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| Name | Class |
|---|---|
| National Institute of Malaria Research, New Delhi, India | UNKNOWN |
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The aim of this study is to assess the clinical performance (sensitivity, specificity, positive and negative predictive values) of the STANDARDâ„¢ 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Malaria/CRP combination test | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 STANDARDâ„¢ 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 |
| 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 STANDARDâ„¢ 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 Cobasâ„¢ c111 chemistry analyser, or equivalent, as the reference test. | Day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged 5 years and above with clinically suspected malaria on the basis of fever or history of fever in the previous 72 h, either enrolled by passive case detection in health care facilities, or by active case detection in the surrounding communities.
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| Name | Affiliation | Role |
|---|---|---|
| Anupkumar Anvikar, MD | National Institute of Malaria Research, New Delhi, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIMR | New Delhi | India |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| D005334 | Fever |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| D000079426 |
| Vector Borne Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |