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

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.

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.