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| Name | Class |
|---|---|
| Universidad de Antioquia | OTHER |
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This is a cross-sectional and multicentre clinical trial to study the performance of the Histidine Rich Protein 2 (HRP2) highly sensitive rapid diagnostic test (HS-RDT) for the detection of malaria during pregnancy in low transmission settings from Colombia and Indonesia. The new HS-RDT will be compared with conventional good quality RDTs, microscopy, and NAATs [loop-mediated isothermal amplification (LAMP), nested PCR (nPCR)], in peripheral blood samples with quantitative reverse transcription PCR (qRT-PCR) as reference standard.
The activities proposed will be performed in the context of health centres receiving pregnant women for antenatal care visit. Finger-prick blood (300 µL) will be collected and used to test for malaria with the HS-RDT, as well as with conventional good quality RDTs, microscopy and local NAATs (LAMP and nPCR). Dried blood spots will also be collected for qRT-PCR testing. Patient information (demographics, obstetric history, malaria prevention measures, etc.) as well as laboratory results will be recorded and entered into a dedicated database.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-RDT | Diagnostic Test | A single finger-prick blood sample will be collected and used to test participants with the HS-RDT. The results of the results of the test will not be used for treatment purposes nor used to inform patient care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy | Sensitivity, specificity, negative predictive value, positive predictive value, diagnostic odds ratio (DOR) and the area under the receiver operating characteristic curve (AUROC) of HRP2 HS-RDT for the detection of P. falciparum during pregnancy, compared with conventional good quality RDTs, microscopy and NAATs (LAMP, nPCR,), in peripheral blood with qRT-PCR as reference standard. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include pregnant women
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Consecutive pregnant women self-presenting at the selected health care facilities and meeting the eligibility criteria will be invited to participate in the study. After study staff provides full information about the study, pregnant women willing to participate will be asked to sign the informed consent form. They will consent to be interviewed and to provide finger-prick blood. For women younger than 18 years old, additional approval from the parent or legal guardian will be needed if required by local Institutional Review Board (IRB). Participants will be invited to participate at any visit at any trimester.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Salud el Reposo | Quibdó | Colombia | ||||
| Hospital Divino Nino |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32736543 | Derived | Vasquez AM, Velez G, Medina A, Serra-Casas E, Campillo A, Gonzalez IJ, Murphy SC, Seilie AM, Ding XC, Tobon Castano A. Evaluation of highly sensitive diagnostic tools for the detection of P. falciparum in pregnant women attending antenatal care visits in Colombia. BMC Pregnancy Childbirth. 2020 Jul 31;20(1):440. doi: 10.1186/s12884-020-03114-4. |
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| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| D008288 | Malaria |
| D004194 | Disease |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| Tumaco |
| Colombia |
| D000079426 |
| Vector Borne Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |