艾滋病尿诊断试剂河南现场考核结果

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为了考核由FDA批准、中国SDA注册的美国卡里普特生物医学公司(Calypte Biomedical Corpora-tion)生产的尿液艾滋病病毒(HIV-1)酶联免疫诊断试剂在现场作为初筛试剂的效果,我们在河南省进行其它项目调查时,将该尿诊断试剂与荷兰进口的检测血液HIV抗体的阿克苏试剂进行比较,结果见表1。 本次考核由于样本量较小,结果仅供参考,但值得一提的是,尿诊断试剂实验显示,HIV抗体阳性标本与阴性标本的OD值与cut off值均有较大的距离,因此十分容易判断。本次实验的cut off值为0.334,其中13份HIV抗体阳性标本中OD值大于 In order to assess the effectiveness of the HIV-1 ELISA test produced by SDA-registered Calypte Biomedical Corpora in the field as a primary screening reagent approved by the FDA, We conducted other projects in Henan Province survey, the urine diagnostic reagents imported from the Netherlands and the detection of blood HIV antibody Akesu reagent comparison, the results in Table 1. Due to the small sample size for this assessment, the results are for reference only, but it is worth mentioning that urine diagnostic reagents showed that HIV antibody-positive specimens and negative specimens OD values ​​and cut off values ​​are a large distance, so very Easy to judge. The cut off value of this experiment was 0.334, of which 13 were positive for OD value in HIV antibody positive samples
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