[Product Name]Freeze-dried Ureaplasma Urealyticum Nucleic Acid Detection Kit(Enzymatic

Probe Isothermal Amplification)
[Packaging Size] 48 tests/kit
[Intended Use]
This kit is used for the qualitative detection of ureaplasma urealyticum nucleic acid in genitourinary tract samples in vitro.

Ureaplasma urealyticum (UU) is the smallest prokaryotic microorganism that can live independently between bacteria and viruses, and is also a pathogenic microorganism that is prone to genital and urinary tract infections [1]. For men, it can cause prostatitis, urethritis, pyelonephritis, etc. [2]. For women, it can cause inflammatory reactions in the reproductive tract such as vaginitis, cervicitis, and pelvic inflammatory disease. It is one of the pathogens that cause infertility and abortion[3]. Ureaplasma urealyticum is divided into 14 serotypes, which are divided into two groups according to molecular biological characteristics: biological group I (Up) and biological group II (Uu). Biogroup I includes 4 serotypes with smaller genomes (1, 3, 6, and 14); biogroup II includes the remaining 10 serotypes with larger genomes [4].

The test result of this kit is not the only indicator for the diagnosis of ureaplasma urealyticum 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 Amplification (EPIA), and designs specific primers and RNA base-containing probes (rProbe) for the highly conserved region of UU, 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.Test should be performed immediately after reconstitution of the freeze-dried reaction buffer and positive control, the reconstituted reaction buffer should be stored below -15°C and protected from light. The validity period is 1 week, and repeated freezing and thawing should be avoided ( limited to 2 cycles).
3.Transportation conditions: It can be transported stably for 1 month when the temperature is not higher than 37°C.
4. See the packaging label for the production date, production batch number and expiration 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. Shipping
Ultra-low temperature transportation of liquid nitrogen and dry ice is recommended.