26486 Mycoplasma genitalium, Transcription-Mediated Amplification, Urine or Urogenital Swab (AMGEN)

​​​AMGEN

Mycoplasma genitalium

Mycoplasmoides genitalium

M gen

​Detection of Mycoplasma genitalium in cases of suspected infection

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

​Specimen source is required.

Submit only 1 of the above specimen types. 

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.

Collection Instructions for Endocervix/cervix:

1. Specimens must be collected using the Aptima Unisex Swab Collection Kit

2. Use cleaning swab (white shaft) to remove excess mucus from endocervix/cervix.

3. Discard the cleaning swab.

4. 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.

5. Place the blue shaft swab into transport tube provided in collection kit.

6. Snap off swab at score line so swab fits into closed tube.

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

8. Maintain 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.

Collection Instructions for Vaginal:

1. Specimens must be collected using the Aptima Multitest Swab Collection Kit.
2. Insert swab (pink shaft) about 5 cm past introitus and rotate gently for 30 seconds.
3. Place 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. Maintain 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.

Collection Instructions for Urethra (Male patients only):

1. Specimens must be collected using the Apitma Unisex Sab Collection Kit.

2. Patient should not have urinated for at least 1 hour prior to collection.
3. With a rotating movement, insert swab (blue shaft) 2 to 4 cm into urethra.
4. Once inserted, rotate swab gently at least 1 full rotation using sufficient pressure to ensure swab comes in contact with all urethral surfaces. Allow swab to remain inserted for 2 to 3 seconds.
5. Place swab in transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.
6. Cap tube securely, and label tube with patient's entire name, date and time of collection.
7. Maintain 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.

 Collection Instructions for Urine (Male and female patients):

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. Within 24 hours of collection, transfer 2 mL of urine into the Aptima Urine Specimen Transport Tube using the disposable pipette provided. The correct volume of urine has been added when the fluid level is between the black fill lines on the urine transport tube.
4. Place the labels on the transport tube so the black fill lines are still visible for volume confirmation at Mayo Clinic Laboratories.
5. Maintain urine specimen transport container at 2 to 30 degrees C (refrigerate is preferred temperature) within 30 days of collection. If longer storage is needed, freeze at -20 to -70 degrees C up to an additional 90 days.

Collection Instructions for Penile/meatal:

1. Specimens must be collected using the Aptima Multitest Swab Collection Kit.

2. Roll the swab (pink shaft) 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.

3. Immediately place the swab into the collection tube.
4. Carefully break the swab shaft at the score line and recap the tube.

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

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 are 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.

​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.

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 a specific 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.​