product key technologies
The Strep B Rapid Test Device (Swab) is a qualitative lateral flow immunoassay for the rapid detection of Group B Streptococcus (GBS) antigens in vaginal, rectal, or neonatal swabs. Designed for professional in vitro diagnostics, this test enables early identification of GBS colonization in pregnant women, facilitating timely antibiotic prophylaxis to reduce neonatal infection risks.
Background on Strep B
What is Strep B?
Group B Streptococcus (GBS or Strep B), scientifically known as Streptococcus agalactiae, is a type of bacteria.
Who does it affect?
1. Newborns (The primary at-risk group)
Due to their immature immune systems, newborns exposed to GBS during birth can develop serious and potentially life-threatening infections. It is a leading cause of neonatal sepsis and meningitis.
2. Pregnant Women & Adults with Certain Health Conditions
Pregnant Women: GBS colonization can cause urinary tract infections, intra-amniotic infection (chorioamnionitis), and postpartum endometritis.
Is prenatal screening necessary?
Yes, it is a standard and critically important prenatal care procedure. Approximately 25% of healthy pregnant people are colonized with GBS but have no symptoms. Without screening, there is no way to identify carriers.
Product Specification
|
Intended use |
Detection of Strep B |
|
Storage |
4-30°C |
|
Shelf Life |
24 Months |
|
Sensitivity |
96.2% |
|
Specificity |
97.5% |
|
Accuracy |
97.1% |
Ordering Information
|
Product Name |
Catalog No. |
Specimen |
Format |
Certification |
|
Strep B Rapid Test Device (Swab) |
STB-6011 |
Vaginal secretion |
Strip |
CE |
|
STB-6012 |
Vaginal secretion |
Cassette |
CE |
Product Advantages
High Accuracy: High Sensitivity&Specificity
Rapid Results: Clear interpretation in 5 minutes (read window: 5–15 minutes).
Simple Workflow: 5-step procedure with minimal training required.
Stable Storage: Room temperature (4–30°C) storage with 24-month shelf life.
Operation Steps
Allow test components (kit, reagents, specimens) to equilibrate at ambient temperature (15–30°C) prior to use.
1.Reagent Activation:
- Dispense 4 drops of Reagent A and 4 drops of Reagent B into the extraction tube. Gently swirl to combine.
2.Sample Processing:
- Immerse the swab into the reagent mixture, vigorously agitate for 10 rotations, and incubate statically for 60 seconds.
- While withdrawing the swab, compress it against the tube inner wall to express residual liquid. Discard the used swab appropriately.
3.Assay Execution:
- Secure the dropper tip onto the extraction tube and transfer 3 drops (≈180µL) of the processed sample into the device's specimen well (S).
- Immediately initiate the timer upon completion of sample addition.
4.Result Interpretation:
- Visual assessment of band development should occur precisely at the 5-minute mark. Results interpreted beyond 15 minutes are considered invalid.
FAQ
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