Clinical Protocol SeCore, uTYPE and 3500 Dx System

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01285427

Enrollment

300

Registered

2011-01-28

Start date

2011-01-31

Completion date

2011-06-30

Last updated

2014-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Leukocyte Antigens (HLA)

Keywords

DNA, sequencing, Identification and definition of Class I and II Human Leukocyte Antigens (HLA)

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Deidentified leftover blood samples

Design outcomes

Primary

Measure	Time frame	Description
All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI)	10 weeks	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)	10 weeks	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)	10 weeks	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)	10 weeks	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)	10 weeks	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)	10 weeks	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)	10 weeks	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)	10 weeks	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)	10 weeks	The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method

Participant flow

Recruitment details

Not applicable. De-identified, archived whole blood samples

Participants by arm

Arm	Count
DNA Loci (SeCore vs. SSP UniTray Platforms)	300
Total	300

Baseline characteristics

Characteristic	DNA Loci (SeCore vs. SSP UniTray Platforms)
Age, Categorical <=18 years	NA Participants
Age, Categorical >=65 years	NA Participants
Age, Categorical Between 18 and 65 years	NA Participants
Age, Continuous	NA years
de-identified whole blood samples	300 participants
Sex: Female, Male Female	NA Participants
Sex: Female, Male Male	NA Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0

Outcome results

Primary

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

Time frame: 10 weeks

Arm	Measure	Value (NUMBER)
Concordance	All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI)	99.6 percentage of concordant alleles

Primary

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

Time frame: 10 weeks

Arm	Measure	Value (NUMBER)
Concordance	SeCore® Kit, A Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)	100.0 percentage of concordant alleles

Primary

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.

Time frame: 10 weeks

Arm	Measure	Value (NUMBER)
Concordance	SeCore® Kit, B Locus (Single Amp), Primary Analysis of Concordance Rate (Clopper-Pearson CI)	99.7 percentage of concordant alleles

Primary

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.

Time frame: 10 weeks

Arm	Measure	Value (NUMBER)
Concordance	SeCore® Kit, C Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)	99.7 percentage of concordant alleles

Primary

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

Time frame: 10 weeks

Arm	Measure	Value (NUMBER)
Concordance	SeCore® Kit, DPB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)	97.7 percentage of concordant alleles

Primary

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

Time frame: 10 weeks

Arm	Measure	Value (NUMBER)
Concordance	SeCore® Kit, DQB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)	100.0 percentage of concordant alleles

Primary

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

Time frame: 10 weeks

Arm	Measure	Value (NUMBER)
Concordance	SeCore® Kit, DRB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)	100.0 percentage of concordant alleles

Primary

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

Time frame: 10 weeks

Arm	Measure	Value (NUMBER)
Concordance	SeCore® Kit, DR Group Kit (DRB1 Locus), Primary Analysis of Concordance Rate (CI)	100 percentage of concordant alleles

Primary

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

Time frame: 10 weeks

Arm	Measure	Value (NUMBER)
Concordance	SeCore® Kit, DR Group Kit (DRB345 Loci), Primary Analysis of Concordance Rate Clopper-Pearson CI)	99.7 percentage of concordant alleles

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Clinical Protocol SeCore, uTYPE and 3500 Dx System

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Design outcomes

Primary

Participant flow

Recruitment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI)

SeCore® Kit, A Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)

SeCore® Kit, B Locus (Single Amp), Primary Analysis of Concordance Rate (Clopper-Pearson CI)

SeCore® Kit, C Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)

SeCore® Kit, DPB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)

SeCore® Kit, DQB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)

SeCore® Kit, DRB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)

SeCore® Kit, DR Group Kit (DRB1 Locus), Primary Analysis of Concordance Rate (CI)

SeCore® Kit, DR Group Kit (DRB345 Loci), Primary Analysis of Concordance Rate Clopper-Pearson CI)