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首页> 外文期刊>Journal of Clinical Microbiology >Comparison of an Industry-Derived LCx Chlamydia pneumoniae PCR Research Kit to In-House Assays Performed in Five Laboratories
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Comparison of an Industry-Derived LCx Chlamydia pneumoniae PCR Research Kit to In-House Assays Performed in Five Laboratories

机译:业界来源的LCx肺炎衣原体PCR研究试剂盒与在五个实验室进行的内部分析的比较

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In a multicenter comparison of PCR assays utilizing 120 quantitated samples of 16 Chlamydia pneumoniae isolates, an LCx research-use-only (RUO) PCR developed by Abbott Laboratories demonstrated 100% sensitivity on 48 samples with >1 copy of DNA per μl of specimen. The sensitivities of five in-house PCR assays ranged from 54 to 94% for the same samples. All six assays showed decreased sensitivities as the DNA copy numbers of the samples decreased. Overall, sensitivities ranged from 68% for the LCx PCR assay to 29% for one of the in-house tests. The LCx RUO PCR and three of the five in-house PCR tests reported no false positives with the 24 negative samples. Increasing the number of replicates tested increased the sensitivities of all of the assays, including the LCx PCR. The LCx RUO assay showed high reproducibility for a single technologist and between technologists, with a kappa agreement of 0.77. The within-center agreements of the five in-house PCR tests varied from 0.19 to 0.74 on two challenges of 60 specimens 1 month apart. The LCx C. pneumoniae RUO PCR shows excellent potential for use in clinical studies, which could enable standardization of results in the field.
机译:在使用120种量化的16个肺炎衣原体分离株样本进行PCR分析的多中心比较中,由雅培(Abbott Laboratories)开发的LCx仅研究使用(RUO)PCR方法对48个样本(含1个以上拷贝)具有100%的敏感性每微升样本中的DNA含量。对于相同样品,五种内部PCR测定的灵敏度范围为54%至94%。随着样品DNA拷贝数的减少,所有六个测定均显示出敏感性降低。总体而言,灵敏度范围从LCx PCR分析的68%到内部测试之一的29%。 LCx RUO PCR和五个内部PCR测试中的三个报告24个阴性样品均未出现假阳性。重复测试次数的增加增加了包括LCx PCR在内的所有测定的灵敏度。 LCx RUO分析显示单个技术人员和技术人员之间具有很高的重现性,kappa值为0.77。五个内部PCR测试的中心内一致性在两个挑战(间隔1个月)的60个样本中从0.19到0.74不等。 LCx C。肺炎RUO PCR在临床研究中显示出极好的潜力,可以使该领域的结果标准化。

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