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26486 Mycoplasma genitalium, Transcription-Mediated Amplification, Varies (AMGEN)

Mycoplasma genitalium, Transcription-Mediated Amplification, Varies (AMGEN)
Test Code: AMGENSO
Synonyms/Keywords

AMGEN

Mycoplasma genitalium

Mycoplasmoides genitalium

Useful For

​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). 

Specimen Requirements
Specimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
​Endocervix​Aptima Collection Unisex Swab​Swab
​Vaginal, genital​Aptima Collection Multitest Swab​Swab
​Urethra (Male patients only)​Aptima Collection Unisex Swab​Swab
​Urine (Male and female patients) and post-prostatic massage urine (VBIII)​Aptima Urine Specimen Transport Tube​15-20 mL​2 mL
​Peritoneal Fluid (pelvic wach or cul-de-sac fluid)​Aptima Specimen Transfer Tube​1 mL
Collection Processing Instructions

​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:

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.

Collection Instructions for Vaginal, genital:

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.

Collection Instructions for Urethra (Male patients only):

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.

 Collection Instructions for Urine (Male and female patients) and post-prostatic massage urine (VBIII)

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.

Collection Instructions Peritoneal Fluid (pelvic wash or cul-de-sac fluid):

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.

Specimen Stability Information
Specimen TypeTemperatureTime
​Varies​Varies (see collection instructions above)
Rejection Criteria
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
Interference

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

Performing Laboratory Information
Performing LocationDay(s) Test PerformedReport AvailableMethodology/Instrumentation
​Mayo Clinic Laboratories​Monday through Saturday​1 to 4 days​Transcription-Mediated Amplification
Reference Lab
Reference Range Information
Performing LocationReference Range
​Mayo Clinic Laboratories​Negative
Interpretation

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.

Outreach CPTs
CPTModifier
(if needed)
QuantityDescriptionComments
​87563​1
Synonyms/Keywords

AMGEN

Mycoplasma genitalium

Mycoplasmoides genitalium

Ordering Applications
Ordering ApplicationDescription
​COM​Mycoplasma genitalium, TMA (AMGEN)
​Cerner​Mycoplasma genitalium, TMA (AMGEN)
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Specimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
​Endocervix​Aptima Collection Unisex Swab​Swab
​Vaginal, genital​Aptima Collection Multitest Swab​Swab
​Urethra (Male patients only)​Aptima Collection Unisex Swab​Swab
​Urine (Male and female patients) and post-prostatic massage urine (VBIII)​Aptima Urine Specimen Transport Tube​15-20 mL​2 mL
​Peritoneal Fluid (pelvic wach or cul-de-sac fluid)​Aptima Specimen Transfer Tube​1 mL
Collection Processing

​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:

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.

Collection Instructions for Vaginal, genital:

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.

Collection Instructions for Urethra (Male patients only):

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.

 Collection Instructions for Urine (Male and female patients) and post-prostatic massage urine (VBIII)

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.

Collection Instructions Peritoneal Fluid (pelvic wash or cul-de-sac fluid):

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.

Specimen Stability Information
Specimen TypeTemperatureTime
​Varies​Varies (see collection instructions above)
Rejection Criteria
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
Interference

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

Useful For

​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). 

Reference Range Information
Performing LocationReference Range
​Mayo Clinic Laboratories​Negative
Interpretation

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.

For more information visit:
Performing Laboratory Information
Performing LocationDay(s) Test PerformedReport AvailableMethodology/Instrumentation
​Mayo Clinic Laboratories​Monday through Saturday​1 to 4 days​Transcription-Mediated Amplification
Reference Lab
For billing questions, see Contacts
Outreach CPTs
CPTModifier
(if needed)
QuantityDescriptionComments
​87563​1
For most current information refer to the Marshfield Laboratory online reference manual.