Test Details
Methodology
Nucleic acid amplification (NAA)
Result Turnaround Time
3 - 4 days
Use
Detect Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma spp
Specimen Requirements
Test Includes
Mycoplasma genitalium; Mycoplasma hominis; Ureaplasma spp
Limitations
This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.
Specimen
Endocervical, vaginal, or male urethral swab in Aptima® swab transport.
Volume
One Aptima® swab (endocervical, vaginal, or male urethral)
Container
Aptima® unisex or vaginal swab
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; 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−Gen-Probe® 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 Gen-Probe® 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) |
LOINC® Map
Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
---|---|---|---|---|---|---|
180089 | Genital Mycoplasmas NAA, Swab | 91134-7 | 180077 | Mycoplasma genitalium NAA | 69935-5 | |
180089 | Genital Mycoplasmas NAA, Swab | 91134-7 | 180022 | Mycoplasma hominis NAA | 68546-1 | |
180089 | Genital Mycoplasmas NAA, Swab | 91134-7 | 180023 | Ureaplasma spp NAA | 68547-9 | |
Order Code | 180089 | |||||
Order Code Name | Genital Mycoplasmas NAA, Swab | |||||
Order Loinc | 91134-7 | |||||
Result Code | 180077 | |||||
Result Code Name | Mycoplasma genitalium NAA | |||||
UofM | ||||||
Result LOINC | 69935-5 | |||||
Order Code | 180089 | |||||
Order Code Name | Genital Mycoplasmas NAA, Swab | |||||
Order Loinc | 91134-7 | |||||
Result Code | 180022 | |||||
Result Code Name | Mycoplasma hominis NAA | |||||
UofM | ||||||
Result LOINC | 68546-1 | |||||
Order Code | 180089 | |||||
Order Code Name | Genital Mycoplasmas NAA, Swab | |||||
Order Loinc | 91134-7 | |||||
Result Code | 180023 | |||||
Result Code Name | Ureaplasma spp NAA | |||||
UofM | ||||||
Result LOINC | 68547-9 |