๐ Performance evaluation of the PowerChek MERS (upE & ORF1a) real-time PCR kit for the detection of middle east respiratory syndrome coronavirus RNA
Background: Molecular detection of Middle East respiratory syndrome coronavirus (MERS-CoV) using real-time reverse transcription (rRT)-PCR assays is the method of choice for diagnosis of MERS. We evaluated the performance of the Power. Chek MERS (upE & ORF1a) real-time PCR Kit (Power. Chek MERS assay; Kogene Biotech, Korea) a one-step rRT-PCR assay for the qualitative detection of MERS-CoV. Methods: We evaluated Power. Chek MERS assay performance in comparison with nested RT-PCR and sequencing of the RNA-dependent RNA polymerase (Rd. Rp) and N genes. To evaluate diagnostic sensitivity and specificity, 100 clinical specimens (50 positive and 50 negative for MERS-CoV) were simultaneously tested by using the Power. Chek MERS and sequencing assays. Assay performance, including limit of detection and precision, was evaluated in vitro by using MERS-CoV RNA transcripts. Analytical specificity was evaluated with a diverse collection of 16 respiratory virus-positive clinical specimens and 14 respiratory bacterial isolates. Results: The 95% limits of detection of the Power. Chek MERS assay for the upE and the open rading frame (ORF)1a were 16.2 copies/ฮผL and 8.2 copies/ฮผL, respectively. No cross-reactivity was observed. The diagnostic sensitivity and specificity of the Power. Chek MERS assay were both 100% (95% confidence interval, 91.1-100%). Conclusions: The Power. Chek MERS assay is a straightforward and accurate assay for detecting MERS-CoV RNA. The assay will be a useful tool for the rapid diagnosis of MERS and could prove especially important for MERS outbreak control.
keywords
๐ syndrome coronavirus (1074)
๐ reverse transcription (205)
๐ real-time reverse (87)
๐ clinical specimens (44)
๐ respiratory syndrome (2004)
๐ confidence interval (64)
author
๐ค Huh, Hee Jae
๐ค Kim, Ji Youn
๐ค Kwon, Hyeon Jeong
๐ค Yun, Sun Ae
๐ค Lee, Myoung Keun
๐ค Ki, Chang Seok
๐ค Lee, Nam Yong
๐ค Kim, Jong Won
year
โฐ 2017
issn
๐ 22343814 22343806
volume
37
number
6
page
494-498
citedbycount
2
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