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- Publisher Website: 10.1080/14737159.2021.1933445
- Scopus: eid_2-s2.0-85107473840
- PMID: 34014785
- WOS: WOS:000657928500001
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Article: Comparative evaluation of a dual-target real-time RT-PCR assay for COVID-19 diagnosis and assessment of performance in pooled saliva and nasopharyngeal swab samples
Title | Comparative evaluation of a dual-target real-time RT-PCR assay for COVID-19 diagnosis and assessment of performance in pooled saliva and nasopharyngeal swab samples |
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Authors | |
Keywords | SARS-CoV-2 COVID-19 real-time RT-PCR diagnostic test evaluation pooling |
Issue Date | 2021 |
Publisher | Taylor & Francis. The Journal's web site is located at http://www.tandfonline.com/loi/iero20#.VgGYxUaFOnI |
Citation | Expert Review of Molecular Diagnostics, 2021, v. 21, p. 741-747 How to Cite? |
Abstract | Objectives:
Sensitive molecular diagnostic assays are essential for COVID-19 diagnosis. We evaluated the Hecin Scientific SARS-CoV-2 nucleic acid test kit, a dual-target real-time RT-PCR assay targeting the SARS-CoV-2 N and ORF1ab genes.
Methods:
The Hecin test kit’s diagnostic performance in detecting SARS-CoV-2 RNA was compared to the LightMix Modular SARS and Wuhan CoV E-gene kit (TIB Molbiol) and an in-house single-tube nested real-time RT-PCR using 296 clinical specimens, 11 proficiency testing samples, and 30 low-positive deep throat saliva and nasopharyngeal swab (NPS) samples pooled into negative samples in ratios of 1:5, 1:10, and 1:30.
Results:
The limit-of-detection of the Hecin test kit was around 500 dC/mL for the N and ORF1ab targets. Sensitivity and specificity of the Hecin test kit were 98.1% (95% CI: 93.4–99.8%) and 100% (98.1–100%), respectively, when measured against the reference method. The Hecin test kit showed fair sensitivity (80%) in low-positive NPS samples pooled in ratios of 1:5 and 1:10. Its performance in pooled samples could be dramatically improved by adjusting the assay Ct cutoff.
Conclusion:
The Hecin test kit enables sensitive and specific detection of SARS-CoV-2 in clinical samples and pooled samples. |
Description | Bronze open access |
Persistent Identifier | http://hdl.handle.net/10722/304683 |
ISSN | 2021 Impact Factor: 5.670 2020 SCImago Journal Rankings: 1.482 |
PubMed Central ID | |
ISI Accession Number ID |
DC Field | Value | Language |
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dc.contributor.author | Yip, CCY | - |
dc.contributor.author | Leung, KH | - |
dc.contributor.author | Ng, ACK | - |
dc.contributor.author | Chan, KH | - |
dc.contributor.author | To, KKW | - |
dc.contributor.author | Chan, JFW | - |
dc.contributor.author | Hung, IFN | - |
dc.contributor.author | Cheng, CCV | - |
dc.contributor.author | Sridhar, S | - |
dc.date.accessioned | 2021-10-05T02:33:39Z | - |
dc.date.available | 2021-10-05T02:33:39Z | - |
dc.date.issued | 2021 | - |
dc.identifier.citation | Expert Review of Molecular Diagnostics, 2021, v. 21, p. 741-747 | - |
dc.identifier.issn | 1473-7159 | - |
dc.identifier.uri | http://hdl.handle.net/10722/304683 | - |
dc.description | Bronze open access | - |
dc.description.abstract | Objectives: Sensitive molecular diagnostic assays are essential for COVID-19 diagnosis. We evaluated the Hecin Scientific SARS-CoV-2 nucleic acid test kit, a dual-target real-time RT-PCR assay targeting the SARS-CoV-2 N and ORF1ab genes. Methods: The Hecin test kit’s diagnostic performance in detecting SARS-CoV-2 RNA was compared to the LightMix Modular SARS and Wuhan CoV E-gene kit (TIB Molbiol) and an in-house single-tube nested real-time RT-PCR using 296 clinical specimens, 11 proficiency testing samples, and 30 low-positive deep throat saliva and nasopharyngeal swab (NPS) samples pooled into negative samples in ratios of 1:5, 1:10, and 1:30. Results: The limit-of-detection of the Hecin test kit was around 500 dC/mL for the N and ORF1ab targets. Sensitivity and specificity of the Hecin test kit were 98.1% (95% CI: 93.4–99.8%) and 100% (98.1–100%), respectively, when measured against the reference method. The Hecin test kit showed fair sensitivity (80%) in low-positive NPS samples pooled in ratios of 1:5 and 1:10. Its performance in pooled samples could be dramatically improved by adjusting the assay Ct cutoff. Conclusion: The Hecin test kit enables sensitive and specific detection of SARS-CoV-2 in clinical samples and pooled samples. | - |
dc.language | eng | - |
dc.publisher | Taylor & Francis. The Journal's web site is located at http://www.tandfonline.com/loi/iero20#.VgGYxUaFOnI | - |
dc.relation.ispartof | Expert Review of Molecular Diagnostics | - |
dc.rights | This is an Accepted Manuscript of an article published by Taylor & Francis in [JOURNAL TITLE] on [date of publication], available online: http://www.tandfonline.com/[Article DOI]. | - |
dc.subject | SARS-CoV-2 | - |
dc.subject | COVID-19 | - |
dc.subject | real-time RT-PCR | - |
dc.subject | diagnostic test evaluation | - |
dc.subject | pooling | - |
dc.title | Comparative evaluation of a dual-target real-time RT-PCR assay for COVID-19 diagnosis and assessment of performance in pooled saliva and nasopharyngeal swab samples | - |
dc.type | Article | - |
dc.identifier.email | Yip, CCY: yipcyril@hku.hk | - |
dc.identifier.email | Leung, KH: khl17@hku.hk | - |
dc.identifier.email | Chan, KH: chankh2@hkucc.hku.hk | - |
dc.identifier.email | To, KKW: kelvinto@hku.hk | - |
dc.identifier.email | Chan, JFW: jfwchan@hku.hk | - |
dc.identifier.email | Hung, IFN: ivanhung@hkucc.hku.hk | - |
dc.identifier.email | Sridhar, S: sid8998@hku.hk | - |
dc.identifier.authority | Yip, CCY=rp01721 | - |
dc.identifier.authority | Chan, KH=rp01921 | - |
dc.identifier.authority | To, KKW=rp01384 | - |
dc.identifier.authority | Chan, JFW=rp01736 | - |
dc.identifier.authority | Hung, IFN=rp00508 | - |
dc.identifier.authority | Sridhar, S=rp02249 | - |
dc.description.nature | link_to_OA_fulltext | - |
dc.identifier.doi | 10.1080/14737159.2021.1933445 | - |
dc.identifier.pmid | 34014785 | - |
dc.identifier.pmcid | PMC8182820 | - |
dc.identifier.scopus | eid_2-s2.0-85107473840 | - |
dc.identifier.hkuros | 325981 | - |
dc.identifier.volume | 21 | - |
dc.identifier.spage | 741 | - |
dc.identifier.epage | 747 | - |
dc.identifier.isi | WOS:000657928500001 | - |
dc.publisher.place | United Kingdom | - |