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Neisseria Gonorrhoeae Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)

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Neisseria Gonorrhoeae Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)

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Introduction

[Product Name] Neisseria Gonorrhoeae Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)
[Packaging Size] 50 tests/kit


[Intended Use]
This kit is used for the qualitative detection of Neisseria gonorrhoeae nucleic acid in genitourinary tract samples in vitro.
Gonorrhea is a classic sexually transmitted disease caused by infection with Neisseria gonorrhoeae (NG), which mainly manifests as purulent inflammation of the mucous membranes of the genitourinary system [1]. In 2012, the World Health Organization (WHO) estimated that there were 78 million cases in adults worldwide [2]. Neisseria gonorrhoeae invades the genitourinary system and breeds, causing urethritis in men and urethritis and cervicitis in women. If not treated completely, it can spread to the reproductive system. The fetus can be infected through the birth canal resulting in neonatal gonorrhea acute conjunctivitis. Humans have no natural immunity to Neisseria gonorrhoeae, and are all susceptible. The immunity after illness is not strong and cannot prevent reinfection [3-4].
The test results of this kit are not the only indicators for the diagnosis of Neisseria gonorrhoeae infection in patients. The clinical characteristics of the patients and other laboratory test data must be combined to correctly determine the infection or colonization of the pathogen, and formulate a reasonable treatment plan to make the treatment safe and effective.

[Test Principles]

This kit adopts Enzymatic Probe Isothermal AmplifiNGtion (EPIA), and designs specific primers and RNA base-containing probes (rProbe) for the highly conserved region of NG, and adds Bst enzyme and RNaseH enzyme at the same time, in which the left and right ends of the RNA base of rProbe are labeled with fluorescent groups and quencher, respectively. Use the DNA polymerase activity and strand displacement activity of Bst enzyme to amplify the target to be tested at a constant temperature, the RNaseH enzyme can cleave the RNA bases on the target-probe hybrid chain, so that the fluorescent group and quencher of rProbe are separated thereby fluorescing. In addition, the left fragment of the residual rProbe RNA base can be used as a primer to further extend to form a product, which further accumulates the product. The fluorescent signal is continuously accumulated with the formation of the product, thereby realizing the detection of the target nucleic acid. 

In the system, the recombinant pine chloroplast gene plasmid is used as an exogenous internal reference to control the quality of the reagents and the operation itself to avoid false negatives.

[Storage Conditions and Shelf-life]

This kit should be stored below -18°C away from light, and the shelf-life is 9 months. The opening and repeated freezing and thawing should be no more than 4 cycles. The kit should be transported below -18°C away from light and can be stably stored for 5 days.
See the packaging label for the production date, production batch number and expiry date.

[Applicable Instruments]

Applied Biosystems 7500 Real-Time PCR Systems, SLAN-96P Real-Time PCR Systems(Shanghai Hongshi Medical Technology Co., Ltd. ), LightCycler®480 Real-Time PCR system, Real-time Fluorescence Constant Temperature Detection System Easy Amp HWTS1600.

[Requirements for Samples]

1. Sample Collection
Use a medical cotton swab to insert about 1-2cm into the male urethra or female cervical orifice, rotate for 1 round, and take it out after staying for 10 seconds. Put the swab head into 1ml of normal saline and stick it to the tube wall and squeeze, the sample is obtained.
2. Storage
The samples should be stored at 2-8°C for no more than 7 days, below -18°C for no more than 4 months, and below -70°C for 12 months. Repeated freezing and thawing of samples should be avoided.
3. Transport
It is not more than 5 days for sealed transportation in foam box with dry ice, and not more than 3 days for low temperature transportation in ice packs.

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