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

> **NCT04971343** · — · COMPLETED · sponsor: **Beckman Coulter, Inc.** · enrollment: 8650 (actual)

## Conditions studied

- HIV I Infection
- HIV-2 Infection

## Interventions

- **DIAGNOSTIC_TEST:** Access HIV_blood donor
- **DIAGNOSTIC_TEST:** Access HIV_Hospitalized patient
- **DIAGNOSTIC_TEST:** Access HIV_known HIV-1 antibody positives
- **DIAGNOSTIC_TEST:** Access HIV_known HIV-2 antibody positives
- **DIAGNOSTIC_TEST:** Access HIV_known HIV-1 p24 Ag positive
- **DIAGNOSTIC_TEST:** Access HIV_Canada's requirements_Blood donor
- **DIAGNOSTIC_TEST:** Access HIV_Canada's requirements_HIV positive
- **DIAGNOSTIC_TEST:** Access HIV_Canada's requirements_P24 Positive

## Key facts

- **NCT ID:** NCT04971343
- **Lead sponsor:** Beckman Coulter, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** COMPLETED
- **Start date:** 2019-12-04
- **Primary completion:** 2022-06-22
- **Final completion:** 2022-09-23
- **Target enrollment:** 8650 (ACTUAL)
- **Last updated:** 2025-03-19


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04971343

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04971343, "Access HIV Ag/Ab Combo Assay - European Union (EU) Clinical Trial Protocol". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT04971343. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*