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Test Code URRP Ureaplasma species, Molecular Detection, PCR, Varies

Reporting Name

Ureaplasma PCR

Useful For

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

Real-Time Polymerase Chain Reaction (PCR) using LightCycler and Fluorescent Resonance Energy Transfer (FRET)

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Varies


Necessary Information


Specimen source is required.



Specimen Required


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.


Specimen Minimum Volume

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

Specimen Stability Information

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

Reject Due To

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

Reference Values

Not applicable

Day(s) Performed

Monday through Friday

CPT Code Information

87798 x 2

87999 (if appropriate for government payers)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
URRP Ureaplasma PCR 69934-8

 

Result ID Test Result Name Result LOINC Value
SRC80 Specimen source 31208-2
35128 Ureaplasma urealyticum PCR 51988-4
35129 Ureaplasma parvum PCR 69933-0

Clinical Information

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.

Interpretation

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

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.

Method Description

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)

Report Available

3 to 4 days

Test Classification

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.