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

TitleEvaluation of the commercially available LightMix® Modular E-gene kit using clinical and proficiency testing specimens for SARS-CoV-2 detection
Authors
KeywordsLightMix E-gene
SARS-CoV-2
COVID-19
Diagnostic
Evaluation
Issue Date2020
PublisherElsevier BV. The Journal's web site is located at http://www.elsevier.com/locate/jcv
Citation
Journal of Clinical Virology, 2020, v. 129, p. article no. 104476 How to Cite?
AbstractBackground: 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.
Persistent Identifierhttp://hdl.handle.net/10722/284254
ISSN
2019 Impact Factor: 2.777
2015 SCImago Journal Rankings: 1.503
PubMed Central ID

 

DC FieldValueLanguage
dc.contributor.authorYip, CCY-
dc.contributor.authorSridhar, S-
dc.contributor.authorCheng, AKW-
dc.contributor.authorLeung, KH-
dc.contributor.authorChoi, GKY-
dc.contributor.authorChen, JHK-
dc.contributor.authorPoon, RWS-
dc.contributor.authorChan, KH-
dc.contributor.authorWu, AKL-
dc.contributor.authorChan, HSY-
dc.contributor.authorChau, SKY-
dc.contributor.authorChung, TWH-
dc.contributor.authorTo, KKW-
dc.contributor.authorTsang, QTY-
dc.contributor.authorHung, IFN-
dc.contributor.authorCheng, VCC-
dc.contributor.authorYuen, KY-
dc.contributor.authorChan, JFW-
dc.date.accessioned2020-07-20T05:57:16Z-
dc.date.available2020-07-20T05:57:16Z-
dc.date.issued2020-
dc.identifier.citationJournal of Clinical Virology, 2020, v. 129, p. article no. 104476-
dc.identifier.issn1386-6532-
dc.identifier.urihttp://hdl.handle.net/10722/284254-
dc.description.abstractBackground: 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.-
dc.languageeng-
dc.publisherElsevier BV. The Journal's web site is located at http://www.elsevier.com/locate/jcv-
dc.relation.ispartofJournal of Clinical Virology-
dc.subjectLightMix E-gene-
dc.subjectSARS-CoV-2-
dc.subjectCOVID-19-
dc.subjectDiagnostic-
dc.subjectEvaluation-
dc.titleEvaluation of the commercially available LightMix® Modular E-gene kit using clinical and proficiency testing specimens for SARS-CoV-2 detection-
dc.typeArticle-
dc.identifier.emailYip, CCY: yipcyril@hku.hk-
dc.identifier.emailSridhar, S: sid8998@hku.hk-
dc.identifier.emailLeung, KH: khl17@hku.hk-
dc.identifier.emailChen, JHK: jonchk@hku.hk-
dc.identifier.emailPoon, RWS: rosana@hkucc.hku.hk-
dc.identifier.emailChan, KH: chankh2@hkucc.hku.hk-
dc.identifier.emailWu, AKL: alanklwu@hkucc.hku.hk-
dc.identifier.emailTo, KKW: kelvinto@hku.hk-
dc.identifier.emailHung, IFN: ivanhung@hkucc.hku.hk-
dc.identifier.emailCheng, VCC: vcccheng@hkucc.hku.hk-
dc.identifier.emailYuen, KY: kyyuen@hkucc.hku.hk-
dc.identifier.emailChan, JFW: jfwchan@hku.hk-
dc.identifier.authorityYip, CCY=rp01721-
dc.identifier.authoritySridhar, S=rp02249-
dc.identifier.authorityChan, KH=rp01921-
dc.identifier.authorityTo, KKW=rp01384-
dc.identifier.authorityHung, IFN=rp00508-
dc.identifier.authorityYuen, KY=rp00366-
dc.identifier.authorityChan, JFW=rp01736-
dc.description.naturelink_to_OA_fulltext-
dc.identifier.doi10.1016/j.jcv.2020.104476-
dc.identifier.pmid32516739-
dc.identifier.pmcidPMC7255195-
dc.identifier.scopuseid_2-s2.0-85085924980-
dc.identifier.hkuros310969-
dc.identifier.volume129-
dc.identifier.spagearticle no. 104476-
dc.identifier.epagearticle no. 104476-
dc.publisher.placeNetherlands-

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