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Mycoplasma genitalium

Clinical Specimen Submission Guidance

Submit all specimens to 50 Orms St, Providence RI 02904. Open Monday to Friday 8:30 AM to 4:30 PM

Lab

STI & Arbovirus Laboratory 401-222-5591

Analyte Name

Mycoplasma genitalium

Disease

Mycoplasma genitalium

Test Description

Mycoplasma genitalium testing is performed using the FDA-approved Aptima Mycoplasma genitalium assay on the Hologic Panther System.

FDA cleared specimens include the following: clinician-collected 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 clinical settings)

Results should be used in conjunction with the patient's clinical symptoms, medical history, and other clinical/laboratory findings to determine an overall clinical diagnosis.

Special Instructions

Specimen Collection: (Follow instructions for collection printed on each collection kit) This test is only approved for specimen types listed in Specimen Section. Specimens received from other sites will be rejected.

The performance of the Aptima Combo 2 Assay has not been evaluated in adolescents less than 15 years of age.

Specimen

NOTE: SPECIMENS RECEVIED FROM ADOLESCENTS LESS THAN 15 YEARS OF AGE WILL NOT BE TESTED BY RISHL

Aptima Unisex Swab Collection Kit: (Clinician-collected) endocervical and male urethral.

Aptima Multitest Swab Collection Kit: (Clinician or patient collected) vaginal and penile meatal.

Note: It is recommended that 2 samples are taken and sent however, if requested, a single Clinician-collected Unisex Swab Collection Kit (endocervical) or Clinician-collected Multitest Swab Collection Kit (vaginal) can be used for testing Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium.

Aptima Urine Collection Kit: male and female urine specimens.

Note: It is recommended that 2 samples are taken and sent however, if requested, a single Urine Collection Kit can be used for testing Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium.

For additional information refer to the specimen collection tube guidance chart

Treatment information for Mycoplasma genitalium can be found at https://cdc.gov/std/mgen/

Hold specimen at 2° - 30°C until transport.

CLIA regulations require two patient identifiers on the specimen container and the test requisition.

Form Required

Rhode Island State Health Laboratories (RISHL) test requisition form

https://health.ri.gov/forms/LabRequisitionForm.pdf

Test Request

Mycoplasma genitalium

Indicate source type in Source/Site box on requisition

Transport

Swab specimen must be received within 60 days of collection.

Urine specimen must be received within 30 days of collection.

Specimens must be packaged and transported in accordance with current federal shipping regulations.

Integrity

Specimens not received in appropriate collection kit will be rejected.

Normal Value

Negative

Turnaround Time

3 business days

Kit

Kits are available from RISHL Center for Laboratory Support Services and may be obtained Monday - Friday between 8:30 am and 4:30 pm. Test kit order forms can be faxed to (401) 222-6985