SureSwab® Mycoplasma/Ureaplasma Panel, Real-Time PCR
Test Summary
Mycoplasma and Ureaplasma spp. have been associated with genital tract infection. M. genitalium has been implicated in cervicitis, endometritis, and PID. M. hominis has also been associated with cervicitis and is present in increased numbers in vaginosis. Ureaplasma spp. have been linked to upper genitourinary tract infection and to premature labor and abortion. Because of their nature, these organisms are not routinely cultured and are better detected by molecular methods.
Recently, by molecular means two groups of Ureaplasma spp. have been distinguished- U. parvum and U. urealyticum, with the former being more prevalent in the lower genital tract of a healthy woman. It is not clear which species more predominantly causes infection. M. hominis and the ureaplasmas appear to be opportunists when they infect the upper genitourinary tract. These organisms have also been targeted as having a possible role in infertility, although this remains a gray area.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
1 vaginal swab collected in an Aptima® Vaginal Swab Collection Kit or Multitest Collection Kit (orange label), or
1 male urethral swab collected in an Aptima® Unisex Swab Specimen Collection Kit (white label), or
2 mL male urine collected in an Aptima® Urine Transport Tube
1 male urethral swab collected in an Aptima® Unisex Swab Specimen Collection Kit (white label), or
2 mL male urine collected in an Aptima® Urine Transport Tube
Minimum Volume
1 swab • 2 mL urine
Instructions
Vaginal Swabs: Follow instructions in the Aptima® Vaginal Swab Collection Kit or Multitest Collection Kit (orange label).
Male Urethral Swabs: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit (white label).
Swab specimen collection kit (orange or white label). Excess mucus should be removed prior to sampling.
Male Urine: Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the Aptima® urine specimen transport within 24 hours of collection and before being assayed. Use the tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane on the tube label.
Male Urethral Swabs: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit (white label).
Swab specimen collection kit (orange or white label). Excess mucus should be removed prior to sampling.
Male Urine: Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the Aptima® urine specimen transport within 24 hours of collection and before being assayed. Use the tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane on the tube label.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Room temperature
Specimen Stability
- Room temperature: 14 days
- Refrigerated: 14 days
- Frozen: 30 days
Limitations
N/A
Other Acceptable Specimens
No other acceptable specimens
Unacceptable Specimens
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 the fluid level is not between the black fill
Order Code
MUPANL
EPIC (Premier) Code
LAB5543
Includes
SureSwab®, Mycoplasma hominis, Real-Time PCR
Mycoplasma genitalium, rRNA, TMA
SureSwab®, Ureaplasma species, Real-Time PCR
Mycoplasma genitalium, rRNA, TMA
SureSwab®, Ureaplasma species, Real-Time PCR
CPT Code
- 87563
- 87798 (x3)
Billing Code
- 670907
- 670908
CPT Statement
Methodology
See individual tests
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly VA, 20153
14225 Newbrook Drive
Chantilly VA, 20153
Department
Reference Testing
Reference Range
| Mycoplasma hominis, Real-Time PCR | Not detected |
| Mycoplasma genitalium, rRNA, TMA | Not detected |
| Ureaplasma species, Real-Time PCR | |
| U. parvum DNA | Not detected |
| U. urealyticum DNA | Not detected |
Setup Schedule / Expected Turnaround Time
Monday - Saturday; Report available: 4 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
1 vaginal swab collected in an Aptima® Vaginal Swab Collection Kit or Multitest Collection Kit (orange label), or
1 male urethral swab collected in an Aptima® Unisex Swab Specimen Collection Kit (white label), or
2 mL male urine collected in an Aptima® Urine Transport Tube
1 male urethral swab collected in an Aptima® Unisex Swab Specimen Collection Kit (white label), or
2 mL male urine collected in an Aptima® Urine Transport Tube
Minimum Volume
1 swab • 2 mL urine
Instructions
Vaginal Swabs: Follow instructions in the Aptima® Vaginal Swab Collection Kit or Multitest Collection Kit (orange label).
Male Urethral Swabs: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit (white label).
Swab specimen collection kit (orange or white label). Excess mucus should be removed prior to sampling.
Male Urine: Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the Aptima® urine specimen transport within 24 hours of collection and before being assayed. Use the tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane on the tube label.
Male Urethral Swabs: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit (white label).
Swab specimen collection kit (orange or white label). Excess mucus should be removed prior to sampling.
Male Urine: Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the Aptima® urine specimen transport within 24 hours of collection and before being assayed. Use the tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane on the tube label.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Room temperature
Specimen Stability
- Room temperature: 14 days
- Refrigerated: 14 days
- Frozen: 30 days
Limitations
N/A
Other Acceptable Specimens
No other acceptable specimens
Unacceptable Specimens
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 the fluid level is not between the black fill
Result Information
Methodology
See individual tests
Testing Laboratory
N/A
Reference Range
| Mycoplasma hominis, Real-Time PCR | Not detected |
| Mycoplasma genitalium, rRNA, TMA | Not detected |
| Ureaplasma species, Real-Time PCR | |
| U. parvum DNA | Not detected |
| U. urealyticum DNA | Not detected |
Setup Schedule / Expected Turnaround Time
Monday - Saturday; Report available: 4 days