Test Details
Methodology
Nucleic acid amplification (NAA)
Result Turnaround Time
3 - 4 days
Use
This test detects the presence of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium via nucleic acid amplification (NAA). If M. genitalium is detected, a reflex test for the presence of mutations conferring macrolide resistance will be performed.
Special Instructions
If reflex test is performed, additional charges/CPT code(s) may apply.
Specimen Requirements
Test Includes
Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium with possible reflex to Mycoplasma genitalium, NAA, Urine with Reflex to Macrolide Resistance Testing
Limitations
A negative result does not preclude a possible infection. Test results may be affected by improper specimen collection or target levels below the assay limit of detection (LoD). Results from this testing should be interpreted in conjunction with other clinical and laboratory data available to the clinician. Reliable results are dependent on adequate specimen collection, transport, storage and processing. Failure to observe proper procedures in any one of these steps can lead to incorrect results.
The macrolide resistance reflex test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary.
References
Getman D, Jiang A, O'Donnell M, Cohen S. Mycoplasma genitalium prevalence, coinfection and macrolide antibiotic resistance frequency in a multicenter clinical study cohort in the United States. J Clin Microbiol. 2016 Sep;54(9):2278-2283. PubMed 27307460
Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187. PubMed 34292926
Specimen
Endocervical, vaginal or male urethral swab in Aptima® swab transport
Volume
One Aptima® swab (endocervical, vaginal or male urethral)
Minimum Volume
One Aptima® swab (endocervical, vaginal or male urethral)
Container
Aptima® Multitest Swab Specimen Collection Kit or Aptima® Unisex Swab Specimen Collection Kit
Storage Instructions
Maintain specimen at room temperature or refrigerate (2°C to 30°C).
Causes for Rejection
Specimen with incorrect patient identification; unlabeled specimen; inappropriate specimen transport conditions, including specimens received frozen; specimens received after prolonged delay (usually greater than 72 hours); specimen leaked in transit; specimen in expired transport or incorrect transport device; specimens with inappropriate source for test requested; specimen with fixative or additives; Aptima® urine transport; Aptima® swab transport greater than 30 days from collection; Aptima® swab specimen without a swab; cleaning swab (white-shaft swab) in Aptima® swab transport; any non-Aptima® swab submitted in Aptima® transport device; transport device with multiple swabs; bloody or grossly mucoid specimens; bacterial swabs; specimen in ProbeTec™ UPT transport; ProbeTec™ Q-swabs
Collection Instructions
Vaginal swab: Collect vaginal fluid sample using the Aptima® Multitest swab by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap.
Endocervical swab: Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white-shaft swab in the package with red printing) provided in the Aptima® Unisex collection kit. Discard this swab. Insert the specimen collection swab (blue-shaft swab in the package with green printing) into the endocervical canal. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling. Withdraw the swab carefully; avoid contact with the vaginal mucosa. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube. Carefully break the swab shaft at the scoreline; use care to avoid splashing of the contents. Recap the swab specimen transport tube tightly.
Male urethral swab: The patient should not have urinated for at least one hour prior to specimen collection. Insert the specimen collection swab from the Aptima® Unisex Swab kit (blue-shaft swab in the package with the green printing) 2 to 4 cm into the urethra. Gently rotate the swab clockwise for two to three seconds in the urethra to ensure adequate sampling. Withdraw the swab carefully. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the specimen transport tube. Carefully break the swab shaft at the scoreline; use care to avoid splashing of contents. Recap the swab specimen transport tube tightly.
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 30 days (stability provided by manufacturer or literature reference) |
| Refrigerated | 30 days (stability provided by manufacturer or literature reference) |
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 180120 | Ct Ng Mgen w/Rflx, NAA, Swab | 180097 | Chlamydia trachomatis, NAA | 21613-5 | ||
| 180120 | Ct Ng Mgen w/Rflx, NAA, Swab | 180104 | Neisseria gonorrhoeae, NAA | 32705-6 | ||
| 180120 | Ct Ng Mgen w/Rflx, NAA, Swab | 180095 | Mycoplasma genitalium NAA | 100706-1 | ||
| Order Code | 180120 | |||||
| Order Code Name | Ct Ng Mgen w/Rflx, NAA, Swab | |||||
| Order Loinc | ||||||
| Result Code | 180097 | |||||
| Result Code Name | Chlamydia trachomatis, NAA | |||||
| UofM | ||||||
| Result LOINC | 21613-5 | |||||
| Order Code | 180120 | |||||
| Order Code Name | Ct Ng Mgen w/Rflx, NAA, Swab | |||||
| Order Loinc | ||||||
| Result Code | 180104 | |||||
| Result Code Name | Neisseria gonorrhoeae, NAA | |||||
| UofM | ||||||
| Result LOINC | 32705-6 | |||||
| Order Code | 180120 | |||||
| Order Code Name | Ct Ng Mgen w/Rflx, NAA, Swab | |||||
| Order Loinc | ||||||
| Result Code | 180095 | |||||
| Result Code Name | Mycoplasma genitalium NAA | |||||
| UofM | ||||||
| Result LOINC | 100706-1 |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 180088 | M gen Macrolide Resistance | 180088 | M gen Macrolide Resistance | Pending | |
| Reflex 1 | ||||||
| Order Code | 180088 | |||||
| Order Name | M gen Macrolide Resistance | |||||
| Result Code | 180088 | |||||
| Result Name | M gen Macrolide Resistance | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||