Test Catalog

Test Id : AMGEN

Mycoplasma genitalium, Transcription-Mediated Amplification, Varies

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detection of Mycoplasma genitalium in cases of suspected infection

 

This test is not intended for use in medico-legal applications.

Highlights

This test performs analysis on both FDA-approved and non-FDA-approved sources.

FDA-approved sources include vaginal, endocervical, female/male urine, male urethral, and penile/meatal swabs (genital). Non-FDA-approved sources include prostatic secretion/post-prostatic massage urine (VBIII) and peritoneal fluid (pelvic wash, cul-de-sac fluid).

Method Name
A short description of the method used to perform the test

Transcription-Mediated Amplification

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Mycoplasma genitalium, TMA, Varies

Aliases
Lists additional common names for a test, as an aid in searching

AMGEN

Mycoplasma genitalium

Mycoplasmoides genitalium

Specimen Type
Describes the specimen type validated for testing

Varies

Necessary Information

Specimen source is required.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Submit only 1 of the following specimens:

 

Swab specimen must be collected using an Aptima Collection Unisex Swab or Aptima Collection Multitest Swab. These swabs are contained in the Aptima Collection Kit.

 

Supplies: Swab, Aptima Male/Female Collection (T583)

Specimen Type: Endocervix

Container/Tube: Aptima Collection Unisex Swab

Specimen Volume: Swab

Collection Instructions:

1. Use cleaning swab (white shaft) to remove excess mucus from endocervix and discard.

2. Insert second swab (blue shaft) 1 to 1.5 cm into endocervical canal, and rotate swab gently for 30 seconds. Avoid touching vaginal wall when removing swab.

3. Place second swab into transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.

4. Cap tube securely, and label tube with patient's entire name, and date and time of collection.

5. Transport and store swab container at 2 to 30 degrees C (refrigerate is preferred temperature) within 60 days of collection. If longer storage is needed, freeze at -20 to -70 degrees C for an additional 90 days.

 

Supplies: Swab, Aptima Multitest Swab Specimen Collection Kit (T584)

Specimen Type: Vaginal, genital

Container/Tube: Aptima Collection Multitest Swab

Specimen Volume: Swab

Collection Instructions:

1. Insert swab (pink shaft) about 5 cm past introitus and rotate gently for 30 seconds.

2. Place swab into transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.

3. Cap tube securely, and label tube with patient's entire name, and date and time of collection.

4. Transport and store swab container at 2 to 30 degrees C (refrigerate is preferred temperature) within 60 days of collection. If longer storage is needed, freeze at -20 to -70 degrees C for an additional 90 days.

 

Supplies: Swab, Aptima Male/Female Collection (T583)

Specimen Type: Urethra (Male patients only)

Container/Tube: Aptima Collection Unisex Swab

Specimen Volume: Swab

Collection Instructions:

1. Patient should not have urinated for at least 1 hour prior to collection.

2. With a rotating movement, insert swab (blue shaft) 2 to 4 cm into urethra.

3. Once inserted, rotate swab gently at least 1 full rotation using sufficient pressure to ensure swab comes into contact with all urethral surfaces. Allow swab to remain inserted for 2 to 3 seconds.

4. Place swab in transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.

5. Cap tube securely, and label tube with patient's entire name, and date and time of collection.

6. Transport and store swab container at 2 to 30 degrees C (refrigerate is preferred temperature) within 60 days of collection. If longer storage is needed, freeze at -20 to -70 degrees C for an additional 90 days.

 

 

Supplies: Aptima Urine Transport Tube (T582)

Specimen Type: Urine (Male and female patients) and post-prostatic massage urine (VBIII)

Container/Tube: Aptima Urine Specimen Transport Tube

Specimen Volume: 15 to 20 mL

Collection Instructions:

1. Patient should not have urinated for at least 1 hour prior to specimen collection.

2. Patient should collect first portion of random voided urine (first part of stream) into a sterile, plastic, preservative-free container.

3. Transfer 2 mL of urine into the Aptima Urine Specimen Transport Tube using the disposable pipette provided within 24 hours of collection. The correct volume of urine has been added when the fluid level is between the black fill lines on the urine transport tube. Place the labels on the transport tube so the black fill lines are still visible for volume confirmation at Mayo Clinic Laboratories.

4. Transport and store urine or post-prostatic massage urine (VBIII) specimen transport container at 2 to 30 degrees C (refrigerate is preferred temperature) within 30 days of collection. If longer storage is needed for urine specimens other than VBIII, freeze at -20 to -70 degrees C an additional 90 days. VBII cannot be sent frozen.

