GeneXpert Xpert MTB RIF User Manual

BCR-ABL say
GXMTB/RIF-10GXMTB/RIF-10
301-0191 Rev. C, May 2012
In Vitro Diagnostic Medical Device
Xpert MTB/RIF
R

GeneXpert Xpert MTB RIF Specifications

General

Brand	GeneXpert
Model	Xpert MTB RIF
Category	Medical Equipment
Language	English

Summary

Intended Use

Summary and Explanation

Principle of the Procedure

Reagents and Instruments

Material Provided

Details the specific components included in the Xpert MTB/RIF kit (GXMTB/RIF-10).

Storage and Handling

Materials Required but Not Provided

Warnings and Precautions

Specimen Collection and Transport

Storage and Transport

Specifies conditions for storing and transporting collected specimens prior to processing.

Specimen Collection Procedure

Step-by-step instructions for collecting sputum samples from patients.

Assay Procedure(s)

Sputum Sediments Procedure

Provides specific instructions for processing sputum sediment samples for the assay.

Expectorated Sputum Sample Procedure

Preparing the Cartridge

Starting the Test

Discarding Used Cartridges

Viewing and Printing Results

Quality Control

Interpretation of Results

Reasons to Repeat the Assay

Retest Procedure

Limitations

Performance Characteristics

Performance Testing - Clinical

Describes the clinical evaluation of the Xpert MTB/RIF Assay for TB and RIF resistance.

Overall Results

MTB Detection Results

RIF Resistance

Interfering Substances

Analytical Sensitivity

Analytical Specificity (Exclusivity)

Species/Strains Tested for Specificity

Analytical Inclusivity

Analytical Inactivation of Mycobacteria in Sputum Samples

References

Assistance

Table of Symbols