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

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.

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Key information

Conditions

Fever Malaria Body Temperature Changes Fever Infections Malaria Mosquito-Borne Diseases Parasitic Diseases Pathological Conditions, Signs and Symptoms Protozoan Infections Signs and Symptoms Vector Borne Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NIMR

New Delhi, India

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Malaria/CRP combination test

Diagnostic Test

Testing with a malaria/CRP combination test, in parallel with a standard malaria RDT (to guide case management), preparation of thin/thick films for expert malaria microscopy, and collection of venous blood for subsequent CRP quantification.

Primary outcomes

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).
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.

Sponsors and collaborators

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland

Other

Collaborators

National Institute of Malaria Research, New Delhi, India

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Mar 10, 2021
Registry last updated: Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed