Development of an immunoassay for differentiating human immunodeficiency virus infections--from vaccine-induced immune response in Tiantan vaccine trials in China.

Abstract:

OBJECTIVE:To develop a Rapid Flow-through assay for distinguishing replicating Tiantan vaccine-generated serological response from true HIV infection. DESIGN AND METHOD:A Rapid Flow-through Test including gp41, gp36, sk1, sk2 and sk3 antigens was established and the performance of the assay was evaluated in clinical studies and compared with ELISA assay. RESULTS:Sk1, sk2 and sk3 peptides performed at 100% specificity and slightly but not significantly different sensitivities between ELISA assay (92%, 76% and 41%) and Flow-through Test Kit (92%, 75% and 40%) in diagnosing HIV-1 infections. Of particular importance, Tiantan vaccine recipients that gave false-positive results in gp41 serodetection scored negative for sk1, sk2 and sk3 antibodies. CONCLUSION:The Rapid Flow-through Test could be a robust tool in both diagnosing HIV-1/2 infections and differentiating between vaccines induced immunity and immunity resulting from natural exposure, thus serving as potential implementation in HIV vaccine trials.

journal_name

Clin Biochem

journal_title

Clinical biochemistry

authors

Yuan Z,Chen W,Zhang J,Zhang J,Xiang T,Hu J,Wu Z,Du X,Huang A,Zheng J

doi

10.1016/j.clinbiochem.2012.05.013

subject

Has Abstract

pub_date

2012-10-01 00:00:00

pages

1219-24

issue

15

eissn

0009-9120

issn

1873-2933

pii

S0009-9120(12)00248-2

journal_volume

45

pub_type

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