Quidel - Amplivue - M902 - Gbs Sexual Health Test Kit Molecular Diagnostic Group B Streptococcus Vaginal Secretion / Rectal Swab Sample 16 Tests Clia Moderate Complexity

Below are the key product attributes and specifications that provide detailed information about this item:

The Quidel AmpliVue GBS Test Kit (M902) is a molecular diagnostic assay designed for the qualitative detection of Group B Streptococcus (GBS) in vaginal/rectal swab specimens. This CLIA moderate complexity test provides accurate and reliable results, aiding in the identification of GBS colonization in pregnant women to help prevent neonatal infections.

Features:
- Rapid Results: Delivers clear, objective results in approximately 75 minutes.
- High Sensitivity & Specificity: Utilizes advanced molecular technology for precise detection of GBS.
- Simple Workflow: Minimal hands-on time with no DNA extraction required.
- CLIA Moderate Complexity: Suitable for use in clinical laboratories with moderate-complexity certification.
- 16 Tests per Kit: Convenient packaging for efficient batch testing.

Specifications:
- Test Method: Isothermal DNA amplification with hybrid protection assay.
- Sample Type: Vaginal/rectal swab specimens.
- Storage: Store at 2–30°C (36–86°F).
- Regulatory Status: For in vitro diagnostic use under CLIA moderate complexity.

Use Suggestion:
This test is recommended for prenatal screening of pregnant women at 35–37 weeks gestation to detect GBS colonization. Positive results should guide appropriate intrapartum antibiotic prophylaxis to reduce the risk of neonatal GBS disease. Follow standard specimen collection and handling protocols for optimal performance.