1. A positive result does not necessarily indicate presence of viable organisms. However it indicates a presumptive presence of MTB.

2. A negative result does not preclude Mycobacterium Tuberculosis infection because results depend on adequate specimen collection, absence of inhibitors, and sufficient DNA to be detected.

3. Results may be affected by antecedent or concurrent antibiotic therapy. Hence therapeutic success or failure cannot be assessed by this test as DNA might persist following antimicrobial therapy.

Interpretation of Results
The results are interpreted by the GeneXpert DX System from measured fluorescent signals and embedded calculation algorithms and will be displayed in the “View Results” window. Lower Ct values represent a higher starting concentration of DNA template; higher Ct values represent a lower concentration of DNA template.
MTB Detected
MTB target DNA is detected•

MTB Detected—The MTB result will be displayed as High, Medium, Low or Very Low
depending on the Ct value of the MTB target present in the sample.