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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04791800

Enrollment

1808

Registered

2021-03-10

Start date

2019-04-08

Completion date

2020-09-01

Last updated

2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever Malaria

Keywords

malaria, fever, C-reactive protein, point-of-care testing

Brief 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.

Interventions

DIAGNOSTIC_TESTMalaria/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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

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.

Design outcomes

Primary

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026