CBT NAT Blood Testing Solution

• Unique assay format offers direct detection of three analytes to test HIV-1, HCV and HBV in a single test.
• Earliest detection with reduced window period.
• Integrated line of NAT products designed specifically for blood screening.
• Instrument systems enable efficient workflow, superior productivity, single donor and mini-pool testing.
• Assays and systems deliver consistently high performance.

Ultrio Assay Goals

• Sensitivity of at least 15 IU/ml of HBV; 100 copies/mL of HIV-1 and 30 IU/mL of HCV.
• Detection of HIV-1; HCV and HBV subtypes; closure of seroconversion window.
• Analytical specificity > 99.5 %
• Internal Control for assay monitoring in each sample.
• HIV-1; HCV and HBV Discriminatory Assays for resolution of multiplex assay repetitive reactives.
• Same assay formulations applicable Procleix® and fully automated TIGRIS™ instrument platforms.

Analytical Sensitivity

• Sensitivity of Ultrio Assay
• 95% Detection of HIV-1 at ~ 20 copies/mL
• 95% Detection of HCV at ~2.5 IU/mL
• 95% Detection of HBV at ~ 7.5 IU/mL
• No statistically significant differences between Ultrio and Discriminatory Assays
• Sensitivity of detection of HIV-1 and HCV is similar to the sensitivity of detection observed with the HIV-1/HCV Assay

Detection of Genetic Variants

• Detection of HIV-1 variants, including M subtypes A-G and types N and O at 100 copies/mL or better.
• Improved detection of HCV genotypes 2b, 3a and 4 to 100 copies/mL or better.
• Detection of HBV genotypes A-G at 100 copies/mL or better.

Donor and Donation Factors

• No cross-reactivity or interference in icteric, hemolyzed or lipemic specimens.
• No cross-reactivity or interference in specimens from patients with autoimmune diseases or with liver diseases not caused by HCV or HBV infection.
• No interference or cross- reactivity in bacterially contamined plasma, or in plasma from patients with other viral infections.

• Initial reactive rates in blood bank donor specimens was 0%, 0.14%, 0.54% and 0.27% for Ultrio, d-HIV, d-HCV and d-HBV assays, respectively.
• Repeat reactive rates were 0% for 100% specificity after repeat testing.

Clinical Sensitivity

• Clinical sensitivity in known positive specimens was 99.75%, 100%, 99,75% and 98,73% for Ultrio, d-HIV, d-HCV and d-HBV assays, respectively.
• Detection in seroconversion panels:
• HIV-1 RNA detection 14, 11.5 and 11.5 days earlier than HIV1/2 antibody in neat, 1:8 and 1:16 samples, respectively
• HCV RNA detection 32 days earlier than HCV antibody in neat, 1:8 or 1:16 samples
• HBV DNA detection 18.5, 11.5 and 6.5 days earlier than Prism-HBsAg in neat, 1:8 and 1:16 samples, respectively