tetano
Editor, Senior Moderator
Infect Drug Resist
. 2022 Feb 22;15:595-603.
doi: 10.2147/IDR.S349669. eCollection 2022.
Clinical Comparative Evaluation of the LabTurbo [SUP]TM[/SUP] AIO [SUP]®[/SUP] Reverse Transcription-Polymerase Chain Reaction and World Health Organization-Recommended Assays for the Detection of Emerging SARS-CoV-2 Variants of Concern
Chih-Kai Chang[SUP] #[/SUP][SUP] 1 [/SUP], Ming-Jr Jian[SUP] #[/SUP][SUP] 1 [/SUP], Hsing-Yi Chung[SUP] 1 [/SUP], Jung-Chung Lin[SUP] 2 [/SUP], Shan-Shan Hsieh[SUP] 1 [/SUP], Sheng-Hui Tang[SUP] 1 [/SUP], Cherng-Lih Perng[SUP] 1 [/SUP], Chien-Wen Chen[SUP] 3 [/SUP], Kuo-Sheng Hung[SUP] 4 [/SUP], Feng-Yee Chang[SUP] 2 [/SUP], Hung-Sheng Shang[SUP] 1 [/SUP]
Affiliations
Abstract
Purpose: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent behind coronavirus disease-2019 (COVID-19). Single-plex reverse transcription-polymerase chain reaction (RT-PCR)-based assays are widely used for COVID-19 detection but exhibit decreased sensitivity and specificity in detecting the rapidly spreading SARS-CoV-2 variants; in contrast, multiplex RT-PCR reportedly yields better results. Here, we aimed at comparatively analyzing the clinical performance of the LabTurbo[SUP]TM[/SUP] AIO COVID-19 RNA testing kit, a multiplex quantitative RT-PCR kit, including a three-target (E, N1, and RNase P), single-reaction, triplex assay used for SARS-CoV-2 detection, with that of the WHO-recommended RT-PCR assay.
Materials and methods: Residual, natural, nasopharyngeal swabs obtained from universal transport medium specimens at SARS-CoV-2 testing centers (n = 414) were collected from May to October 2021. For SARS-CoV-2 qRT-PCR, total viral nucleic acid was extracted. The limit of detection (LOD) and the comparative clinical performances of the LabTurbo[SUP]TM[/SUP] AIO COVID-19 RNA kit and the WHO-recommended RT-PCR assay were assessed. Statistical analysis of the correlation was performed and results with R[SUP]2[/SUP] values >0.9 were considered to be highly correlated.
Results: The LOD of the LabTurbo[SUP]TM[/SUP] AIO COVID-19 RNA kit was 9.4 copies/reaction for the target genes N1 and E. The results obtained from 102 SARS-CoV-2-positive and 312 SARS-CoV-2-negative samples showed 100% correlation with previous WHO-recommended RT-PCR assay results.
Conclusion: Multiplex qRT-PCR is a critical tool for detecting unknown pathogens and employs multiple target genes. The LabTurbo[SUP]TM[/SUP] AIO COVID-19 RNA testing kit provides an effective and efficient assay for SARS-CoV-2 detection and is highly compatible with SARS-CoV-2 variants.
Keywords: COVID-19; COVID-19 RNA testing kit; SARS-CoV-2; multiplex qRT-PCR; variants of concern.
. 2022 Feb 22;15:595-603.
doi: 10.2147/IDR.S349669. eCollection 2022.
Clinical Comparative Evaluation of the LabTurbo [SUP]TM[/SUP] AIO [SUP]®[/SUP] Reverse Transcription-Polymerase Chain Reaction and World Health Organization-Recommended Assays for the Detection of Emerging SARS-CoV-2 Variants of Concern
Chih-Kai Chang[SUP] #[/SUP][SUP] 1 [/SUP], Ming-Jr Jian[SUP] #[/SUP][SUP] 1 [/SUP], Hsing-Yi Chung[SUP] 1 [/SUP], Jung-Chung Lin[SUP] 2 [/SUP], Shan-Shan Hsieh[SUP] 1 [/SUP], Sheng-Hui Tang[SUP] 1 [/SUP], Cherng-Lih Perng[SUP] 1 [/SUP], Chien-Wen Chen[SUP] 3 [/SUP], Kuo-Sheng Hung[SUP] 4 [/SUP], Feng-Yee Chang[SUP] 2 [/SUP], Hung-Sheng Shang[SUP] 1 [/SUP]
Affiliations
- PMID: 35237052
- PMCID: PMC8882663
- DOI: 10.2147/IDR.S349669
Abstract
Purpose: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent behind coronavirus disease-2019 (COVID-19). Single-plex reverse transcription-polymerase chain reaction (RT-PCR)-based assays are widely used for COVID-19 detection but exhibit decreased sensitivity and specificity in detecting the rapidly spreading SARS-CoV-2 variants; in contrast, multiplex RT-PCR reportedly yields better results. Here, we aimed at comparatively analyzing the clinical performance of the LabTurbo[SUP]TM[/SUP] AIO COVID-19 RNA testing kit, a multiplex quantitative RT-PCR kit, including a three-target (E, N1, and RNase P), single-reaction, triplex assay used for SARS-CoV-2 detection, with that of the WHO-recommended RT-PCR assay.
Materials and methods: Residual, natural, nasopharyngeal swabs obtained from universal transport medium specimens at SARS-CoV-2 testing centers (n = 414) were collected from May to October 2021. For SARS-CoV-2 qRT-PCR, total viral nucleic acid was extracted. The limit of detection (LOD) and the comparative clinical performances of the LabTurbo[SUP]TM[/SUP] AIO COVID-19 RNA kit and the WHO-recommended RT-PCR assay were assessed. Statistical analysis of the correlation was performed and results with R[SUP]2[/SUP] values >0.9 were considered to be highly correlated.
Results: The LOD of the LabTurbo[SUP]TM[/SUP] AIO COVID-19 RNA kit was 9.4 copies/reaction for the target genes N1 and E. The results obtained from 102 SARS-CoV-2-positive and 312 SARS-CoV-2-negative samples showed 100% correlation with previous WHO-recommended RT-PCR assay results.
Conclusion: Multiplex qRT-PCR is a critical tool for detecting unknown pathogens and employs multiple target genes. The LabTurbo[SUP]TM[/SUP] AIO COVID-19 RNA testing kit provides an effective and efficient assay for SARS-CoV-2 detection and is highly compatible with SARS-CoV-2 variants.
Keywords: COVID-19; COVID-19 RNA testing kit; SARS-CoV-2; multiplex qRT-PCR; variants of concern.