Test Code MGEN Mycoplasma genitalium, Amplified DNA Probe (Hologic GenProbe)
Additional Codes
LAB2093
Useful For
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.
Methodology
Transcription Mediated Amplification (TMA) Hologic Aptima Assay performed on the Hologic Panther
Specimen Requirements
Specimen Type: Cervix
Container/Tube: GEN-PROBE Unisex swab specimen collection for Endocervical and Male Urethral specimens in GEN-PROBE transport vial (Blue Shaft Swab)
Specimen Volume: Swab
Collection Instructions:
1. Do not use lubricant on speculum.
2. Remove excess mucus from the cervical os and surrounding
mucosa using the cleaning swab (white shaft swab in the package
with red printing). Discard this swab.
3. Insert the specimen collection swab (blue shaft swab in the
package with the green printing) into the endocervical canal.
4. Gently rotate the swab clockwise for 10 to 30 seconds in the
endocervical canal to ensure adequate sampling.
5. Withdraw the swab carefully; avoid any contact with the
vaginal mucosa.
6. Remove the cap from the swab specimen transport tube and
immediately place the specimen collection swab into the transport
tube.
7. Carefully break the swab shaft against the side of the tube
at the scoreline and discard the top portion of the swab shaft; use
care to avoid splashing of contents.
8. Re-cap the swab specimen transport tube tightly.
9. Label vial with patient’s full name, date of
birth, date and time of collection, and source of
specimen.
Specimen Type: Vaginal
Container/Tube: GEN-PROBE Unisex swab specimen collection for Endocervical and Male Urethral specimens in GEN-PROBE transport vial (Blue Shaft Swab)
Specimen Volume: Swab
Collection Instructions:
1.Carefully insert the Blue shaft
swab into the vagina about 2 inches (5 cm) past the introitus and
gently rotate the swab for 10 to 30 seconds. Make sure the swab
touches the walls of the vagina so that moisture is absorbed by the
swab and then withdraw the swab without touching the
skin.
2. Remove the cap from the swab specimen transport tube and
immediately place the specimen collection swab into the transport
tube.
3. Carefully break the swab shaft against the side of the tube
at the scoreline and discard the top portion of the swab shaft; use
care to avoid splashing of contents.
4. Re-cap the swab specimen transport tube tightly.
5. Label vial with patient’s full name, date of
birth, date and time of collection, and source of
specimen.
Specimen Type: Urethra (males)
Container/Tube: GEN-PROBE Unisex swab specimen collection for Endocervical and Male Urethral specimens in GEN-PROBE transport vial (Blue Shaft Swab)
Specimen Volume: Swab
Collection Instructions:
1. Collect discharge specimen ≥1 hour after urination
using swab.
2. Insert Blue swab 2 to 4 cm into urethra.
3. Rotate swab so that it comes into contact with all urethral
surfaces. Leave swab inserted 2 to 3 seconds before removing.
4. Place swab in transport vial.
5. Label vial with patient’s full name, date of birth, date
and time of collection, and source of specimen.
Specimen Type: Urine (male and female)
Container/Tube: GEN-PROBE collection
container or Sterile Urine container
Specimen Volume: First portion
of voided urine
Specimen Minimum Volume: 2 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 a voided urine (first
part of stream-not midstream) into sterile urine container.
3. Label container with patient’s full name, date of
birth, date and time of collection, and source of specimen.
Submit Sterile Urine container within 24 hours, keep refrigerated.
Specimen Stability
Specimen |
Temp |
Stability |
Swab |
2-8 °C or RT |
60 days |
Urine (preserved) |
2-8 °C or RT |
30 days |
Urine (non-preserverd) |
2-8 °C |
24 hours |
Specimen Rejection Criteria
Sources other than Cervical, vaginal, male urethral and female/male urine.
Specimens received outside of stability requirements.
Reference Ranges
Normal Finding: negative for Mycoplasma genitalium
Abnormal Finding:positive for Mycoplasma genitalium
Day(s) Performed
Monday, Wednesday, Friday
Performing Laboratory
Bronson Laboratory Services-Microbiology
Sample Retention Time
1 week
CPT Code
CPT Code 87563