（For Research Use Only）

Tuberculosis and non-tuberculosis diseases caused by mycobacterial infections are highly infectious diseases that pose a serious threat to human health. They are prevalent worldwide and are among the key infectious diseases targeted for control globally. Due to the similarity in symptoms between tuberculosis and non-tuberculosis diseases, but with distinctly different treatment approaches, most non-tuberculous mycobacteria naturally exhibit resistance to anti-tuberculosis drugs. Furthermore, tuberculosis mycobacteria that undergo drug-resistant mutations can also develop resistance against anti-tuberculosis drugs. With the widespread use of hematopoietic stem cell transplantation, solid organ transplantation, immunosuppressive agents, chemotherapy drugs, and various interventional therapies, the incidence of invasive pulmonary fungal infections is gradually increasing. Clinically, patients with pulmonary fungal infections do not exhibit specific manifestations, making early diagnosis challenging. The condition is easily masked by underlying diseases, leading to misdiagnosis, missed diagnosis, and delayed treatment, resulting in high mortality rates. Therefore, accurate identification of mycobacterial infections in lung tissue, identification of invasive fungal infections, and correct detection of drug-resistant mutations in anti-tuberculosis drugs are crucial for the diagnosis and treatment of these diseases.

DETECTION CONTENT

DETECTION METHOD

Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF-MS) is a novel soft ionization technique used for the analysis of biomolecules. It involves irradiating the sample with a laser, which forms a co-crystallized thin film with a matrix. The matrix absorbs energy from the laser and transfers it to the biomolecules, causing their ionization. The ionized biomolecules then accelerate through a flight tube under the influence of an electric field. By measuring the flight time of the ions to the detector, the molecular weight of the biomolecules can be directly calculated, enabling accurate identification and separation.

PRODUCT INFORMATION

DETECTION SIGNIFICANCE

Accurate identification of the clinically common 26 pathogenic mycobacteria, including the Mycobacterium tuberculosis complex, and 30 invasive fungi, as well as the evaluation of drug resistance for six anti-tuberculosis drugs, is essential to determine the causative pathogens and their drug sensitivity. This allows for personalized and precise treatment approaches.

FEATURES & ADVANTAGES

1. Technological dvancement:  The method combines PCR technology to analyze the nucleic acid molecules of bacterial infections in the lungs. It eliminates the need for processes like in vitro cultivation, reduces manual handling, and provides a simple and rapid detection process. Results can be obtained within a day.

2. Stability and eliability:  The detection results are not affected by common lung microorganisms such as Burkholderia cepacia, Pseudomonas aeruginosa, Streptococcus pneumoniae, Legionella pneumophila, and Bordetella pertussis.

3. Good Specificity: Capable of handling 100 ng of wild-type human genomic DNA without exhibiting non-specific effects.

4. High ensitivity: It can detect mycobacterial nucleic acid DNA with a content as low as 200 copies in 20 ng of human genomic DNA.

DETECTION PROCESS

1. DNA Extraction

2. Template Sample Adding

3. Mass Spectrometry Detection

4. Data Analysis

5. Reporting