User Manual Q&AAnswer
Feb 28, 2025 - 11:03 AM
To interpret the test results from the BOSCH STI Test for Sexually Transmitted Infections, follow these steps:
1. After the test is completed, the test result (list of positively/negatively detected pathogens) will be shown on the screen of the Vivalytic analyzer.
2. For further information and more detailed results, you can navigate through different levels of detail using the software. The microarray data level shows a software-modified and normalized picture of the microarray with the immobilized target-specific DNA probes.
3. In case of a valid test, the internal controls for successful extraction, amplification, and conjugation can be viewed in the tab control. If the extraction/amplification control is absent, the test is automatically rated as invalid. If the conjugation control is absent, the microarray cannot be evaluated, and the test is rated as failed.
4. In the printed test report, all pathogens, results, and information on the user, patient, and analyzer are listed, along with a signature field. However, controls are not listed in detail.
5. A valid test corresponds to successful extraction, amplification, and conjugation. In case of an invalid test, check if any notices are displayed after the run. Possible reasons for an invalid run might be poor sample quality or no DNA. Repeat the analysis with a new aliquot of the same sample if required. Ensure that you use the correct sample type, follow the right sample collection and storage procedures, and maintain proper operating conditions of the analyzer.
6. If the test is shown as invalid due to insufficient human cells in the sample (extraction/amplification control), the detected pathogens will still be displayed.
7. In case of a failed test, first check for correct operating conditions of the analyzer. Restart the analyzer. If the problem persists, contact customer service for further assistance.
It is important to note that the results of the BOSCH STI Test should be interpreted by a trained healthcare professional and should not be used as the sole parameter for diagnosis. A negative result does not exclude the presence of STI pathogens at a level below assay sensitivity or a pathogen that is not covered by this assay.
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