M-14004 Chlamydia Trachomatis Test Kit

Diagnostic Significance: Chlamydia trachomatis (C.T.) is a major pathogen causing non-gonococcal urethritis. In recent years, infections caused by Chlamydia trachomatis, leading to conditions such as non-gonococcal urethritis, vaginitis, cervicitis, and endometritis, have surpassed gonococcal infections as the leading sexually transmitted diseases. Approximately 70% of infected women and 50% of infected men are asymptomatic. Furthermore, 86% of infected women and 55% of infected men experience persistent infections for over a year, leading to more severe retrograde infections such as urethritis, cervicitis, endometritis, and pelvic inflammatory disease, which can result in infertility. Chlamydia trachomatis infections during pregnancy can lead to serious complications like preterm delivery, miscarriage, premature rupture of membranes, and embryonic arrest. Perinatal infections can cause acute conjunctivitis in infants. Mother-to-child transmission of Chlamydia trachomatis can lead to neonatal conjunctivitis or pneumonia, with risks ranging from 20% to 50% and 10% to 20%, respectively.
Clinical diagnosis of Chlamydia trachomatis must be corroborated by laboratory test results, and labs should choose accurate and effective testing methods.
Clinical Departments: Gynecology, Obstetrics, Reproductive Centers, Dermatovenereology, Urology, etc.
Sample Collection: Cervical secretions from women; urethral, prostate fluids, or semen from men.
Product Features:
High specificity and sensitivity, with actual positive rates consistent with epidemiological statistics.
Results are straightforward and easy to interpret.
Simple, convenient, and quick to administer.
Immunofluorescence is the most mature and widely applied confirmation test method for Chlamydia trachomatis in developed countries in Europe and America. It is also the recommended immunological method for Chlamydia trachomatis detection according to the Chinese Ministry of Health's industry standards WS238-2003 "Diagnosis Standard and Treatment Principles for Non-gonococcal Urethritis" and WS237-2003 "Diagnosis Standard and Treatment Principles for Sexually Transmitted Lymphogranuloma Venereum".
Comparison of Various Testing Methods:
Method
Operability
Sensitivity
Specificity
Accuracy
PCR
Complex
Good
Average
Good
ELISA
Complex
Average
Good
Average
Colloidal Gold
Simple
Poor
Average
Poor, not suitable for low infection populations
Immunofluorescence
Simple
Good
Good
Good
Test Kit Performance
-
92.72%
97.89%
97.18%
Note: The data for the produced Chlamydia trachomatis test kits are derived from comparisons with similar commercially available test kits certified by the U.S. FDA.
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:
Gynecology and Obstetrics Departments: For diagnosing and monitoring Chlamydia trachomatis infections in women, particularly those presenting with vaginitis, cervicitis, and endometritis.
Reproductive Centers: For screening and managing infections that could impact fertility and pregnancy outcomes.
Dermatovenereology and Urology Departments: For diagnosing non-gonococcal urethritis and other Chlamydia-related conditions in both men and women.
Hospitals and Clinics: For routine screening of sexually transmitted infections (STIs) in at-risk populations.
Suitable Countries and Regions:
Developed Countries: United States, Canada, Western Europe (e.g., Germany, France, UK), Japan, Australia, etc., where there is a high demand for advanced diagnostic tools for STI management and prevention.
Emerging Markets: China, India, Southeast Asia, Latin America, Eastern Europe, Middle East, etc., where healthcare systems are expanding diagnostic capabilities for sexually transmitted infections.
Global Health Programs: International health initiatives focused on improving STI diagnosis and management in low-resource settings.