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10.1080/14737159.2021.1933445

http://scihub22266oqcxt.onion/10.1080/14737159.2021.1933445
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suck abstract from ncbi


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pmid34014785      Expert+Rev+Mol+Diagn 2021 ; 21 (7): 741-747
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  • 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 #MMPMID34014785
  • Yip CCY; Leung KH; Ng ACK; Chan KH; To KKW; Chan JFW; Hung IFN; Cheng VCC; Sridhar S
  • Expert Rev Mol Diagn 2021[Jul]; 21 (7): 741-747 PMID34014785show ga
  • 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.
  • |*COVID-19 Nucleic Acid Testing[MESH]
  • |*COVID-19/diagnosis/genetics[MESH]
  • |*Real-Time Polymerase Chain Reaction[MESH]
  • |*Reverse Transcriptase Polymerase Chain Reaction[MESH]
  • |*Specimen Handling[MESH]
  • |Humans[MESH]
  • |RNA, Viral/genetics[MESH]


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