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Multicenter Evaluation of the Vitek 2 Anaerobe and Corynebacterium Identification Card

机译:Vitek 2厌氧菌和棒状杆菌识别卡的多中心评估

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The new anaerobe and Corynebacterium (ANC) identification card for Vitek 2 was compared with a 16S rRNA gene sequencing (16S) reference method for accuracy in the identification of corynebacteria and anaerobic species. Testing was performed on a Vitek 2 XL system with modified software at three clinical trial laboratories. Reproducibility was determined with nine ATCC quality control strains that were tested 20 times over a minimum of 10 days at all three sites. A challenge set of 50 well-characterized strains and 365 recent fresh and frozen clinical isolates were included in the study. The expected positive and negative biochemical well reactions were also evaluated for substrate reproducibility. All strains were tested with the ANC card, and clinical isolates were saved for 16S rRNA gene sequencing. All reproducibility tests yielded expected results within a 95% confidence interval, except for that with Corynebacterium striatum ATCC 6940, for which identification failed at one trial site. For the challenge isolates, there was 98% correct identification, 5% low discrimination, and 2% incorrect identification, and 0% were unidentified. For clinical strains, there was 95.1% correct identification, 4.9% low discrimination, and 4.6% incorrect identification, and 0.3% were unidentified. The 4.6% (17/365) of clinical isolates that were incorrectly identified consisted of 14 isolates that were correct at the genus level and three that were incorrect at the genus level. The new ANC card met all performance criteria within a 95% confidence interval compared to the identification performance by 16S rRNA gene sequencing.
机译:将用于Vitek 2的新型厌氧菌和棒状杆菌(ANC)识别卡与16S rRNA基因测序(16S)参考方法进行比较,以鉴定棒状细菌和厌氧菌。在三个临床试验实验室对Vitek 2 XL系统和改进的软件进行了测试。用九种ATCC质量控制菌株测定了可重复性,在所有三个地点均在至少10天的时间内对它们进行了20次测试。这项研究包括一组挑战性的50株特征明确的菌株和365种近期新鲜和冷冻的临床分离株。还评估了预期的阳性和阴性生化孔反应的底物重现性。用ANC卡测试所有菌株,并保存临床分离株用于16S rRNA基因测序。除了使用 Corynebacterium striatum ATCC 6940进行的鉴定均无法在一个试验位点进行鉴定外,所有可重复性试验均在95%的置信区间内产生了预期结果。对于挑战隔离株,有98%的正确识别,5%的低歧视和2%的不正确识别,还有0%的未识别。对于临床菌株,正确识别率为95.1%,低识别率为4.9%,错误识别率为4.6%,未识别率为0.3%。被错误鉴定的4.6%(17/365)临床分离株由14个在属水平上正确的分离株和3个在属水平上不正确的分离株组成。与通过16S rRNA基因测序的鉴定性能相比,新的ANC卡在95%的置信区间内符合所有性能标准。

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