Test Catalog

Test Id : URRP

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Ureaplasma species, Molecular Detection, PCR, Varies

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Overview

Test Catalog

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, bone, spine, joint, and lower respiratory sources This test is not intended for medicolegal use.

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)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Ureaplasma PCR

Specimen Type
Describes the specimen type validated for testing

Varies

Necessary Information

Specimen source is required.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
SRC80 Specimen Source

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

The high sensitivity of amplification by polymerase chain reaction requires the specimen to be processed in an environment in which contamination of the specimen by Ureaplasma DNA is not likely. Submit only 1 of the following specimens: Specimen Type: Swab Supplies: -Culturette (BBL Culture Swab) (T092) -BD E-Swab (T853) -M4-RT (T605) Sources: Vaginal, cervix, urethra, urogenital, chest/mediastinal; bronchus or lung (donor swab), or upper respiratory sources (only infants <3 months: nasopharynx, nose, throat) Container/Tube: Preferred: Culture swab transport system (Dacron or rayon swab with aluminum or plastic shaft with either Stuart or Amies liquid medium) Acceptable: Swab in transport media: M4, M4-RT, M5, M6, universal transport media, or ESwab Specimen Volume: 1 swab Collection Instructions: Vaginal: 1. Collect specimen by swabbing back and forth over mucosa surface to maximize recovery of cells. 2. Place swab back into swab cylinder. Urethra or cervical: 1. Collect specimen by inserting swab 1 to 3 cm and rotating 360 degrees. 2. Place swab back into swab cylinder. Wound: 1. Collect specimen by swabbing back and forth over wound surface to maximize recovery of cells. 2. Place swab back into swab cylinder. Specimen Type: Fluid Sources: Pelvic, peritoneal, amniotic, prostatic secretions, semen, reproductive drainage or fluid, pleural/chest, chest tube, pericardial Container/Tube: Sterile container Specimen Volume: 1 to 2 mL Specimen Type: Respiratory Sources: Sputum, tracheal secretions, bronchial washings, bronchoalveolar lavage, lung; or nasal washings (Note: Nasal washings may only be submitted for infants <3 months of age) Container/Tube: Sterile container Specimen Volume: 1 to 2 mL Specimen Type: Synovial fluid Container/Tube: Preferred: Lavender top (EDTA) Acceptable: Pink top (EDTA), royal blue top (EDTA), sterile vial containing EDTA-derived aliquot, red top (no anticoagulant), or sterile container Specimen Volume: 1 mL Collection Instructions: Send specimen in original tube. Specimen Type: Urine-first void, kidney/bladder stone, or ureter Container/Tube: Sterile container Specimen Volume: 10 mL or entire specimen Collection instructions: Urine first void: Specimen can be collected at any time during the day. The patient should not have urinated for at least 1 hour prior to specimen collection. The first voided portion is the initial 20 to 30 mL of the urine stream obtained without cleaning the external urethra. Specimen Type: Tissue Sources: Placenta, products of conception, urogenital, respiratory, bronchus, chest/mediastinal, bone, spine, or joint Container/Tube: Sterile container Specimen Volume: 5 mm(3) Collection Instructions: 1. Collect fresh tissue specimen. 2. Submit fresh tissue only, do not add fluid to tissue 3. Refrigerate or freeze specimen.

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

Fluid: 1 mL Urine-first void: 2 mL Swab: 1 swab Tissue: 5 mm(3)

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Thawing Cold OK; Warm reject Cotton or calcium alginate-tipped swab, wooden shaft swab, transport swab containing gel or charcoal Formalin-fixed and/or paraffin-embedded tissues, Port-a-Cul tube Anaerobic fluid vials Dry swab (no pledget or sponge) Bone marrow Decalcified bone Slides Respiratory fluid specimens placed in viral transport medium (M4-RT, M4, or M5) Body fluid specimens placed in viral transport medium (M4-RT, M4, or M5) Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred) 7 days
Frozen 7 days

