Acar Ali, Kemahli Sabri, Altunay Husnu, Kosan Erdogan, Oncul Oral, Gorenek Levent, Cavuslu Saban
Department of Infectious Disease and Clinical Microbiology, Gulhane Military Medical Academy, Haydarpasa Training Hospital, Uskudar, Istanbul.
Transfus Med. 2010 Jun;20(3):152-9. doi: 10.1111/j.1365-3148.2009.00987.x. Epub 2010 Jan 5.
The purpose of this study was to investigate the intra-assay correlations amongst initial reactive and repeat screening results used in enzyme immunoassays (EIAs) for hepatitis B virus (HBV), hepatitis C virus (HCV) and HIV in blood donors. This study evaluated the value of using the power of the signal to cut-off (S/CO) ratio index for confirming anti-HCV/HIV reactive screening results, thereby touching upon the utility of S/CO indices in determining whether further confirmatory testing was necessary. Screening test results of the 72,695 blood donors were evaluated over a 1-year period. Correlation analysis among each initial test and retests was done by Pearson r test. Appropriate S/CO values to determine the need of the confirmation testing was investigated by ROC analyses. EIA intra-assay correlations were of statistical significance and were determined as follows: 0.948 for anti-HCV, 0.827 for anti-HIV and 0.948 for HBsAg. The threshold S/CO ratio values which predicted more than 95% of the confirmation test result were 3.8 for HCV and 5.6 for HIV. We were able to demonstrate a strong level of intra-assay correlation amongst EIAs, thereby eliminating the need for repetition of the screening test. Hence, we suggest that repeat screening should only be limited to HBV and HIV tests with low EIA S/CO ratios. Thus, using the power of the S/CO ratio in determining the need for HCV confirmation testing can be a cost-effective measure, especially if the S/CO value is >or=3.8.
本研究的目的是调查在献血者中用于乙型肝炎病毒(HBV)、丙型肝炎病毒(HCV)和人类免疫缺陷病毒(HIV)酶免疫测定(EIA)的初始反应性和重复筛查结果之间的批内相关性。本研究评估了使用信号与临界值(S/CO)比值指数来确认抗HCV/HIV反应性筛查结果的价值,从而涉及S/CO指数在确定是否需要进一步确证检测方面的效用。在1年的时间里对72695名献血者的筛查检测结果进行了评估。通过Pearson r检验对每次初始检测和重新检测之间进行相关性分析。通过ROC分析研究用于确定是否需要确证检测的合适S/CO值。EIA批内相关性具有统计学意义,结果如下:抗HCV为0.948,抗HIV为0.827,乙肝表面抗原(HBsAg)为0.948。预测超过95%确证检测结果的临界S/CO比值,HCV为3.8,HIV为5.6。我们能够证明EIA之间存在很强的批内相关性,从而无需重复筛查检测。因此,我们建议重复筛查应仅限于EIA S/CO比值较低的HBV和HIV检测。因此,在确定是否需要进行HCV确证检测时使用S/CO比值可能是一种具有成本效益的措施,特别是当S/CO值≥3.8时。