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Test Code LABCBSRP Coxiella burnetii (Q Fever), Molecular Detection, PCR, Serum

Additional Codes

Test Name in EPIC EPIC Test Code Mnemonic Mayo Test ID
COXIELLA BURNETII (Q FEVER) PCR LABCBSRP CBSRP CBSRP

 

Reporting Name

Coxiella burnetii (Q fever) PCR, S

Useful For

Aiding in the diagnosis of Coxiella burnetii infection (ie, Q fever) using serum specimens

Method Name

Real-Time Polymerase Chain Reaction (PCR)

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum


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.

 

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Sterile vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into a sterile vial within 2 hours of collection.


Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Frozen (preferred) 7 days
  Refrigerated  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
CBSRP Coxiella burnetii (Q fever) PCR, S 90443-3

 

Result ID Test Result Name Result LOINC Value
35189 Specimen Source 31208-2
35190 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 obligately 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 Coxiella burnetii infection. Mayo Clinic Laboratories has developed a real-time PCR test that rapidly detects Coxiella burnetii DNA in clinical specimens by targeting a sequence of the shikimate dehydrogenase gene (aroE) unique to Coxiella 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 was determined to contain polymerase chain reaction (PCR) inhibitors and 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 21.6 targets/mcL for serum.

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 Coxiella 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

2 to 7 days

Specimen Retention Time

7 days

Forms

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