Detection Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence Probing)
REF No.:TB001
Detection Kit for Drug-Resistant Mycobacterium Tuberculosis DNA (PCR-Fluorescence Probing)
REF No.: TB002
Descriptions
Tuberculosis (TB) is an infectious disease caused predominantly by bacteria (Mycobacterium tuberculosis) and it most often affects the lungs.
TB is spread through the air when people with lung TB cough, sneeze, or spit. A person needs to inhale only a few germs to become infected.
Every year, 10 million people fall ill with tuberculosis (TB). Despite being a preventable and curable disease, 1.5 million people die from TB each year – making it the world’s top infectious killer.
Humans are the only reservoir for Mycobacterium tuberculosis.
According to the WHO guidelines for tuberculosis diagnosis and treatment, rifampicin and isoniazid are the most important anti-tuberculosis drugs currently available. ROPB gene-related mutations are the most important drug-resistant genes for rifampicin, and the most common mutation causing resistance is the 511-531 site mutation. The regulatory genes inhA and katG, with a 315 site mutation in katG gene, are relatively common in isoniazid-resistant strains.
Intended Use
Detection Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence Probing)
is used for in vitro qualitative detection of Mycobacterium tuberculosis complex (MTBC) specific DNA fragment, including Mycobacterium africanum, Mycobacterium bovis, Mycobacterium canettii, Mycobacterium microti, and M. tuberculosis, in samples extracted from human sputum specimens by means of Real-Time PCR. The test results are for clinical reference only and cannot be used as a basis for confirming or excluding cases alone.
Detection Kit for Drug-Resistant Mycobacterium Tuberculosis DNA (PCR-Fluorescence Probing)
is based on real-time fluorescence quantitative PCR technology, with specific primers and corresponding fluorescent probes designed for the conserved region of MTBC, for high-specificity detection. By detecting changes in fluorescence signals, it can be used for qualitative detection of MTBC nucleic acid, as well as ROPB drug-resistant gene mutations and inhA drug-resistant genes in sputum specimens.
Features
RAPID DETECTION
The amplification can be completed within 30mins
WIDE APPLICABILITY
Compatible with a wide range of real-time PCR devices
CONTAMINATION PREVENTION
PCR buffer and polyase mix contain Uracil-DNA glycosylase (UDG) eliminating carryover contamination
EASY-TO-USE CONCEPT
One kit contains all components for PCR amplification, simplifies laboratory workflow
Technical Specifications
REF No. |
TB001 |
TB002 |
Regulatory Status |
CE IVD |
|
Packing Specifications |
48 Tests/ Kit, 96 Tests/Kit |
|
Technology |
Real-time PCR |
|
Type Of Analysis |
Qualitative |
|
Sample Type |
Sputum |
|
Reaction Volume |
30μL |
30μL |
Species |
Mycobacterium africanum, Mycobacterium bovis, Mycobacterium canettii, Mycobacterium microti, and M. tuberculosis |
MTBC,ROPB drug-resistant gene mutations and inhA drug-resistant genes |
Analytical Sensitivity |
1000 copies/mL |
10 bacteria/mL forMycobacterium tuberculosis complex, 5000 copies/mL for RIF drug-resistant gene ropB gene mutation, and 1000 copies/mL inhfordrug-resistant gene inhA gene regulation gene katG mutation |
Precision |
CV≤5% |
|
Storage |
-20±5℃ in dark for 12 months |
|
Main Components |
PCR Buffer, Polyase Mix, Negative Control, Positive Control |
PCR Reaction Solution, Enzyme Mix,Negative Control, Positive Control |
Validated Extraction Method |
Whole blood extraction kit (Singuway REF:MTQB064/MTQB096) is recommended. |
Nucleic acid extraction kit (Singuway REF: MTQ064) is recommended. |
Instruments |
A real-time PCR instrument including FAM and HEX/VIC fluorescence channels, such as Singuway Singu9600, Bio-Rad CFX96, ABI 7500, Thermo Fisher StepOnePlus, Tianlong 96E, AccuRa-32. |
|
Required Detection Channels |
FAM, HEX |
FAM,HEX,ROX,CY5 |