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

Summary

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

Conditions

• HIV I Infection
• HIV-2 Infection

Interventions

DIAGNOSTIC_TEST

Access HIV_blood donor

Samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Roche - Cobas - Elecsys® HIV Duo . * All initially reactive specimen results will be tested in duplicate per IFU . * All RR specimens will be confirmed using testing including ImmunoBlot, Western Blot or HIV-1/HIV-2 differentiation test and HIV-1 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).

DIAGNOSTIC_TEST

Access HIV_Hospitalized patient

All samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Abbott Architect HIV Ag/Ab combo assay for hospitalized patient. * All initially reactive specimen results will be tested in duplicate per IFU . * All RR specimens will be confirmed using testing including ImmunoBlot, Western Blot or HIV-1/HIV-2 differentiation test and HIV-1 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).

DIAGNOSTIC_TEST

Access HIV_known HIV-1 antibody positives

Samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Abbott Architect HIV Ag/Ab combo assay . * All initially reactive specimen results will be tested in duplicate per IFU . * For the known positive cohorts (sensitivity cohorts), samples will be identified as positive at enrollment/time of testing according to inclusion criteria prior to testing or in parallel of testing with Access and Reference HIV Ag/Ab combo assays. In case of discrepant results or concordant negative results between Access and Reference HIV Ag/Ab combo assay among known HIV-1 antibody positive patients, the IB/WB test will be repeated by the site to confirm sample status. If this IB/WB result is negative or indeterminate, the sample will be excluded from the statistical analysis

DIAGNOSTIC_TEST

Access HIV_known HIV-2 antibody positives

Samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Abbott Architect HIV Ag/Ab combo assay. * All initially reactive specimen results will be tested in duplicate per IFU . * For the known positive cohorts (sensitivity cohorts), samples will be identified as positive at enrollment/time of testing according to inclusion criteria prior to testing or in parallel of testing with Access and Reference HIV Ag/Ab combo assays.

DIAGNOSTIC_TEST

Access HIV_known HIV-1 p24 Ag positive

All samples will be tested with both Reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFUs/study guide to determine non-reactive (NR), initially reactive (IR), and repeatedly reactive (RR). Reference assay will be Abbott - ARCHITECT HIV Ag/Ab Combo Assay. * Due to volume constraints, all known HIV-1 p24 Ag positive samples that will be tested during the EU HIV clinical trial will be tested in singulare only with the Reference HIV Ag/Ab combo assay, and in singulare and then in duplicate if IR with Access HIV Ag/Ab combo assay. * For the known positive cohorts (sensitivity cohorts), samples will be identified as positive at enrollment/time of testing according to inclusion criteria prior to testing or in parallel of testing with Access and Reference HIV Ag/Ab combo assays

DIAGNOSTIC_TEST

Access HIV_Canada's requirements_Blood donor

To fit with Canada's requirements: * 4,000 additional blood donor samples from geographically distinct regions will be collected and tested. Blood donor sample testing will be equally distributed over three blood donor sites, using 3 different lots of reagents: the first 2,000 blood donor samples from CE-marking study (out of the 6,000 tested) will be used plus the 4,000 additional blood donor samples. * Retesting of 1000 blood donor samples will be done internally with 1 lot close to expiration to satisfy Canadian requirements

DIAGNOSTIC_TEST

Access HIV_Canada's requirements_HIV positive

To fit with Canada's requirements: o HIV positive samples will be equally distributed and tested at leat three (3) testing sites, using 3 lots of reagents.

DIAGNOSTIC_TEST

Access HIV_Canada's requirements_P24 Positive

To fit with Canada's requirements: * HIV positive samples will be equally distributed and tested at leat three (3) testing sites, using 3 lots of reagents. * Collection and testing of maximum 210 additional HIV-1 Ag positive sample beyond the 50 required by CTS

Sponsors & Collaborators

• Beckman Coulter, Inc.

  lead INDUSTRY

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-04

Primary Completion

2022-06-22

Completion

2022-09-23

Countries

• France

Study Locations