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, bone, spine, joint, and lower respiratory sources This test is not intended for medicolegal use.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Ureaplasma urealyticum and Ureaplasma parvum have been associated with a number of clinically significant infections, although their clinical significance may not always be clear as they are part of the normal genital microbiota. U urealyticum and U parvum have been associated with urethritis and epididymitis. They may cause upper urinary tract infection and have been associated with infected kidney stones. U urealyticum and U parvum may be isolated from amniotic fluid of women with preterm labor, premature rupture of membranes, spontaneous term labor, or chorioamnionitis. They may also cause neonatal infections, including meningoencephalitis and pneumonia. In addition, U urealyticum and U parvum have been reported to cause unusual infections, such as prosthetic joint infection and infections in transplant recipients. Recently, U urealyticum and U parvum have been found to cause hyperammonemia in lung transplant recipients.(1) In lung transplant recipients with hyperammonemia, the ideal diagnostic specimen is a lower respiratory specimen (eg, bronchoalveolar lavage fluid), although U urealyticum and U parvum may also be detected in blood. Treatment directed against these organisms has resulted in resolution of hyperammonemia. Culture of Ureaplasma species is laborious, requiring a high degree of technical skill and taking several days. Polymerase chain reaction (PCR) detection is sensitive, specific, and provides same-day results. In addition, PCR allows the differentiation of U urealyticum and U parvum, which is not easily accomplished with culture. The PCR assay has replaced conventional culture for U urealyticum and U parvum at Mayo Clinic Laboratories due to its speed and equivalent performance to culture.

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 polymerase chain reaction (PCR) result for the presence of a specific sequence found within the Ureaplasma urealyticum and Ureaplasma parvum ureC gene indicates the presence of U urealyticum or U parvum DNA in the specimen. A negative PCR result indicates the absence of detectable U urealyticum and U parvum DNA in the specimen but does not rule out infection as false-negative results may occur due to inhibition of PCR, sequence variability underlying the primers and probes, or the presence of U urealyticum or U 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. Since Ureaplasma species may be part of the normal microbiota, results should be interpreted accordingly.

Supportive Data

This assay was clinically validated in a blinded manner using 283 archived genitourinary specimens submitted to our laboratory for Ureaplasma culture. Ureaplasma PCR detected 139/144 Ureaplasma culture-positive specimens, as well as 9 that were culture negative (sensitivity, 97%; specificity, 94%). Of the specimens that tested positive for Ureaplasma species, Ureaplasma urealyticum alone was detected in 33, Ureaplasma parvum alone in 109, and both in 6. Discordant results (n=14) were tested by a different PCR assay at the Albany Medical Center, where it was found that 5 of the 9 specimens that were PCR positive/culture negative were PCR positive using the second assay, and all of the 5 specimens that were PCR negative/culture positive were PCR negative using the second assay.(2) The limit of detection of the assay is 100 targets/mcL. A case of prosthetic joint infection caused by Ureaplasma parvum has been diagnosed using the assay.(3)

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Bharat A, Cunningham SA, Scott Budinger GR, et al. Disseminated Ureaplasma infection as a cause of fatal hyperammonemia in humans. Sci Transl Med. 2015;7(284):284re3 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(4):1528-1533 3. Farrell JJ, Larson JA, Akeson JW, et al. Ureaplasma parvum prosthetic joint infection detected by PCR. J Clin Microbiol. 2014;52(6):2248-2250 4. Waites KB, Bebear C: Mycoplasma and Ureaplasma. In: Carroll KC, Pfaller MA, eds. Manual of Clinical Microbiology. 12th ed. ASM Press; 2019;1117-1136 5. Kenny GE. Genital mycoplasmas: Mycoplasma genitalium, Mycoplasma hominis, and Ureaplasma species. In: Bennett JE, Dolin R, Blaser MJ, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. 9th ed. Churchill Livingstone; 2020:chap 184

Method Description
Describes how the test is performed and provides a method-specific reference

This polymerase chain reaction (PCR) method employs a target-specific detection system including primers, as well as fluorescent resonance energy transfer (FRET) hybridization probes designed for ureC gene 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.(Cunningham SA, Mandrekar JN, Rosenblatt JE, Patel R: Rapid PCR detection of Mycoplasma hominis, Ureaplasma urealyticum, and Ureaplasma parvum. Int J Bacteriol. 2013;2013:168742. doi: 10.1155/2013/168742)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

3 to 4 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

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 Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87798 x 2 87999 (if appropriate for government payers)

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
URRP Ureaplasma PCR 69934-8
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
SRC80 Specimen source 31208-2
35129 Ureaplasma parvum PCR 69933-0
35128 Ureaplasma urealyticum PCR 51988-4

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
Test Changes - Specimen Information 2023-10-10