| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
SureSwab®, Ureaplasma species, Real-Time PCR
Test Code91476
CPT Codes
87798 (x2)
Includes
U. parvum DNA and U. urealyticum DNA
Preferred Specimen
1 vaginal or male urethral swab collected in an Aptima® Transport Tube or
2 mL male urine in Aptima® Urine Transport Tube
2 mL male urine in Aptima® Urine Transport Tube
Patient Preparation
Male urine: Patient should not have urinated within one hour prior to collection.
Instructions
Vaginal swabs: Follow instructions in the Aptima® Vaginal Swab Collection Kit or Multitest Collection Kit (orange label).
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.
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 container • Female urine • Specimens in broken containers
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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
A.M. Sets up 6 days a week.
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.
