A minimally invasive liquid biopsy for infectious diseases.
Karius SpectrumTM is a blood test leveraging metagenomic sequencing of microbial cell-fee DNA to detect over 1,000 fungi, bacteria, 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 that can delay treatment for vulnerable hospitalized patients.
The Karius Spectrum test is a laboratory developed test (LDT) that was developed and its performance characteristics determined by Karius, Inc. This test is not required to be cleared or approved by the FDA. The Karius laboratory is CLIA-certified and CAP-accredited.
The Karius Spectrum test requires a single blood draw to reveal information-rich, microbial cell-free DNA, potentially reducing the need for invasive diagnostic procedures.1,2
The Karius Spectrum test results typically report the next day after sample receipt, compared with standard methods which can take days to weeks to yield results.3,4,5
Karius Spectrum pathogen identification and the addition of genotypic bacterial antimicrobial resistance (AMR) detection may help clinicians to optimize antimicrobial treatment.6,7
Over 800,000 immunocompromised patients are hospitalized for pneumonia every year, including both complex and community-acquired cases.8 Rapid diagnosis is critical, but conventional testing and other procedures can fail to provide answers in up to 50–75% of patients.9-12 Discover how the Karius Spectrum test offers a fast, minimally invasive solution to this diagnostic challenge.
Clinical studies validate performance of the Karius Spectrum test across high-risk patient populations and diagnostic applications.
Karius Spectrum provides pathogen detection results within one day after sample receipt, with bacterial AMR marker detection available the following day.
Specimen collection - 5-mL standard blood draw in plasma preparation tube
Sample received by Karius laboratory
Specimen processing - Microbial cell-free DNA isolation and library preparation
Sequencing and analysis - Microbial cell–free DNA sequencing and curated clinical-grade pathogen database
Karius Spectrum Report - Quantitative amounts of clinically relevant Pathogens.
AMR marker detection / AMR addended report is provided if specimen volume is sufficient for testing and additional analytical conditions are met.
Currently, Karius Spectrum is validated only for blood specimens. However, this does not mean that we can only detect bloodstream infections. We have found that even when an infection is localized in the CSF, in the lung, or in a deep abscess, pathogen cfDNA from that infection can be detected in the plasma.
Karius Spectrum can detect cell-free DNA (cfDNA) from dead and dying pathogens released into the bloodstream. Therefore, the cfDNA signal of a pathogen may still be detected even when a patient has been pre-treated with antibiotics. However, the longer you wait, the lower the abundance which can make interpretation more challenging.21
Karius Spectrum AMR capabilities include detection of antimicrobial resistance for 18 bacterial pathogens and 4 classes of antimicrobial resistance:
Methicillin-resistant Staphylococci (SCCmec, mecA, mecC), Vancomycin-resistant Enterococci (vanA, vanB), Carbapenem-resistant Gram-negative bacteria (KPC), Extended spectrum beta-lactamase (ESBL)-producing Gram-negative bacteria (CTX-M).
You can reach us Monday - Sunday 6am-4pm PST by phone at 1-866-452-7487 or by email at help@kariusdx.com.
The Karius Spectrum test is a laboratory developed test (LDT) that was developed and its performance characteristics determined by Karius, Inc. This test is not required to be cleared or approved by the FDA. The Karius laboratory is CLIA-certified and CAP-accredited.
Please see our Licensure Page, for more information and to download copies of Karius’s licenses and certifications.
Package the specimen along with a printed Karius Spectrum Test Requisition Form using packaging and transportation supplies provided by Karius. Specimens should be shipped at ambient temperature and should arrive at Karius within 4 days (96 hours) of draw.
We recommend that specimens be shipped via UPS Next Day Air® Early to ensure that the specimens are received at Karius before 8:30 AM. Karius covers UPS Next Day Air® Early fees. You can use the UPS pre-printed airbills included in our kits or select the option to print a UPS label when you submit the requisition online.
