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Reference Laboratory Division of TB Elimination Laboratory User Guide for U.S. Public Health Laboratories Molecular Detection of Drug Resistance MDDR in Mycobacterium tuberculosis Complex by DNA Sequencing Version 2.
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How to fill out Laboratory User Guide for U.S. Public Health Laboratories: Molecular Detection of Drug Resistance (MDDR) in Mycobacterium tuberculosis Complex by DNA Sequencing (Version 2.0)

01
Obtain a copy of the Laboratory User Guide for U.S. Public Health Laboratories: Molecular Detection of Drug Resistance (MDDR) in Mycobacterium tuberculosis Complex by DNA Sequencing (Version 2.0).
02
Review the introduction to understand the purpose and scope of the document.
03
Familiarize yourself with the requirements for sample collection and preparation as outlined in the guide.
04
Follow the step-by-step procedures for DNA extraction specific to the Mycobacterium tuberculosis complex.
05
Ensure you have the necessary reagents and equipment mentioned in the guide.
06
Adhere to the quality control measures and validation processes as described.
07
Document all findings and results as per the provided templates.
08
Review the troubleshooting section for common issues and resolutions.
09
Submit the filled-out guide along with your findings to the relevant authorities.

Who needs Laboratory User Guide for U.S. Public Health Laboratories: Molecular Detection of Drug Resistance (MDDR) in Mycobacterium tuberculosis Complex by DNA Sequencing (Version 2.0)?

01
Public health laboratories that diagnose and monitor drug resistance in Mycobacterium tuberculosis.
02
Healthcare professionals involved in tuberculosis management and treatment.
03
Research institutions studying Mycobacterium tuberculosis and its resistance patterns.
04
Regulatory bodies and organizations setting standards for laboratory practices in infectious diseases.
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People Also Ask about

Recommended tests. There are two tests that are used to determine if a person has been infected with TB bacteria: TB blood tests (Interferon Gamma Release Assay [IGRA]) and the TB skin test (Mantoux tuberculin skin test).
Culture. Mycobacterial culture is a recommended test for the diagnosis of TB, and a positive culture is considered confirmatory. The CDC recommends that all specimens be cultured, regardless of AFB smear results.
In 2020, the updated WHO guidelines recommended the use of molecular assays (Xpert MTB/RIF and Xpert MTB/RIF [Xpert Ultra]; GeneXpert) as the initial test for the diagnosis of pulmonary and extrapulmonary TB and rifampicin resistance in adults and children [19,24].
All specimens should be cultured, regardless of whether the smear is positive or negative. Culture is the gold standard for laboratory confirmation of TB disease. A positive culture for M. tuberculosis confirms the diagnosis of TB disease.
A health care provider may diagnose you with inactive TB or active TB disease based on your: Medical history. Physical examination. Test for TB infection (TB blood test or TB skin test) Chest x-ray. Laboratory tests to see if TB germs are present (sputum smear and culture) Laboratory tests for drug resistance.
Molecular Detection of Drug Resistance (MDDR) can provide rapid and accurate results for detection of drug resistance in Mycobacterium tuberculosis complex (MTBC).
The RISHL utilizes the Cepheid Xpert MTB/RIF assay for NAAT, an automated molecular diagnostic test that is used to detect the presence of Mycobacterium tuberculosis complex (MTB-complex) DNA in respiratory specimens.

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The Laboratory User Guide for U.S. Public Health Laboratories: Molecular Detection of Drug Resistance (MDDR) in Mycobacterium tuberculosis Complex by DNA Sequencing (Version 2.0) is a comprehensive document that provides guidelines and protocols for the detection of drug resistance in Mycobacterium tuberculosis using DNA sequencing techniques.
Public health laboratories involved in the molecular detection of drug resistance in Mycobacterium tuberculosis, as well as any clinical laboratories that implement the techniques described in the guide, are required to follow and file according to the Laboratory User Guide.
To fill out the Laboratory User Guide, laboratories must adhere to the step-by-step instructions provided in the guide, which include detailing sample information, methodologies used for testing, results obtained, and any relevant quality control measures taken during the analysis.
The purpose of the guide is to standardize testing methods for detecting drug resistance in Mycobacterium tuberculosis, ensuring accurate and reliable results that can guide treatment decisions and public health responses.
The information that must be reported includes patient demographics, sample type and origin, assay results, genetic mutations detected, and any quality control data that supports the validity of the test results.
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