Intended Use
This assay is an in vitro nucleic acid amplification assay for the qualitative detection & differentiation of sexually transmitted infections caused by Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, Trichomonas vaginalis, Gardnerella vaginalis, Ureaplasma urealyticum/parvum and Herpes simplex virus 1 & 2 using Real Time PCR System.
Specimen Required
Urine, Rectal and Genital Swab samples: Patient must be 14 years of age or older.
Patient Preparation
- Sample Collection and Specimen Preparation:
- Swab: Place swab in Swab Specimen Transport Tube, break shaft off at scoreline then recap tube.
- Urine: Transfer 2 mL urine within 24 hours to Urine Specimen Transport Tube.
- Storage/Transport Temperature: Store and transport specimens at 2–8ºC if testing is within 24–48 hours.
- Unacceptable Conditions: Heparinized specimens
- Remarks: Proper aseptic technique and sample handling are critical to avoid contamination or degradation.
- Stability
- Swab: Ambient: 2 months; Refrigerated: 2 months; Frozen: 1 year
- Urine Specimen Transport Tube: Ambient: 1 month; Refrigerated: 1 month; Frozen: 3 months
Methodology
The assay uses real-time PCR amplification targeting highly conserved DNA regions in each STD pathogen.
Sample Received to Report Turnaround Time (TAT)
Twice in a Week (Scheduled Test)
Reference Interval
Positive or negative for the presence of above-mentioned specific pathogen’s DNA.
Interpretive Data
Refer to the Report.
Resources
- Additional Technical Information
- Test Request Form
Sample Reports
- Enhanced Report
- See report