+86-512-6515-8191（Marketing & Sales） Nantong Office: No. 888 Zhujiang Road, Juegang Street, Rudong County, Jiangsu Province Suzhou Office: Building 1, No. 188, Fuchunjiang Road, High-tech Zone, Suzhou Beijing Office: Building 2, No. 28, Yuhua Road, Airport Science and Technology Park, Shunyi District, Beijing Contact Number:+86-10-80497001
[Product Name] Freeze-dried Neisseria Gonorrhoeae Nucleic Acid Detection Kit (Enzymatic
Probe Isothermal Amplification)
[Packaging Size] 48 tests/kit
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 . In 2012, the World Health Organization (WHO) estimated that there were 78 million cases in adults worldwide . 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.
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]
1. Unopened kit: It should be stored at no higher than 30°C and protected from light, and the shelf-life is 12 months.
2. It should be tested immediately after the freeze-dried nucleic acid reaction buffer and positive control are reconstituted. The reconstituted reaction buffer should be stored below -15°C away from light, and the shelf-time is 1 week and the repeated freezing and thawing should be avoided (no more than 2 cycles).
3. Transportation conditions: It can be transported stably for 1 month below 37°C.
4. See the packaging label for the production date, production batch number and expiry date.
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.
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.
Ultra-low temperature transportation of liquid nitrogen and dry ice is recommended.
Suzhou Office: Building 1, No. 188, Fuchunjiang Road, High-tech Zone, Suzhou
Beijing Office: Building 2, No. 28, Yuhua Road, Airport Science and Technology Park, Shunyi District, Beijing
Contact number: +86-10-80497001
Nantong Office: No. 888 Zhujiang Road, Juegang Street, Rudong County, Jiangsu Province
Contact number: +86-513-80562882（Administration & Human Resources）