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Singuway Nucleic Acid Detection Kit
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Mycobacterium Tuberculosis

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


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