Clinical Protocol SeCore, uTYPE and 3500 Dx System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Life Technologies Corporation
ClinicalTrials.gov Identifier:
NCT01285427
First received: January 12, 2011
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


Condition
Human Leukocyte Antigens (HLA)

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: SeCore Sequencing Kit and 3500xl Dx Genetic Analyzer Clinical Performance Testing vs. SSP UniTray

Further study details as provided by Life Technologies Corporation:

Primary Outcome Measures:
  • All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    All kits,the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method

  • SeCore® Kit, A Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    SeCore Kit, A Locus,the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method

  • SeCore® Kit, B Locus (Single Amp), Primary Analysis of Concordance Rate (Clopper-Pearson CI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    SeCore® Kit, B Locus (Single Amp), The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method.

  • SeCore® Kit, C Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    SeCore® Kit, C Locus, the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method.

  • SeCore® Kit, DPB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    SeCore® DPB1 Locus, the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method

  • SeCore® Kit, DQB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method

  • SeCore® Kit, DRB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method

  • SeCore® Kit, DR Group Kit (DRB1 Locus), Primary Analysis of Concordance Rate (CI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method

  • SeCore® Kit, DR Group Kit (DRB345 Loci), Primary Analysis of Concordance Rate Clopper-Pearson CI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method


Biospecimen Retention:   Samples With DNA

DNA isolated from whole blood samples


Enrollment: 300
Study Start Date: January 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
DNA loci (SeCore vs. SSP UniTray platforms)

Detailed Description:

Testing will be performed on A, B, C, DRB1, DRB3/4/5, DQB1, and DPB1 loci. Additionally, testing will be performed using the following locus specific Group Specific Sequencing Primers: A, B, Cw, DPB1, DQB1 and DRB.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A, B, C, DRB1, DRB3/4/5, DQB1, DPB1 loci

Criteria

Inclusion Criteria:

  • Deidentified leftover blood samples
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285427

Sponsors and Collaborators
Life Technologies Corporation
Investigators
Study Chair: Deanna Vella Life Technologies
  More Information

No publications provided

Responsible Party: Life Technologies Corporation
ClinicalTrials.gov Identifier: NCT01285427     History of Changes
Other Study ID Numbers: DMR0000279
Study First Received: January 12, 2011
Results First Received: May 8, 2013
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Life Technologies Corporation:
DNA, sequencing
Identification and definition of Class I and II Human Leukocyte Antigens (HLA)

ClinicalTrials.gov processed this record on April 17, 2014