Test Catalog

Test Id : CBRP

Coxiella burnetii (Q fever), Molecular Detection, PCR, Varies

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aiding in the diagnosis of Coxiella burnetii infection (eg, Q fever) using tissue specimens

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

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

Coxiella burnetii (Q fever) PCR

Aliases
Lists additional common names for a test, as an aid in searching

Q fever

C. burnetii

Coxiella burnetii

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Specimen Type
Describes the specimen type validated for testing

Varies

Necessary Information

Specimen source is required.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
SRCQF 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 PCR requires the specimen to be processed in an environment in which contamination of the specimen by Coxiella burnetii DNA is unlikely.

 

Submit only 1 of the following specimens:

 

Specimen Type: Fresh tissue or biopsy

Sources: Lung, bone, liver, heart valve, aorta, or endocardium

Container/Tube: Sterile container

Specimen Volume: Entire collection or 5 mm(3) - approximately the size of a pencil eraser

Collection Instructions:

1. Collect fresh tissue specimen.

2. Submit tissue only, do not add fluid to tissue

3. Refrigerate or freeze specimen.

Specimen Stability Information: Refrigerated (preferred) <7 days/ Frozen <7 days

 

Preferred Paraffin-embedded tissue block:

Supplies: Tissue Block Container (T553)

Specimen Type: Formalin-fixed, paraffin-embedded tissue block (FFPE)

Sources: Lung, bone, liver, heart valve, aorta, or endocardium

Container/Tube: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block to be cut and returned.

Specimen Stability Information: Ambient (preferred)/Refrigerated

 

Acceptable Paraffin-embedded tissue block:

Specimen Type: Formalin-fixed, paraffin-embedded tissue block (FFPE)

Sources: Lung, bone, liver, heart valve, aorta, or endocardium

Container/Tube: Sterile container for each individual cut section (scroll).

Collection Instructions: Perform microtomy and prepare five separate 10-micron sections. Each section (scroll) must be placed in a separate sterile container for submission.

Specimen Stability Information: Ambient (preferred)/Refrigerated

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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

Fresh tissue or biopsy: 5 mm(3)

Paraffin-embedded tissue block: two 10-micron sections

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

Other Tissue in formalin, formaldehyde, or acetone; bone marrow; decalcified bone; bone marrow; slides

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 Varies

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aiding in the diagnosis of Coxiella burnetii infection (eg, Q fever) using tissue specimens

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Coxiella burnetii, the causative agent of Q fever, is a small obligate intracellular bacterium, which is associated with animals. It is acquired through aerosol exposure and generally causes mild respiratory disease. A small number of acute cases advance to a chronic infection, which typically manifests as endocarditis. Left untreated, Q fever endocarditis may be fatal. Serologic and histopathologic studies may be nonspecific and subjective, respectively, limiting usefulness for patient diagnosis.

 

Evaluation of infected tissue, blood, or serum using PCR may be a useful tool for diagnosing some cases of C burnetii infection. Mayo Clinic Laboratories has developed a real-time PCR test that rapidly detects C burnetii DNA in clinical specimens by targeting a sequence of the shikimate dehydrogenase gene (aroE) unique to C burnetii.

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 result indicates the presence of Coxiella burnetii DNA.

 

A negative result indicates the absence of detectable C burnetii DNA, but does not negate the presence of the organism and may occur due to inhibition of PCR, sequence variability underlying primers or probes, or the presence of C burnetii DNA 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

Test results should be used as an aid in diagnosis and not be considered diagnostic in themselves. The single assay should not be used as the only criteria to form a clinical conclusion, but results should be correlated with patient symptoms and clinical presentation. A negative result does not negate the presence of the organism or active disease.

Supportive Data

This assay was clinically validated in a blinded manner using 52 archived, formalin-fixed, paraffin-embedded heart valve specimens from patients with endocarditis. A single sample within this set determined to contain PCR inhibitors was omitted from the final analysis set. Compared with existing diagnostic data, PCR had a sensitivity of 100% (8/8) and specificity of 100% (43/43). All samples were assayed with a second PCR assay targeting the IS1111 element.(1) Complete concordance was noted between the 2 assays (P >0.999). The limit of detection (LoD) of the assay is 216 targets/mcL for fresh tissue and estimated (by Probit analysis) to be 9.7 targets/mcL in formalin-fixed paraffin-embedded tissue.

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

1. Frangoulidis D, Meyer H, Kahlhofer C, Splettstoesser WD: 'Real-time' PCR-based detection of Coxiella burnetii using conventional techniques. FEMS Immunol Med Microbiol 2012;64:134-136

2. Marrie TJ, Raoult D: Coxiella burnetii (Q fever). In Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. Edited by GL Mandell, JE Bennett, R Dolin. Seventh edition. Philadelphia, Churchill Livingstone/Elsevier, 2010, pp 2511-2519

3. Maurin M, Raoult D: Q fever. Clin Microbiol Rev 1999;12:518-533

4. Fenollar F, Fournier PE, Raoult D: Molecular detection of Coxiella burnetii in the sera of patients with Q fever endocarditis or vascular infection. J Clin Microbiol 2004;42:4919-4924

5. Fournier PE, Raoult D: Comparison of PCR and serology assays for early diagnosis of acute Q fever. J Clin Microbiol 2003;41:5094-5098

6. Tande A, Cunningham S, Raoult D, et al: Coxiella burnetii prosthetic joint infection-case report and assay for detection. J Clin Microbiol 2013;51:66-69

7. CDC Releases First National Guidelines on Managing Q Fever. JAMA 2013;309(18):1887

8. Anderson A, Bijlmer H, Fournier PE, et al: Diagnosis and management of Q fever-United States, 2013: recommendations from CDC and the Q Fever Working Group. MMWR Recomm Rep 2013;62(RR-03):1-30

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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

Bacterial nucleic acid is extracted from the specimen using the automated MagNA Pure instrument. The purified DNA is placed on the LightCycler instrument, which amplifies and monitors by fluorescence the development of target nucleic sequences after each PCR cycle. A specific target sequence from Coxiella burnetii is amplified and the resulting segment is detected using specific hybridization probes. Detection of the C burnetii target is performed through melting curve analysis using the LightCycler software.(Cockerill FR, Uhl JR: Applications and challenges of real-time PCR for the clinical microbiology laboratory. In Rapid Cycle Real-Time PCR Methods and Applications. Edited by U Reischl, C Wittwer, F Cockerill. Berlin, Germany, Springer-Verlag, 2002, pp 3-27;Kersh G, Bleeker-Rovers C: Coxiella, In Manual of Clinical Microbiology. 12th edition. Edited by K Carroll, M Pfaller. Washington DC, ASM Press, 2019, pp 1180-1188)

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, Wednesday, 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.

2 to 7 days

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

1 week

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 Regional Manager. 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. This test 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

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
CBRP Coxiella burnetii (Q fever) PCR 90442-5
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.
SRCQF Specimen Source 31208-2
62193 Coxiella burnetii PCR 90442-5

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