Low MOQ for Mycobacterium Tuberculosis - Mycobacterium Tuberculosis DNA Detection Kit (Isothermal Amplificaion) – Macro & Micro-Test

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Low MOQ for Mycobacterium Tuberculosis - Mycobacterium Tuberculosis DNA Detection Kit (Isothermal Amplificaion) – Macro & Micro-Test Detail:

Product name

Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Mycobacterium tuberculosis

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Intended Use

This kit is used for the in vitro qualitative detection of the patients with tuberculosis-related signs/symptoms or confirmed by X-ray examination of mycobacterium tuberculosis infection and sputum specimens of the patients requiring diagnosis or differential diagnosis of mycobacterium tuberculosis infection.

Epidemiology

Mycobacterium tuberculosis (Tubercle bacillus, TB) is a type of obligate aerobic bacteria with positive acid-fast staining. There is pili on TB but no flagellum. Although TB has microcapsules but does not form spores. The cell wall of TB has neither teichoic acid of gram-positive bacteria nor lipopolysaccharide of gram-negative bacteria^[1]. Mycobacterium tuberculosis which is pathogenic to humans is generally divided into human type, bovine type, and African type. The pathogenicity of TB may be related to inflammation caused by the proliferation of bacteria in tissue cells, the toxicity of bacterial components and metabolites, and the immune damage to bacterial components. Pathogenic substances are related to capsules, lipids and proteins^[2]. Mycobacterium tuberculosis can invade susceptible population through respiratory tract, digestive tract or skin damage, causing tuberculosis in a variety of tissues and organs, of which tuberculosis caused by the respiratory tract is the most. Occurs mostly in children, with symptoms such as low-grade fever, night sweats, and a small amount of hemoptysis. Secondary infections are mainly manifested as low-grade fever, night sweats, hemoptysis and other symptoms; chronic onset, a few acute attacks^[3,4]. Tuberculosis is one of the ten leading causes of death in the world. In 2018, about 10 million people in the world were infected with Mycobacterium tuberculosis, about 1.6 million people died. China is a country with a high burden of tuberculosis, and its incidence rate ranks second in the world^[5].

Features

Internal control: Internal and external quality control to avoid false positive and false negative results.

High sensitivity: 2000Copies/mL

High specificity: No cross-reactivity with other mycobacteria and pathogens in the non-Mycobacterium tuberculosis complex.

Channel

FAM: Mycobacterium tuberculosis·

CY5: Internal Control

Real Time Isothermal Amplification Conditions Setting

Step	Temperature	Duration	Cycle	Fluorescent signal measurement
1	63℃	1min	30 cycles	Yes

Technical Parameters

Storage	≤-18℃ In dark
Shelf-life	9 months
Specimen Type	Sputum
Tt	＜30
CV	≤10％
LoD	2000Copies/mL
Specificity	No cross-reactivity with other mycobacteria in the non-Mycobacterium tuberculosis complex (e.g. Mycobacterium kansas, Mycobacter surga, Mycobacterium marinum, etc.) and other pathogens (e.g. Streptococcus pneumoniae, Haemophilus influenzae, Escherichia coli, etc.).
Applicable Instruments	Applied Biosystems 7500 Real-Time PCR Systems, SLAN ® -96P Real-Time PCR Systems, Easy Amp Real-time Fluorescence Isothermal Detection System（HWTS1600）

Main Components

S/N	Component (50tests/kit)	Specification	Quantity	Component description
1	TB Reaction Mix	830μL/vial	1 vial	Reagents and primers, etc
2	TB Enzyme Mix	170μL/vial	1 vial	Enzyme, probe and RNaseH, etc
3	TB Positive Control	600μL/vial	1 vial	106Copies/mL TB Recombinant strain
4	TB Internal Control	250μL/vial	1 vial	106Copies/mL TB Internal Control plasmid
5	TB Negative Control	600μL/vial	1 vial	DNase/RNase-Free Deionize Water

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Mycobacterium Bacteria