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Test Code SOFT: Z1000 Coxiella burnetii (Q fever), Molecular Detection, PCR, Blood

Additional Codes

 

Ordering Mnemonic Mayo Test ID
EPIC NAME: MISC. LAB TEST CBBRP
EPIC CODE: LAB000  

 

Reporting Name

Coxiella burnetii (Q fever) PCR, B

Useful For

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

Method Name

Real-Time Polymerase Chain Reaction (PCR)

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Whole Blood EDTA


Ordering Guidance


 



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 Coxiella burnetii DNA is unlikely.

 

Container/Tube:

Preferred: Lavender top (EDTA)

Acceptable: Royal blue top (EDTA), pink top (EDTA), or sterile vial containing EDTA-derived aliquot

Specimen Volume: 1 mL

Collection Instructions: Send whole blood specimen in original tube (preferred).


Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Whole Blood EDTA Refrigerated (preferred) 7 days
  Frozen  7 days

Reject Due To

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Reference Values

Not applicable

Day(s) Performed

Monday through Friday

CPT Code Information

87798

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CBBRP Coxiella burnetii (Q fever) PCR, B 90443-3

 

Result ID Test Result Name Result LOINC Value
35191 Specimen Source 31208-2
35192 Coxiella burnetii PCR 90443-3

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.

Clinical Information

Coxiella burnetii, the causative agent of Q fever, is a small obligate intracellular bacterium that is distributed ubiquitously in the environment. Acquired through aerosol exposure, it generally causes mild respiratory disease. A small number of these acute cases will advance to a chronic condition, which typically manifests as endocarditis. If left untreated, cases of Q fever endocarditis are fatal.

 

Current diagnostic methods of Q fever endocarditis include serologic studies and histopathologic examination of excised cardiac tissue. These current methods are subjective and nonspecific, limiting usefulness in patient diagnostics.

 

Evaluation of infected tissue, blood, or serum using polymerase chain reaction (PCR) has been shown to be an effective tool for diagnosing C burnetii infection. Mayo Clinic Laboratories has developed a real-time PCR test that permits rapid identification of C burnetii. The assay targets a unique sequence of the shikimate dehydrogenase gene (aroE) present in C burnetii.

 

The assay targets a unique sequence of the shikimate dehydrogenase gene (aroE) present in C burnetii.

Interpretation

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

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 within this set 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 2.16 targets/mcL for EDTA whole blood.

Clinical Reference

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

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)

Report Available

Same day/1 to 4 days

Specimen Retention Time

1 week

Forms

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

Secondary ID

62248