Sexually Transmitted Infections and Reproductive Health
The rapid and accurate detection of sexually transmitted pathogens is clinically important to obtaining prognostic information, limiting additional diagnostic testing, instituting appropriate infection control precautions, and limiting unnecessary treatment. Molecular methods offer the advantages of rapidity and the ability to detect pathogens regardless of growth requirements or the availability of reagents for rapid diagnostic testing.
The STI Genital Pathogen and Reproductive Health Reagents are rapid in vitro nucleic acid amplification assays for the qualitative detection of sexually transmitted pathogens as well as commensal and reproductive health-associated bacteria.
Nucleic acid from urine specimens, genital swabs collected in a dry format, agar matrix or in Universal Transport Media (UTM) and liquid based cytology (LBC). The test, based on real-time PCR, is compatible with nucleic acids isolated using the EasyScreen™ Sample Processing Kit.
The STI Genital Pathogen and Reproductive Health Reagents include all reagents required to detect the specific viral, bacterial and fungal gene sequences using real-time PCR amplification of the nucleic acid and fluorogenic target-specific hybridization probes for the detection of the amplified nucleic acid.
| Sexual and reproductive health pathogen targets | |
|---|---|
| Chlamydia trachomatis | Lymphogranuloma venereum |
| Neisseria gonorrhoeae (OpaC) | Neisseria gonorrhoeae (PorA) |
| Mycoplasma genitalium | Trichomonas vaginalis |
| Varicella zoster virus | Herpes simplex virus 1 |
| Herpes simplex virus 2 | Treponema pallidum |
ASRs also include an Extraction and Internal Positive Control for each sample to ensure the quality of the extracted DNA and to detect the presence of any inhibitors, respectively.
Regulatory
- Analyte Specific Reagents (ASRs). Analytical and performance characteristics are not characterized.
- EasyScreenTM Sample Processing Kits are FDA-listed clinical concentrators.
ASRs also include an Extraction and Internal Positive Control for each sample to ensure the quality of the extracted DNA and to detect the presence of any inhibitors, respectively.
Regulatory
- Analyte Specific Reagents (ASRs). Analytical and performance characteristics are not characterized.
- EasyScreenTM Sample Processing Kits are FDA-listed clinical concentrators.
- EasyScreenTM Pathogen Detection Kits are for research use only and are not available for in vitro diagnostic use in America. Genetic Signatures also supplies a range of Analyte Specific Reagents for customers in the USA/North America.
