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Diagnosing Infections During the COVID-19 Pandemic

 

The Challenge

Patients with severe COVID-19 infection and those with other infectious diseases may have overlapping clinical presentations. Accurately diagnosing etiologies of pneumonia and fever of unknown origin (FUO) can be a clinical challenge.

 

How the Karius® Test can help

While the Karius Test does not detect SARS-CoV-2, it can non-invasively detect from a single blood sample over 1,000 pathogens causing deep-seated and bloodstream infections. 

Examples of pathogens detected by the Karius Test in patients with pneumonia or FUO, but who have been SARS-CoV-2 negative include:

  • Pneumocystis jirovecii
  • Staphylococcus aureus
  • Legionella spp
  • Nocardia spp
  • Mycobacteria spp
  • Endemic mycoses
  • Fungi including CandidaAspergillus, molds

The diagnosis of an alternative respiratory infection does not rule out infection with SARS-CoV-2. When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a subject’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19.

 

A Non-invasive, Broad, Complementary Test

 

Reduce COVID-19 exposure and transmission risk to healthcare workers from diagnostics such as bronchoscopy or chest CT using the non-invasive Karius Test.

Diagnose infections quickly and accurately to provide appropriate, targeted care.

Stratify patients earlier in the diagnostic workup with a rapid, comprehensive assay to help providers triage patients.

 

 

A Diagnostic Dilemma

 

When a SARS-CoV-2 test comes back negative

Is the patient truly negative?
Repeat SARS-CoV-2 testing

What else is on the differential?
Invasive procedures such as bronchoscopy

Cultures? PCR testing?
Limited hospital & laboratory resources

Diagnosing infections quickly and accurately is critical.

Karius Test can assist with this diagnostic dilemma by non-invasively detecting bacteria, fungi, and DNA viruses causing respiratory or other infections from a single 5 mL blood sample.
 
1 blood sample
1,000+ DNA pathogens
1 day turnaround time*

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

 

 

Talk to a Karius Infectious Disease Specialist

 

 

Clinical Partnerships

 

 

Investigating secondary infections in patients with COVID-19 and the impact on disease severity, disease progression, and mortality

Karius is pursuing partnerships with leading institutions that have established COVID-19 research programs to evaluate the association between secondary infections and outcomes in patients with COVID-19, with a focus on patients with severe illness.

For more information on this clinical partnerships, contact us at medical@kariusdx.com.

 

Perspective on Secondary Infections

 

 

 

Frequently Asked Questions

 

  1. Can the Karius Test detect SARS-CoV-2? 

    No. The Karius Test cannot detect RNA viruses such as SARS-CoV-2. The list of 1,000+ detectable pathogens can be found here: kariusdx.com/pathogenlist.

 

  1. Does a positive Karius Test result rule out COVID-19?

    No. The diagnosis of an alternative respiratory infection does not rule out infection with SARS-CoV-2. As with any diagnostic test, the Karius Test results should be interpreted within the context of clinical data, including patient history, physical findings, epidemiological risk factors, and other laboratory data.

    Our Medical Affairs team of infectious diseases physicians is available for consultation. Please contact Medical Affairs at medical@kariusdx.com or 866-452-7487.

 

  1. Does prior antimicrobial therapy influence Karius Test results?

    The Karius Test 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

 

  1. What is the Karius Test process?

    The Karius Test is a simple and efficient process. One 5 mL blood sample should be collected in a plasma preparation tube (PPT), centrifuged at your hospital, and then shipped overnight to Karius. Karius Test kits, which include collection tubes and shipping supplies, are supplied by Karius. Results are typically reported one day after sample receipt.

 

  1. How will my institution receive the Karius Test result?

    All Karius Test results are faxed to the fax number provided during account setup. Additionally, test results can be accessed via online portal or SMS. Please call Karius Customer Support for assistance with these alternative methods of receiving test results.

 

For additional questions, please contact Karius Customer Support (Phone: 866-452-7487 | Email: help@kariusdx.com). We are available 24/7.

This test was developed and its performance characteristics determined by Karius. This test has not been cleared or approved by the FDA, nor is it required to be. 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.