Mycobacterium Tuberculosis INH Resistance Mutation Detection Kit (InhA, AhpC, KatG) (Fluorescence PCR)

Qualitative detection of isoniazid resistance-associated mutations in Mycobacterium tuberculosis from sputum of TB-positive patients. Targets include mutations in the InhA promoter (-15C>T, -8T>A, -8T>C), AhpC promoter (-12C>T, -6G>A), and KatG codon 315 (G>A, G>C). Aids in tailoring first-line therapy.

SKU Code
AENE-RT137
Approval
On request
Product Type
Assay / Kit
Status
Available

Qualitative detection of isoniazid resistance-associated mutations in Mycobacterium tuberculosis from sputum of TB-positive patients. Targets include mutations in the InhA promoter (-15C>T, -8T>A, -8T>C), AhpC promoter (-12C>T, -6G>A), and KatG codon 315 (G>A, G>C). Aids in tailoring first-line therapy.

Product typeAssay / Kit
Technology platformFluorescence PCR
Application areaMycobacterium Tuberculosis

Epidemiology

Tuberculosis is caused by Mycobacterium tuberculosis, also known as the tubercle bacillus. The standard first-line anti-tuberculosis agents include isoniazid (INH), rifampicin, and ethambutol. Second-line drugs comprise fluoroquinolones, amikacin, and kanamycin, while newer options such as linezolid, bedaquiline, and delamanid have been developed. Unfortunately, misuse of these medications and the unique cell wall structure of the bacterium have led to drug resistance, posing significant challenges to tuberculosis control and treatment.

Work Flow

When using the General DNA/RNA Kit (compatible with an Automatic Nucleic Acid Extractor), proceed by sequentially adding 200 µL of the negative control and the processed sputum sample to be tested. Add 10 µL of the internal control separately to the negative control and the processed sputum sample. Strictly follow the extraction kit instructions for all subsequent steps. The input sample volume is 200 µL, and the recommended elution volume is 100 µL.

SKU codeAENE-RT137
Storage≤-18℃
Shelf-life12 months
Specimen Typesputum
CV≤5%
LoDThe detection limit for wild-type INH bacteria is 2x103 bacteria/mL, and the detection limit for mutant bacteria is 2x103 bacteria/mL.
Specificitya. There is no cross reaction among human genome, other nontuberculous mycobacteria and pneumonia pathogens detected by this kit. b. The mutation sites of other drug resistant genes in wild-type Mycobacterium tuberculosis, such as the resistance determining region of the rifampicin rpoB gene, were detected, and the test results showed no resistance to INH, indicating no cross reactivity.
Applicable InstrumentsSLAN-96P Real-Time PCR Systems BioRad CFX96 Real-Time PCR Systems LightCycler480 ® Real-Time PCR System
ApprovalOn request
DocumentsDatasheet, 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.

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