Mycoplasma genitalium, rRNA, TMA

Mycoplasma genitalium, rRNA, TMA

Test Code

91475
87563
91475
87563
Ordering Restrictions may apply. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection may be available in your area for purchase through Quest Mobile.

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 ...

Test Resources

Test FAQ

Mycoplasma genitalium, rRNA, TMA

Clinical Focus

Sexually Transmitted Infections Associated With Urethritis, Cervicitis, and PID

Specimen Handling - Specimen Collection Guide

Specimen Collection guides for Aptima

Test Details

Patient Preparation

Refer to the appropriate specimen collection kit package insert for specific collection instructions

Methodology

Transcription-Mediated Amplification (TMA)

Reference Range(s)

Not detected

Alternative Name(s)

MGEN

LOINC® Codes, Performing Laboratory

Service Area must be determined
Refer to the appropriate specimen collection kit package insert for specific collection instructions

Methodology

Transcription-Mediated Amplification (TMA)

Reference Range(s)

Not detected

Alternative Name(s)

MGEN
Service Area must be determined

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.

IMPORTANT: Please review the Specimen Collection instructions Specimen Collection guides for Aptima for this test

Transport Container

Aptima Unisex Swab Specimen Collection Kit
Aptima Multitest Swab Specimen Collection Kit
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 less than 15 years of age

Setup Schedule

Service Area must be determined
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
2 mL urine
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.
IMPORTANT: Please review the Specimen Collection instructions Specimen Collection guides for Aptima for this test
Aptima Unisex Swab Specimen Collection Kit
Aptima Multitest Swab Specimen Collection Kit
Aptima Urine Collection Kit
Room temperature
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
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 less than 15 years of age
Service Area must be determined
Ordering Restrictions may apply. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection may be available in your area for purchase through Quest Mobile.
Test Details

Clinical Significance

Test Resources

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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