Utility of Multiplexed Rapid Fever Panel Kit among Hospitalized Febrile Patients in India and Its Impact on Antimicrobial Use and Diagnosis

Post Date: 
2019-10-24
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Clinical Sites: 
Summary: 

Introduction
Easy to use and multiplex diagnostic tools are needed to identify common causes of fever caused by vector-borne infectious diseases. Chembio has developed dual path platform (DPP) technology which differs from traditional lateral flow rapid diagnostic tests (RDT) by separating the sample and conjugate lateral flow pathways. DPP promises to improve upon traditional RDTs by increasing speed and sensitivity, reducing migration issues for large particles, and improving readability for highly multiplexed assays. A collaboration of Chembio with The Foundation for Innovative New Diagnostics (FIND) and Mahidol‐Oxford Tropical Medicine Research Unit has developed a multiplex DPP fever panel tailored for the detection of common vector-borne and zoonotic infections which are the most common cause of acute febrile illness in the Asia Pacific region. In this protocol we will prospectively evaluate the test characteristics of the Chembio DPP® Fever Panel II assay, determine practical barriers to its use, and model its potential impact on clinical care.

Primary objectives: 
Estimate the sensitivity and specificity of the Chembio assay to:

  1. Identify malaria, dengue, chikungunya, Leptospira, Orientia tsutsugamushi, Rickettsia typhi, and Burkholderia pseudomallei in prospectively collected samples from patients with AFI compared to diagnostic tests recommended by the National Vector Borne Disease Control Programme.
  2. Identify practical barriers to the deployment of the Chembio DPP fever panel in a setting representative of its intended use. 

Secondary objectives: 

  1. To determine the impact of missed or delayed diagnosis and antibiotic use in hospitalized patients in India with vector-borne and zoonotic infections.
  2. To model the potential impact of the DPP Fever Panel II diagnostic test (Aim 4) on patient care and average costs in India based on the expected % of more targeted treatments that could have been provided in more timely manner.
  3. To establish a repository of specimens to validate novel diagnostic techniques for acute febrile illness.