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SureSwab®, Mycoplasma hominis, Real-Time PCR
Test Code91474
CPT Codes
87798
Preferred Specimen
1 vaginal swab collected in a APTIMA® Vaginal Swab Collection Kit or Multitest Collection Kit (orange label) or
1 male urethral swab collected in a APTIMA® Unisex Swab Specimen Collection Kit (white label) or
2 mL male urine collected in a APTIMA® urine transport tube.
1 male urethral swab collected in a APTIMA® Unisex Swab Specimen Collection Kit (white label) or
2 mL male urine collected in a APTIMA® urine transport tube.
Patient Preparation
Male Urine: Patient should not have urinated within one hour prior to collection.
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.
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 30 days
Refrigerated: 14 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 the fluid level is not between the black fill lines • Urine submitted in non-Aptima® transport containers • Female urine
Methodology
Real-Time Polymerase Chain Reaction
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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Mon-Sat; Report available: 4 days
Reference Range
Not detected
Clinical Significance
Mycoplasma hominis was first identified as a cause of inflammatory urogenital disease in men but has since been implicated in causing pelvic inflammatory disease/cervicitis in women. Because of its fastidious nature, this organism is not routinely cultured and is better detected by molecular methods. PCR allows for rapid detection of M. hominis.
Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153
