Test Catalog

Test Id : KKBRP

Kingella kingae, Molecular Detection, PCR, Blood

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

Aiding in the diagnosis of Kingella kingae infection using whole blood 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, B

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

Whole Blood EDTA

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 Kingella kingae 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 specimen in original tube (preferred).

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

0.5 mL

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

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

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
Whole Blood EDTA Refrigerated (preferred) 7 days
Frozen 7 days

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

Aiding in the diagnosis of Kingella kingae infection using whole blood 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 blood by PCR 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 ETDA whole blood samples and 10-negative samples. No PCR inhibitors were 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 EDTA-whole blood 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;55:3113-3122

2. Murphy TF: 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 2774-2776

3. Zbinden R: Aggregatibacter, Capnocytophaga, Eikenella, Kingella, Pasteurella, and Other Fastidious or Rarely Encountered Gram-Negative Rods. In Manual of Clinical Microbiology. Edited by JH Jorgensen, KC Carroll, G Funke, MA Pfaller. 11th edition. Washington DC. ASM Press 2015, pp 652-666

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

5. Madigan T, Cunningham SA, Ramanan P, et al: Real-Time PCR Assay for Detection of Kingella kingae in Children. J Pediatr Infect Dis 2018;13:216-233

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 FRET hybridization probes. This real-time PCR reaction 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 Rapid Cycle Real-Time PCR Methods and Applications. Edited by U Reischl, C Wittwer, F Cockerill. Berlin, Germany, Springer-Verlag, 2002, pp 3-27; Zbinden R: Aggregatibacter, Capnocytophaga, Eikenella, Kingella, Pasteurella, and Other Fastidious or Rarely Encountered Gram-Negative Rods. In Manual of Clinical Microbiology. 12th edition. Edited by K Carroll, M Pfaller. Washington DC, ASM Press, 2019, pp 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, 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

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