At a glance
ClinicalIndex Comparison RecordN/ACompleted· 300 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
SeCore Sequencing Kit and 3500xl Dx Genetic Analyzer Clinical Performance Testing vs. SSP UniTray
In Brief
An observational study for Human Leukocyte Antigens (HLA). Completed, enrolled 300 participants.
Detailed Summary
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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Leukocyte Antigens (HLA)
Countries--
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2011
First PostedJan 2011
Primary CompletionJun 2011
TodayJul 2026
First PostedJan 28, 2011
Enrollment StartJan 1, 2011
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.4 years ago