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

Foundation for Innovative New Diagnostics (FIND)

Status: Completed

Conditions: Fever Malaria

Treatments: Diagnostic Test: Malaria/CRP combination test

Study type: Observational

Funder types: Other

Identifiers

NCT04791800

8820-2/1

Details and patient eligibility

About

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.

Enrollment: 1,808 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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.