M-14002 Gardnerella Vaginalis Test Kit
Diagnostic Significance: Gardnerella vaginalis (G.V.) is a major pathogen causing bacterial vaginosis (BV) and urethritis. It dominates the microbial flora in BV cases, where its levels are significantly higher compared to other non-normal flora, establishing it as a critical pathogen for BV. There is a significant difference in the detection rate of Gardnerella between patients with BV and healthy individuals. Testing for Gardnerella antigens is an important diagnostic marker for BV, which, when combined with clinical symptoms, aids in diagnosis. Clinical studies also indicate that Gardnerella infection is highly correlated with infertility and adverse pregnancy outcomes, such as ectopic pregnancies, preterm premature rupture of membranes, and preterm birth. Gardnerella can be detected in 30-40% of patients with infertility and adverse pregnancy histories, with a high transmission rate of up to 90% between partners. Testing for Gardnerella vaginalis is significantly important for the prevention and diagnosis of gynecological diseases and infertility.
Features: High specificity, high sensitivity, and fast testing, with results available within one hour. The test is easy to operate and requires minimal environmental and equipment conditions.
Technical Principle: The Direct Immunofluorescence Assay (DFA) uses fluorophores directly labeled on antibodies without affecting antigen-antibody activity. This binds to corresponding antigens in the sample, and specific fluorescent imaging is displayed under a fluorescence microscope with specific wavelength excitation.
Sample Collection: Vaginal secretions from women; semen from men.
Clinical Testing Recommendations:
- Gynecology Outpatient:
- Patients with vaginitis, especially those with recurrent, persistent infections.
- Obstetrics Outpatient:
- Routine screening during pregnancy (around 18 weeks); postpartum follow-up; pre-pregnancy check-ups.
- Infertility Specialty:
- Initial consultation for female patients; initial consultation for male patients.
- Family Planning Department:
- Pre-operative check-ups for miscarriages and other procedures.
Comparison of Different Testing Methodologies:
| Method | Operability | Sensitivity | Specificity | Accuracy |
|---|---|---|---|---|
| Culture Method | Complex, time-consuming | Good | Good | Good |
| Immunofluorescence | Simple | Good | Good | Good |
| Test Kit Performance | - | 94.53% | 97.51% | 96.82% |
Note: Data for the Gardnerella vaginalis test kit are derived from clinical comparisons with the culture method.
Packaging Specifications: 50 tests per box.
Storage Conditions and Shelf Life: Store in a dark, cool place at 2-8°C, with a shelf life of 14 months.
Usage Scenarios:
- Emergency Departments: For early diagnosis of Acute Myocardial Infarction (AMI) and rapid exclusion of AMI in patients presenting with chest pain.
- Cardiology Departments: For monitoring myoglobin levels to assess myocardial injury and diagnose reinfarction or infarct extension.
- Hospitals and Clinics: For evaluating patients with suspected cardiac events and differentiating between myocardial and skeletal muscle injury.
- Diagnostic Laboratories: For routine testing of serum myoglobin levels as part of cardiac health assessments.
Suitable Countries and Regions:
- Developed Countries: United States, Canada, Western Europe (e.g., Germany, France, UK), Japan, Australia, etc., where advanced diagnostic tools are used for comprehensive cardiac care and early detection of myocardial infarction.
- Emerging Markets: China, India, Southeast Asia, Latin America, Eastern Europe, Middle East, etc., where healthcare systems are improving cardiac diagnostic capabilities and expanding access to modern diagnostic tools.
- Global Health Programs: International health initiatives focused on improving the diagnosis and management of cardiac conditions in low-resource settings.
