Abstract:
BACKGROUND:During the 2015 outbreak of Middle East Respiratory Syndrome coronavirus (MERS-CoV), six different commercial MERS-CoV RNA detection kits based on real-time reverse-transcription polymerase chain reaction (rRT-PCR) were available in Korea. We performed analytical and clinical validations of these kits. METHODS:PowerChek (Kogene Biotech, Korea), DiaPlexQ (SolGent, Korea), Anyplex (Seegene, Korea), AccuPower (Bioneer, Korea), LightMix (Roche Molecular Diagnostics, Switzerland), and UltraFast kits (Nanobiosys, Korea) were evaluated. Limits of detection (LOD) with 95% probability values were estimated by testing 16 replicates of upstream of the envelope gene (upE) and open reading frame 1a (ORF1a) RNA transcripts. Specificity was estimated by using 28 nasopharyngeal swabs that were positive for other respiratory viruses. Clinical sensitivity was evaluated by using 18 lower respiratory specimens. The sensitivity test panel and the high inhibition panel were composed of nine specimens each, including eight and six specimens that were positive for MERS-CoV, respectively. RESULTS:The LODs for upE ranged from 21.88 to 263.03 copies/reaction, and those for ORF1a ranged from 6.92 to 128.82 copies/reaction. No cross-reactivity with other respiratory viruses was found. All six kits correctly identified 8 of 8 (100%) positive clinical specimens. Based on results from the high inhibition panel, PowerChek and AccuPower were the least sensitive to the presence of PCR inhibition. CONCLUSIONS:The overall sensitivity and specificity of all six assay systems were sufficient for diagnosing MERS-CoV infection. However, the analytical sensitivity and detection ability in specimens with PCR inhibition could be improved with the use of appropriate internal controls.
journal_name
Ann Lab Medjournal_title
Annals of laboratory medicineauthors
Kim MN,Ko YJ,Seong MW,Kim JS,Shin BM,Sung Hdoi
10.3343/alm.2016.36.5.450subject
Has Abstractpub_date
2016-09-01 00:00:00pages
450-6issue
5eissn
2234-3806issn
2234-3814pii
36.450journal_volume
36pub_type
杂志文章abstract::[This corrects the article on p. 439 in vol. 40.]. ...
journal_title:Annals of laboratory medicine
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journal_title:Annals of laboratory medicine
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journal_title:Annals of laboratory medicine
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journal_title:Annals of laboratory medicine
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journal_title:Annals of laboratory medicine
pub_type: 杂志文章
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更新日期:2015-01-01 00:00:00
abstract:BACKGROUND:We reviewed patients with multiple myeloma (MM) in order to assess the incidence of genetic abnormalities and their associations with clinical parameters, risk groups, and prognosis. METHODS:A total of 130 patients with MM were enrolled. The incidences of genetic abnormalities were determined in all patient...
journal_title:Annals of laboratory medicine
pub_type: 杂志文章
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journal_title:Annals of laboratory medicine
pub_type: 杂志文章
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更新日期:2019-05-01 00:00:00
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journal_title:Annals of laboratory medicine
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pub_type: 杂志文章
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更新日期:2021-03-01 00:00:00
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journal_title:Annals of laboratory medicine
pub_type: 杂志文章
doi:10.3343/alm.2015.35.6.618
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