Mycoplasma Genitalium (Aptima® Mycoplasma Genitalium Assay) -IVD

TEST:   CPT: 87563

Unisex Swab in female

Unisex Swab in male

Urine collection male or female

Storage Instructions

Causes for Rejection

Limitations

Methodology

CDC INFO

Expected Turnaround Time 1-4 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the report is sent to the ordering provider.  Additional time should be allowed for confirmatory, or reflex tests. 

Additional Documentation

SPECIMEN COLLECTION GUIDE

SAMPLE REPORT

Specimen Requirements

Specimen

Vaginal, endocervical, or male urethral swab, or first-void urine (patient should not have urinated for one hour prior to specimen collection).

Collection

Click on the images for a color guide

Multitest Vaginal Swab: 

Care provider specimen: Collect vaginal fluid sample using the Gen-Probe® Aptima® Vaginal Swab Kit by contacting the swab to the lower third of the vaginal wall, rotating the swab for 10 to 30 seconds to absorb the fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap. 

Patient self-collection instructions: Partially open the package. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima® Vaginal Swab Specimen Collection Kit. Remove the swab. Carefully insert the swab into the vagina about 2" past the introitus and gently rotate the swab for 10 to 30 seconds, making sure the swab touches the walls of the vagina so that moisture is absorbed by the swab. Withdraw the swab without touching the skin. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap.

Endocervical swab: 

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. Insert the specimen collection swab (blue shaft swab in the package with green printing) into the endocervical canal. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling. Withdraw the swab carefully; avoid contact with the vaginal mucosa. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube. Carefully break the swab shaft at the scoreline using care to avoid splashing of the contents. Recap the swab specimen transport tube tightly.

Male urethral swab: The patient should not have urinated for at least one hour prior to specimen collection. Insert the specimen collection swab (blue shaft swab in the package with the green printing) 2 to 4 cm into the urethra. Gently rotate the swab clockwise for two to three seconds in the urethra to ensure adequate sampling. Withdraw the swab carefully. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the specimen transport tube. Carefully break the swab shaft at the scoreline using care to avoid splashing of contents. Recap the swab specimen transport tube tightly.

Urine specimen: The patient should not have urinated for at least one hour prior to specimen collection. Direct patient to provide a first-catch urine (approximately 20 mL to 30 mL of the initial urine stream) into a urine collection cup free of any preservatives. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity; lesser volumes may not adequately rinse organisms into the specimen. Female patients should not cleanse the labial area prior to providing the specimen. Add urine to the Aptima® COMBO 2 urine collection device. The final volume must be between the two black lines on the device (about 2 mL).

Store and transport specimens at room temperature (15 to 30°C). DO NOT freeze.

Specimen with incorrect patient identification; unlabeled specimen; inappropriate specimen transport conditions; specimens received after prolonged delay from time of pickup (usually >72 hours); specimen leaked in transit; specimen in expired transport or incorrect transport device; specimens with inappropriate source for test requested; specimen with fixative or additives; Aptima® urine transport >30 days from collection; Aptima® urine transport with incorrect specimen volume; <15 mL urine submitted in sterile container; receipt of urine in sterile container >24 hours from collection; Aptima® swab transport >30 days from collection; Aptima® swab specimens with incorrect specimen volume; Aptima® swab specimen without a swab; cleaning swab (white-shaft swab) in Aptima® swab transport; any non−Gen-Probe® swab submitted in Aptima® transport device; wooden-shaft swab in transport device; transport device with multiple swabs; female urethral swab; bloody or grossly mucoid specimens; bacterial swabs; specimen in ProbeTec™ UPT transport; ProbeTec™ Q-swabs; UTM-RT

Test Details

Use

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 on the fully automated Panther® system. 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. The assay may be used to test the following specimens: clinician-collected and self-collected vaginal swabs (in a clinical setting), clinician-collected endocervical swabs, female and male urine, clinician-collected male urethral swabs, and self-collected penile meatal swabs (in a clinical setting). For females, a vaginal swab is the preferred specimen type due to higher clinical sensitivity for detecting M. genitalium than other specimen types; however, female urine or clinician-collected endocervical swabs may be used as alternative specimens when vaginal swab specimens are not available. If female urine or clinician-collected endocervical swab specimens test negative, testing with a vaginal swab may be indicated, if M. genitalium infection is suspected.

A negative result does not preclude a possible infection. Test results may be affected by improper specimen collection, technical error, specimen mix-up, or target levels below the assay limit of detection (LoD).

Results from the Aptima Mycoplasma genitalium assay should be interpreted in conjunction with other clinical and laboratory data available to the clinician.

For females, a vaginal swab is the preferred specimen type due to higher clinical sensitivity for detecting M. genitalium than other specimen types; however, female urine or cliniciancollected endocervical swabs may be used as alternative specimens when vaginal swab specimens are not available. If female urine or clinician-collected endocervical swab specimens test negative, testing with a vaginal swab may be indicated, if M. genitalium infection is suspected.

See Product insert for full list of limitations.

Nucleic acid amplification (NAAT)

CDC Treatment resources:

Unisex Swab

Multitest Swab in female