Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol

Abbott

Status

Completed

Conditions

Healthy

Treatments

Device: Alinity s HIV Ag/Ab Combo Assay

Device: Alinity s HTLV I/II Assay

Device: Alinity s Chagas Assay

Device: Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay

Device: Alinity s Anti-HCV Assay

Device: Alinity s Anti-HBc Assay

Study type

Interventional

Funder types

Industry

Identifiers

NCT03285295

9DY-02-14U01-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

106,881 patients

Sex

All

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

106,881 participants in 1 patient group

Screening

Experimental group

Description:

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.