Low MOQ for Mycobacterium Tuberculosis - Mycobacterium Tuberculosis DNA Detection Kit (Isothermal Amplificaion) – Macro & Micro-Test
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
Certificate
CE
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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By Nicole from Morocco - 2018.12.28 15:18
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By Christopher Mabey from Vietnam - 2017.02.28 14:19