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Staphylococcus Aureus and Methicillin-Resistant Staphylococcus Aureus Nucleic Acid Detection Kit (Fluorescence PCR)

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Staphylococcus Aureus and Methicillin-Resistant Staphylococcus Aureus Nucleic Acid Detection Kit (Fluorescence PCR)

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Introduction

[Product Name]
Staphylococcus Aureus and Methicillin-Resistant Staphylococcus Aureus Nucleic Acid Detection Kit(Fluorescence PCR)

[Packaging Size] 20 tests/kit, 50 tests/kit

[Intended Use]
This kit is used for the qualitative detection of staphylococcus aureus and methicillin-resistant staphylococcus aureus nucleic acids in human sputum samples, skin and soft tissue infection samples, and whole blood samples in vitro. Sputum sample testing is used in medical institutions to prevent and control MRSA nosocomial infection in hospitalized patients, including intensive care patients, surgical patients and long-term care patients; skin and soft tissue infection sample testing is used in combination with other laboratory tests such as microbial culture to assist diagnose skin and soft tissue infections of MRSA/SA; whole blood sample testing is used for auxiliary diagnosis of MRSA/SA infection in patients who need blood culture detection.

Staphylococcus aureus is one of the important pathogenic bacteria of nosocomial infection. Staphylococcus aureus (SA) belongs to the staphylococcus and is a representative of Gram-positive bacteria, which can produce a variety of toxins and invasive enzymes. The bacteria have the characteristics of wide distribution, strong pathogenicity and high resistance rate. Thermostable nuclease gene (nuc) is a highly conserved gene of staphylococcus aureus.

In recent years, due to the extensive use of hormones and immune preparations and the abuse of broad-spectrum antibiotics, nosocomial infections caused by Methicillin-resistant Staphylococcus aureus (MRSA) in Staphylococcus have been on the rise. The national average detection rate of MRSA was 30.2% in 2019 in China. MRSA is divided into healthcare-associated MRSA (HA-MRSA), community-associated MRSA (CA-MRSA), and livestock-associated MRSA (LA-MRSA). CA-MRSA, HA-MRSA, LA-MRSA have great differences in microbiology, bacterial resistance (eg, HA-MRSA shows more multidrug resistance than CA-MRSA) and clinical characteristics (eg infection site). According to these characteristics, CA-MRSA and HA-MRSA can be distinguished. However, the differences between CA-MRSA and HA-MRSA are narrowing due to the constant movement of people between hospitals and communities. MRSA is multi-drug resistant, not only resistant to β -lactam antibiotics, but also to aminoglycosides, macrolides, tetracyclines and quinolones to varying degrees. There are large regional differences in drug resistance rates and different trends.
Methicillin resistance mecA gene plays a decisive role in staphylococcal resistance. The gene is carried on a unique mobile genetic element (SCCmec), which encodes penicillin-binding protein 2a (PBP2a) and it has low affinity to β-lactam antibiotics, so that antimicrobial drugs

can not hinder the synthesis of cell wall peptidoglycan layer, resulting in drug resistance.
This kit can be used for auxiliary diagnosis and curative effect monitoring of staphylococcus aureus and its methicillin-resistant strains infection. The test results are for clinical reference only, and the final diagnosis should be comprehensively considered in close combination with other clinical indicators.
[Test Principles]
This kit uses the Taqman fluorescent probe method to design primer probes for the highly conserved and specific regions of the staphylococcus aureus nuc gene and the methicillin-resistant mecA gene. The mecA gene probe is labeled with the FAM fluorophore, the nuc gene probe is labeled with the CY5 fluorophore, and the 3' end of the probe is labeled with a quencher. During the amplification process, specific primers and probes are combined with the target sequence, and the formation of PCR products and the accumulation of fluorescent signals are completely synchronized by the DNA polymerase activity of Taq enzyme and 5'-3' exonuclease activity to realize the qualitative detection of staphylococcus aureus and methicillin resistance genes in the samples. UDG enzyme can hydrolyze the "residual contaminants" in the amplification product to generate apyrimidine purine sites. During PCR pre-denaturation, the DNA strands are broken at these sites, losing the function of the template. UDG in the system is inactivated to avoid contamination of amplification products.
The kit contains a human-derived internal reference, the internal reference probe is labeled with a VIC fluorophore, and the 3' end of the probe is labeled with a quencher. It is used as a quality control for reagents, DNA quality, and the operation itself to avoid false negative test results.

[Storage Conditions and Shelf-life]

Storage condition: this kit should be stored below -18°C and protected from light. The shelf life is 12 months. Avoid repeated freezing and thawing (limited to 4 cycles). After opening, it should be stored below -18°C. If it is stored at 2~8°C, please use within 1 week.
Shipping conditions: The kit is stable for 5 days in a shipping box containing dry ice.

See the packaging label for the production date, production batch number and expiration date. [Applicable Instruments]
Applied Biosystems 7500 Real-Time PCR Systems, QuantStudio®5 Real-Time PCR Systems, SLAN-96P Real-Time PCR Systems(Shanghai Hongshi Medical Technology Co., Ltd. ), LightCycler®480 Real-Time PCR system, LineGene 9600 Plus Real-Time PCR Detection System(FQD-96A,Bioer technology), MA-6000 Real-Time Quantitative Thermal Cycler (Suzhou Molarray Co., Ltd.) , BioRad CFX96 Real-Time PCR System, BioRad CFX Opus 96 Real-Time PCR System.

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