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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
January 12, 2011
January 28, 2011
May 8, 2013
April 17, 2014
April 17, 2014
January 2011
June 2011   (Final data collection date for primary outcome measure)
  • 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
Identification and definition of Class I and Class II HLAs [ Time Frame: 6 Months ]
To compare the Invitrogen SeCore sequencing kits with uTYPE to the predicate device Invitrogen SSP UniTray kits with UniMatch so as to show 95% concordance with 90% confidence.
Complete list of historical versions of study NCT01285427 on ClinicalTrials.gov Archive Site
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Clinical Protocol SeCore, uTYPE and 3500 Dx System
SeCore Sequencing Kit and 3500xl Dx Genetic Analyzer Clinical Performance Testing vs. SSP UniTray
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.
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.
Observational
Observational Model: Case-Only
Not Provided
Retention:   Samples With DNA
Description:
DNA isolated from whole blood samples
Non-Probability Sample
A, B, C, DRB1, DRB3/4/5, DQB1, DPB1 loci
Human Leukocyte Antigens (HLA)
Not Provided
DNA loci (SeCore vs. SSP UniTray platforms)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
June 2011
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Deidentified leftover blood samples
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01285427
DMR0000279
No
Not Provided
Not Provided
Life Technologies Corporation
Life Technologies Corporation
Not Provided
Study Chair: Deanna Vella Life Technologies
Life Technologies Corporation
April 2014