Mycoplasma genitalium, (TMA)
CPT Code(s)
87563 Mycoplasma genitalium amplified probe
Synonym(s)
M. gen, MG
Performed
Molecular Diagnostics Laboratory
Clinical Indication and Relevance
The assay is useful to aid in the diagnosis of M. genitalium urogenital infections in male and female patients. This assay can be used to test the following specimens: clinician and self-collected vaginal swabs (in a clinical setting), clinician-collected endocervical swabs, female and male urine, clinician-collected male urethral swabs, and self-collected penile meatal swabs (in a clinical setting).
Methodology
The assay uses transcription mediated amplification (TMA) on the Hologic Panther System.
Specimen Collection / Handling Requirements
Sample Type:
Aptima Multitest Swab Specimen Collection Kit for vaginal and penile meatal swabs
Aptima Urine Specimen Collection Kit for male and female urine specimens
Specimen Labeling:
The specimen must be labeled with two identifiers at the time of collection. Examples of acceptable identifiers include but are not limited to patient name, date of birth, hospital medical record number, accession number. A location (e.g., hospital room number) is not an acceptable identifier. Collection date and collector’s identifier are required.
A completed requisition form should be submitted with every sample, and at minimum, the following is required: ordering physician name, phone number, fax number, and patient’s name, identifying number of patients, patient sex, patient date of birth specimen type, collection date, tests requested, provisional diagnosis or clinical rationale for test, and billing information.
Minimum Specimen Requirements
Transport:
Specimens can contain high levels of organisms. Specimens must be shipped and transported in accordance with applicable local, national, and international transportation regulations. Maintain proper storage conditions of 2-8°C during shipping to ensure integrity of the specimen.
Stability:
Swab specimens: After collection, transport and store the swab in the swab specimen transport tube at 2-30°C up to 60 days after collection. Urine specimens: Transport to the lab at 2-30°C where it should be transferred to the Aptima urine specimen transport tube within 24 hours of collection. Store Aptima urine specimen transport tube at 2-30°C and test within 30 days of collection.
Unacceptable Samples:
Improperly labeled or incorrect patient identification, specimen leaked, incorrect media, specimen transport tube with no swab or two swabs, a cleaning swab or a swab not supplied by Hologic. For urine transport tubes, the liquid level must fall between the two black indicator lines on the tube label. Specimen does not meet transport, storage, or date of collection requirements.
Turnaround time
1-3 Business Days.
Micro requisition provided.