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Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women — HSRDT MiP  

Diagnoses Disease Clinical Trial

Official title:
Clinical Performance of the Histidine Rich Protein 2 (HRP2) Highly Sensitive Rapid Diagnostic Test (HS-RDT) for Malaria Diagnosis in Pregnant Women

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03172221
Study type Observational
Source Foundation for Innovative New Diagnostics, Switzerland
Contact
Status Completed
Phase
Start date July 25, 2017
Completion date January 31, 2018
View Details
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