Test Catalog

Test Id : KKRP

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Kingella kingae, Molecular Detection, PCR, Varies

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Overview

Test Catalog

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

Aiding in the diagnosis of Kingella kingae infection using tissue or synovial fluid specimens

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

Real-Time Polymerase Chain Reaction (PCR)

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

Kingella kingae PCR

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

HACEK

Moraxella kingae

Kingella kingae

K. kingae

Specimen Type
Describes the specimen type validated for testing

Varies

Necessary Information

Specimen source is required.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
KKSRC 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 Kingella kingae DNA is unlikely.

 

Submit only 1 of the following specimens:

 

Specimen Type: Synovial fluid

Preferred: Lavender top (EDTA)

Acceptable: Pink top (EDTA), royal blue top (EDTA), sterile vial containing EDTA-derived aliquot, red clot tube (no anticoagulant), or sterile container

Specimen Volume: 0.5 mL

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

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

 

Specimen Type: Fresh tissue or biopsy

Sources: Bone, joint, synovium, 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: Bone, joint, synovium, 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: Bone, joint, synovium, 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

Forms

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

Fluid/fresh tissue or biopsy: See Specimen Required

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 Decalcified bone Bone marrow
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 Kingella kingae infection using tissue or synovial fluid specimens

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

Kingella kingae is a fastidious short gram-negative bacillus that may colonize the oropharynx of young children. Colonization may occasionally lead to invasive disease via hematogenous dissemination, primarily in children younger than 4 years of age. This most commonly results in bone and joint infection; K kingae is the most frequent cause of osteomyelitis and septic arthritis in children aged 6 to 36 months. K kingae may also cause endocarditis, involving both native and prosthetic valves, in patients of any age and is considered part of the HACEK (Haemophilus species, Aggregatibacter species, Cardiobacterium hominis, Eikenella corrodens, and Kingella species) group of organisms, known for causing culture-negative endocarditis. K kingae produces a repeat-in-toxin (RTX) toxin.

 

Diagnosis of K kingae infection may be challenging due to the fastidious nature of the organism in culture. Evaluation of cardiac, bone, joint tissue, or fluid by polymerase chain reaction is a useful tool for the diagnosis of some cases of K kingae infection.

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 Kingella kingae DNA.

 

A negative result indicates the absence of detectable K kingae 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 K kingae 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. 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.

 

This assay does not detect species of Kingella other than kingae or negevensis (see Supportive Data).

 

This assay cross-reacts with Kingella negevensis.(1)

Supportive Data

This assay was validated by testing 30-spiked positive samples and 10-negative samples for each accepted sample type; fresh tissue, formalin-fixed paraffin-embedded tissue (FFPE), synovial fluid, and EDTA blood. No PCR inhibition was encountered. The assay was 100% sensitive and specific. The assay showed no cross-reactivity when tested with a panel of 67 bacterial isolates, including Kingella species other than kingae. The limit of detection (LOD) in fresh tissue and FFPE was 73.7 CFU/mcL. The LOD of synovial fluid was 1.3 CFU/mcL.

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

1. El Houmami N, Bzdreng J, Durand GA, et al: Molecular tests that target the RTX locus do not distinguish between Kingella kingae and the recently described Kingella negevensis species. J Clin Microbiol. 2017 Oct;55(10):3113-3122

2. Murphy TF: Moraxella catarrhalis, Kingella, and other gram-negative cocci. In: Bennett JE. Dolin R, Blaser MJ, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. 9th ed. Elsevier; 2020:chap 213

3. Yagupsky P: Kingella kingae: carriage, transmission, and disease. Clin Microbiol Rev. 2015 Jan;28(1):54-79

4. Madigan T, Cunningham SA, Ramanan P, et al: Real-time PCR assay for detection of Kingella kingae in children. J Pediatr Infect Dis. 2018;13(3):216-233. doi: 10.1055/s-0038-1641603

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

Nucleic acid is extracted from the specimen using the automated MagNA Pure instrument. Target specific primers are used to amplify the rxtB gene region of Kingella kingae; amplification is monitored by detecting fluorescence produced by target specific fluorescence resonance energy transfer hybridization probes. This real-time polymerase chain reaction (PCR) takes place on a LightCycler instrument. Detection of the K kingae 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: Reischl U, Wittwer C, Cockerill F, eds. Rapid Cycle Real-Time PCR Methods and Applications. Springer-Verlag, 2002:3-27; Zbinden R: Aggregatibacter, Capnocytophaga, Eikenella, Kingella, Pasteurella, and other fastidious or rarely encountered gram-negative rods. In: Carroll K, Pfaller M, eds. Manual of Clinical Microbiology. 12th ed. ASM Press; 2019:656-669)

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 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.

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
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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.

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
KKRP Kingella kingae PCR 65809-6
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.
KKSRC Specimen Source 31208-2
48324 Kingella kingae PCR 65809-6

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.

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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