NCT03285295

Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106,881 (actual)
• Sponsor: Abbott Diagnostics Division · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay	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.
DEVICE	Alinity s HTLV I/II Assay	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.
DEVICE	Alinity s Anti-HCV Assay	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.
DEVICE	Alinity s HIV Ag/Ab Combo Assay	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.
DEVICE	Alinity s Anti-HBc Assay	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.
DEVICE	Alinity s Chagas Assay	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.

Timeline

• Start date: 2017-09-15
• Primary completion: 2018-05-23
• Completion: 2018-06-21
• First posted: 2017-09-18
• Last updated: 2019-10-09
• Results posted: 2019-10-09

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study