[Product Name] Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)

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

[Intended Use]

This kit is used to qualitatively detect group B streptococcus nucleic acid DNA in vitro rectal swabs, vaginal swabs or rectal/vaginal mixed swabs of pregnant women with high-risk factors around 35 ~37 weeks of pregnancy, and other gestational weeks with clinical symptoms such as premature rupture of membranes, threatened preterm labor, etc.

Group B Streptococcus (GBS), also known as streptococcus agalatiae, is a gram-positive opportunistic pathogen that normally inhabits the lower gastrointestinal and urogenital tracts of the human body. Approximately 10%-30 % of pregnant women have GBS vaginal sojourn. Pregnant women are susceptible to GBS infection due to changes in the internal environment of the reproductive tract due to changes in hormone levels in the body, which will cause adverse pregnancy outcomes such as preterm labor, premature rupture of membranes, and stillbirth, and can also lead to puerperal infections in pregnant women. In addition, 40%-70% of mothers infected with GBS will transmit GBS to their newborns during delivery through the birth canal, causing serious neonatal infectious diseases such as neonatal sepsis and meningitis. If the newborns carry GBS, about 1%-3% will develop early invasive infection, of which 5% will result in death. Neonatal group B streptococcus is associated with perinatal infection and is an important pathogen of severe infectious diseases such as neonatal sepsis and meningitis. By accurately diagnosing group B streptococcus infection, this kit minimizes the incidence and harm of the infection of pregnant women and newborns and the unnecessary economic burden caused by this harm.

This kit provides an auxiliary means for the diagnosis of GBS infection in pregnant women during puerperium. The test results are for clinical reference only, and the final diagnosis must be closely combined with other clinical indicators for comprehensive analysis.

[Test Principle]

This kit uses a combination of PCR amplification and fluorescent probes, selects the conserved region of GBS as the detection target gene region, and designs specific primer probes for fluorescence detection. The 5' end of the probe is labeled with FAM, and the 3' end quencher is BHQ1 and BHQ2 respectively. At the same time, the endogenous internal control is introduced, and the IC3 gene is designed with a specific primer probe for fluorescence detection. The 5' end of the probe is labeled with VIC (HEX), and the 3' end quencher is BHQ2. During the PCR amplification process, the specific primers and probes of the GBS gene and the internal control gene are combined with their respective target sequences. Through the DNA polymerase activity and 5'-3' exonuclease activity of the Taq enzyme, complete synchronization of PCR product formation and fluorescence signal accumulation is achieved, enabling qualitative detection of GBS genes in samples.

[Storage Conditions and Shelf-life]

1.Unopened kit: It should be stored at no higher than 30℃ and protected from light, and the shelf-life is 12 months.

2.Detection should be performed immediately after reconstitution of the freeze-dried reaction buffer and positive control, otherwise it should be stored below -15℃ 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 lower than 37℃.

4.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 and BioRad CFX Opus 96 Real-Time PCR System.

[Requirements for Samples]

1.Sample collection

1) Freshly collected swab samples of genital and rectal secretions.

2) Wipe the excess secretions from the vulva area, and then place a sterile swab on the lower 1/3 of the vagina and rotate to wipe the excess vaginal secretions, and place the sampled swab on the sterile swab tube, sealed for inspection;

3) Gently rotate a sterile swab 2-3cm above the anal sphincter to take rectal secretions, place the sampled swab in a sterile swab tube, and seal it for inspection;

4) It is recommended that the above two swabs after sampling be placed in the same sterile swab tube and sealed for inspection to improve the positive detection rate;

5) It is recommended that subjects avoid using any antibiotics and lotions within one week before sampling.

2.Storage

Test samples should be stored at 2-8°C for no more than 7 days, and should be stored below -18°C for no more than 4 months, and could be stored below -70°C for 12 months. The samples should be repeated freezing and thawing.

3. Shipping

The kits should be sealed in foam box with dry ice and shipped for no more than 5 days. The kits should be stored with ice bag at low temperature and shipped for no more than 3 days.