Clinical Protocol SeCore, uTYPE and 3500 Dx System
Recruitment status was Active, not recruiting
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.
Human Leukocyte Antigens (HLA)
|Study Design:||Observational Model: Case-Only|
|Official Title:||SeCore Sequencing Kit and 3500xl Dx Genetic Analyzer Clinical Performance Testing vs. SSP UniTray|
- 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.
Biospecimen Retention: Samples With DNA
DNA isolated from whole blood samples
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||May 2011|
|Estimated Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
|DNA loci (SeCore vs. SSP UniTray platforms)|
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.