An observational study in Fever, sponsored by MeMed Diagnostics Ltd.. Completed at 2 sites in Israel. Open to participants aged 3 Months to 18 Years. Per ClinicalTrials.gov, last updated 2022-08-04.
Sponsored by MeMed Diagnostics Ltd. · Observational
This is a retrospective external field study of a novel in vitro diagnostic (IVD) assay (ImmunoXpert™).
The study will involve reviewing the medical charts of about 4500 pediatric patients that were tested using ImmunoXpert™ as part of the routine workup for acute febrile illness.
ImmunoXpert™ uses a computer algorithm to combine immunoassay measurements of three host immune proteins (TRAIL, IP-10, and CRP) present in human blood. The test is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection.
Statistical analysis will be performed to compare the diagnostic accuracy of ImmunoXpert™ with that of current practice lab testing e.g., WBC, CRP, and PCT (whichever were taken as part of routine care) and clinical suspicion at time of requisition.
The febrile illness should also fulfill the following criteria:
The non-infectious disease control group will include:
Exclusion Criteria:
Host based immune response test distinguishing viral versus bacterial infection
The sensitivity and specificity of a host-response based diagnostics in differentiating between bacterial and viral etiology of patients with an acute febrile disease.
Time frame: 0-7 days after the initiation of symptoms
The sensitivity and specificity of a host-response based diagnostics in differentiating between infectious and non-infectious disease etiology
Time frame: 0-7 days after the initiation of symptoms
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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MeMed Diagnostics Ltd.