GeneXpert Xpert MTB RIF Manuals

Manuals and User Guides for GeneXpert Xpert MTB RIF. We have 1 GeneXpert Xpert MTB RIF manual available for free PDF download: User Manual

GeneXpert Xpert MTB RIF User Manual

GeneXpert Xpert MTB RIF User Manual (25 pages)

semi-quantitative nested real-time PCR in-vitro diagnostic test

Brand: GeneXpert | Category: Medical Equipment | Size: 2 MB

Table of Contents

Intended Use
3
Summary and Explanation
3
Principle of the Procedure
4
Reagents and Instruments
4
Material Provided
4
Storage and Handling
5
Materials Required but Not Provided
6
Warnings and Precautions
6
Specimen Collection and Transport
7
Assay Procedure
7
Specimen Collection Procedure
7
Sputum Sediments Procedure
7
Expectorated Sputum Sample Procedure
8
Preparing the Cartridge
9
Starting the Test
10
Discarding Used Cartridges
11
Viewing and Printing Results
11
Quality Control
12
Interpretation of Results
12
Reasons to Repeat the Assay
14
Xpert MTB/RIF Assay Results and Interpretations
14
Limitations
15
Performance Characteristics
15
Retest Procedure
15
Overall Results
16
MTB Detection Results
16
RIF Resistance
17
Interfering Substances
19
Analytical Sensitivity
19
Analytical Specificity
19
Species/Strains Tested for Specificity
20
Analytical Inclusivity
21
Analytical Inactivation of Mycobacteria in Sputum Samples
21
References
22
Assistance
23
Table of Symbols
24

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