N/A
N=300
Clinical Protocol SeCore, uTYPE and 3500 Dx System
Human Leukocyte Antigens (HLA)
Bottom Line
View on ClinicalTrials.gov: NCT01285427 ↗Enrolled (actual)
300
Serious AEs
—
Results posted
Apr 2014
Primary outcome: Primary: All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI) — 99.6 percentage of concordant alleles
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Life Technologies Corporation
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI) |
99.6 | — |
| PRIMARY SeCore® Kit, A Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI) |
100.0 | — |
| PRIMARY SeCore® Kit, B Locus (Single Amp), Primary Analysis of Concordance Rate (Clopper-Pearson CI) |
99.7 | — |
| PRIMARY SeCore® Kit, C Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI) |
99.7 | — |
| PRIMARY SeCore® Kit, DPB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI) |
97.7 | — |
| PRIMARY SeCore® Kit, DQB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI) |
100.0 | — |
| PRIMARY SeCore® Kit, DRB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI) |
100.0 | — |
| PRIMARY SeCore® Kit, DR Group Kit (DRB1 Locus), Primary Analysis of Concordance Rate (CI) |
100 | — |
| PRIMARY SeCore® Kit, DR Group Kit (DRB345 Loci), Primary Analysis of Concordance Rate Clopper-Pearson CI) |
99.7 | — |
Summary
The purpose of this study is to compare the Invitrogen SeCore(R) sequencing system and uTYPE(R) interpretation software to the predicate device Invitrogen SSP UniTray(R) with UniMatch(R) interpretation software and show 95% concordance with 90% confidence.
Eligibility Criteria
Inclusion Criteria
- Deidentified leftover blood samples
Data sourced from ClinicalTrials.gov (NCT01285427). 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.