Florida Bureau of Public Health laboratories

Amplified Mycoplasma genitalium 

The amplified Mycoplasma genitalium (MGEN) test is an FDA approved transcription-mediated amplification (TMA) test. The laboratory has internally validated additional sources in a laboratory developed test (LDT) to provide additional collection sources for patients.

Analyte(s)

Mycoplasma genitalium (MGEN) 

Test Code

0460

Testing Location

Jacksonville Laboratory

Testing Department

Serology

Pre-approval Required?

No

Required Forms

BPHL Test Requisition, DH1847
(not needed if orders are placed via electronic order)

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Minimum Volume

Urine must be filled within fill lines.
Do not pour out or spill the media in collection kit. Use a new kit if media is spilled.

Turn Around time

3 business days after receipt at the laboratory.

Collection Kit Ordering

Collection kits may be requested from your servicing laboratory. Collection kits ordered from the BPHL should only be used for specimen sent to the BPHL for testing.

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Collection Media

Urine Specimen: use the Aptima Urine Specimen Transport Tube (yellow tube) 

Vaginal, Rectal, Throat and Penile Meatal Specimen: use the Aptima multitest swab transport media (orange tube with pink swab) 

Urethral and Cervical: use the unisex specimen collection kit (white tube with blue swab)

Only use the collection swab provided with the kit.

Specimen Sources

Unisex swab – Clinician collected urethral or clinician collected cervical.

Multitest swab – Clinician and patient collected vaginal swab, clinician collected rectal, patient collected penile meatal swab specimens and clinician collected throat.

Urine – Male and female urine collected in a clinical setting. 
 
Note: Patient Collected = in a Clinical Setting

Specimen Labeling

Specimen must be labeled with at least two unique patient identifiers, e.g., name and DOB.

Information on the specimen must match the requisition and/or test order. 

Do not cover the fill area with labels. 

Special SPecimen Preparation

1) Use only the collection swab provided in collection kit.
2) Urine must be first catch and transferred to collection tube within 24 hours of collection.
3) Fill Urine between indicated fill line.
4) Break swab at indicated scoreline and discard the excess portion of the swab.
5) DO NOT cover foil on cap with parafilm.
6) Make sure that the lid is on tightly.
7) DO NOT puncture the foil cap.

Storage Conditions

Unisex or Multitest swabs: stable 60 days at 2-30° C.

Urine: good for 30 days at 2-30° C after urine is transferred to Aptima tube. Urine must be transferred to the Aptima tube within 24 hours of collection.

Packaging and Shipping

Specimens should be shipped at 2-30° C. It is preferred to ship in coolers with ice packs and packaged with absorbent material in order to avoid possible leaks, it is preferred that specimens are shipped in separate biohazard bags to avoid contamination in the event of a leak. 

NOTE: If you do not ship the specimen in a cooler with ice packs, you must include a temperature indicator strip that will indicate if the specimen in your package went above 30°C during shipping. These can be purchased from Fisher Scientific under catalog number 22-111-005.

unsatisfactory specimen

Urine: Specimen was not filled between the fill lines indicated on the collection device, etc.

Swab: No swab in tube, two swabs in tube, a cleaning swab or wrong swab for specimen source or wrong swab for collection kit, swabs not broken at score line, swab upside down in tube, multiple swabs in tube, broken half of swab in tube, no media in tube, etc. 

Temperature: Tubes not received at 2-30° C or packaged incorrectly.

Damaged: Specimen leaked during transit.

Age of Patient: Under the age of 15 years old.

Note: Conjunctiva specimens cannot be tested. 

Interferences and Limitations

Contaminated media such as excess mucus during collection.

Testing should not be performed on patients under 15 years of age.

Reliable results are dependent on adequate specimen collection.

Broken half of swab left in the tube.

Reference Range

Negative (Not Detected)

Result Indicator

Negative

Positive

Indeterminate: due to equivocal – cannot tell if negative or positive OR due to invalid – did not return any result twice. All Indeterminates should submit a new sample and re-order test. 

Reference lab

None

Reflex testing

None

Specimen quick guidance

A medical instruction image showing an Aptima Urine collection kit. The top part displays a transfer pipette and a urine transport tube. The bottom part shows three tubes: one labeled 'ACCEPT' with the swab correctly broken and submerged, and two labeled 'REJECT' with the urine improperly filled outside of the fill window
A medical instruction image showing an Aptima collection kit. The top part displays a pink swab and a transport tube. The bottom part shows two tubes: one labeled 'ACCEPT' with the swab correctly broken and submerged, and one labeled 'REJECT' with the swab improperly broken and protruding, highlighted by a red circle.
An instructional image showing a medical swab and collection tube. It demonstrates the correct way to break a swab at its breakpoint for insertion into a Hologic Aptima tube ('ACCEPT'), compared to an incorrect insertion where too much of the swab stick remains in the tube ('REJECT'), highlighted by a red circle.