Technology
ALERT
April 2016
Horizon Scanning Research &
Intelligence Centre
ImmunoXpert™ for diagnosing
bacterial and viral infections
Click here
for Lay
Summary
TECHNOLOGY
The ImmunoXpert™ test is an in vitro
diagnostic test developed by MeMed to
distinguish between bacterial and viral
infections.
The test measures three immune system
biomarkers in serum: TNF-related apoptosisinducing ligand (TRAIL), Interferon gammainduced protein-10 (IP-10) and C-reactive
protein (CRP). A computer algorithm is then
used to compute a score indicating the
likelihood of a bacterial versus viral (or other
non-bacterial) immune response.
©
MeMed
The test is performed by a laboratory technician, with a turn-around time of 99 minutes. The
ImmunoXpert™ test can be performed on patients aged ≥3 months with a suspected acute
infection such as a respiratory tract infection, symptom duration of less than seven days and
a temperature of ≥38°C from the time of symptom onset.
The company state ImmunoXpert™ is not intended for use as a stand-alone diagnostic tool
and should be used in conjunction with other clinical data. The company add
ImmunoXpert™ is not intended to distinguish between infectious and non-infectious
aetiologies.
ImmunoXpert™ was CE marked in 2014 and is in clinical use in select pilot sites in Israel
and Europe. The company anticipate NHS hospital use under the MeMed ImmunoXpert™
early access program, from July 2016. ImmunoPoc™, a point-of-care, hand-held device
version of the test that provides results within 15 minutes, is currently in development.
FebriDx® is another rapid, point of care lateral flow immunoassay developed by RPS
diagnostics. It uses a blood sample to identify and differentiate a clinically significant immune
response to suspected acute viral and/or bacterial respiratory infection. The company is in
the process of introducing the technology to the NHS.
This alert presents independent research funded by the National Institute for
Health Research (NIHR). The views expressed are those of the author and
not necessarily those of the NHS, the NIHR or the Department of Health.
NIHR Horizon Scanning Research & Intelligence Centre,
University of Birmingham. Email: [email protected]
Web: www.hsric.nihr.ac.uk
NIHR Horizon Scanning Research & Intelligence Centre
POTENTIAL FOR IMPACT
Bacterial and viral infections may be clinically indistinguishable, leading to inappropriate
patient management and antibiotic misuse. Routine microbiological diagnostic tests include
culture, serology and nucleic acid-based tests, which help clinicians determine the cause of
the infection. However, current options present challenges for pathogen detection in cases
where the infection site is not readily accessible (e.g. pneumonia), or is unknown (e.g. fever
without source in children) and the patient presents with potential bacterial and viral coinfection.
ImmunoXpert™ does not directly detect the infecting pathogens. Instead it uses a host
immune signature that comprises three soluble circulating proteins- TRAIL, IP-10 and CRPwhich are involved in different physiological pathways and exhibit distinctive and
complementary behaviours in response to infection. By assessing the host’s immune
response, the type of infection need not be known or accessible.
The company claim ImmunoXpert™ demonstrated superior accuracy when compared to
clinical parameters used in the differential diagnosis of bacterial or viral infections (e.g. white
blood cell count, absolute neutrophil count, CRP, erythrocyte sedimentation rate and
procalcitonin). According to the company ImmunoXpert™ is capable of detecting co-infection
in addition to pure bacterial infections, thereby improving antibiotic treatment decisions.
The company state benefits for patients include informed treatment decisions and timely
antibiotic administration, potentially curbing the rise in antibiotic resistance and the
associated financial implications. The company add, through confirmation of a bacterial
infection, the test offers the potential to improve patient management and satisfaction by
avoiding unnecessary hospital admission, tests and procedures such as multiplex PCR and
lumbar puncture. The company anticipate early detection of the infection may improve health
outcomes and influence hospitalisation (admittance and discharge) decisions. The company
also predict cost-savings through a reduction in prescription of unwarranted antibiotics,
complications associated with incorrect or delayed diagnosis and unnecessary follow-up
tests and procedures such as imaging. As a consequence of these reductions, the company
also anticipate expedited triage and workflow and savings in clinician time.
If clinical and cost-effectiveness can be demonstrated, ImmunoXpert™ may offer an
additional testing option for patients with infection.
This technology is predicted to have an impact on the following domains of the NHS
Outcomes Framework (www.england.nhs.uk/resources/resources-for-ccgs/out-frwrk):
Domain 1
Preventing people from dying prematurely;
Domain 3
Helping people to recover from episodes of ill health or following injury
EVIDENCE
PUBLISHED PAPERS AND ABSTRACTS
Oved K, Cohen A, Boico O et al. A novel host-proteome signature for distinguishing between
acute bacterial and viral Infections. PLoS ONE 2015;10(3):e0120012.
http://www.ncbi.nlm.nih.gov/pubmed/25785720
Oved K, Cohen A, Boico O et al. Combining traditional bacterially and novel virally induced
proteins for distinguishing between acute bacterial and viral infections. Pioneering
diagnostics beyond genomics and MALDI-TOF ECCMID. April 2015. Abstract O061.
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NIHR Horizon Scanning Research & Intelligence Centre
https://www.escmid.org/escmid_library/online_lecture_library/?search=1&current_page=1&s
earch_term=Combining+traditional+bacterial
Cohen A, Bont L, Engelhard D et al. A multi-faceted ‘omics’ approach for addressing the
challenge of antimicrobial resistance. Future Microbiology 2015;10(3):365-376.
http://www.ncbi.nlm.nih.gov/pubmed/25812460
Oved K, Cohen A, Boico O et al. A novel immunoassay that distinguishes between bacterial
and viral infections based on a patient’s immune response. American Association for Clinical
Chemistry 2015. AACC Annual Meeting & Clinical Lab Expo. July 2015. Poster.
https://www.aacc.org/~/media/files/annual-meeting/2015/abstracts2/aacc15_b058_b115.pdf?la=en
Oved K, Boico O, Cohen A et al. A novel host-immune signature for diagnosing bacterial
infections and guiding antibiotic treatment. European Federation of Clinical Chemistry and
Laboratory Medicine. 2014. Abstract Th155.
http://www.me-med.com/html5/Web/2466/Abstract%20for%20website.pdf
ONGOING STUDIES
ClinicalTrials.gov. A retrospective, blinded validation of a host-response based diagnostics
(PATHFINDER).
https://clinicaltrials.gov/ct2/show/NCT01911143 Accessed 22nd April.
ClinicalTrials.gov. Assess a diagnostic tool to distinguish between bacterial and viral
infection (OPPORTUNITY).
https://clinicaltrials.gov/ct2/show/NCT01931254 Accessed 22nd April.
ClinicalTrials.gov. Prospective Study to Characterize Novel pathogen-and Host-related
Factors in Hospitalized Patients and Patients on the Emergency Department Presenting
With Lower Respiratory Tract Infections and/or Sepsis (TailoredT).
https://clinicaltrials.gov/ct2/show/NCT02025699 Accessed 22nd April.
A further prospective clinical utility study (Rosetta) and clinical validation study (Observer)
are planned.
INFORMATION FROM
This Alert is based on information from the company and a time-limited internet search.
Lay summary
ImmunoXpert™ is a blood test to check if a patient has an infection from a bacteria or a
virus. After the patient provides a blood sample, the ImmunoXpert™ test makes
measurements that are read by special computer software which tells the doctor if the
infection is caused by a bacteria or virus. The developer says this test will help patients
receive the right antibiotic treatment and more quickly.
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