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 Mycoplasma genitalium in genital-based swab collections. If M. genitalium is detected, further testing for the presence of macrolide resistance will be performed.
Special Instructions
If reflex testing 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 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
Specimen Requirements
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 (preferred) or Aptima® Unisex Swab Specimen Collection Kit
Collection Instructions
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.
Male urethral swab: The patient should not have urinated for at least one hour prior to specimen collection. Insert the specimen collection swab (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) |
Storage Instructions
Maintain specimen at room temperature or refrigerate (2°C to 30°C).
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 180092 | M genitalium NAA, Swab w/ Rflx | 100706-1 | 180095 | Mycoplasma genitalium NAA | 100706-1 | |
| Order Code | 180092 | |||||
| Order Code Name | M genitalium NAA, Swab w/ Rflx | |||||
| Order Loinc | 100706-1 | |||||
| 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 | |||||