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

NCT04971343 | Completed

• 1 other identifier: DC-TR18-0410
• Study Type: observational
• Target: 8,650
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity

  Sensitivity and specificity relative to the final patient HIV infection status determined from confirmatory testing will be calculated.

  Baseline

Study Arms (5)

Unselected blood donors

Diagnostic Test: Access HIV_blood donor; Diagnostic Test: Access HIV_Canada's requirements_Blood donor

Hospitalized patients

Diagnostic Test: Access HIV_Hospitalized patient

Known HIV-1 Ab positive

Diagnostic Test: Access HIV_known HIV-1 antibody positives; Diagnostic Test: Access HIV_Canada's requirements_HIV positive

Known HIV-2 Ab positive

Diagnostic Test: Access HIV_known HIV-2 antibody positives; Diagnostic Test: Access HIV_Canada's requirements_HIV positive

Known Acute HIV-1 p24 Ag positive

Diagnostic Test: Access HIV_known HIV-1 p24 Ag positive; Diagnostic Test: Access HIV_Canada's requirements_HIV positive; Diagnostic Test: Access HIV_Canada's requirements_P24 Positive

Interventions

Access HIV_blood donor DIAGNOSTIC_TEST

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).

Unselected blood donors

Access HIV_Hospitalized patient DIAGNOSTIC_TEST

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).

Hospitalized patients

Access HIV_known HIV-1 antibody positives DIAGNOSTIC_TEST

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

Known HIV-1 Ab positive

Access HIV_known HIV-2 antibody positives DIAGNOSTIC_TEST

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.

Known HIV-2 Ab positive

Access HIV_known HIV-1 p24 Ag positive DIAGNOSTIC_TEST

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

Known Acute HIV-1 p24 Ag positive

Access HIV_Canada's requirements_Blood donor DIAGNOSTIC_TEST

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

Unselected blood donors

Access HIV_Canada's requirements_HIV positive DIAGNOSTIC_TEST

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.

Known Acute HIV-1 p24 Ag positive; Known HIV-1 Ab positive; Known HIV-2 Ab positive

Access HIV_Canada's requirements_P24 Positive DIAGNOSTIC_TEST

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

Known Acute HIV-1 p24 Ag positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The test population includes : * 6,000 unselected blood donors sample * 2,000 hospitalized patients * 500 Known HIV-1 Ab positive * 100 Known HIV-2 Ab positive * 50 Known acute HIV-1 p24 Ag positive

You may qualify if:

• 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:

You may not qualify if:

• Samples from subjects already included in the study

Sponsors & Collaborators

• Beckman Coulter, Inc.: lead

Study Sites (6)

Etablissement Français du Sang (EFS) Hauts-de-France - Normandie

Bois-Guillaume, 76232, France

Location

Eurofins Biomnis

Ivry-sur-Seine, 94208, France

Location

Qbd, Efs Hfno

Loos, 59120, France

Location

UPR Lille, Établissement français du sang Hauts-de-France - Normandie

Loos, 59373, France

Location

Laboratoire de Virologie, Laboratoire associé au CNR du VIH

Rouen, 76031, France

Location

Cerba Xpert

Saint-Ouen-l'Aumône, 95310, France

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 21, 2021
• Study Start: December 4, 2019
• Primary Completion: June 22, 2022
• Study Completion: September 23, 2022
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)