Africa Ready Malaria Screening

Study Overview
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Brief Summary
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This study aims to develop immuno-analytical assays for testing the titres of malaria antibodies in Ghanaian patients' and/or donors' sera using a recombinantly produced MSP119 fusion protein and/or MSP119-derived synthetic peptides as antigens.

Detailed Description
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In this study, immuno-analytical assays will be developed for determining the titres of malaria antibodies in sera of two groups (malaria patients and donors/healthy volunteers) using a recombinantly produced MSP119 fusion protein and/or MSP119-derived synthetic peptides as antigens. Individuals in the two groups presenting to Shai-Osudoku District hospital will be screened for signs and symptoms of malaria according to the WHO criteria. Those within the inclusion and exclusion criteria will be introduced to the study through informed consent for adults (18 years and over) or parents/guardians for children below 12 years and assent for adolescents between 12 and below 18 years, along with informed consent from their parents. Enrolled study participants' demographic data and vital signs will be captured electronically onto the CRF. Patients will have their clinical history and detailed physical examination done by the study clinicians and then be sent to the laboratory for investigations to confirm the malaria diagnosis. The results of patients will be communicated to the study clinician to commence the appropriate treatment. At the of the study, the results of all assays will be analyzed to determine if this test can be used to diagnose malaria infection.

Official Title
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Africa Ready Malaria Screening

Conditions
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Malaria

Intervention / Treatment
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* Diagnostic Test: Immuno analytical assay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with confirmed malaria (uncomplicated and complicated cases) are diagnosed by the national guidelines. Healthy individuals without confirmed malaria per the national guidelines. Adults and parents or guardians of children below 12 years willing to participate based on signed informed consent. Willing to give assent to adolescents between the ages of 12 and below 18 years. Willing to give a blood sample for the necessary investigations as explained in the informed consent. Willing to adhere to study procedures and a follow-up visit at the clinic, hospital, or health facility. Exclusion Criteria: Anyone refusing informed consent (or assent for adolescents) to be part of the study. Refusal to study procedures or giving of sample for the necessary investigations.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Malaria patients<br>Malaria patients | Diagnostic Test: Immuno analytical assay<br>* The eluted antibodies will be used in immuno-analytical assays, such as ELISA or Western blot, or surface-coated bead-based screening platforms using either recombinantly produced MSP119 fusion protein or synthetic peptides derived from MSP119 as antigens according to standard protocols.<br>|
| Active Comparator: Non malaria donors<br>Healthy individuals (donors; controls) | Diagnostic Test: Immuno analytical assay<br>* The eluted antibodies will be used in immuno-analytical assays, such as ELISA or Western blot, or surface-coated bead-based screening platforms using either recombinantly produced MSP119 fusion protein or synthetic peptides derived from MSP119 as antigens according to standard protocols.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MSP1-19 malaria antigen | Number of participants with MSP1-19 malaria antigen as assessed by a lateral flow test kit. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-MSP1-19 malaria antibody | Number of participants with antiMSP1-19 malaria antibody as assessed by a lateral flow test kit. | three years |