Test ID: URRP
Ureaplasma species, Molecular Detection, PCR
NY State Approved 
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Rapid, sensitive, and specific identification of Ureaplasma urealyticum and Ureaplasma parvum from genitourinary, reproductive, and lower respiratory sources
Method Name A short description of the method used to perform the test
Real-Time Polymerase Chain Reaction (PCR) Using LightCycler and Fluorescent Resonance Energy Transfer (FRET)
(PCR is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Forms: If not ordering electronically, submit a Microbiology Request Form (Supply T244) with the specimen.
Specimen source is required.
Submit only 1 of the following specimens:
Specimen Type: Vaginal
Container/Tube:
Preferred: Dacron or rayon swab with aluminum or plastic shaft (does not need to be in transport media)
Acceptable: Swab in transport media: M5 (Supply T484), M4, or universal transport media
Specimen Volume: 1 swab
Collection Instructions: Collect specimen by swabbing back and forth over mucosa surface to maximize recovery of cells.
Specimen Type: Cervix, urethra, urogenital
Container/Tube:
Preferred: Dacron or rayon swab with aluminum or plastic shaft (does not need to be in transport media)
Acceptable: Swab in transport media: M5 (Supply T484), M4, or universal transport media
Specimen Volume: 1 swab
Collection Instructions: Collect specimen by inserting swab 1 to 3 cm and rotating 360 degrees.
Specimen Type: Pelvic, amniotic, prostatic secretion, semen, reproductive drainage/fluid, lower respiratory
Container/Tube:
Preferred: Sterile container
Acceptable: Specimen in 3 mL of transport media: M5 (Supply T484), M4, or universal transport media
Specimen Volume: 1-2 mL
Specimen Type: Urine, kidney stones
Container/Tube: Sterile container
Specimen Volume: 10 mL
Specimen Type: Tissue
Sources: Placenta, products of conception, genitourinary
Container/Tube: Sterile container
Specimen Volume: 5 mm
Collection Instructions: Submit only fresh tissue.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| Other | Wooden shaft, cotton swab |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Varies | Refrigerated (preferred) | 7 days |
| Frozen | 7 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Ureaplasma species can cause acute urethritis and have been associated with bacterial vaginosis, preterm birth, and neonatal respiratory disease. Culture of Ureaplasma species is laborious, requiring a high degree of technical skill and taking several days. PCR detection is sensitive, specific, and provides same-day results. This PCR assay has replaced conventional culture for Ureaplasma urealyticum and Ureaplasma parvum at Mayo Medical Laboratories.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Not applicable
Interpretation Provides information to assist in interpretation of the test results
A positive PCR result for the presence of a specific sequence found within the Ureaplasma urealyticum and Ureaplasma parvum ureC gene indicates the presence of Ureaplasma urealyticum or Ureaplasma parvum DNA in the specimen.
A negative PCR result indicates the absence of detectable Ureaplasma urealyticum and Ureaplasma parvum DNA in the specimen, but does not rule-out infection as false-negative results may occur due to the following; inhibition of PCR, sequence variability underlying the primers and/or probes, or the presence of Ureaplasma urealyticum or Ureaplasma parvum in quantities less than the limit of detection of the assay.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Interfering substances may affect the accuracy of this assay; results should always be interpreted in conjunction with clinical and epidemiological findings.
Supportive Data
This assay was clinically validated in a blinded manner using 292 archived specimens submitted for Ureaplasma culture, 281 of which were in M4, M5, or Universal Transport Medium (UTM). The specimens consisted of 251 genitourinary, 32 reproductive fluids or tissues, and 9 respiratory specimens. Compared to culture, the PCR assay had 96.6% (141/146) sensitivity and 93.8% (137/146) specificity (p=0.29). Discordant results on the archived specimens (n=14) were tested by PCR by Dr. Kathleen A. Stellrecht at the Albany Medical Center (Journal of Clinical Microbiology 2004;42:1528-1533). Dr. Stellrecht found 5 of the 9 specimens that were PCR positive/culture negative to be PCR positive, and all of the 5 specimens that were PCR negative/culture positive to be PCR negative. The limit of detection of the assay is 100 targets/mcL for all validated sources. Additional whole organism Ureaplasma urealyticum and Ureaplasma parvum spiking studies (at the limit of detection of the assay) were performed using 30 each or more of the following: genitourinary swabs, respiratory specimens, genitourinary fluid, reproductive tissue/fluid, and kidney stones. All results (except for 1) were as expected.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Waites KB, Taylor-Robinson D: Mycoplasma and Ureaplasma. In Manual of Clinical Microbiology. 10th edition. Edited by J Versalovic. ASM Press, Washington, DC, 2011
2. Stellrecht KA, Woron AM, Mishrik NG, Venezia RA: Comparison of multiplex PCR assay with culture detection of genital mycoplasmas. J Clin Microbiol 2004;42:1528-1533
3. Kenny GE: Genital,mycoplasmas: Mycoplasma genitalium, Mycoplasma hominis, and Ureaplasma species. In Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. Edited by GL Mandell, et al. Churchill Livingstone, New York, 2008
4. Yoshida T, Maeda SI, Deguchi T, et al: Rapid detection of Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma parvum, and Ureaplasma urealyticum organisms in genitourinary samples by PCR-microtiter plate hybridization assay. J Clin Microbiol 2003;41:1850-1855
5. Cunningham SA, Shannon SK, Rosenblatt J, Patel R: Comparison of culture and rapid polymerase chain reaction detection of Mycoplasma hominis, Ureaplasma urealyticum and Ureaplasma parvum from genitourinary specimens. 48th Annual Infectious Diseases Society of America Meeting, 2010.
Method Description Describes how the test is performed and provides a method-specific reference
This PCR method employs a target-specific detection system including primers, as well as fluorescent resonance energy transfer (FRET) hybridization probes designed for ureC of Ureaplasma urealyticum and Ureaplasma parvum. The LightCycler instrument amplifies and monitors target nucleic acid sequences by fluorescence during PCR cycling. This is an automated PCR system that can rapidly detect amplified product development. The detection of amplified products is based on the FRET principle. For FRET product detection, a hybridization probe with a donor fluorophore, fluorescein, on the 3' end is excited by an external light source, which emits light that is absorbed by a second hybridization probe with an acceptor fluorophore, LC-Red 640, on the 5' end. The acceptor fluorophore then emits light of a different wavelength that is measured with a signal that is proportional to the amount of specific PCR product. The process is completed in a closed tube system and the melting temperature of the probes allows differentiation of Ureaplasma urealyticum from Ureaplasma parvum.(Unpublished Mayo method)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
87798
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| SRC80 | Specimen source | 31208-2 |
| 35128 | Ureaplasma urealyticum PCR | 51988-4 |
| 35129 | Ureaplasma parvum PCR | 69933-0 |
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