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.
                
            
    
    For more information see Infective Endocarditis: Diagnostic Testing for Identification of Microbiological Etiology
    
        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.
                
            
    
    
    
        Reporting Name
            
                
                
                    
                    Lists a shorter or abbreviated version of the Published Name for a test
                
            
    
    
    
        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.
                
            
    
    For more information see Infective Endocarditis: Diagnostic Testing for Identification of Microbiological Etiology
    
        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 polymerase chain reaction 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: 
Specimen Type: Formalin-fixed, paraffin-embedded tissue block (FFPE)
Sources: Lung, bone, liver, heart valve, aorta, or endocardium
Supplies: Tissue Block Container (T553)
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 5 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. The minimum volume is sufficient for one attempt at testing.
                
            
    
    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
                
            
    
    | Tissue in formalin formaldehyde, or acetone Bone marrow Decalcified bone Unstained slides | 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 | 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.
                
            
    
    For more information see Infective Endocarditis: Diagnostic Testing for Identification of Microbiological Etiology
    
        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 associated with animals. Acquired through aerosol exposure, it 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 polymerase chain reaction (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 it does not negate the presence of the organism and may occur due to inhibition of polymerase chain reaction, 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. A 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 determined to contain polymerase chain reaction (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 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 Feb;64(1):134-136.
2. Liesman RM, Pritt BS, Maleszewski JJ, Patel R. Laboratory diagnosis of infective endocarditis. J Clin Microbiol. 2017 Sep;55(9):2599-2608. doi: 10.1128/jcm.00635-17.
3. Kersh GJ, Bleeker-Rovers CP: Coxiella: Evaluation, interpretation, and reporting results. In: Carroll K, Pfaller M, eds. Manual of Clinical Microbiology. 12th ed. ASM Press; 2019:1185-1186.
4. 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.
    
        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 FR: Applications and challenges of real-time PCR for the clinical microbiology laboratory. In: Reischl U, Wittwer C, Cockerill F, eds. Rapid Cycle Real-Time PCR, 2002:3-27; Kersh GJ, Bleeker-Rovers CP: Coxiella. In: Carroll K, Pfaller M, eds. Manual of Clinical Microbiology. 12th ed. ASM Press; 2019:1180-1188)
    
        PDF Report
            
                
                
                    
                    Indicates whether the report includes an additional document with charts, images or other enriched information
                
            
    
    
    
        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.
                
            
    
    
    
        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
            
                
                
                    
                    Indicates the location of the laboratory that performs the test
                
            
    
    
    
        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.
                
            
    
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- 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.
                
            
    
    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.
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|---|---|---|
| SRCQF | Specimen Source | 31208-2 | 
| 62193 | Coxiella burnetii PCR | 90442-5 |