Test Details
Methodology
Nucleic Acid Amplification (NAA)
Result Turnaround Time
3 - 4 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
This test is used to detect the presence of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium rRNA in swab specimens. If M. genitalium is detected, additional testing for macrolide resistance determination will be performed.
Special Instructions
If reflex test is performed, additional charges/CPT code(s) may apply.
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.
Specimen Requirements
Specimen
Vaginal or endocervical swab
Volume
One Aptima® swab
Minimum Volume
One Aptima® swab
Container
Aptima® Multitest Swab Specimen Collection Kit or Aptima® Unisex Swab Collection Kit
Collection Instructions
Clinician collected vaginal swab: Collect vaginal fluid sample using the Aptima® 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). 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.
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) |
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 >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 >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; devices with improperly broken or folded over swabs; bloody or grossly mucoid specimens; bacterial swabs; specimen in ProbeTec™ UPT transport; ProbeTec™ Q-swabs
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 180111 | Ct/GC/Tv/Mg Rflx MacRes NAA Sw | 180087 | Trich vag by NAA | 62461-9 | ||
| 180111 | Ct/GC/Tv/Mg Rflx MacRes NAA Sw | 180097 | Chlamydia trachomatis, NAA | 21613-5 | ||
| 180111 | Ct/GC/Tv/Mg Rflx MacRes NAA Sw | 180104 | Neisseria gonorrhoeae, NAA | 32705-6 | ||
| 180111 | Ct/GC/Tv/Mg Rflx MacRes NAA Sw | 180095 | Mycoplasma genitalium NAA | 100706-1 | ||
| Order Code | 180111 | |||||
| Order Code Name | Ct/GC/Tv/Mg Rflx MacRes NAA Sw | |||||
| Order Loinc | ||||||
| Result Code | 180087 | |||||
| Result Code Name | Trich vag by NAA | |||||
| UofM | ||||||
| Result LOINC | 62461-9 | |||||
| Order Code | 180111 | |||||
| Order Code Name | Ct/GC/Tv/Mg Rflx MacRes NAA Sw | |||||
| Order Loinc | ||||||
| Result Code | 180097 | |||||
| Result Code Name | Chlamydia trachomatis, NAA | |||||
| UofM | ||||||
| Result LOINC | 21613-5 | |||||
| Order Code | 180111 | |||||
| Order Code Name | Ct/GC/Tv/Mg Rflx MacRes NAA Sw | |||||
| Order Loinc | ||||||
| Result Code | 180104 | |||||
| Result Code Name | Neisseria gonorrhoeae, NAA | |||||
| UofM | ||||||
| Result LOINC | 32705-6 | |||||
| Order Code | 180111 | |||||
| Order Code Name | Ct/GC/Tv/Mg Rflx MacRes NAA Sw | |||||
| 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 | |||||