 

Supplies: Aptima Specimen Transport Tube (T652)

Specimen Type: Peritoneal fluid (pelvic wash or cul-de-sac fluid)

Container/Tube: Aptima Specimen Transfer Tube

Specimen Volume: 1 mL

Collection Instructions:

1. After collection, peritoneal fluid can be stored at 2 to 30 degrees C for up to 24 hours.

2. Transfer specimen into the Aptima Specimen Transfer Tube within 24 hours of collection.

3. Cap tube securely and label tube with patient's entire name and collection date and time.

4. Transport and store specimen container at 2 to 30 degrees C (refrigerate is preferred temperature) within 30 days of collection. Specimen cannot be sent frozen.

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

Urine: 2 mL

Swabs (endocervical, urethral, vaginal): See Specimen Required

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Midstream urine specimen
Overfilled or underfilled urine transport tubes
Specimen collected into a SurePath Prep device or ThinPrep vial
Transport tubes containing a cleaning swab or more than 1 swab
Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Varies Varies (preferred) APTIMA VIAL

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detection of Mycoplasma genitalium in cases of suspected infection

 

This test is not intended for use in medico-legal applications.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Mycoplasma genitalium, an under-recognized sexually transmitted infection (STI), causes acute and chronic non-gonococcal urethritis, cervicitis, and pelvic inflammatory disease. Due to its growing prevalence, M genitalium was cited as an emerging public health threat by the CDC in 2015. In high-risk populations, prevalence has been reported as high as 9% to 24% in male patients and 11% to 16% in female patients. M genitalium is commonly misdiagnosed as other STIs (eg, chlamydia and gonorrhea), which can lead to improper treatment of the underlying cause and an increase in duration of infection. In 2021, the CDC updated their STI guidelines to recommend that men with recurrent non-gonococcal urethritis and women with recurrent cervicitis and/or pelvic inflammatory disease should be tested for M genitalium.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

Interpretation
Provides information to assist in interpretation of the test results

A positive result indicates the presence of nucleic acid from Mycoplasma genitalium.

 

A negative result indicates that nucleic acid from M genitalium was not detected in the specimen.

 

The predictive value of an assay depends on the prevalence of the disease in any particular population. In settings with a high prevalence of sexually transmitted infections, positive assay results have a high likelihood of being truly positive. In settings with a low prevalence of sexually transmitted infections, or in any setting in which a patient's clinical signs and symptoms or risk factors are inconsistent with urogenital infection, positive results should be carefully assessed, and if appropriate, the patient retested by other methods.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Care must be taken to avoid cross-contamination during handling of specimens.

 

This test does not detect other Mycoplasma or Ureaplasma spp.

 

This test is intended for use in clinical monitoring or management of patients; it is not intended for use in medico-legal applications.

 

Appropriate specimen collection and handling is necessary for optimal assay performance.

 

Results should be interpreted in conjunction with other laboratory and clinical findings.

 

A negative test result does not exclude the possibility of infection. Improper specimen collection, concurrent antibiotic therapy, presence of inhibitors, or low numbers of organisms in the specimen (ie, below the sensitivity of the test) may cause false-negative test results.

 

In low prevalence populations, positive results must be interpreted carefully as false-positive results may occur more frequently than true-positive results in this setting.

 

In general, this assay should not be used to assess therapeutic success or failure, since nucleic acids from these organisms may persist for 3 weeks or more following antimicrobial therapy.

 

The effects of use of tampons, douching, specimen types other than those listed in Specimen Required, and specimen collection variables have not been determined.

 

Testing of urine specimens with this method is not intended to replace cervical exam and endocervical sampling for diagnosis of urogenital infection; infections may result from other causes or concurrent infections may occur.

 

Interference in assay results was observed when mucus at a final concentration of 0.3% w/v was added to clinical specimen matrix. Interference was not observed when mucus at a final concentration of 0.03% w/v was added to clinical specimen matrix.

Performance of the assay has not been evaluated in individuals < 15 years of age

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Shipitsyna E, Unemo M: Mycoplasma genitalium assay (Hologic) and key priorities in the management of M. genitalium infections. Expert Rev Mol Diagn. 2020 Nov;20(11):1063-1074

2. Daley GM, Russell DB, Tabrizi SN, McBride J: Mycoplasma genitalium: a review. Int J STD AIDS. 2014 Jun;25(7):475-487

Method Description
Describes how the test is performed and provides a method-specific reference

The HOLOGIC APTIMA Combo 2 Assay combines the technologies of target capture, transcription-mediated amplification, and dual kinetic assay. The detection of the ribosomal RNA amplification product sequences (amplicon) is achieved using nucleic acid hybridization. Single-stranded chemiluminescent DNA probes are labeled and combine with amplicon to form stable RNA:DNA hybrids. Light emitted from the labeled RNA:DNA hybrids is measured as photon signals in a luminometer.(Package insert: APTIMA Mycoplasma genitalium Assay. AW-1794 Hologic, Inc; Rev 002, 04/2019)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 4 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87563

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
AMGEN Mycoplasma genitalium, TMA, Varies 88226-6
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
616592 Mycoplasma genitalium Result 88226-6
AMGES Specimen Source: 31208-2

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Create a PDF

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports