• 3

  Intended Use
• 3

  Summary and Explanation
• 4

  Principle of the Procedure
• 4

  Reagents and Instruments
• 4

  Material Provided
• 5

  Storage and Handling
• 6

  Materials Required but Not Provided
• 6

  Warnings and Precautions
• 7

  Specimen Collection and Transport
• 7

  Assay Procedure
• 7

  Specimen Collection Procedure
• 7

  Sputum Sediments Procedure
• 8

  Expectorated Sputum Sample Procedure
• 9

  Preparing the Cartridge
• 10

  Starting the Test
• 11

  Discarding Used Cartridges
• 11

  Viewing and Printing Results
• 12

  Quality Control
• 12

  Interpretation of Results
• 14

  Reasons to Repeat the Assay
• 14

  Xpert MTB/RIF Assay Results and Interpretations
• 15

  Limitations
• 15

  Performance Characteristics
• 15

  Retest Procedure
• 16

  Overall Results
• 16

  MTB Detection Results
• 17

  RIF Resistance
• 19

  Interfering Substances
• 19

  Analytical Sensitivity
• 19

  Analytical Specificity
• 20

  Species/Strains Tested for Specificity
• 21

  Analytical Inclusivity
• 21

  Analytical Inactivation of Mycobacteria in Sputum Samples
• 22

  References
• 23

  Assistance
• 24

  Table of Symbols

Genexpert User Manual Pdf

Genexpert User Manual Free

Up to 2,074 test results in a mere 24 hour period. Less than 52 minutes time to first result. Less than 2 minutes sample prep time per test. With results lik.