Chlamydia trachomatis and Neisseria gonorrhoeae, Nucleic Acid Amplification, Varies
Use
This test is utilized to detect Chlamydia trachomatis and/or Neisseria gonorrhoeae infections. Chlamydia trachomatis is the most prevalent sexually transmitted infection caused by bacteria in the United States. It can lead to complications such as pelvic inflammatory disease in women and epididymitis in men. Neisseria gonorrhoeae is also a common sexually transmitted infection that can cause genitourinary infections and complications such as pelvic inflammatory disease in women and gonococcal epididymitis in men. The nucleic acid amplification test (NAAT) provides high sensitivity and specificity for diagnosing these infections, allowing for early treatment and reducing the risk of disease spread.
Special Instructions
Specimens must be collected using the appropriate Aptima collection kit. Specimen source is required for the test. Avoid cross-contamination during specimen collection and handling. Only approved for certain specimen types as listed in specimen required section.
Limitations
This test is not intended for use in medico-legal applications and is not useful for the detection of other Chlamydia species. The performance has not been evaluated in adolescents younger than 14 years or in pregnant women using vaginal swab specimens. A negative result does not exclude the possibility of infection, and false-negative results may occur due to improper specimen collection, concurrent antibiotic therapy, or low organism numbers.
FDA ApprovedNew York Approved
Methodology
PCR-based (Transcription Mediated Amplification)
Biomarkers
LOINC Codes
- 64017-7
- 43304-5
- 43305-2
- 31208-2
Result Turnaround Time
1-4 days
Related Documents
For more information, please review the documents below
Specimen
Cervical Swab
Volume
1 Swab
Minimum Volume
Not provided
Container
Aptima Unisex Swab
Collection Instructions
1. Must be collected using the Aptima Unisex Swab Collection Kit. Use cleaning swab to remove mucus from endocervix/cervix. Insert second swab 1-1.5 cm into endocervical canal, rotate for 30 seconds. Avoid touching vaginal wall. Place in transport tube; maintain at 2-30°C or freeze at -20 to -70°C for up to 12 months.
Storage Instructions
Refrigerate preferred; transport within 60 days or freeze for 12 months.
Causes for Rejection
Overfilled or underfilled urine transport tubes.
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 60 days |
| Frozen | 12 months |