[Evaluation of procleix HIV/HCV RNA diagnostic assay].

Zhonghua Shi Yan He Lin Chuang Bing Du Xue Za Zhi

Department of Cell Biology, National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China.

Published: March 2006

AI Article Synopsis

  • The study assessed the effectiveness of the Procleix HIV/HCV RNA diagnostic assay in detecting HIV and HCV in blood samples.
  • Results showed that the Procleix assay had high sensitivity, accurately identifying all samples positive for both viruses and distinguishing them from negatives.
  • The findings suggest that using this assay in blood screening could help reduce the transmission of HIV and HCV during the early infection window period.

Article Abstract

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.

Conclusion: 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.

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