Performance Evaluation of the PowerChek MERS (upE & ORF1a) Real-Time PCR Kit for the Detection of Middle East Respiratory Syndrome Coronavirus RNA
Annals of Laboratory Medicine
; : 494-498, 2017.
Article
em En
| WPRIM
| ID: wpr-224347
Biblioteca responsável:
WPRO
ABSTRACT
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 PowerChek MERS (upE & ORF1a) real-time PCR Kit (PowerChek MERS assay; Kogene Biotech, Korea) a one-step rRT-PCR assay for the qualitative detection of MERS-CoV. METHODS: We evaluated PowerChek MERS assay performance in comparison with nested RT-PCR and sequencing of the RNA-dependent RNA polymerase (RdRp) 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 PowerChek 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 PowerChek MERS assay for the upE and the open rading frame (ORF)1a were 16.2 copies/µL and 8.2 copies/µL, respectively. No cross-reactivity was observed. The diagnostic sensitivity and specificity of the PowerChek MERS assay were both 100% (95% confidence interval, 91.1–100%). CONCLUSIONS: The PowerChek 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.
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Índice:
WPRIM
Assunto principal:
Técnicas In Vitro
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RNA Polimerase Dependente de RNA
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RNA
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Sensibilidade e Especificidade
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Infecções por Coronavirus
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Transcrição Reversa
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Diagnóstico
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Limite de Detecção
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Reação em Cadeia da Polimerase em Tempo Real
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Coronavírus da Síndrome Respiratória do Oriente Médio
Tipo de estudo:
Diagnostic_studies
/
Qualitative_research
País/Região como assunto:
Asia
Idioma:
En
Revista:
Annals of Laboratory Medicine
Ano de publicação:
2017
Tipo de documento:
Article