Mycoplasma genitalium, rRNA, TMA

91475

1 endocervical or male urethral swab collected in an Aptima ® Unisex Swab Specimen Collection Kit or
1 vaginal or penile meatal swab in Aptima ® Multitest Swab Specimen Collection Kit or
2 mL (2 mL minimum) male or female urine collected in an Aptima ® Urine Collection Kit

2 mL urine

Performance of the assay has not been evaluated in individuals less than 15 years of age.
For a complete list of assay limitations we recommend that you review the manufacturers package insert: https://www.hologic.com/package-inserts/diagnostic-products/aptima-mycoplasma-genitalium-assay

Urine must be transferred to an Aptima urine transport tube in accordance with the instructions in the urine collection kit package insert. After collection, urine specimens in the primary collection container can be stored at 2° C to 30° C for up to 24 hours before urine is transferred to the transport tube.
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.

Aptima Unisex Swab Specimen Collection Kit
Aptima Multitest Swab Specimen Collection Kit
Aptima Urine Collection Kit

Room temperature

Swabs
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 90 days

Urine in Aptima Urine Collection Kit
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 90 days

Transport tubes with 2 swabs • Transport tubes with non-Aptima® swabs • Swab transport tubes with no swab • Swab submitted in non-Aptima® transport containers • Urine samples where fluid level is not between the black fill lines • Urine submitted in non-Aptima® transport containers

Mon-sat

3-5 days

Not detected

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. Infection with M.genitalium was shown to be strongly associated with non-gonococcal urethritis (NGU) in men and cervicitis in women. Infection with M.genitalium is associated with increased risk for cervicitis, pelvic inflammatory disease, preterm birth, spontaneous abortion, and infertility. M.genitalium infections largely go unrecognized, as infected individuals are either asymptomatic or have symptoms similar to those associated with other bacterial infections of the urogenital tract.