Mycoplasma genitalium, rRNA, TMA

Test code

91475

CPT code(s)*

87563

In-home collection may be available in your area for purchase through Quest Mobile.

IMPORTANT: Please review the Specimen Collection instructions SPECIMEN COLLECTION GUIDES FOR APTIMA for this test

Clinical significance

Mycoplasma genitalium, rRNA, TMA - The Aptima Mycoplasma genitalium assay is an in vitro nucleic acid amplification test (NAAT) for the qualitative detection of ribosomal RNA (rRNA) from Mycoplasma genitalium. It is intended for use as an aid in the diagnosis of M. genitalium urogenital infections in male and female patients suspected of M. genitalium infection. Infection with M. genitalium was shown to be strongly associated with non-gonococcal urethritis (NGU) in men and cervicitis in women. Infection with M. genitalium is associated with increased risk for cervicitis, pelvic inflammatory disease, preterm birth, spontaneous abortion, and infertility. M. genitalium…

Test resources

Details

Test details

Methodology

Transcription-Mediated Amplification (TMA)

Alternative name(s)

MGEN

Specimen requirements
Patient preparation	Refer to the appropriate specimen collection kit package insert for specific collection instructions
Preferred specimen(s)	1 endocervical or male urethral swab collected in an Aptima® Unisex Swab Specimen Collection Kit or 1 vaginal or penile meatal swab in Aptima® Multitest Swab Specimen Collection Kit or 2 mL male or female urine collected in an Aptima® Urine Collection Kit
Minimum volume	2 mL urine
Collection instructions	⁠⁠⁠⁠⁠⁠⁠Performance of the assay has not been evaluated in individuals less than 15 years of age. For a complete list of assay limitations we recommend that you review the manufacturers package insert: https://www.hologic.com/package-inserts/diagnostic-products/aptima-mycoplasma-genitalium-assay Urine must be transferred to an Aptima urine transport tube in accordance with the instructions in the urine collection kit package insert. After collection, urine specimens in the primary collection container can be stored at 2° C to 30° C for up to 24 hours before urine is transferred to the transport tube. For females, a vaginal swab is the preferred specimen type due to higher clinical sensitivity for detecting M. genitalium than other specimen types; however, female urine or clinician collected endocervical swabs may be used as alternative specimens when vaginal swab specimens are not available. If female urine or clinician-collected endocervical swab specimens test negative, testing with a vaginal swab may be indicated, if M. genitalium infection is suspected.
Transport container	Aptima Unisex Swab Specimen Collection Kit or Aptima Multitest Swab Specimen Collection Kit or Aptima Urine Collection Kit
Transport temperature	Room temperature
Specimen stability	Swabs Room temperature: 60 days Refrigerated: 60 days Frozen: 90 days Urine in Aptima Urine Collection Kit Room temperature: 30 days Refrigerated: 30 days Frozen: 90 days
Reject criteria	Transport tubes with 2 swabs • Transport tubes with non-Aptima swabs • Swab transport tubes with no swab • Swab submitted in non-Aptima transport containers • Urine samples where fluid level is not between the black fill lines • Urine submitted in non-Aptima transport containers • Patients <15 years of age

Reference range(s)

Not Detected

LOINC® codes

The Result and LOINC® information listed below should not be used for electronic interface maintenance with Quest Diagnostics. Please contact the Quest Diagnostics Connectivity Help Desk for more information at 800-697-9302.

NOTE: The codes listed in the table are not orderable Test Codes

Result code	Result name	LOINC code	Component name
86028449	MYCOPLASMA GENITALIUM, rRNA,TMA	100706-1	Mycoplasma genitalium rRNA

Performing lab & setup schedule

Performing laboratory

Quest Diagnostics - East Region

Setup schedule

Set up: Mon-Sat (All shifts); Report available: 2 days

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

*The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

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