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检测人类免疫缺陷病毒抗体的商用试剂盒的敏感性和可重复性研究。

Studies of the sensitivity and reproducibility of commercial kits to detect antibodies to the human immunodeficiency virus.

作者信息

Ujhelyi E, Füst G, Mihaleczky G, Králl G, Zimonyi I, Nagy K, Mayer V, Hollán S R

出版信息

Transfusion. 1987 Mar-Apr;27(2):210-2. doi: 10.1046/j.1537-2995.1987.27287150204.x.

DOI:10.1046/j.1537-2995.1987.27287150204.x
PMID:3029906
Abstract

Nine serial three-fold dilutions (1:1 to 1:6561) were prepared from 18 sera obtained from hemophiliacs confirmed to have antibodies to the human immunodeficiency virus. The dilutions were tested with five different commercial enzyme immunoassay kits and twelve sera were retested 5 to 7 months later by different lots of three kits. The dilution that gave an absorbance (OD) equal to the cut-off OD was considered as the titer of antibody. Sensitivities of the kits were compared by statistical and regression analysis; the same approach was used for studying reproducibility from the results of retesting. The highest titers were found with the Wellcome kit, the lowest with Organon and Pasteur kits, whereas intermediate values were found with the Sorin/Biomedica and Electronucleonics kits. With the Organon and Wellcome kits, excellent reproducibility was observed on later retesting; however, a significant change in titers was seen on retesting the Sorin kit.

摘要

从确诊感染人类免疫缺陷病毒抗体的血友病患者身上采集了18份血清,制备了9个系列的三倍稀释液(1:1至1:6561)。用5种不同的商业酶免疫分析试剂盒对这些稀释液进行检测,并在5至7个月后用不同批次的3种试剂盒对12份血清进行重新检测。将吸光度(OD)等于临界OD的稀释度视为抗体滴度。通过统计和回归分析比较试剂盒的灵敏度;采用相同方法研究重新检测结果的可重复性。发现威康试剂盒的滴度最高,欧加农和巴斯德试剂盒的滴度最低,而索林/生物医学和电子核子学试剂盒的滴度处于中间值。使用欧加农和威康试剂盒时,重新检测显示出极好的可重复性;然而,重新检测索林试剂盒时,滴度出现了显著变化。

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