Clinical Evaluation of the STANDARD™ Q Malaria/CRP Duo Test

March 9, 2021 updated by: Foundation for Innovative New Diagnostics, Switzerland

Evaluation of the Clinical Performance of the STANDARD™ Q Malaria/CRP Duo Test (SD Biosensor, South Korea) for the Diagnosis of Malaria and the Detection of C-reactive Protein (CRP) in Fingerprick Blood of Febrile Patients

The aim of this study is to assess the clinical performance (sensitivity, specificity, positive and negative predictive values) of the STANDARD™ Q Malaria/CRP Duo Test when used by health care workers (HW) in a point of care (POC) setting in malaria endemic areas in India. Performance will be assessed in comparison with expert microscopy as the reference test for malaria, and with a high quality, commercially available C-Reactive Protein (CRP) test kit run on a laboratory machine as a reference test for CRP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1808

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • New Delhi, India
        • NIMR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 5 years and above with clinically suspected malaria on the basis of fever or history of fever in the previous 72 h, either enrolled by passive case detection in health care facilities, or by active case detection in the surrounding communities.

Description

Inclusion Criteria:

  • clinically suspected malaria on the basis of fever or history of fever in the previous 72 h
  • age ≥ 5 years, (iii) having been informed of the study and signed a written consent form

Exclusion Criteria:

  • signs of severe malaria or other severe disease
  • patients not fulfilling the inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance of the Malaria/CRP combination test for malaria diagnosis at day 0
Time Frame: Day 0
Point estimates (with 95% confidence intervals) of the sensitivity, specificity, positive and negative predictive values of the STANDARD™ Q Malaria/CRP Duo Test for the diagnosis of malaria, in comparison with expert microscopy as the reference test at day 0 (first day of presentation).
Day 0
Clinical performance of the Malaria/CRP combination test for detection of high levels of C-reactive protein at day 0
Time Frame: Day 0
Point estimates (with 95% confidence intervals) of the sensitivity, specificity, positive and negative predictive values of the STANDARD™ Q Malaria/CRP Duo Test for the detection of CRP at day 0, in comparison with the CRP-LX reagent kit used with the Roche Diagnostics Cobas™ c111 chemistry analyser, or equivalent, as the reference test.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation for Innovative New Diagnostics, Switzerland

Collaborators

National Institute of Malaria Research, New Delhi, India

Investigators

  • Principal Investigator: Anupkumar Anvikar, MD, National Institute of Malaria Research, New Delhi, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2019

Primary Completion (Actual)

March 16, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

March 9, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8820-2/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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