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Chlamydia trachomatis and Neisseria gonorrhoeae, TMA amplified

Updated

10/12/2009

Other Names
CT/GC, CT/NG, CT & GC, Chlamydia combo test, Chlamydia and gonorrhea screen
How to Order
Region X IPP sites use the Chlamydia Test Region X- IPP (Form DHS 8351) for clients who meet screening criteria
For all other tests and submitters check the “Chlamydia/Gonorrhea by NAAT” box under the “Other” heading on the Virology/Immunology Request (form 42). See Important information regarding rectal and pharyngeal specimens or at:
Availability
All Clients
Methodology
Transcription-Mediated Amplification; Nucleic Acid Hybridization
Performed
Monday through Friday
Time to Reporting
Next working day
CPT Code
87491, 87591


Specimen Collection Details

Collection
Endocervical or urethral swab specimens: use the Gen-Probe APTIMA Combo 2 Unisex Collection Kit. When collecting male urethral specimens, the patient should not have urinated at least one hour prior to specimen collection. Carefully follow the instructions printed on the collection kit.    
     Vaginal specimens: use the Gen-Probe APTIMA Combo 2 Vaginal Collection Kit. These specimens can be either clinician collected or self-collected by the patient at the clinic site. Carefully follow the instructions printed on the collection kit.
     Urine specimens: Collect 20-30 mL of first catch urine in a sterile urine container. Patient should not have urinated for at least one hour prior to specimen collection. Transfer urine to the Gen-Probe APTIMA Combo 2 Assay Urine Specimen Collection Kit. Urine level should fall between black fill lines on the kit. Carefully follow the instructions printed on the collection kit.
Optimal Volume
2 mL urine, not applicable for swabs.
Minimum Volume
2 mL urine, not applicable for swabs.
Handling
All sample types may be stored and transported at 4-30°C.  All sample types are stable for 30 days. 
Transport
Ambient temperature or refrigerated.
Rejection Criteria
Unisex swab collection kits received containing the white cleaning swab (large white swab is for preparatory cleaning of the endocervix and is unacceptable for testing), a vaginal swab, or no swab; Vaginal swab collection kits containing a unisex swab or no swab; urine specimens that have not been transferred to the urine collection device or contain other urine preservatives; specimens received in any transport devices other than the Gen-Probe APTIMA Combo 2 collection kits.
Comments
This method has been tested using endocervical, vaginal, and male urethral swab specimens; and female and male urine specimens only. Performance with other specimen types has not been evaluated. Specimens other than those collected with the APTIMA Combo 2 Assay Unisex Swab Specimen Collection Kit for Endocervical and Urethral Swab Specimens, the APTIMA Combo 2 Vaginal collection kit for vaginal specimens, or the APTIMA Combo 2 Assay Urine Collection Kit for Male and Female Urine Specimens have not been evaluated.