Effective Wednesday, November 13, 2019, the new Mycoplasma genitalium (mgen) assay is now available using the Aptima target nucleic acid amplification test (NAAT) for the qualitative detection of ribosomal RNA (rRNA) from Mycoplasma genitalium to aid in the diagnosis of M. genitalium urogenital infections in male and female patients.
The following orderables are available:
APTIMA Mycoplasma genitalium NAAT
APTIMA STI NAAT Panel, which includes the APTIMA Chlamydia NAAT, APTIMA Gonococcus NAAT, APTIMA Trichomonas NAAT and APTIMA Mycoplasma genitalium NAAT
This assay has been FDA cleared for use with Aptima multitest swabs for vaginal specimens, Aptima unisex swabs for female endocervical specimens, Aptima unisex swabs for male urethral specimens and male and female urine specimens.
NOTE: 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.
Results for Mycoplasma genitalium will be reported as Positive or Negative (presumed negative for Mycoplasma genitalium rRNA). For specimens receiving a result of Invalid, a new specimen should be collected.
NOTE: The performance of this assay has not been evaluated in individuals less than 14 years of age, so testing will not be performed on patients in this age group.
Questions regarding Aptima testing may be directed to the Molecular Diagnostic department using the “contact us” link above.
APTIMA Mycoplasma genitalium NAAT [Epic Code #LAB1230560, Interface Code #1230560]
APTIMA STI NAAT Panel [Epic Code #LAB1230566, Interface Code #1230560]