Clinical Protocol SeCore, uTYPE and 3500 Dx System

Life Technologies

Status: Completed

Conditions: Human Leukocyte Antigens (HLA)

Study type: Observational

Funder types: Industry

Identifiers

NCT01285427

DMR0000279

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Deidentified leftover blood samples

Trial design

300 participants in 1 patient group

DNA loci (SeCore vs. SSP UniTray platforms)