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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1808 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-08

Study Completion Date

2020-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Fever Malaria

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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