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

Completed

• Conditions: Fever Malaria

• Registration Number: NCT04791800
• Lead Sponsor: Foundation for Innovative New Diagnostics, Switzerland

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-08
• Primary Completion: 2020-03-16
• Study First Submitted: 2020-08-10
• Study Completion: 2020-09-01
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-09
• Last Update Submitted: 2021-03-09
• Study First Posted: 2021-03-10
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1808

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical performance of the Malaria/CRP combination test for malaria diagnosis at day 0	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	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.

Trial Locations

Locations (1)

NIMR; 🇮🇳 New Delhi, India