Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol
Public ClinicalTrials.gov record NCT03285295. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this study is to demonstrate the performance and intended use of each of the Alinity s investigational assays in a donor screening environment using clinical specimens to evaluate assay performance characteristics. A comparison of assay performance will be done versus the Food and Drug Administration (FDA) licensed assays. The data will be used to support regulatory submissions and/or publications.
Study identification
- NCT ID
- NCT03285295
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 106,881 participants
Conditions and interventions
Conditions
Interventions
- Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay Device
- Alinity s HTLV I/II Assay Device
- Alinity s Anti-HCV Assay Device
- Alinity s HIV Ag/Ab Combo Assay Device
- Alinity s Anti-HBc Assay Device
- Alinity s Chagas Assay Device
Device
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 14, 2017
- Primary completion
- May 22, 2018
- Completion
- Jun 20, 2018
- Last update posted
- Oct 8, 2019
2017 – 2018
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Biotest Pharmaceuticals Corporation | Boca Raton | Florida | 33431 | — |
| American Red Cross National Testing Laboratory | St Louis | Missouri | 63108 | — |
| CSL Plasma Inc. | Knoxville | Tennessee | 37932 | — |
| QualTex Laboratories | San Antonio | Texas | 78201 | — |
| Bloodworks Northwest | Renton | Washington | 98057 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03285295, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 8, 2019 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03285295 live on ClinicalTrials.gov.