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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DNA loci (SeCore vs. SSP UniTray platforms) |
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| 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 |
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Inclusion Criteria:
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A, B, C, DRB1, DRB3/4/5, DQB1, DPB1 loci
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| Name | Affiliation | Role |
|---|---|---|
| Deanna Vella | Life Technologies | Study Chair |
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Not applicable. De-identified, archived whole blood samples
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| ID | Title | Description |
|---|---|---|
| FG000 | DNA Loci (SeCore vs. SSP UniTray Platforms) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | DNA Loci (SeCore vs. SSP UniTray Platforms) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | 90% Confidence Interval | percentage of concordant alleles | 10 weeks | de-identified leftover blood samples | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Concordance | All SeCore Kits |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deanna Vella, Staff Regulatory Engineer | Life Technologies | 760-918-3000 | deanna.vella@lifetech.com |
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DNA isolated from whole blood samples
| 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 |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| de-identified whole blood samples | Number | participants |
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| de-identified leftover blood samples |
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| 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 | Posted | Number | 90% Confidence Interval | percentage of concordant alleles | 10 weeks | de-identified leftover blood samples | Participants |
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| 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. | Posted | Number | 90% Confidence Interval | percentage of concordant alleles | 10 weeks | de-identified leftover blood samples | Participants |
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| 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. | Posted | Number | 90% Confidence Interval | percentage of concordant alleles | 10 weeks | de-identified leftover blood samples | Participants |
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| 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 | Posted | Number | 90% Confidence Interval | percentage of concordant alleles | 10 weeks | de-identified leftover blood samples | Participants |
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| 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 | Posted | Number | 90% Confidence Interval | percentage of concordant alleles | 10 weeks | de-identified leftover blood samples | Participants |
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| 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 | Posted | Number | 90% Confidence Interval | percentage of concordant alleles | 10 weeks | de-identified leftover blood samples | Participants |
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| 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 | Posted | Number | 90% Confidence Interval | percentage of concordant alleles | 10 weeks | de-identifies leftover blood samples | Participants |
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| 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 | Posted | Number | 90% Confidence Interval | percentage of concordant alleles | 10 weeks | de-identified leftover blood samples | Participants |
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