Access HIV Ag/Ab Combo Assay - European Union (EU) Clinical Trial Protocol

Evaluation of the Beckman Coulter Access HIV Ag/Ab Combo Assay as an Aid in the Diagnosis of HIV-1 and/or HIV-2 Infection: EU Clinical Trial Protocol

The objective of this study is the collection and testing of clinical samples to determine the clinical performance of the Access HIV Ag/Ab Combo assay on the DxI 9000 Access Immunoassay Analyzer

The study will involve a multicenter, prospective and retrospective sample collection, and testing of samples with the investigational HIV assay as required per the EU Common Technical Specification (CTS). The CTS requires testing of samples from blood donors, hospitalized patients, known HIV-1 Ab positive patients, known HIV-2 Ab positive patients, and known HIV-1 p24 Ag positive patients. Any retrospectively collected samples will meet all inclusion/exclusion criteria.

All samples collected will be anonymized or pseudo-anonymized, leftover, remnant samples. pseudo-anonymized collection of samples will required oral patient consent documented in their medical record or electronic case report form (eCRF). For CE marking, below is the number of samples that will be included per group :

• Unselected blood donors : 6,000 fresh samples (requirements CTS : 5,000)
• Hospitalized patients : 1,200 frozen samples and 800 fresh samples (requirements CTS : 200)
• Known HIV-1 Ab positive : 470 frozen samples and 30 fresh samples (requirements CTS : 400)
• Known HIV-2 Ab positive : 100 frozen samples (requirements CTS : 100)
• Known acute HIV-1 p24 Ag positive : 50 frozen samples (requirements CTS : 50)

The following additional design requirements will be incorporated to EU study to satisfy Canadian regulations, but additional data generated on the additional samples will not be used for CE-marking:

• Collection and testing of 4,000 additional blood donor samples. Blood donors' samples should include 300 blood donor matched fresh plasma and serum samples
• Distribution of blood donor sample testing equally over three (3) blood donor sites, using 3 different lots of reagents
• Retesting of 1000 blood donor samples internally with 1 lot close to expiration
• Collection and testing of maximum 210 additional p24 Ag positive sample beyond the 50 required by CTS
• Distribution of p24 Ag and HIV-1 Ab positive sample testing equally over three (3) testing sites, using 3 different lots of reagents.

Additional Canadian requirements will be covered by US protocol(s) and Verification and validation protocols.

Inclusion Criteria:

Anonymized or pseudo-anonymized leftover samples from

• Males or females

• Aged ≥18 years of age

• Belonging to one of the following enrollment groups:

  • Unselected blood donor

  • Hospitalized patient

  • Known HIV-1 antibody positive patients

    • confirmed positive by Immunoblot, Western blot or HIV-1/HIV-2 antibody differentiation test either at time of enrollment vai same study draw or historically from medical record

  • Known HIV-2 antibody positive patients

    • confirmed HIV-2 positive by BioPlex 2200 HIV Ag-Ab Assay

  • Known HIV-1 Ag positive patients

    • For samples from HIV seroconversion panels

      • Tested during EU HIV clinical trial: confirmed positive by screening HIV Ag/Ab combo positive for p24 Ag, and p24 Ag screening test positive (result from CoA or additional testing)
      • Tested as part of seroconversion panel studies (V&V studies): First sample of the panel that is ARCHITECT Ag/Ab combo assay positive or BioPlex 2200 HIV Ag-Ab Assay p24 positive, and p24 Ag test positive (result from CoA or additional R&D testing)

    • For routine clinical samples:

      • Confirmed positive by screening HIV Ag/Ab combo assay positive for p24 Ag , and p24 Ag test positive by confirmatory test, or
      • Confirmed positive by screening HIV Ag/Ab combo assay HIV positive, and p24 Ag test positive by confirmatory test and PCR HIV POS and IB/WB HIV negative or indetermined.

• with at least 2.0 mL leftover EDTA plasma sample from hospitalized patients OR

• at least 1.5 mL leftover EDTA plasma or serum sample from blood donors or known HIV-1 antibody positive patients, with confirmatory test already done as per inclusion criteria OR

• at least 1.0 mL leftover EDTA plasma or serum sample from known p24 Ag positive patients or known HIV-2 antibody positive patients, with confirmatory test already done as per inclusion criteria

Exclusion Criteria:

• Samples from subjects already included in the study