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

NCT04791800 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1808

Last updated 2021-03-10

No results posted yet for this study

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.

Conditions

  • Fever Malaria

Interventions

DIAGNOSTIC_TEST

Malaria/CRP combination 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.

Sponsors & Collaborators

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

  • National Institute of Malaria Research, New Delhi, India

    collaborator UNKNOWN

Principal Investigators

  • Anupkumar Anvikar, MD · National Institute of Malaria Research, New Delhi, India

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-08
Primary Completion
2020-03-16
Completion
2020-09-01

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04791800 on ClinicalTrials.gov