SureSwab®, Ureaplasma species, Real-Time PCR

Test Code

91476

CPT Codes
87798 (x2)

Includes

U. parvum DNA and U. urealyticum DNA

Preferred Specimen

1 vaginal or male urethral swab in Aptima® transport tube, or
2 mL male urine in 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 or Multitest Collection Kit (orange label).

Urethral Swabs: Follow instructions in the Aptima® Unisex 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

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Transport tubes with 2 swabs • Transport tubes with non-Aptima® swabs • Swab submitted in non-Aptima® transport containers • Urine submitted in non-Aptima® transport container • 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: 3-5 days

Reference Range

U. parvum DNA	Not detected
U. urealyticum DNA	Not detected

Clinical Significance

Ureaplasma spp. have been linked to upper genitourinary tract infection and to premature labor and abortion. Recently, by molecular means two groups have been distinguished, U.parvum and U. urealyticum, with the former being more prevalent in the lower genital tract of healthy women. It is not clear which species more predominantly causes infection. Ureaplasma spp. 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.

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.