NCT04791800

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,808 (actual)
• Sponsor: Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: —

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

Type	Name	Description
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.

Timeline

• Start date: 2019-04-08
• Primary completion: 2020-03-16
• Completion: 2020-09-01
• First posted: 2021-03-10
• Last updated: 2021-03-10

Locations

1 site across 1 country: India