N/A
Completed N=300
Clinical Protocol SeCore, uTYPE and 3500 Dx System
Human Leukocyte Antigens (HLA)
Source: ClinicalTrials.gov NCT01285427 ↗
Enrolled (actual)
300
Serious AEs
—
Results posted
Apr 2014
Primary outcomePrimary: All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI) — 99.6 percentage of concordant alleles
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.
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 | — |
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. Informational only — not medical advice.