tetano
Editor, Senior Moderator
J Clin Microbiol
. 2020 Jun 1;JCM.00936-20.
doi: 10.1128/JCM.00936-20. Online ahead of print.
Clinical Performance of the Luminex NxTAG CoV Extended Panel for SARS-CoV-2 Detection in Nasopharyngeal Specimens of COVID-19 Patients in Hong Kong
Jonathan Hon-Kwan Chen[SUP] 1 2 [/SUP], Cyril Chik-Yan Yip[SUP] 3 2 [/SUP], Jasper Fuk-Woo Chan[SUP] 2 4 [/SUP], Rosana Wing-Shan Poon[SUP] 3 2 [/SUP], Kelvin Kai-Wang To[SUP] 2 4 [/SUP], Kwok-**** Chan[SUP] 2 4 [/SUP], Vincent Chi-Chung Cheng[SUP] 3 2 [/SUP], Kwok-Yung Yuen[SUP] 2 4 [/SUP]
Affiliations
Abstract
In December 2019, the coronavirus disease 2019 (COVID-19) pandemic caused by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) was first reported in the Hubei Province of China and later spread all over the world. There was an urgent need of a high-throughput molecular testing for screening the COVID-19 patients in the community. The Luminex NxTAG CoV Extended Panel is a high-throughput FDA emergency use authorized molecular diagnostic assay for SARS-CoV-2 detection. This system targets three genes (ORF1ab, N and E gene) of SARS-CoV-2, ORF1ab region of SARS-CoV and ORF5 region of MERS-CoV.In this study, we evaluated the diagnostic performance of this system with nasopharyngeal swab specimens of 214 suspected COVID-19 patients in Hong Kong. The results were compared with our routine COVID-19 RT-PCR protocol with LightMix SarbecoV E-gene kit and an in-house RdRp/Hel RT-PCR assay. The NxTAG CoV Extended panel demonstrated a 97.8% sensitivity and 100% specificity to SARS-CoV-2 in nasopharyngeal specimens. On low viral load specimens, the sensitivity of the NxTAG panel could still maintain at 85.71%. High agreement was observed between the NxTAG panel and the routine COVID-19 RT-PCR protocol (kappa value = 0.98). Overall the E gene target of the NxTAG panel demonstrated the highest sensitivity among the three SARS-CoV-2 targets while the N gene targets demonstrated the least.In conclusion, the NxTAG CoV Extended Panel is simple to use and it has high diagnostic sensitivity and specificity to SARS-CoV-2 in nasopharyngeal specimens. we recommend this diagnostic system for high-throughput COVID-19 screening in the community.
. 2020 Jun 1;JCM.00936-20.
doi: 10.1128/JCM.00936-20. Online ahead of print.
Clinical Performance of the Luminex NxTAG CoV Extended Panel for SARS-CoV-2 Detection in Nasopharyngeal Specimens of COVID-19 Patients in Hong Kong
Jonathan Hon-Kwan Chen[SUP] 1 2 [/SUP], Cyril Chik-Yan Yip[SUP] 3 2 [/SUP], Jasper Fuk-Woo Chan[SUP] 2 4 [/SUP], Rosana Wing-Shan Poon[SUP] 3 2 [/SUP], Kelvin Kai-Wang To[SUP] 2 4 [/SUP], Kwok-**** Chan[SUP] 2 4 [/SUP], Vincent Chi-Chung Cheng[SUP] 3 2 [/SUP], Kwok-Yung Yuen[SUP] 2 4 [/SUP]
Affiliations
- PMID: 32482633
- DOI: 10.1128/JCM.00936-20
Abstract
In December 2019, the coronavirus disease 2019 (COVID-19) pandemic caused by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) was first reported in the Hubei Province of China and later spread all over the world. There was an urgent need of a high-throughput molecular testing for screening the COVID-19 patients in the community. The Luminex NxTAG CoV Extended Panel is a high-throughput FDA emergency use authorized molecular diagnostic assay for SARS-CoV-2 detection. This system targets three genes (ORF1ab, N and E gene) of SARS-CoV-2, ORF1ab region of SARS-CoV and ORF5 region of MERS-CoV.In this study, we evaluated the diagnostic performance of this system with nasopharyngeal swab specimens of 214 suspected COVID-19 patients in Hong Kong. The results were compared with our routine COVID-19 RT-PCR protocol with LightMix SarbecoV E-gene kit and an in-house RdRp/Hel RT-PCR assay. The NxTAG CoV Extended panel demonstrated a 97.8% sensitivity and 100% specificity to SARS-CoV-2 in nasopharyngeal specimens. On low viral load specimens, the sensitivity of the NxTAG panel could still maintain at 85.71%. High agreement was observed between the NxTAG panel and the routine COVID-19 RT-PCR protocol (kappa value = 0.98). Overall the E gene target of the NxTAG panel demonstrated the highest sensitivity among the three SARS-CoV-2 targets while the N gene targets demonstrated the least.In conclusion, the NxTAG CoV Extended Panel is simple to use and it has high diagnostic sensitivity and specificity to SARS-CoV-2 in nasopharyngeal specimens. we recommend this diagnostic system for high-throughput COVID-19 screening in the community.