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Mycoplasma genitalium rRNA, NAAT with Reflex to Macrolide Resistance
Test Code18456
CPT Codes
87563
Includes
If Mycoplasma genitalium, rRNA, NAAT is Detected, then Macrolide Resistance will be performed at an additional charge (CPT code(s): 87999).
Preferred Specimen
1 vaginal swab collected in Aptima® Multitest Swab Specimen Collection Kit or
2 mL male or female urine collected in an Aptima® Urine Collection Kit or
1 endocervical or male urethral swab collected in an Aptima® Unisex Swab Specimen Collection Kit
2 mL male or female urine collected in an Aptima® Urine Collection Kit or
1 endocervical or male urethral swab collected in an Aptima® Unisex Swab Specimen Collection Kit
Minimum Volume
1 swab • 2 mL urine
Instructions
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.
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.
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 30 days
Refrigerated: 30 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
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 • Patients <15 years of age
Methodology
Transcription-Mediated Amplification (TMA)
Setup Schedule
Set up: Mon-Sat; Report available: 3-7 days
Reference Range
| M. genitalium rRNA, NAAT | Not Detected |
| Macrolide Resistance | Not Detected |
Clinical Significance
This test is for the detection of Mycoplasma genitalium and macrolide resistance markers in M. genitalium positive samples. Macrolide resistance testing may be useful for resistance-guided therapy in patients with M. genitalium infection. A two-stage therapy approach which includes doxycycline as the initial empiric therapy and follow-up treatment based on results from resistance testing is recommended.
M.genitalium is a sexually transmitted bacteria that can cause urethritis in men and cervicitis and pelvic inflammatory disease in women. Resistance to macrolides has been increasing and contributes to treatment failure, although rates of resistance vary by geographical region and patient population. Doxycycline is recommended as the initial empiric therapy, followed by azithromycin for patients with macrolide sensitive M. genitalium infections or moxifloxacin for macrolide resistant infections. This approach is aimed at reducing organism load and facilitates clearance, ultimately decreasing the risk of treatment failure in infected patients.
A detected macrolide resistance result for this test indicates that the organism contains one of the characterized mutations (A2056G, A2058C, A2059G, A2059C, A2058T) associated with the resistance to macrolides. Although a not detected result may suggest a macrolide sensitive infection, macrolide resistance may still be present even when markers are not detected due to differences in analytical sensitivity between the detection of M.genitalium nucleic acid and markers of resistance. Analytical sensitivity may also vary based on the specific mutation associated with the macrolide resistance.
References:
1. Wood, GE, et al. Update in epidemiology and management of Mycoplasma genitalium infections. Infec. Dis. Clin., 37 (2) (2023), pp. 311-333
2. Workowski, K, et al. CDC Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23; 70(4):1-187.
3. Machalek, DA, et al. Prevalence of mutations associated with resistance to macrolides and fluoroquinolones in Mycoplasma genitalium: a systematic review and meta- analysis. Lancet Infect Dis. 2020 Nov;20(11):1302-1314.
M.genitalium is a sexually transmitted bacteria that can cause urethritis in men and cervicitis and pelvic inflammatory disease in women. Resistance to macrolides has been increasing and contributes to treatment failure, although rates of resistance vary by geographical region and patient population. Doxycycline is recommended as the initial empiric therapy, followed by azithromycin for patients with macrolide sensitive M. genitalium infections or moxifloxacin for macrolide resistant infections. This approach is aimed at reducing organism load and facilitates clearance, ultimately decreasing the risk of treatment failure in infected patients.
A detected macrolide resistance result for this test indicates that the organism contains one of the characterized mutations (A2056G, A2058C, A2059G, A2059C, A2058T) associated with the resistance to macrolides. Although a not detected result may suggest a macrolide sensitive infection, macrolide resistance may still be present even when markers are not detected due to differences in analytical sensitivity between the detection of M.genitalium nucleic acid and markers of resistance. Analytical sensitivity may also vary based on the specific mutation associated with the macrolide resistance.
References:
1. Wood, GE, et al. Update in epidemiology and management of Mycoplasma genitalium infections. Infec. Dis. Clin., 37 (2) (2023), pp. 311-333
2. Workowski, K, et al. CDC Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23; 70(4):1-187.
3. Machalek, DA, et al. Prevalence of mutations associated with resistance to macrolides and fluoroquinolones in Mycoplasma genitalium: a systematic review and meta- analysis. Lancet Infect Dis. 2020 Nov;20(11):1302-1314.
