Evaluation of the Performance of a hsRDT Versus cRDT in Reactive Case Detection of Malaria Infections

Study Overview
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Brief Summary
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A systematic review assessing the role, appropriateness and benefits of the active case detection strategy, both proactive and reactive, in low malaria transmission settings. A common indication is that more studies should be carried out to optimize the ACD strategy to the local context, or to provide evidence for the adoption of improved methods. One possible improved method is the use of more accurate diagnostic tools, such as the hsRDT proposed in this study, with an increased capacity to detect lower levels of parasitemia. It can provide a timely and relevant contribution for their development of national Standard Operating Procedures for a screening tool in the reactive case detection strategy.

Detailed Description
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The study is conducted in the areas under Sakhanmaw Rural Health Center, Ann Township in Southern Rakhine State, Myanmar. General objective was to evaluate the performance of the new highly-sensitive rapid diagnostic test (RDT) developed by SD Bioline versus conventional RDT, compared with PCR as the gold standard, in reactive case detection of malaria infections in Rakhine State, Myanmar. Specific objectives To evaluate the prevalence of malaria identified by the new hsRDT in comparison with that by cRDT and PCR To assess the diagnostic performance characteristics of hsRDT versus cRDT, using PCR as gold standard, in the detection of P.falciparum infections To evaluate correlation of detection capability between cRDT and hsRDT To identify risk factors associated with malaria infection, including but not limited to, socio-demographic factors and travel history related with malaria index cases This is a prospective community-based single-center reactive case detection (RCD) study to assess the performance of hsRDT versus cRDT in identifying individuals with malaria infection (Secondary case) in a population living and/or working in a close physical proximity to an index case. All cases parasitologically confirmed by conventional RDT will be promptly notified to the study team and interviewed with a standardized case investigation form at their home, possibly within 3 days. All members of the primary case household and those of the nearest 10 households, aged 5 years and above, will be invited to participate in the study. A blood spot will be collected for subsequent PCR analysis. At least 50 index cases are targeted for investigation and reactive case detection and an estimated number of 1,980 persons will be involved in the study. It is expected that this study will be an important input for the national malaria control program in Myanmar as they develop the strategies to conduct reactive case detection. A suitable statistical software, e.g. STATA will be used to analyze the data resulting from the participant interviews and 3 parasitological tests. Logistic regression models will be developed to examine factors significantly associated with malaria infections.

Official Title
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Evaluation of the Performance of a Highly-sensitive Rapid Diagnostic Test (RDT) Versus Conventional RDT, Compared With PCR as the Gold Standard, in Reactive Case Detection of Malaria Infections in Rakhine State, Myanmar

Conditions
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Malaria Diagnosis, Malaria,Falciparum

Intervention / Treatment
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* Diagnostic Test: hsRDT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at least 5 years old Resident of the villages, or temporary visitors, or co-workers or co-travelers of index case Willingness to participate in the study evident by informed consent Exclusion Criteria: Presence of severe clinical illness including severe malaria Non-resident index cases Refusal to participate in the study

Ages Eligible for Study
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Minimum Age: 5 Years

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
Intervention Model: Single Group Assignment
Interventional Model Description: If P.f malaria case were detected, the responsible malaria worker or basic health staff will inform to survey team and blood samples for cRDT, hsRDT, Dried Blood Spot for PCR will be collected from index case and contacts (nearby 10-household members and peers). Then the results of cRDT and hsRDT will be confirmed by PCR for evaluating their performance. Then the applicability of hsRDT to detect low parasitaemia for enhancing malaria elimination activities will be evaluated.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diagnostic performance of hsRDT<br>Comparing diagnostic power of two diagnostics | Diagnostic Test: hsRDT<br>* Testing highly sensitive RDT detection for low parasitemia<br>* Other names: Highly sensitive RDT is also used as ultrasensitive RDT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of malaria infections identified by the new hsRDT | Outcomes measured by malaria test positivity rate by cRDT, hsRDT and PCR, respectively | PCR diagnosis of samples will occur after 10 months of data collection. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance characteristics of hsRDT versus cRDT using PCR as gold standard, in the detection of P.falciparum infections | Outcomes measured between hsRDT and cRDT | Outcomes will be analyzed after 10 months of data collection | 
| Correlation of detection capability between cRDT and hsRDT | Outcomes measured by correlation of test positivity rates | PCR results will be analyzed during month 10 | 
| Risk factors associated with malaria infection cases | Outcomes will be measured by relative risk of malaria in association with different risk factors identified | Outcome will be measured/analyzed in month 10, after PCR results are released | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hsRDT, usRDT, Reactive Case Detection (RCD), High risk for malaria