PROCLEIX® HIV-1/HCV Assay
Performance Characteristics1
- Pivotal trial for PROCLEIX® HIV1/HCV Assay conducted at 6 U.S. study sites in September and October 2000
- Study compared PROCLEIX HIV1/HCV Assay and HIV-1 and HCV discriminatory assays with serological assays in three clinical lots
- Clinical studies included:
- Analytical and clinical sensitivity studies
- Specificity studies in normal donor specimens
- Non-specificity studies in high-risk populations
- BLA submitted CBER on Jan. 9, 2001; received approval on Feb. 27, 2002
- PROCLEIX HIV-1/HCV Assay and HIV-1 and HCV discriminatory assays detected these viral subtypes at 100 and 300 copies/mL:
- HIV-1 subtypes
- Group M - Subtypes A, B, C, D, E, F, G
- Group N
- Group O
- HCV subtypes 1, 2*, 3, 4, 5, 6
* 13/13 were reactive at 300 copies/mL, 12/13 were reactive at 100 copies/mL when tested with PROCLEIX HIV1/HCV Assay.
- Excellent sensitivity and specificity
| Sensitivity | Specificity | ||
|---|---|---|---|
| PROCLEIX® HIV-1/ HCV Assay | 16-member pool | 99.67% | 99.3% |
| Individual Donation | 99.87% | 99.8% | |
| HIV-1 Discriminatory | Individual Donation | 99.76% | 100.0% |
| HCV Discriminatory | Individual Donation | 99.71% | 99.6% |
References
- PROCLEIX HIV-1/HCV Assay package insert.
- Linnen JM, Gilker JM, Menez A, et al. Sensitive Detection of Genetic Variants of HIV-1 and HCV with an HIV-1/HCV Assay Based on Transcription Mediated Amplification. J Virol Methods. April 2002;102:139-155.