ACCESS HIV ANTIGEN/ANTIBODY COMBO ASSAY EUROPEAN UNION (EU) CLINICAL TRIAL PROTOCOL

Overview

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 ImmunoAssay Next Gen Immunoassay Analyzer

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: September 2021

Detailed Description

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. The following additional design requirements will be incorporated to satisfy Canadian regulations: – Testing of blood donor and positive samples equally over three sites, using 3 lots of reagents – Retesting of 1000 blood donor samples internally with 1 lot close to expiration – 250 additional HIV-1 p24 Ag positive samples beyond 50 required by CTS – 300 blood donor matched fresh plasma and serum samples

Interventions

  • Diagnostic Test: Access HIV
    • All samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective Instruction for Use to determine non-reactive (NR), initially reactive (IR), and repeatedly reactive (RR). Reference assay will be Abbott Architect HIV Ag/Ab combo assay for hospitalized patient and known HIV positive samples. For blood donors, Abbott PRISM HIV Ag/Ab combo assay will be used as reference. All initially reactive (IR) specimen results will be tested in duplicate per Instruction for Use . For the blood donors and hospitalized patients samples (specificity cohorts), all RR specimens will be confirmed using testing including ImmunoBlot, Western Blot or HIV-1/HIV-2 differentiation test and HIV-1 Polymerase Chain Reaction (PCR) RNA (if Immunoblot, WesternBlot or differentiation test is negative or indeterminate; if Immunoblot, WesternBlot or differentiation test is positive for HIV-2 then HIV-1 PCR will not be tested).

Arms, Groups and Cohorts

  • Unselected blood donors
  • Hospitalized patients
  • Known HIV-1 Ab positive
  • Known HIV-2 Ab positive
  • Known Acute HIV-1 p24 Ag positive

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity and specificity
    • Time Frame: Baseline
    • Sensitivity and specificity relative to the final patient HIV infection status determined from confirmatory testing will be calculated.

Participating in This Clinical Trial

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 o Known HIV-2 antibody positive patients confirmed positive by Immunoblot, WesternBlot or HIV-1/HIV-2 antibody differentiation test o Known HIV-1 Ag positive patients – confirmed positive by screening HIV Ag/Ab combo test positive for p24 Ag and p24 Ag test positive -acute/primary HIV infection – 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 antibody positive patients – With Immunoblot and HIV-1 PCR RNA for screen positive blood donors – With Immunoblot or Western Blot result on same sample draw for HIV antibody positives (for HIV-1, positivity may be historical from medical records) OR – at least 1.2 mL leftover Ethylenediaminetetraacetic Acid (EDTA) plasma or serum sample from p24 Ag positive patients – With screening HIV Ag/Ab combo (giving p24 Ag result) and p24 Ag test on same sample draw Exclusion Criteria:

  • Samples from subjects already included in the study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beckman Coulter, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Juliane HEY, Dr, +33 645 23 81 74, jhey@beckman.com

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