---
title: Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol
nct_id: NCT03285295
overall_status: COMPLETED
phase: NA
sponsor: Abbott Diagnostics Division
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03285295.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03285295"
ct_last_update_post_date: 2019-10-09
last_seen_at: "2026-05-12T06:26:44.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol

**NCT ID:** [NCT03285295](https://clinicaltrials.gov/study/NCT03285295)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 106881
- **Lead Sponsor:** Abbott Diagnostics Division
- **Conditions:** Healthy
- **Start Date:** 2017-09-15
- **Completion Date:** 2018-06-21
- **CT.gov Last Update:** 2019-10-09

## Brief Summary

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.

## Detailed Description

This study evaluates Alinity s investigational assays using the Alinity s System. The Alinity s System is a high-volume, automated, blood-screening analyzer that is designed to determine the presence of specific antigens and antibodies by using chemiluminescent microparticle immunoassay (CMIA) detection technology. The system performs high-throughput routine and stat processing that features continuous access and automated retesting.

The Alinity s System is used for infectious disease marker testing in blood-screening and plasma laboratories for the following assays: Anti-HBc, Anti-HCV, HTLV I/II, Chagas, HBsAg, HBsAg Confirmatory and HIV Ag/Ab Combo.

## Eligibility

- **Minimum age:** 16 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Healthy donors who consented to participate in the study.

Exclusion Criteria:

* For testing with the Alinity s Chagas assay, exclude donors that have been screened on a previous donation using a licensed test for antibodies to T cruzi.

Note: A subject may participate at different times during the study for separate assay studies, but each subject should be represented only once for each assay.

The protocol does not define an age limit. A donor must be at least 17 years old to donate to the general blood supply, or 16 years old with parental/guardian consent, if allowed by state law.
```

## Arms

- **Screening** (EXPERIMENTAL) — All subjects will be tested with at least one of the investigational Alinity s assays (Anti-HBc, Anti-HCV, HTLV I/II, Chagas, HBsAg, HBsAg Confirmatory, HIV Ag/Ab Combo) on Alinity s system.

## Interventions

- **Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay** (DEVICE) — For all donor specimens with investigational Alinity s HBsAg and Alinity s HBsAg Confirmatory results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.
- **Alinity s HTLV I/II Assay** (DEVICE) — For all donor specimens with investigational Alinity s HTLV I/II results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.
- **Alinity s Anti-HCV Assay** (DEVICE) — For all donor specimens with investigational Alinity s Anti-HCV results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.
- **Alinity s HIV Ag/Ab Combo Assay** (DEVICE) — For all donor specimens with investigational Alinity s HIV Ag/Ab Combo results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.
- **Alinity s Anti-HBc Assay** (DEVICE) — For all donor specimens with investigational Alinity s Anti-HBc results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.
- **Alinity s Chagas Assay** (DEVICE) — For all donor specimens with investigational Alinity s Chagas results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.

## Primary Outcomes

- **Alinity s HBsAg Assay Specificity** _(time frame: 10 months)_ — Total of 16993 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HBsAg Assay. Repeatedly reactive specimens were further tested with Alinity s HBsAg Confirmatory and supplemental assays, if required.
- **Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity** _(time frame: 10 months)_ — Total of 432 specimens from subjects known to be HBsAg positive were tested with Alinity s HBsAg and HBsAg Confirmatory assay.
- **Alinity s HTLV I/II Assay Specificity** _(time frame: 10 months)_ — Total of 15877 serum and plasma specimens from whole blood donors specimens were tested with Alinity s HTLV I/II Assay. Repeatedly reactive specimens were further tested with Alinity s HTLV I/II and supplemental assays, if required.
- **Alinity s HTLV I/II Assay Sensitivity** _(time frame: 10 months)_ — Total of 706 specimens from subjects known to be HTLV positive were tested with Alinity s HTLV I/II assay. The population consists of the following:

Anti-HTLV I Positive n = 461 Anti-HTLV II positive n = 141 Anti-HTLV III positive - Undifferentiated n = 4 Individual with HTLV I/II Associated Diseases n = 100
- **Alinity s Anti-HCV Assay Specificity** _(time frame: 10 months)_ — Total of 16,999 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s Anti-HCV assay. Repeatedly reactive specimens were tested further with supplemental assays, if required.
- **Alinity s Anti-HCV Assay Sensitivity** _(time frame: 10 months)_ — Total of 402 specimens from subjects known to be Anti-HCV positive were tested with Alinity s Anti-HCV assay.
- **Alinity s HIV Ag/Ab Combo Assay Specificity** _(time frame: 10 months)_ — Total of 16996 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HIV Ag/Ab Combo Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.
- **Alinity s HIV Ag/Ab Combo Assay Sensitivity** _(time frame: 10 months)_ — Total of 1336 specimens from subjects known to be HIV-1/2 positive were tested with Alinity s HIV Ag/Ab Combo assay.
- **Alinity s Anti-HBc Assay Specificity** _(time frame: 10 months)_ — Total of 15877 serum and plasma specimens from whole blood donor specimens were tested with Alinity s Anti-HBc Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.
- **Alinity s Anti-HBc Assay Sensitivity** _(time frame: 10 months)_ — Total of 404 specimens from individuals with hepatitis B infection were tested with investigational Alinity s Anti-HBc assay. The population consists of the following:

Acute Hepatitis B infection n = 28 Chronic Hepatitis B infection n = 97 Recovered Hepatitis B infection n = 279
- **Alinity s Chagas Assay Specificity** _(time frame: 10 months)_ — Total of 15804 serum and plasma specimens from whole blood donors specimens were tested with Alinity s Chagas Assay. Repeatedly reactive specimens were further tested with Alinity s Chagas and supplemental assays, if required.
- **Alinity s Chagas Assay Sensitivity** _(time frame: 10 months)_ — Total of 320 specimens from subjects known to be Chagas positive were tested with investigational Alinity s Chagas assay.

## Secondary Outcomes

- **Alinity s HBsAg Assay Increased Risk of HBV Infection** _(time frame: 10 months)_
- **Alinity s HBsAg Assay Recovered HBV Infection** _(time frame: 10 months)_
- **Alinity s HTLV Assay Increased Risk of HTLV Infection** _(time frame: 10 months)_
- **Alinity s HTLV I/II Assay Endemics** _(time frame: 10 months)_
- **Alinity s Anti-HCV Assay Increased Risk for HCV** _(time frame: 10 months)_
- **Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2** _(time frame: 10 months)_
- **Alinity s HIV Ag/Ab Combo Assay Endemics** _(time frame: 10 months)_
- **Alinity s Anti-HBc Assay Increased Risk for HBV** _(time frame: 10 months)_
- **Alinity s Chagas Assay Endemics** _(time frame: 10 months)_

## Locations (5)

- Biotest Pharmaceuticals Corporation, Boca Raton, Florida, United States
- American Red Cross National Testing Laboratory, St Louis, Missouri, United States
- CSL Plasma Inc., Knoxville, Tennessee, United States
- QualTex Laboratories, San Antonio, Texas, United States
- Bloodworks Northwest, Renton, Washington, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.biotest pharmaceuticals corporation|boca raton|florida|united states` — added _(2026-05-12)_
- `locations.american red cross national testing laboratory|st louis|missouri|united states` — added _(2026-05-12)_
- `locations.csl plasma inc.|knoxville|tennessee|united states` — added _(2026-05-12)_
- `locations.qualtex laboratories|san antonio|texas|united states` — added _(2026-05-12)_
- `locations.bloodworks northwest|renton|washington|united states` — added _(2026-05-12)_

---

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