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Test ID: KPLA Karius Spectrum, Plasma


Specimen Required


Collection Container/Tube:

Preferred: Plasma preparation tube (PPT)

Acceptable: Lavender top (K2 EDTA)

Submission Container/Tube:

Preferred: PPT

Acceptable: Sterile polypropylene tube

Specimen Volume: 1 mL Plasma

Collection Instructions :

1. Gently invert tube 8 to 10 times to mix whole blood.

2. Centrifuge specimen as follows:

 a. For PPT: Within 6 hours of collection, centrifuge at 1100 x g for 10 minutes.

 b. For K2 EDTA:

  i. Within 24 hours of collection, centrifuge at 1600 x g for 10 minutes. For tubes less than 4 mL, refer to tube manufacturer’s instructions for centrifugation speed and time.

  ii. Aliquot 1 mL of plasma into a sterile polypropylene tube, taking care not to disturb the buffy coat.

3. For complete instructions see Karius Spectrum Specimen Collection and Preparation Process.


Useful For

Rapid and minimally invasive detection of deep-seated and difficult-to-diagnose systemic infections throughout the body.

 

Provide antimicrobial resistance detection for microbes known to utilize the antimicrobial resistance mechanism.

Method Name

Metagenomic Sequencing

Reporting Name

Karius Spectrum, P

Specimen Type

Plasma

Specimen Minimum Volume

Plasma: 0.7 mL

Specimen Stability Information

Specimen Type Temperature Time
Plasma Frozen (preferred) 180 days
  Ambient  4 days

Clinical Information

Karius Spectrum is a blood test leveraging metagenomic sequencing of microbial cell-fee DNA to detect over 1000 bacteria, fungi, parasites, and DNA viruses associated with deep-seated and difficult-to-diagnose systemic infections. The Karius Spectrum test may assist clinicians in reducing low-yield, sequential or diagnostic tests requiring tissue or fluid collection, which can delay treatment for vulnerable hospitalized patients.

 

In addition, Karius Spectrum provides antimicrobial resistance detection when appropriate. This is designed to help healthcare professionals use targeted therapy to improve patient outcomes. Four classes of antimicrobial resistance are detected (methicillin-resistant Staphylococci [SCCmec, mecA, mecC], vancomycin-resistant Enterococci [vanA, vanB], carbapenem-resistant gram-positive bacteria [KPC], and extended spectrum beta-lactamase producing gram-negative bacteria [CTX-M]) for 18 bacterial pathogens.

 

For more information see Karius Spectrum In the Guidelines: Plasma Metagenomic Sequencing (MNGS) of Microbial Cell-Free DNA (MCFDNA).

Reference Values

An interpretive report will be provided.

Interpretation

A positive result indicates that microbial cell-fee DNA (mcfDNA) of one or more potentially pathogenic microorganisms was detected. The concentration of the mcfDNA detected will be provided in the report.

 

A negative result indicates absence of detectable mcfDNA from potentially pathogenic bacteria, fungi, parasites, and DNA viruses. A negative result does not rule the presence of a pathogen due to lack of a reference sequence in the database used or the presence of mcfDNA in quantities lower than the assay's limit of detection. Results should be interpreted in the clinical context of the patient.

 

This test detects antimicrobial resistance conferred by the following markers: SCCmec, mecA, mecC, vanA, vanB, CTX-M, or KPC. Evaluation for these markers will be performed when a microbe known to utilize the antimicrobial resistance mechanism is reported.

 

For more information see Understanding the Karius Spectrum Test Report.

Clinical Reference

1. Blauwkamp TA, Thair S, Rosen MJ, et al. Analytical and clinical validation of a microbial cell-free DNA sequencing test for infectious disease. Nat Microbiol. 2019;4(4):663-674. doi:10.1038/s41564-018-0349-6

2. KC, Pfaller MA, eds. Manual of Clinical Microbiology. 12th ed. ASM Press; 2019

3. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases, 9th ed. Elsevier; 2019

Day(s) Performed

Monday through Saturday

Report Available

2 to 6 days

Test Classification

The Karius Spectrum test was developed and its performance characteristics determined by Karius. The Karius laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) and is accredited by the College of American Pathologists (CAP) to perform high-complexity clinical laboratory testing. This test has not been reviewed or cleared by the US Food and Drug Administration.

CPT Code Information

0152U

LOINC Code Information

Test ID Test Order Name Order LOINC Value
KPLA Karius Spectrum, P Not Provided

 

Result ID Test Result Name Result LOINC Value
KPLA Karius Spectrum, P Not Provided
Mayo Clinic Laboratories | Neurology Catalog Additional Information:

mcl-meningitis