Karius Test | Karius

Karius Test

Karius® Test

 

Discover Clarity in Full Bloom

 

Pathogens can be hard to uncover–find them fast with the Karius Test.

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The Karius Test is a non-invasive blood test based on next-generation sequencing of microbial cell-free DNA. It can identify and quantify over 1,000 clinically relevant pathogens including bacteria, DNA viruses, fungi, and parasites.

Applications include complicated pneumonia, immunocompromised patients, and endocarditis.

 

 

Detecting pathogens with the Karius Test improves infectious disease diagnosis

 

 

Higher diagnostic yield1

The Karius Test demonstrates superior yield when compared to blood culture and other microbiological testing.

 

 

 

Faster time to diagnosis1

The Karius Test can identify etiologies of infections more rapidly than the standard-of-care diagnostic workup.

 

 

 

Non-invasive2,3

The Karius Test helps diagnose deep-seated infections such as invasive fungal infections from a single blood draw.

 

 

 

 

Clinical Applications

 

Pneumonia

 Complicated

Atypical

Immunocompromised patients

Invasive fungal infections

Viral infections

Neutropenic fever

Endocarditis

and

 other cardiovascular infections

 

 

 

View Clinical Data

 

 

Karius Test Performance

 

The clinical and analytical validation of the Karius Test was published in Nature Microbiology. It is a landmark validation study for a metagenomic infectious disease diagnostic test.

 

 

 

Analytical Specificity

>99.99%

per pathogen

 

 

Analytical Sensitivity

>95%

at 50 fragments of cell-free DNA per μL plasma

 

View Validation Data

 

 

The Karius Test detects microbial cell-free DNA in the blood–detecting both bloodstream and deep-seated infections

 

During an acute infection, pathogens leave microbial cell-free DNA (mcfDNA) in the blood. Even when an infection is localized, mcfDNA from the infection can be detected. Detection of mcfDNA in the blood is a breakthrough in the diagnosis of infectious diseases, and mcfDNA offers several advantages over conventional testing:

 

 

 

Detection of infections throughout the body

mcfDNA can be found in the bloodstream even in deep-seated infections.

 

 

 

Breadth and depth of organisms

mcfDNA from multiple organisms can be found in the blood. The Karius Test detects over 1,000 pathogens – DNA viruses, bacteria, fungi, and eukaryotes.

 

 

 

Quantitative results

mcfDNA concentration corresponds with pathogen abundance over time.

High-quality process ensures both speed and accuracy with results delivered typically the next day

 

The Karius Test is a send-out test ordered by the clinician. The patient’s specimen is collected at the hospital and shipped to Karius.

 

Specimen Collection
and Shipping Instructions

 

Once the specimen arrives at Karius, specimen processing to reporting takes 1 day*.

 

 

 

 

Step 1
Specimen Collection

5 mL standard blood draw in Plasma Preparation Tube

 

 

Step 2
Specimen Processing

DNA extraction and library preparation

 

 

Step 3
Sequencing

Microbial cell-free DNA sequencing

 

 

Step 4
Analysis

Curated clinical-grade pathogen database

 

 

Step 5
Reporting

Quantitative amounts of clinically relevant pathogens

Sample Test Report

 

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*More than 85% of specimens received by 8:30 am (PT) Monday through Saturday are reported the next day.

750+

Bacteria detected

Highlighted Bacteria:

Nocardia species (67)
Legionella species (30)
Rickettsia species (17)
Actinomyces species (15)
Mycoplasma species (8)
HACEK organisms (including Haemophilus parainfluenzae,
Kingella denitrificans,
Kingella kingae,
Aggregatibacter actinomycetemcomitans,
Aggregatibacter aphrophilus,
Aggregatibacter segnis,
Cardiobacterium hominis,
Eikenella corrodens and
Haemophilus aegyptius)
Streptobacillus moniliformis
Mycobacterium tuberculosis complex
Mycobacterium avium complex (MAC)
Mycobacterium chimaera

 

Comprehensive pathogen detection of over 1,000 bacteria, DNA viruses, fungi, molds and eukaryotes.

 

Pathogen List

References:

1. Blauwkamp T, et al. Nat Microbiol. 2019;4(4):663-674.

2. Armstrong AE, et al. Pediatr Blood Cancer. 2019;66(7).

3. Hong DK, et al. Diagn Microbiol Infect Dis. 2018;92(3):210-213.