Selected article for: "clinical validation and wide range"
Author: Kim, Mi-Na; Ko, Young Jin; Seong, Moon-Woo; Kim, Jae-Seok; Shin, Bo-Moon; Sung, Heungsup
Title: Analytical and Clinical Validation of Six Commercial Middle East Respiratory Syndrome Coronavirus RNA Detection Kits Based on Real-Time Reverse-Transcription PCR
  • Document date: 2016_6_24
    • ID: 1le537yd_8
    Snippet: Based on validation tests including 28 specificity panel and nine clinical specimens, the clinical sensitivities of detecting upE and ORF1a were 100% (95% CI, 0.60-1.00) for all study kits. Specificity was 100% (95% CI, 0.79-1.00). The positive samples showed a wide range of Ct values, with values between 7.6 and 11.6 resulting from all kits ( Table 2 ). The Ct values of the internal control varied most with PowerChek, from 22.7-32.1, while those.....
    Document: Based on validation tests including 28 specificity panel and nine clinical specimens, the clinical sensitivities of detecting upE and ORF1a were 100% (95% CI, 0.60-1.00) for all study kits. Specificity was 100% (95% CI, 0.79-1.00). The positive samples showed a wide range of Ct values, with values between 7.6 and 11.6 resulting from all kits ( Table 2 ). The Ct values of the internal control varied most with PowerChek, from 22.7-32.1, while those of DiaPlexQ, Anyplex, AccuPower, LightMix, and UltraFast all varied by < 1.0 (Table 2 ). ORF1b, tested by the DiaPlexQ kit, was detected in only five positive specimens (62.5%). The upE results of the UltraFast kit were not available for three positive specimens because one of the capillary PCR chambers holding these specimens leaked.

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