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

Fever Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04791800
• Other study ID #: 8820-2/1
• Status: Completed
• Start date: April 8, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: March 2021
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1808
• Est. completion date: September 1, 2020
• Est. primary completion date: March 16, 2020
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fever Malaria
• Malaria

Intervention

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.

Locations

Country	Name	City	State
India	NIMR	New Delhi

Sponsors (2)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland	National Institute of Malaria Research, New Delhi, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performance of the Malaria/CRP combination test for malaria diagnosis at 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).	Day 0
Primary	Clinical performance of the Malaria/CRP combination test for detection of high levels of C-reactive protein at 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.	Day 0