Clinical Protocol SeCore, uTYPE and 3500 Dx System

April 15, 2014 updated by: Life Technologies Corporation

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A, B, C, DRB1, DRB3/4/5, DQB1, DPB1 loci

Description

Inclusion Criteria:

  • Deidentified leftover blood samples

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
DNA loci (SeCore vs. SSP UniTray platforms)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI)
Time Frame: 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
10 weeks
SeCore® Kit, A Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
Time Frame: 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
10 weeks
SeCore® Kit, B Locus (Single Amp), Primary Analysis of Concordance Rate (Clopper-Pearson CI)
Time Frame: 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.
10 weeks
SeCore® Kit, C Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
Time Frame: 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.
10 weeks
SeCore® Kit, DPB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
Time Frame: 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
10 weeks
SeCore® Kit, DQB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
Time Frame: 10 weeks
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)
Time Frame: 10 weeks
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)
Time Frame: 10 weeks
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)
Time Frame: 10 weeks
The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Life Technologies Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Deanna Vella, Life Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DMR0000279

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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