PROCLEIX® ULTRIO® Assay*
* FDA approved to screen donors for HIV-1 and HCV only.
Minimal impact on current operation
- Pivotal trial for PROCLEIX® ULTRIO® Assay conducted at 4 U.S. study sites.
- Study compared PROCLEIX® ULTRIO® Assay and 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
See PROCLEIX® ULTRIO® Package Insert for complete details on Performance Characteristics.
Performance Highlights
Analytical Sensitivity - PROCLEIX® System - Probit Analysis
| Panel Tested | Assay | Detection Probabilities | |
|---|---|---|---|
| 50% (95% Fiducial Limits) | 95% (95% Fiducial Limits) | ||
| HIV-1 B copies/mL | PROCLEIX® ULTRIO® Assay | 13.9 (12.0-15.9) | 37.7 (33.6-43.0) |
| HIV-1 B copies/mL | dHIV-1 | 12.9 (11.2-14.6) | 35.4 (33.8-36.9) |
| HIV-1 WHO (97/656) IU/mL | dHIV-1 | 7.5 (6.4-8.7) | 18.1 (16.1-20.8) |
| HCV WHO (96/790) IU/mL | PROCLEIX® ULTRIO® Assay | 1.3 (1.0-1.5) | 3.7 (3.3-4.2) |
| HCV WHO (96/790) IU/mL | dHCV | 1.0 (0.9-1.2) | 2.4 (2.1-2.7) |
| HBV WHO (97/746) IU/mL | PROCLEIX® ULTRIO® Assay | 3.3 (3.0-3.8) | 8.0 (7.1-9.3) |
| HBV WHO (97/746) IU/mL | dHBV | 3.0 (2.7-3.4) | 6.8 (6.0-7.7) |
Seroconversion Panels
| Compared to | Median Number of Days Earlier Detection | |||||
|---|---|---|---|---|---|---|
| PROCLEIX® ULTRIO®Assay (Neat) | PROCLEIX® ULTRIO®Assay (Diluted 1:16) | PROCLEIX® ULTRIO®Assay (Diluted 1:8) | dHIV-1 (Neat) | dHCV (Neat) | dHBV (Neat) | |
| Abbott HIVAB HIV-1/HIV-2 (rDNA) EIA Assay | ||||||
| Study 1 | 14 | 11 | N/A | 14 | N/A | N/A |
| Study 2 | 14 | N/A | 11.5 | 14 | N/A | N/A |
| Coulter HIV-1 p24 Assay | ||||||
| Study 1 | 7 | 5 | N/A | 7 | N/A | N/A |
| Study 2 | 8 | N/A | 4 | 7 | N/A | N/A |
| Ortho HCV 3.0 ELISA Assay | ||||||
| Study 1 | 32 | 32 | N/A | N/A | 32 | N/A |
| Study 2 | 32 | N/A | 32 | N/A | 34.5 | N/A |
| Ortho Antibody to HbsAg Test System 3 | ||||||
| Abbott PRISM HbsAg Assay | ||||||
| Study 1 | 17 | 7 | N/A | N/A | N/A | 15 |
| Study 2 | 18.5 | N/A | 11.5 | N/A | N/A | 17 |
Clinical Specificity
| Platform | N | TN | FP | % Specificity (95% C.I.) |
|---|---|---|---|---|
| PROCLEIX System Pool 16 & IDT | 216,180* | 215,869 | 107 | 99.95% (99.94-99.96) |
| PROCLEIX System Pool 16 | 12,028 | 11,786 | 59 | 99.5% (99.4-99.6) |
| PROCLEIX System IDT | 12,780 | 12,479 | 107 | 99.1% (99.0-99.3) |