Clinical Protocol SeCore, uTYPE and 3500 Dx System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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SeCore Sequencing Kit and 3500xl Dx Genetic Analyzer Clinical Performance Testing vs. SSP UniTray

Conditions
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Human Leukocyte Antigens (HLA)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Deidentified leftover blood samples
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DNA loci (SeCore vs. SSP UniTray platforms)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI) | All kits,the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method | 10 weeks | 
| SeCore® Kit, A Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI) | 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 | 10 weeks | 
| SeCore® Kit, B Locus (Single Amp), Primary Analysis of Concordance Rate (Clopper-Pearson CI) | 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. | 10 weeks | 
| SeCore® Kit, C Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI) | 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. | 10 weeks | 
| SeCore® Kit, DPB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI) | SeCore® DPB1 Locus, the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method | 10 weeks | 
| SeCore® Kit, DQB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI) | the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method | 10 weeks | 
| SeCore® Kit, DRB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI) | The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method | 10 weeks | 
| SeCore® Kit, DR Group Kit (DRB1 Locus), Primary Analysis of Concordance Rate (CI) | The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method | 10 weeks | 
| SeCore® Kit, DR Group Kit (DRB345 Loci), Primary Analysis of Concordance Rate Clopper-Pearson CI) | The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DNA, sequencing, Identification and definition of Class I and II Human Leukocyte Antigens (HLA)