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Liaison® XL Murex重组HTLV-I/II免疫分析在血清中HTLV-1/2抗体检测中的性能

Performance of the Liaison® XL Murex recHTLV-I/II Immunoassay in the Detection of HTLV-1/2 Antibodies in Serum.

作者信息

Gantner Pierre, Velay Aurelie, Guigue Nicolas, Barth Heidi, Wendling Marie-Josee, Delaugerre Constance, Fafi-Kremer Samira

出版信息

Clin Lab. 2017 May 1;63(5):997-1001. doi: 10.7754/Clin.Lab.2017.161026.

DOI:10.7754/Clin.Lab.2017.161026
PMID:28627820
Abstract

BACKGROUND

Human T-cell lymphotropic virus type 1 and 2 (HTLV-1/2) immunoassays are used for blood screen- ing from blood products, milk, and organ donors.

METHODS

We assessed the performance of the DiaSorin Liaison® XL murex recHTLV-I/II immunoassay relative to the Abbott Architect® rHTLV-I/II immunoassay and with the Innogenetics immunoblot as confirmation.

RESULTS

A panel of HTLV positive (n = 66) and negative (n = 30) sera was tested in both techniques within the same freeze/thaw cycle. The specificity and sensitivity of DiaSorin immunoassay were 100% and 78.8%, respectively. Abbott and DiaSorin immunoassays showed a correlation in chemiluminiscent signals to cutoff (S/CO) (Pearson r = 0.92). Half of the samples (34/66) from the seropositive panel were not confirmed by immunoblot (S/CO < 5 in both techniques).

CONCLUSIONS

Our data confirmed that the DiaSorin Liaison® XL murex recHTLV-I/II immunoassay is an effective platform for HTLV screening. Due to false-positive reaction, especially for samples with low S/CO, each seropositive sample should be confirmed by immunoblot.

摘要

背景

人类嗜T淋巴细胞病毒1型和2型(HTLV-1/2)免疫测定法用于对血液制品、牛奶和器官捐献者的血液进行筛查。

方法

我们评估了DiaSorin Liaison® XL murex recHTLV-I/II免疫测定法相对于雅培Architect® rHTLV-I/II免疫测定法的性能,并以内基因免疫印迹法作为确认方法。

结果

在同一冻融循环中,用这两种技术对一组HTLV阳性(n = 66)和阴性(n = 30)血清进行了检测。DiaSorin免疫测定法的特异性和敏感性分别为100%和78.8%。雅培和DiaSorin免疫测定法在化学发光信号与临界值(S/CO)方面显示出相关性(Pearson r = 0.92)。血清阳性组的一半样本(34/66)未通过免疫印迹法确认(两种技术的S/CO均<5)。

结论

我们的数据证实,DiaSorin Liaison® XL murex recHTLV-I/II免疫测定法是一种有效的HTLV筛查平台。由于存在假阳性反应,尤其是对于S/CO较低的样本,每个血清阳性样本都应通过免疫印迹法进行确认。

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