[Evaluation of procleix HIV/HCV RNA diagnostic assay].
BACKGROUND
To investigate the sensitivity and specificity of Procleix HIV/HCV RNA diagnostic assay.


METHODS
HIV antibody positive or suspected positive plasmas of blood donors were collected from different provinces and detected with HIV antibody ELISA and HCV antibody ELISA. Samples positive for HIV by ELISA were confirmed by using HIV Blot. All the plasma samples were detected with Procleix HIV/HCV assay, HIV-1 discriminatory assay and HCV discriminatory assay, respectively.


RESULTS
All 74 samples positive for both HIV and HCV antibody were positive and 5 samples negative for both HIV and HCV antibody were negative when detected using Procleix HIV/HCV assay; 82 of 84 supplemental HIV antibody positive samples and 6 of 12 supplemental indeterminate samples were positive for HIV RNA, and all 7 HIV antibody negative samples were negative for HIV RNA when detected by using Procleix HIV discriminatory assay. Seventy of 81 HCV antibody positive samples and 4 of 22 HCV antibody negative samples were positive for HCV RNA when detected by using Procleix HCV discriminatory assay.


CONCLUSIONS
This reagent is more sensitive and could be used in blood screening, thereby can reduce both HIV and HCV transmission of blood in window period of HIV and HCV infection.
Song
Ai-jing
AJ
Department of Cell Biology, National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China.
Zhang
Chun-tao
CT
Li
Xiu-hua
XH
Li
Juan
J
Wang
You-chun
YC
D001782:Blood Donors; D015658:HIV Infections / Q000175:diagnosis / Q000517:prevention & control / Q000821:virology; D015497:HIV-1 / Q000235:genetics*; D016174:Hepacivirus / Q000235:genetics*; D006526:Hepatitis C / Q000175:diagnosis / Q000517:prevention & control / Q000821:virology; D006801:Humans; D021141:Nucleic Acid Amplification Techniques / Q000295:instrumentation / Q000379:methods; D012367:RNA, Viral / Q000097:blood* / Q000235:genetics; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D012367:RNA, Viral