Mycobacterium Tuberculosis Drug-resistant Mutation Detection Kit
Nucleic Acid Mass Spectrometry
Mycobacterium Tuberculosis Drug-resistant Mutation Detection Kit
Assess tuberculosis patient's sensitivity to combination drugs to assist in the customization of anti-tuberculosis treatment regimens.
BACKGROUND

Tuberculosis is one of the major infectious diseases that China focuses on controlling. The Chinese government has always attached great importance to the prevention and control of tuberculosis. In recent years, the Chinese government has issued documents such as the Outline of the Healthy China 2030 Plan, the Action Plan to Curb Tuberculosis (2019-2022) and the Further Strengthening of the Prevention and Control of drug-Resistant Tuberculosis. It is clearly proposed to further strengthen the prevention and control of tuberculosis and drug-resistant tuberculosis, and reduce the incidence and mortality of tuberculosis.

 

MDR-TB remains a global public health crisis, with an estimated 410,000 people living with MDR-TB or Rifampicin-resistant TB (MDR/RR-TB), and only about two in five people receiving treatment. The treatment success rate of MDR/RR-TB patients in China is only 51%, which is still far behind the global treatment success rate of 63%. At the same time, the high cost of diagnosis and treatment also makes it difficult for some patients with drug-resistant tuberculosis to bear, resulting in the delay of individual illness and even the spread of drug-resistant tuberculosis, making the tuberculosis prevention and control situation worse. Therefore, accurate detection of anti-TB drug resistance mutations is essential for the diagnosis and treatment of the disease.


BACKGROUND
DETECTION METHOD


Matrix assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF-MS), the combined molecules are ionized with the help of the matrix, and the ions are accelerated through the flight pipe under the action of an electric field. Their mass and charge can affect their flight time, so the detection objects are accurately separated and identified according to the different flight times when they arrive at the detector.


PRODUCT INFORMATION
Project Name
Detection Method
Pack Size
Instruments Validated
Sample Type
Mycobacterium Tuberculosis Drug-resistant Mutation Detection Kit
Nucleic acid mass spectrometry
40 Tests/Kit
MassARRAY®DNA Mass spectrometry gene analysis system
FFPE
DETECTION SIGNIFICANCE

Accurately identify and evaluate the drug resistance of 6 common first - and second-line anti-tuberculosis drugs, identify pathogenic bacteria and drug sensitivity, and achieve individualized precision treatment.

FEATURES & ADVANTAGES
Advanced technology

Advanced technology

Combined with PCR technology, the analysis of Mycobacterium pulmonary drug resistance at the molecular level of nucleic acid, without in vitro culture and other processes, shorten the detection time, reduce manual operation, simple and fast, can obtain the detection results within one day

Stable and reliable

Stable and reliable

Common lung microorganisms (Nocardia brasiliensis, Corynebacterium pekinensis, pneumococcus, Legionella pneumophila, Bordetella pertussis) will not affect the test results of the product, without crossover reaction

Good specificity

Good specificity

It can tolerate 100 ng wild type human genome DNA, nothing more specific

High sensitivity

High sensitivity

Mycobacterium content as low as 200 copies in a 20 ng DNA sample can be detected

DETECTION PROCESS

1.Nucleic acid extraction

2.Template loading

3.Mass spectrometry detection

4.Data analysis

5.Report generation