Mycoplasma genitalium TMA
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| WSLH Department: | CDD - Communicable Disease Division |
| WSLH Test Code: | SC00300 |
| Day(s) Performed: | Daily, Monday - Friday |
| Turn-around Time: | 1-3 days |
| Recommended Uses: | Symptomatic individuals, particular those who have failed empiric therapy and individuals with sex partners positive for Mycoplasma genitalium. |
| Contraindications: | Non-culture tests like this are not recommended for medico-legal use (sexual abuse/assault) or for post-treatment assessment ("test of cure"). Swab specimens collected from sites other than those listed here will not be tested. Specimens collected using swabs or kits other than those supplied for this assay will be rejected. Specimen (other than urine) received with no swab will be rejected. The performance of this test has not been evaluated in specimens for patients less than 15 years of age and these specimens will not be tested. |
| Additional Tests Performed: |
| Patient Preparations: | Follow instructions included with kit. Use only the collection materials supplied for this assay (with the exception of the primary urine collection device, not supplied.) |
| Specimen Requirements: | Prompt testing is highly recommended. Urogenital swabs should be stored and transported at 2 to 30 degrees Celsius for up to 60 days or frozen (-20 to -70C) within 7 days and analyzed within 90 days of collection. Urine must be transferred to Aptima Urine Collection Kits within 24 hours and be within the fill lines on the tube. From there specimens should be stored and transported between 2 to 30 C and analyzed within 30 days or frozen (-20 to -70C) within 7 days and analyzed within 90 days of collection. |
| Specimen Handling & Transport: | Swab and urine specimens placed in collection kits may be transported to the laboratory at ambient temperatures. Use pressure-resistant bags as inner packaging. To avoid temperature extremes, package in a cooler with a frozen ice pack. |
| Collection Kit/Container: |
27 Yellow - Aptima Urine Collection Kit
29 Orange - Aptima Multitest Swab Collection Kit 29E White - Aptima Unisex Swab Specimen Collection kit |
| Collection Instructions: | Kit 29 (orange), Kit 29E (white), Kit 27 (yellow) |
| Unacceptable Conditions: | Specimens that have not been handled as described above will be rejected. |
| Requisition Form: |
CDD Requisition Form A
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| Required Information: | Clinical information regarding symptoms and onset must be provided. Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier; date and time of collection, patient date of birth and sex, specimen type/site of collection, test request(s), clinician name and UPIN, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label which is required to have a minimum of two identifiers. |
| Results Include: | No Mycoplasma genitalium rRNA detected or Mycoplasma genitalium rRNA detected, Equivocal, and Invalid |
| Limitations: | Positive results in low prevalence populations should be interpreted carefully in conjunction with available clinical and risk information. Improper specimen collection and handling may compromise assay performance. A negative test does not exclude the possibility of infection. Identification of Mycoplasma genitalium does not rule out the possibility of additional causes of symptoms. Therapeutic failure or success, and patient infectivity cannot be determined with the Aptima Mycoplasma genitalium Assay since nucleic acid may persist in the absence of viable organisms. |
| Additional Tests Recommended: | Additional testing may be recommended in cases where false-positive or false-negative results could lead to adverse medical or psychological consequences. |
| Additional Comments: |
| Methodology: | Nucleic Acid Amplification Test (NAAT) using the Hologic Panther real-time probe based transcription mediated amplification (TMA) |
| Includes: | Amplification and qualitative detection of Mycoplasma genitalium nucleic acid from urogenital sites. Approved specimens- Clinician collected and patient collected vaginal swabs, clinician collected endocervical swabs, and urine. |
| CPT Code: | 87563 |
| Price: | $57.00 Price Effective 1/1/25 |