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

January 12, 2011
April 15, 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 ] [ 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
Identification and definition of Class I and Class II HLAs [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01285427
DMR0000279
No
Life Technologies Corporation
Life Technologies Corporation
Not Provided
Study Chair: Deanna Vella Life Technologies
Life Technologies Corporation
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP