Overview
EPIC Code:
- LAB16172
Soft Test Code:
- MGRNA
Send Out Test Code:
- 91475
Alternate Names
- MGEN
- Mycoplasma genitalium PCR
- Mycoplasma genitalium, rRNA, TMA
Clinical Significance
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.
Specimen Collection & Preparation
Specimen Overview
For females Vaginal swab is the preferred specimen type due to higher clinical sensitivity for detecting M. genitalium than other specimen types; however, clinician collected endocervical swabs may be used as alternative specimens when vaginal swab specimens are not available. If female clinician-collected endocervical swab specimens test negative, testing with a vaginal swab may be indicated, if M. genitalium infection is suspected.
Specimen Requirements:
-OR-
1 Penile Meatal Swab in Aptima® Multitest Swab Specimen Collection Kit
Specimen Information:
Collection Instructions:
Refer to the specimen collection kit package insert for specific collection instructions.
Rejection Criteria:
Transport tubes with 2 swabs
Transport tubes with non-Aptima® swabs
Swab transport tubes with no swab
Swab submitted in non-Aptima® transport containers
Specimen on patients less than 15 years of age
Transport and Storage:
-
Ambient (18-24°C):
60 Days
Transport
-
Refrigerated (2-8°C):
60 Days
-
Frozen (-20 C or colder):
90 Days
-OR-
1 Male Urethral Swab in an Aptima® Unisex Swab Specimen Collection Kit
Specimen Information:
Collection Instructions:
Refer to the appropriate specimen collection kit package insert for specific collection instructions
Rejection Criteria:
Transport tubes with 2 swabs
Transport tubes with non-Aptima® swabs
Swab transport tubes with no swab
Swab submitted in non-Aptima® transport containers
Specimen on patients less than 15 years of age
Transport and Storage:
-
Ambient (18-24°C):
60 Days
-
Refrigerated (2-8°C):
60 Days
-
Frozen (-20 C or colder):
90 Days
-OR-
1 Vaginal Swab in an Aptima® Multi-Swab Specimen Collection Kit
Specimen Information:
Collection Instructions:
Refer to the specimen collection kit package insert for specific collection instructions.
Rejection Criteria:
Transport tubes with 2 swabs
Transport tubes with non-Aptima® swabs
Swab transport tubes with no swab
Swab submitted in non-Aptima® transport containers
Specimen on patients less than 15 years of age
Transport and Storage:
-
Ambient (18-24°C):
60 Days
Transport
-
Refrigerated (2-8°C):
60 Days
-
Frozen (-20 C or colder):
90 Days
-OR-
1 Endocervical Swab in an Aptima® Unisex Swab Specimen Collection Kit
Specimen Information:
Collection Instructions:
Refer to the specimen collection kit package insert for specific collection instructions.
Rejection Criteria:
Transport tubes with 2 swabs
Transport tubes with non-Aptima® swabs
Swab transport tubes with no swab
Swab submitted in non-Aptima® transport containers
Specimen on patients less than 15 years of age
Transport and Storage:
-
Ambient (18-24°C):
60 Days
Transport
-
Refrigerated (2-8°C):
60 Days
-
Frozen (-20 C or colder):
90 Days
-OR-
2.0 mL Urine in an Aptima® Urine Collection Kit
Minimum Volume:
2.0 mL Urine** This volume does not allow for repeat testing
Specimen Information:
Rejection Criteria:
Urine samples where fluid level is not between the black fill lines
Urine submitted in non-Aptima® transport containers
Specimen on patients less than 15 years of age
Transport and Storage:
-
Ambient (18-24°C):
30 Days
-
Refrigerated (2-8°C):
30 Days
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.
-
Frozen (-20 C or colder):
90 Days
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.
Clinical Interpretation
Reference Range:
Not Detected
Methodology:
- Transcription-Mediated Amplification (TMA)
Clinical Significance
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.
Documentation
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
Production Schedule
Sites Performed
- Quest - Chantilly
Days Performed
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Departments
- Sendouts - Miscellaneous
Turn Around Time
3 to 5 days
Coding & Compliance
CDM
00919209
CPT Coding
87563