ArticleJournal of clinical laboratory analysis2021
Analytical performance evaluation of five RT-PCR kits for severe acute respiratory syndrome coronavirus 2.
Article in Journal of clinical laboratory analysis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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Who cites it
14 citing papers in PubMed, 21 citations in OpenAlex.
- Diagnostic Concordance of Two- and Three-Gene SARS-CoV-2 Molecular Assays in Cameroon: Implications for Efficient Pandemic Response in Low- and Middle-Income Countries.Journal of clinical laboratory analysis · 2026Article
- Diagnostic value comparative analysis of the commercial kits for the detection of SARS-CoV-2 in clinical samples: a systematic review and meta-analysis.Iranian journal of microbiology · 2025Review
- Applied One Health: Nigeria National Veterinary Research Institute COVID-19 pandemic response.The Onderstepoort journal of veterinary research · 2024Article
- Visual Detection of Stem-Loop Primer Amplification (SPA) Products without Denaturation Using Peroxidase-like DNA Machines (PxDM).International journal of molecular sciences · 2023Article
- COVID-19 diagnostics: Molecular biology to nanomaterials.Clinica chimica acta; international journal of clinical chemistry · 2023Review
- Performances of four Nucleic Acid Amplification Tests for the identification of SARS-CoV-2 in Ethiopia.Scientific reports · 2022Article
- Performance comparison of two nucleic acid amplification systems for SARS-CoV-2 detection: A multi-center study.Journal of clinical laboratory analysis · 2022Article
- Comparison of Real-Q 2019-nCoV and DaAn Gene 2019-nCoV polymerase chain reaction assays for the detection of SARS-CoV-2.Journal of clinical laboratory analysis · 2022Article
- Reliable Diagnostics of SARS-CoV-2 Infections Using One- and Two-Gene Molecular Tests for a Viral RNA Detection-Results Questioning Previous Observations.Diagnostics (Basel, Switzerland) · 2021Article
- Diagnostic performance of a colorimetric RT -LAMP for the identification of SARS-CoV-2: A multicenter prospective clinical evaluation in sub-Saharan Africa.EClinicalMedicine · 2021Article
- Recurrence, Reactivation, or Inflammatory Rebound of SARS-CoV-2 Infection With Acute Vestibular Symptoms: A Case Report and Revision of Literature.Frontiers in human neuroscience · 2021Article
- Repositive RT-PCR test in discharged COVID-19 patients during medical isolation observation.International journal of medical sciences · 2021Article
- Analytical performance evaluation of five RT-PCR kits for severe acute respiratory syndrome coronavirus 2.Journal of clinical laboratory analysis · 2021Article
- Point-of-Care Diagnostic Tools for Surveillance of SARS-CoV-2 Infections.Frontiers in public health · 2021Review
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Authors and funding
10 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundWe aimed to evaluate the analytical performance of five commercial RT-PCR kits (Genekey, Daan, BioGerm, Liferiver, and Yaneng) commonly used in China, since such comparison data are lacking.
methodsA total of 20 COVID-19 confirmed patients and 30 negative nasopharyngeal swab specimens were analyzed by five kits. The detection ability of five RT-PCR kits was evaluated with 5 concentration gradients diluted by a single positive sample. The limit of detection was evaluated by N gene fragment solid standard. Two positive clinical specimens were used to evaluate the repeatability and imprecision. Finally, we used six human coronaviruses plasmid and four respiratory pathogens plasmid to check for cross-reactivity.
resultsThe positive detection rate was 100% for Genekey, Daan, and BioGerm,and 90% for Liferiver and Yaneng in 20 clinical SARS-CoV-2 infection. The coincidence rate of five kits in 10 negative samples was 100%. The detection rate of target genes for Daan, BioGerm, Liferiver, and Yaneng was 100% from Level 1 to Level 3. In Level 4, only Daan detection rate was 100%. In Level 5, five kits presented poor positive rate. The limit of detection declared by each manufacturer was verified. The repeatability for target genes was less than 5% and so did the total imprecision. There is no cross-reactivity of five kits with six human coronaviruses and four respiratory pathogens for ORF1ab and N gene.
conclusionsFive RT-PCR kits assessed in this study showed acceptable analytical performance characteristics and are useful tools for the routine diagnosis of SARS-CoV-2.
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