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Test Code MGEN Mycoplasma genitalium, Amplified DNA Probe (Hologic GenProbe)

Important Note

*URINE SAMPLES MUST BE TRANSFERRED INTO A GENBROBE CONTAINER WITHIN 24 HOURS OF COLLECTION*

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