Investigation of Discrepant Results for the Xpert BCR-ABL Ultra Assay Method Comparison Study
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- STATUS
- Not Recruiting
Summary
The primary objective is to perform testing to investigate discrepent results obtained in the study described in Protocol 231. The study conducted under Protocol 231 is a method comparison study comparing the results of the Xpert BCR-ABL Ultra Assay to the Asuragen QuantideX qPCR BCR-ABL IS assay, which is the predicate device. The results will be provided for information only and are not intended to replace the original comparison results obtained in Protocol 231.
Description
The primary objective is to perform testing to investigate discrepent results obtained in the study described in Protocol 231. The study conducted under Protocol 231 is a method comparison study comparing the results of the Xpert BCR-ABL Ultra Assay to the Asuragen QuantideX qPCR BCR-ABL IS assay, which is the predicate device. The results will be provided for information only and are not intended to replace the original comparison results obtained in Protocol 231.
Details
| Condition | Healthy |
|---|---|
| Age | 100years or below |
| Clinical Study Identifier | TX9357 |
| Last Modified on | 19 February 2024 |
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