Detecting Mycoplasma genitalium in cases of suspected infection
This test is not intended for use in medico-legal applications.
This test performs analysis on both US Food and Drug Administration (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 fluid/urine (VBIII) and peritoneal fluid (ie, pelvic wash, cul-de-sac fluid).
Transcription-Mediated Amplification
AMGEN
Mycoplasma genitalium
Mycoplasmoides genitalium
Varies
Specimen source is required.
| Question ID | Description | Answers |
|---|---|---|
| AMGES | Specimen source: |
PENILE/MEATAL PROSTATIC SECRETIONS/VBIII ENDOCERVICAL/CERVICAL VAGINAL URETHRAL URINE FIRST VOID PERITONEAL |
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.
Specimen Type: Endocervix
Supplies: Swab, Aptima Male/Female Collection (T583)
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, date and time of collection.
5. Transport and store swab container at 2 to 30 degrees C (refrigerate temperature is preferred) within 60 days of collection. If longer storage is needed, freeze at -20 to -70 degrees C for an additional 90 days.
Specimen Type: Vaginal, genital
Supplies: Swab, Aptima Multitest Swab Specimen Collection Kit (T584)
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, 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.
Specimen Type: Urethra (Male patients only)
Supplies: Swab, Aptima Male/Female Collection (T583)
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, 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.
Specimen Type: Urine (Male and female patients) and post-prostatic massage fluid/urine (VBIII)
Supplies: Aptima Urine Transport Tube (T582)
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 fluid/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. VBIII cannot be sent frozen.
Specimen Type: Peritoneal fluid (pelvic wash, cul-de-sac fluid)
Supplies: Aptima Thin Prep Transport Tube (T652)
Container/Tube: Aptima Specimen Transfer Tube
Specimen Volume: 1 mL
Collection Instructions:
1. Collected by paracentesis.
2. Obtain specimen using needle and syringe. Refer to the references below.
3. Thoroughly vortex specimen.
4. Transfer 1 mL of specimen into the Aptima Specimen Transfer kit using a disposable transfer pipette or a pipette tip containing a filter (aerosol barrier or hydrophobic plug) within 24 hours of collection.
5. Recap the specimen transfer tube tightly.
6. 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.
Specimen Type: Penile/meatal swab specimens
Supplies: Swab, Aptima Male/Female Collection (T583)
Container/Tube: Aptima Collection unisex swab
Specimen Volume: swab
Collection Instructions:
1. Roll the swab just at the tip or outside the opening to the penis. Be sure to roll the swab completely around the opening to get the best sample.
2. Immediately place the swab into the collection tube.
3. Carefully break the swab shaft at the score line and recap the tube.
If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.
Urine: 2 mL
Swabs (endocervical, urethral, vaginal): See Specimen Required
| 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 Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Varies | APTIMA VIAL | |
Detecting Mycoplasma genitalium in cases of suspected infection
This test is not intended for use in medico-legal applications.
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 Centers for Disease Control and Prevention (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 trachomatis or 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.
Negative
A positive result indicates the presence of nucleic acid from Mycoplasma genitalium and strongly supports the diagnosis of a M genitalium infection.
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.
Care must be taken to avoid cross-contamination during handling of specimens.
This test does not detect other Mycoplasma or Ureaplasma species.
This test is intended for 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% weight/volume was added to clinical specimen matrix. Interference was not observed when mucus at a final concentration of 0.03% weight/volume was added to clinical specimen matrix.
Performance of the assay has not been evaluated in individuals younger than 15 years of age.
Waites KB, Crabb DM, Ratliff AE, Geisler WM, Atkinson TP, Xiao L: Latest advances in laboratory detection of Mycoplasma genitalium. J Clin Microbiol. 2023 Jan:e0079021. doi: 10.1128/jcm.00790-21
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 combined 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-17946 Hologic, Inc; Rev 002, 04/2019)
Monday through Sunday
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.
87563
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| AMGEN | Mycoplasma genitalium, TMA, Varies | 100706-1 |
| 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 | 100706-1 |
| AMGES | Specimen Source: | 31208-2 |