Fluorescence PCR · Pregnancy & Fertility
Group B Streptococcus Nucleic Acid Detection Kit (Fluorescence PCR)
Qualitative detection of Group B Streptococcus DNA in rectal, vaginal, or rectovaginal swabs from pregnant women at 35–37 weeks gestation, or at other weeks with clinical indications such as premature rupture of membranes or threatened preterm labor, to guide intrapartum prophylaxis decisions.
- SKU Code
AENE-UR027- Approval
- On request
- Product Type
- Assay / Kit
- Status
- Available
Qualitative detection of Group B Streptococcus DNA in rectal, vaginal, or rectovaginal swabs from pregnant women at 35–37 weeks gestation, or at other weeks with clinical indications such as premature rupture of membranes or threatened preterm labor, to guide intrapartum prophylaxis decisions.
| Product type | Assay / Kit |
|---|---|
| Technology platform | Fluorescence PCR |
| Application area | Pregnancy & Fertility |
Certificate
CE, FDA
Epidemiology
GBS (group B Streptococcus) is a gram-positive, opportunistic bacterium commonly found in the lower gastrointestinal and urogenital tracts. Vaginal colonization with GBS occurs in about 10–30% of pregnant women.
Hormonal changes during pregnancy alter the reproductive tract environment, increasing susceptibility to GBS infection. This can lead to adverse outcomes including preterm labor, premature rupture of membranes, stillbirth, and puerperal infections.
Neonatal GBS infection is linked to perinatal transmission and remains a major cause of severe conditions like sepsis and meningitis in newborns. Transmission occurs during vaginal delivery in 40–70% of cases where the mother is colonized. Among colonized infants, 1–3% develop early-onset invasive disease, with a mortality rate of approximately 5%.
| SKU code | AENE-UR027 |
|---|---|
| Storage | Liquid: ≤-18℃ in dark; Lyophilization: ≤30℃ in dark |
| Shelf-life | 12 months |
| Specimen Type | Genital and Rectal Secretions |
| Ct | ≤38 |
| CV | ≤5.0％ |
| LoD | 1×10 3 Copies/mL |
| Covering Subtypes | Detect group B streptococcus serotypes (I a, I b, I c, II, III, IV, V, VI, VII, VIII, IX and ND) and the results are all positive. |
| Specificity | Detect other genital tract and rectal swab samples such as candida albicans, trichomonas vaginalis, chlamydia trachomatis, ureaplasma urealyticum, neisseria gonorrhoeae, mycoplasma hominis, mycoplasma genitalium, herpes simplex virus, human papilloma virus, lactobacillus, gardnerella vaginalis, staphylococcus aureus, national negative reference N1-N10 (streptococcus pneumoniae, streptococcus pyogenes, streptococcus thermophilus, streptococcus mutans, streptococcus pyogenes, lactobacillus acidophilus bacillus, lactobacillus reuteri, escherichia coli DH5α, candida albicans) and human genomic DNA, the results are all negative for group B streptococcus. |
| Applicable Instruments | It can match the mainstream fluorescent PCR instruments on the market. SLAN-96P Real-Time PCR Systems ABI 7500 Real-Time PCR Systems QuantStudio®5 Real-Time PCR Systems LightCycler®480 Real-Time PCR Systems LineGene 9600 Plus Real-Time PCR Detection Systems MA-6000 Real-Time Quantitative Thermal Cycler |
| Approval | On request |
|---|---|
| Documents | Datasheet, IFU, SDS, COA / conformance, origin, and export documents where available |
FAQ
What should be confirmed before quotation?
Sample context, collection method, and extraction workflow should be confirmed before final kit selection.
Which documents can be requested?
Datasheet, IFU, SDS, COA / conformance, origin, insurance, and export documents can be checked where available.
Can the format be adjusted for different workflows?
Liquid or lyophilized format options should be confirmed together with instrument compatibility and shipment requirements.
Inquiry
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