用于检测HIV-1和HCV RNA的血液筛查检测方法的临床特异性和敏感性。

Clinical specificity and sensitivity of a blood screening assay for detection of HIV-1 and HCV RNA.

作者信息

Vargo Janet, Smith Katie, Knott Caroline, Wang Songbai, Fang Chyang, McDonough Sherrol, Giachetti Cristina, Caglioti Sally, Gammon Richard, Gilbert Denise, Jackson J Brooks, Richards William, Stramer Susan, Mimms Larry

机构信息

Gen-Probe Incorporated, San Diego, California 92121, USA.

出版信息

Transfusion. 2002 Jul;42(7):876-85. doi: 10.1046/j.1537-2995.2002.00130.x.

DOI:10.1046/j.1537-2995.2002.00130.x

PMID:12375660

Abstract

BACKGROUND

An HIV-1 and HCV NAT blood screening assay (Procleix HIV-1/HCV, Gen-Probe, Inc.) simultaneously detecting HIV-1 and HCV RNA) has been implemented. Donor plasma samples reactive in the Procleix HIV-1/HCV assay are tested with the HIV-1 and HCV discriminatory assays to resolve whether HIV-1 RNA, HCV RNA, or both are present.

STUDY DESIGN AND METHODS

To determine the specificity of the Procleix HIV-1/HCV assay, data were analyzed for samples from 192,288 donations, tested in 16-member pools. To determine sensitivity, data were analyzed for 2014 commercial samples known to contain HIV-1, HCV, or both, as well as 10 HIV-1 and 10 HCV commercial seroconversion panels.

RESULTS

The specificity of the Procleix HIV-1/HCV assay was 99.7 percent. The HIV-1 and HCV discriminatory assays showed similar specificity. The sensitivity of the Procleix HIV-1/HCV assay was 99.9, 99.6, and 100 percent, respectively, for samples containing HIV-1, HCV, or both. The Procleix discriminatory assays were comparably sensitive. The Procleix discriminatory assays detected all tested samples of known HIV-1 subtype or HCV genotype. Procleix HIV-1/HCV testing of seroconversion panels showed that the median times to a positive reaction for HIV-1 and HCV were reduced by 3 and 25 days, respectively, compared to serologic tests.

CONCLUSION

These studies support the use of the Procleix HIV-1/HCV assay for routine blood donor screening.

摘要

背景

已实施一种同时检测HIV-1和HCV RNA的HIV-1和HCV核酸血液筛查检测方法（Procleix HIV-1/HCV，基因探针公司）。在Procleix HIV-1/HCV检测中呈反应性的供体血浆样本，会用HIV-1和HCV鉴别检测方法进行检测，以确定是否存在HIV-1 RNA、HCV RNA或两者都存在。

研究设计与方法

为确定Procleix HIV-1/HCV检测方法的特异性，对192288份捐赠样本的数据进行了分析，这些样本以16人混合样本进行检测。为确定敏感性，对2014份已知含有HIV-1、HCV或两者的商业样本以及10个HIV-1和10个HCV商业血清转化样本组的数据进行了分析。

结果

Procleix HIV-1/HCV检测方法的特异性为99.7%。HIV-1和HCV鉴别检测方法显示出相似的特异性。对于含有HIV-1、HCV或两者的样本，Procleix HIV-1/HCV检测方法的敏感性分别为99.9%、99.6%和100%。Procleix鉴别检测方法具有相当的敏感性。Procleix鉴别检测方法检测出了所有已知HIV-1亚型或HCV基因型的检测样本。血清转化样本组的Procleix HIV-1/HCV检测显示，与血清学检测相比，HIV-1和HCV呈阳性反应的中位时间分别缩短了3天和25天。