Trial Outcomes & Findings for Clinical Protocol SeCore, uTYPE and 3500 Dx System (NCT NCT01285427)

Results Overview

All kits,the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method

Recruitment status

COMPLETED

Target enrollment

300 participants

Primary outcome timeframe

10 weeks

Results posted on

2014-04-17

Participant Flow

Not applicable. De-identified, archived whole blood samples

Participant milestones

Participant milestones
Measure	DNA Loci (SeCore vs. SSP UniTray Platforms)
Overall Study STARTED	300
Overall Study COMPLETED	299
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Protocol SeCore, uTYPE and 3500 Dx System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DNA Loci (SeCore vs. SSP UniTray Platforms) n=300 Participants
Age, Categorical <=18 years	NA Participants n=99 Participants
Age, Categorical Between 18 and 65 years	NA Participants n=99 Participants
Age, Categorical >=65 years	NA Participants n=99 Participants
Age, Continuous	NA years STANDARD_DEVIATION NA • n=99 Participants
Sex: Female, Male Female	NA Participants n=99 Participants
Sex: Female, Male Male	NA Participants n=99 Participants
de-identified whole blood samples	300 participants n=99 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Concordance n=299 de-identified leftover blood samples All SeCore Kits
All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI)	99.6 percentage of concordant alleles Interval 99.29 to 99.77

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Concordance n=299 de-identified leftover blood samples All SeCore Kits
SeCore® Kit, A Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)	100.0 percentage of concordant alleles Interval 99.01 to 100.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Concordance n=299 de-identified leftover blood samples All SeCore Kits
SeCore® Kit, B Locus (Single Amp), Primary Analysis of Concordance Rate (Clopper-Pearson CI)	99.7 percentage of concordant alleles Interval 98.43 to 99.98

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Concordance n=299 de-identified leftover blood samples All SeCore Kits
SeCore® Kit, C Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)	99.7 percentage of concordant alleles Interval 98.43 to 99.98

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Concordance n=299 de-identified leftover blood samples All SeCore Kits
SeCore® Kit, DPB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)	97.7 percentage of concordant alleles Interval 95.65 to 98.9

PRIMARY outcome

Timeframe: 10 weeks

the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method

Outcome measures

Outcome measures
Measure	Concordance n=299 de-identified leftover blood samples All SeCore Kits
SeCore® Kit, DQB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)	100.0 percentage of concordant alleles Interval 99.01 to 100.0

PRIMARY outcome

Timeframe: 10 weeks

The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method

Outcome measures

Outcome measures
Measure	Concordance n=299 de-identified leftover blood samples All SeCore Kits
SeCore® Kit, DRB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)	100.0 percentage of concordant alleles Interval 99.01 to 100.0

PRIMARY outcome

Timeframe: 10 weeks

The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method

Outcome measures

Outcome measures
Measure	Concordance n=299 de-identifies leftover blood samples All SeCore Kits
SeCore® Kit, DR Group Kit (DRB1 Locus), Primary Analysis of Concordance Rate (CI)	100 percentage of concordant alleles Interval 99.01 to 100.0

PRIMARY outcome

Timeframe: 10 weeks

The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method

Outcome measures

Outcome measures
Measure	Concordance n=299 de-identified leftover blood samples All SeCore Kits
SeCore® Kit, DR Group Kit (DRB345 Loci), Primary Analysis of Concordance Rate Clopper-Pearson CI)	99.7 percentage of concordant alleles Interval 98.39 to 99.98

Adverse Events

Concordance

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Deanna Vella, Staff Regulatory Engineer

Life Technologies

Phone: 760-918-3000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place