HIV I Infection Clinical Trial
Official title:
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. ;
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