ArticleJournal of clinical laboratory analysis2020
Laboratory verification of an RT-PCR assay for SARS-CoV-2.
Article in Journal of clinical laboratory analysis, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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The trial behind it
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Who cites it
10 citing papers in PubMed, 19 citations in OpenAlex.
- M gene targeted qRT-PCR approach for SARS-CoV-2 virus detection.Scientific reports · 2023Article
- Portable high-throughput multimodal immunoassay platform for rapid on-site COVID-19 diagnostics.Analytica chimica acta · 2023Article
- Dengue amid COVID-19 pandemic.PLOS global public health · 2023Article
- Current molecular diagnostics assays for SARS-CoV-2 and emerging variants.Methods in microbiology · 2022Article
- Evaluation of Alternative Transport Media for RT-qPCR-Based SARS-CoV-2 Testing.International journal of analytical chemistry · 2022Article
- A loop-mediated isothermal amplification-enabled analytical assay for the detection of SARS-CoV-2: A review.Frontiers in cellular and infection microbiology · 2022Review
- Rapid and Convenient Quantitative Analysis of SARS-CoV-2 RNA in Serous Saliva with a Direct PCR Method.Epidemiologia (Basel, Switzerland) · 2021Article
- Analytical performance evaluation of five RT-PCR kits for severe acute respiratory syndrome coronavirus 2.Journal of clinical laboratory analysis · 2021Article
- Comparison of four commercial RT-PCR diagnostic kits for COVID-19 in China.Journal of clinical laboratory analysis · 2021Article
- Laboratory verification of an RT-PCR assay for SARS-CoV-2.Journal of clinical laboratory analysis · 2020Article
Corrections and comments
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
Abstract
backgroundReverse transcription-polymerase chain reaction (RT-PCR) is an extremely common clinical method for detecting pathogens, particularly for emerging infectious diseases such as the new coronavirus disease (COVID-19). Currently, detection of the RNA from the novel coronavirus SARS-CoV-2 is the gold standard for establishing a COVID-19 diagnosis. This study evaluates the characteristic performance of the analytical system in a clinical laboratory.
methodsA commercial SARS-CoV-2 RNA RT-PCR Kit used in a clinical laboratory is assessed based on ISO 15189 verification requirements. A multiple real-time RT-PCR assay for the RdRP, N, and E genes in SARS-CoV-2 is verified.
resultsThe analytical system exhibits good analytical sensitivity (1000 copies/mL) and specificity (100%); however, the values of 86.7% and 100% for analytical accuracy deserved attention, compared with two other types of methods. Overall, the kit is potentially useful for SARS-CoV-2 diagnostic testing and meets the verification requirements.
conclusionCompliance with international standards, such as ISO 15189, is valuable for clinical laboratories and for improving laboratory medicine quality and safety. Normalization is essential for obtaining reliable results from the SARS-CoV-2 RNA RT-PCR assay. This study aims to develop an improved SARS-CoV-2 verification framework compared with traditional molecular diagnostic methods, given the urgency of implementing new assays in clinical laboratories.
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