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Clinical Protocol SeCore, uTYPE and 3500 Dx System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01285427
First Posted: January 28, 2011
Last Update Posted: April 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Life Technologies Corporation
  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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285427


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

Responsible Party: Life Technologies Corporation
ClinicalTrials.gov Identifier: NCT01285427     History of Changes
Other Study ID Numbers: DMR0000279
First Submitted: January 12, 2011
First Posted: January 28, 2011
Results First Submitted: May 8, 2013
Results First Posted: April 17, 2014
Last Update Posted: April 17, 2014
Last Verified: April 2014

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