Fluorescence PCR · Mycobacterium Tuberculosis
Mycobacterium tuberculosis and Rifampicin/Isoniazid Resistance Detection Kit (Fluorescence PCR)
In vitro qualitative detection of Mycobacterium tuberculosis DNA and mutations in the rpoB gene rifampicin resistance-determining region (codons 507-533) and main isoniazid resistance mutation sites, in human sputum, solid and liquid culture, and bronchial lavage fluid. Aids in diagnosis of TB and detection of resistance to rifampicin and isoniazid.
- SKU Code
AENE-RT147- Approval
- On request
- Product Type
- Assay / Kit
- Status
- Available
In vitro qualitative detection of Mycobacterium tuberculosis DNA and mutations in the rpoB gene rifampicin resistance-determining region (codons 507-533) and main isoniazid resistance mutation sites, in human sputum, solid and liquid culture, and bronchial lavage fluid. Aids in diagnosis of TB and detection of resistance to rifampicin and isoniazid.
| Product type | Assay / Kit |
|---|---|
| Technology platform | Fluorescence PCR |
| Application area | Mycobacterium Tuberculosis |
Epidemiology
Mycobacterium tuberculosis, the bacterium responsible for tuberculosis (TB), is treated with first-line drugs including isoniazid, rifampicin, and ethambutol[1]. However, improper use of these drugs and the unique cell wall structure of the bacterium contribute to the development of drug resistance. A particularly serious form is multidrug-resistant TB (MDR-TB), which is resistant to both rifampicin and isoniazid, the two most effective first-line agents[2].
Drug-resistant TB is present in all countries monitored by the WHO. To improve treatment outcomes, detecting resistance—especially to rifampicin—has become a WHO-recommended step in TB care[3]. While rifampicin resistance often indicates MDR-TB, testing only for rifampicin overlooks patients with mono-resistant isoniazid (resistant to isoniazid but susceptible to rifampicin) or mono-resistant rifampicin (susceptible to isoniazid but resistant to rifampicin), potentially leading to suboptimal initial treatment. Hence, testing for both isoniazid and rifampicin resistance is the minimum required in all drug-resistant TB control programs[4].
| SKU code | AENE-RT147 |
|---|---|
| Storage | ≤-18℃ |
| Shelf-life | 12 months |
| Specimen Type | Sputum Sample, Solid Culture (L-J Medium), Liquid Culture (MGIT Medium) |
| CV | 5.0% |
| LoD | The LoD of the kit for detecting Mycobacterium tuberculosis is 10 bacteria/mL; the LoD of the kit for detecting rifampicin wild type and mutant type is 150 bacteria/mL; the LoD of the kit for detecting isoniazid wild type and mutant type is 200 bacteria/mL. |
| Specificity | 1) There is no cross reaction when using the kit to detect human genomic DNA (500ng), other 28 types of respiratory pathogens, and 29 types of non-tuberculous mycobacteria (as shown in Table 3). 2) There is no cross reaction when using the kit to detect the mutation sites of other drug-resistant genes of rifampicin and isoniazid sensitive Mycobacterium tuberculosis (as shown in Table 4). 3) Common interfering substances in the samples to be tested, such as rifampicin (9mg/L), isoniazid (12mg/L), ethambutol (8mg/L), amoxicillin (11mg/L), oxymetazoline (1mg/L), mupirocin (20mg/L), pyrazinamide (45mg/L), zanamivir (0.5mg/L), dexamethasone (20mg/L) drugs, have no effect on the kit test results. |
| Applicable Instruments | SLAN-96P Real-Time PCR Systems (Hongshi Medical Technology Co. Ltd.), BioRad CFX96 Real-Time PCR System |
| Approval | On request |
|---|---|
| Documents | Datasheet, IFU, SDS, COA / conformance, origin, and export documents where available |
FAQ
What should be confirmed before quotation?
Sample context, collection method, and extraction workflow should be confirmed before final kit selection.
Which documents can be requested?
Datasheet, IFU, SDS, COA / conformance, origin, insurance, and export documents can be checked where available.
Can the format be adjusted for different workflows?
Liquid or lyophilized format options should be confirmed together with instrument compatibility and shipment requirements.
Inquiry
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