Human Lung Tissue Mycobacteria Identification Detection Kit
Nucleic Acid Mass Spectrometry; CE-IVD
Human Lung Tissue Mycobacteria Identification Detection Kit
26 species of Mycobacterium and Mycobacterium tuberculosis complex group
BACKGROUND

According to the World Health Organization's (WHO) Global Tuberculosis Report 2023, there are 10.6 million new cases of TB worldwide in 2022, and a total of 1.3 million TB-related deaths. China is one of the top three countries with a high burden of TB in the world, with an estimated 748,000 new cases of TB in 2022, accounting for 7.1% of the global new cases.


Tuberculosis (TB) and non-tuberculosis (NTB) caused by mycobacterium infection in High TB burden countries are serious infectious diseases that harm human health. They are prevalent in the world and are one of the key infectious diseases under global control. Because TB and non-TB symptoms are similar but treatment regimens are very different, most non-TB mycobacteria are naturally resistant to anti-TB drugs. Therefore, accurate detection of mycobacterium infection identification in lung tissue is essential for the diagnosis and treatment of the disease.



BACKGROUND
DETECTION CONTENT



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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
Human Lung Tissue Mycobacteria Identification Detection Kit
Nucleic acid mass spectrometry
40Tests/Kit
MassARRAY®DNA Mass pectrometry gene analysis system
FFPE
DETECTION SIGNIFICANCE

Accurate identification of common clinical mycobacterium tuberculosis complex groups and 26 pathogenic mycobacteria, clear pathogenic bacteria, to achieve individualized precision treatment.

FEATURES & ADVANTAGES
Advanced technology

Advanced technology

Combined with PCR technology, the analysis of lung infection bacteria 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 test 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

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