N/A
N=17,987
Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03285295 ↗Enrolled (actual)
17,987
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Alinity s HBsAg Assay Specificity — 16985; 6; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- 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)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Abbott Diagnostics Division
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alinity s HBsAg Assay Specificity |
16985; 6; 2 | — |
| PRIMARY Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity |
0; 432; 0 | — |
| PRIMARY Alinity s HTLV I/II Assay Specificity |
15864; 2; 11 | — |
| PRIMARY Alinity s HTLV I/II Assay Sensitivity |
0; 706 | — |
| PRIMARY Alinity s Anti-HCV Assay Specificity |
16975; 14; 10 | — |
| PRIMARY Alinity s Anti-HCV Assay Sensitivity |
0; 402 | — |
| PRIMARY Alinity s HIV Ag/Ab Combo Assay Specificity |
16981; 13; 2 | — |
| PRIMARY Alinity s HIV Ag/Ab Combo Assay Sensitivity |
0; 1336; 0 | — |
| PRIMARY Alinity s Anti-HBc Assay Specificity |
15833; 16; 28 | — |
| PRIMARY Alinity s Anti-HBc Assay Sensitivity |
0; 404; 0 | — |
| PRIMARY Alinity s Chagas Assay Specificity |
15787; 3; 14 | — |
| PRIMARY Alinity s Chagas Assay Sensitivity |
0; 320; 0 | — |
| SECONDARY Alinity s HBsAg Assay Increased Risk of HBV Infection |
400; 0; 3; 0 | — |
| SECONDARY Alinity s HBsAg Assay Recovered HBV Infection |
51; 0; 0; 0 | — |
| SECONDARY Alinity s HTLV Assay Increased Risk of HTLV Infection |
491; 0; 0; 0; 11; 0 | — |
| SECONDARY Alinity s HTLV I/II Assay Endemics |
495; 0; 4; 0; 10; 0 | — |
| SECONDARY Alinity s Anti-HCV Assay Increased Risk for HCV |
316; 0; 0; 0; 90; 1 | — |
| SECONDARY Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2 |
582; 0; 0; 0; 21; 2 | — |
| SECONDARY Alinity s HIV Ag/Ab Combo Assay Endemics |
472; 0; 2; 10; 49; 2 | — |
| SECONDARY Alinity s Anti-HBc Assay Increased Risk for HBV |
319; 0; 70; 14 | — |
| SECONDARY Alinity s Chagas Assay Endemics |
466; 2; 0; 0; 146; 1 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03285295). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.