2020
DOI: 10.1002/jcla.23605
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Comparison of four commercial RT‐PCR diagnostic kits for COVID‐19 in China

Abstract: We compared the sensitivity and specificity of four commercial coronavirus disease (COVID‐19) diagnostic kits using real‐time reverse transcription–polymerase chain reaction (RT‐PCR). Kits I‐IV approved by the State Drug Administration of China were selected, and the detection targets were ORF1ab gene and N gene. Specificity was evaluated by detecting other respiratory viruses. The sensitivity and batch effect of each kit were evaluated by testing 10‐fold dilutions of RNA. Clinical application was verified by … Show more

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Cited by 15 publications
(8 citation statements)
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“…The authors conclude that this is likely the result of the use of half the elution volume and thus a higher RNA concentration. Also, there are similar studies by van Kasteren et al (35) and Shen et al (36), but about the evaluation of diagnostic kits. Very few studies have carried out this type of evaluation, and it is impossible to compare the results of this study directly.…”
Section: Evaluation Of Performance Characteristics Of Kitsmentioning
confidence: 66%
“…The authors conclude that this is likely the result of the use of half the elution volume and thus a higher RNA concentration. Also, there are similar studies by van Kasteren et al (35) and Shen et al (36), but about the evaluation of diagnostic kits. Very few studies have carried out this type of evaluation, and it is impossible to compare the results of this study directly.…”
Section: Evaluation Of Performance Characteristics Of Kitsmentioning
confidence: 66%
“…A number of studies have independently evaluated SARS-CoV-2 diagnostic kits with various performance outcomes ( 12 17 ). In this study, we evaluated the analytical performance of four standalone SARS-COV-2 RT-PCR kits that are available in South Africa, using a concise testing panel.…”
Section: Discussionmentioning
confidence: 99%
“…Despite the presence of many serum-based laboratory tests, antibody detection serological tests and many real-time PCR-based assays, most still have drawbacks. Moreover, there is great variability in the sensitivity and specificity of existing PCR-based tests, depending on the vendor, the strain, the viral load and the location at which the swab is used [43,44]. Additionally, PCR results should be correlated with patient history and symptoms for infection confirmation; for instance, a negative COVID-19 PCR test does not exclude infection for the above-mentioned reasons.…”
Section: Discussionmentioning
confidence: 99%