Search Results

HemosIL FII & FV DNA Control is intended for in vitro diagnostic use as a heterozygous quality control to monitor analytical performance of the extraction, amplification and detection steps of the Xpert™ HemosIL FII & FV genotyping assay on the GeneXpert® Dx System used in the detection of both the Factor II 20210G>A and Factor V 1691G>A (Leiden) mutations.

HemosIL FII & FV DNA Control is synthetic Factor V DNA suspended in a non-infectious blood-like matrix. Each vial includes normal and mutated Factor II and Factor V DNA sequences and is configured as a heterozygous control for both Factor II 20210G>A and Factor V 1691G>A (Leiden) mutations.

The quality control material is validated for use with Xpert™ HemosIL® FII & FV genotyping assay on the GeneXpert® Dx System and is processed exactly as whole blood samples during the extraction, amplification and detection steps.

The HemosIL® FII & FV DNA Control is a quality control material intended to monitor the analytical performance of the Xpert™ HemosIL FII & FV genotyping assay on the GeneXpert® Dx System.

Here's an analysis of its acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this quality control device appear to be the consistent and correct genotyping of the FII and FV mutations. The performance data below supports this. While explicit percentage cutoffs for "acceptance" are not stated, 100% correct genotyping across all tests strongly indicates that the device met these criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: A total of 201 tests were performed with the HemosIL FII & FV DNA Control.
• Data Provenance: The testing was conducted both internally at the control manufacturer and externally at multiple sites.
  • External Sites: Seven external sites participated, including two clinical laboratory sites in Europe, one site at the instrument/assay manufacturer (Cepheid), one site at Instrumentation Laboratory Co., and three clinical laboratory sites in the United States. This indicates a mix of clinical and manufacturing settings.
  • Retrospective or Prospective: The study design described (testing manufactured lots, using a specific assay) suggests a prospective study, specifically designed to evaluate the performance of the control.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the summary. For a quality control material, the "ground truth" for the test set is inherent in the design and manufacturing of the control itself. The control is engineered to have specific normal and mutated Factor II and Factor V DNA sequences. The method used to validate the presence of these mutations in the control during its manufacturing is stated as "Bi-directional sequencing," which is a highly accurate method for determining DNA sequences.

4. Adjudication Method for the Test Set

This information is not explicitly stated. However, for a quality control material designed to yield a specific and known genotype, the assessment of "correct genotype" is typically a direct comparison to the expected result. Discrepancies would likely be investigated, as was the case for the single indeterminate result attributed to "operator error."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret results, and the AI's effect on human performance is being evaluated. The HemosIL FII & FV DNA Control is a quality control material, not a direct diagnostic device that requires human interpretation in the same way.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

This study primarily evaluates the standalone performance of the quality control material when processed by the Xpert HemosIL FII & FV Assay on the GeneXpert Dx System. The "algorithm" here is the assay system itself identifying the genotype of the control. The studies demonstrate the assay's consistent ability to correctly identify the known genotype of the control, thus, evaluating the performance of the control in conjunction with the automated assay. There is no external "human-in-the-loop" interpretation step being evaluated here for the control's performance.

7. The Type of Ground Truth Used

The ground truth for the HemosIL FII & FV DNA Control is based on the engineered composition of the control material itself, which contains specific, known normal and mutated Factor II and Factor V DNA sequences. This composition was validated using bi-directional sequencing during the control's manufacturing.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The HemosIL FII & FV DNA Control is a quality control material, not an AI/algorithm that requires a "training set" in the conventional machine learning sense. The Xpert HemosIL FII & FV genotyping assay, which uses this control, would have its own development and validation data, but that is separate from the control product itself.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided as the device is a quality control material and not an AI/algorithm requiring a training set.

Ask a specific question about this device