| Mycoplasma genitalium Amplified Assay (LAB002144) | |
|---|---|
| Test Mnemonic: | MGEN |
| Specimen Requirements: | Female- endocervical swab, vaginal swab, urine first catch (first void) Male- urethral swab, urine first catch (first void)
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| Test Included: | Mycoplasma genitalium nucleic acid assay |
| Collection: | Swabs- Follow the instructions found with the Aptima ® collection kit for endocervical/vaginal/male urethral specimens. Urine- Patient should not have urinated at least 1 hour prior to collection. Patient is instructed to collect a first-catch urine (approximately 20 to 30 mL of the initial urine stream) in a urine collection container free from any preservatives. Collection of larger volumes of urine may reduce test sensitivity. Female patients should not cleanse the labial area prior to providing the specimen. |
| Container: | Aptima ® Unisex transport tube (endocervical swab and male urethral samples only) Aptima ® Vaginal/Multitest transport tube (vaginal swab samples only) Aptima ® Urine transport tube (sterile urine container also acceptable) |
| Minimum Volume: | Urine- 2 mL aliquot from a 20 to 30 mL collection |
| Storage/Transport: | Refrigerated or room temperature (2 - 30ºC) Do not allow contact with other patient samples in order to avoid any cross contamination. |
| Specimen Preparation: | Urine- Transfer 2 mL urine first-catch (first void) into the Aptima ® Urine Specimen Transport tube using the disposable pipette provide in the kit. The correct volume of urine has been added when the fluid level is between the black fill lines on the urine specimen transport tube label. |
| Stability: | Urine sample (2 - 30ºC) that are not transferred into a Aptima ® Urine Transport tube must be received in the laboratory within 24 hours of collection. Aptima ® transport tubes- 30 days refrigeration/room temperature |
| Causes for Rejection: | Specimens must meet criteria set forth in the Laboratory Services Labeling and Requests for Testing policy. Failure to use Aptima ® collection kit for endocervical/vaginal/urethral swabs Samples from non-approved sources Urine in tube with preservatives Insufficient quantity of urine for test requirements |
| Reference Range: | Negative |
| Turnaround Time: | Test is batched tested 2-3 days per week |
| Methodology: | Qualitative Transcription-Mediated Amplification |
| Performed: | Lab: Clinical Microbiology |
| Synonyms: | M. genitalium, Mycoplasma, MGEN, M Gen, non-gonococcal urethritis (NGU), urethritis, cervicitis, PID, pelvic inflammatory disease |
| Clinical Indication: | This test is used for the detection of Mycoplasma genitalium in urine first catch (first void), endocervical, vaginal, and male urethral specimens |
| Patient Preparation : | Endocervical or vaginal collection, male urethral, urine first catch (first void) |
| CPT 4 Code: | 87563 |
| Note: | A negative result does not completely rule out infection with Mycoplasma genitalium. Results should be interpreted in conjunction with other clinical data. This test is intended for medical purposes only and is not valid for the evaluation of suspected sexual abuse or for other forensic purposes. Method performance specifications have not been established for patients under 15 years of age.
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| When ordering tests for which Medicare or Medicaid reimbursement will be sought, physicians should only order tests that are medically necessary for the diagnosis or treatment of the patient. Components of the organ or disease panels may be ordered individually. The diagnostic information must substantiate all tests ordered and must be in the form of an ICD-10 code or its verbal equivalent. | |