix® Modular E-gene kit using clinical and proficiency testing specimens for SARS-CoV-2 detection.
J Clin Virol. 2020 08; 129:104476.JC

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 well-validated 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.

Authors+Show Affiliations

Department of Microbiology, Queen Mary Hospital, Pokulam, Hong Kong Special Administrative Region, China.State Key Laboratory of Emerging Infectious Diseases, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China; Department of Microbiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China; Carol Yu Centre for Infection, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China.Department of Microbiology, Queen Mary Hospital, Pokulam, Hong Kong Special Administrative Region, China.Department of Microbiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China.Department of Microbiology, Queen Mary Hospital, Pokulam, Hong Kong Special Administrative Region, China.Department of Microbiology, Queen Mary Hospital, Pokulam, Hong Kong Special Administrative Region, China.Department of Microbiology, Queen Mary Hospital, Pokulam, Hong Kong Special Administrative Region, China.State Key Laboratory of Emerging Infectious Diseases, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China; Department of Microbiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China; Carol Yu Centre for Infection, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China.Department of Clinical Pathology, Pamela Youde Nethersole Eastern Hospital, Hong Kong Special Administrative Region, China.Department of Medicine, Queen Elizabeth Hospital, Hong Kong Special Administrative Region, China.Department of Pathology, United Christian Hospital, Hong Kong Special Administrative Region, China.Department of Microbiology, Queen Mary Hospital, Pokulam, Hong Kong Special Administrative Region, China.State Key Laboratory of Emerging Infectious Diseases, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China; Department of Microbiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China; Carol Yu Centre for Infection, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China.Department of Medicine and Geriatrics, Princess Margaret Hospital, Hong Kong Special Administrative Region, China.Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China.Department of Microbiology, Queen Mary Hospital, Pokulam, Hong Kong Special Administrative Region, China.State Key Laboratory of Emerging Infectious Diseases, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China; Department of Microbiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China; Carol Yu Centre for Infection, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China; Hainan Medical University-The University of Hong Kong Joint Laboratory of Tropical Infectious Diseases, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China. Electronic address: kyyuen@hku.hk.State Key Laboratory of Emerging Infectious Diseases, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China; Department of Microbiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China; Carol Yu Centre for Infection, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China; Hainan Medical University-The University of Hong Kong Joint Laboratory of Tropical Infectious Diseases, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China. Electronic address: jfwchan@hku.hk.

Pub Type(s)

Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32516739

Citation

Yip, Cyril Chik-Yan, et al. "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, vol. 129, 2020, p. 104476.
Yip CC, Sridhar S, Cheng AK, et al. Evaluation of the commercially available LightMix® Modular E-gene kit using clinical and proficiency testing specimens for SARS-CoV-2 detection. J Clin Virol. 2020;129:104476.
Yip, C. C., Sridhar, S., Cheng, A. K., Leung, K. H., Choi, G. K., Chen, J. H., Poon, R. W., Chan, K. H., Wu, A. K., Chan, H. S., Chau, S. K., Chung, T. W., To, K. K., Tsang, O. T., Hung, I. F., Cheng, V. C., Yuen, K. Y., & Chan, J. F. (2020). 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, 129, 104476. https://doi.org/10.1016/j.jcv.2020.104476
Yip CC, et al. Evaluation of the Commercially Available LightMix® Modular E-gene Kit Using Clinical and Proficiency Testing Specimens for SARS-CoV-2 Detection. J Clin Virol. 2020;129:104476. PubMed PMID: 32516739.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of the commercially available LightMix® Modular E-gene kit using clinical and proficiency testing specimens for SARS-CoV-2 detection. AU - Yip,Cyril Chik-Yan, AU - Sridhar,Siddharth, AU - Cheng,Andrew Kim-Wai, AU - Leung,Kit-Hang, AU - Choi,Garnet Kwan-Yue, AU - Chen,Jonathan Hon-Kwan, AU - Poon,Rosana Wing-Shan, AU - Chan,Kwok-Hung, AU - Wu,Alan Ka-Lun, AU - Chan,Helen Shuk-Ying, AU - Chau,Sandy Ka-Yee, AU - Chung,Tom Wai-Hin, AU - To,Kelvin Kai-Wang, AU - Tsang,Owen Tak-Yin, AU - Hung,Ivan Fan-Ngai, AU - Cheng,Vincent Chi-Chung, AU - Yuen,Kwok-Yung, AU - Chan,Jasper Fuk-Woo, Y1 - 2020/05/27/ PY - 2020/05/23/received PY - 2020/05/26/accepted PY - 2020/6/10/pubmed PY - 2020/8/12/medline PY - 2020/6/10/entrez KW - COVID-19 KW - Diagnostic KW - Evaluation KW - LightMix E-gene KW - PCR KW - SARS-CoV-2 SP - 104476 EP - 104476 JF - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology JO - J Clin Virol VL - 129 N2 - 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 well-validated 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. SN - 1873-5967 UR - https://www.unboundmedicine.com/medline/citation/32516739/Evaluation_of_the_commercially_available_LightMix®_Modular_E_gene_kit_using_clinical_and_proficiency_testing_specimens_for_SARS_CoV_2_detection_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1386-6532(20)30218-3 DB - PRIME DP - Unbound Medicine ER -