NCT03172221

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 880 (actual)
• Sponsor: Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
• Sex: Female
• Age: 15 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Plasmodium Falciparum
• Pregnancy Malaria
• Diagnoses Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	HS-RDT	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.

Timeline

• Start date: 2017-07-25
• Primary completion: 2018-01-31
• Completion: 2018-01-31
• First posted: 2017-06-01
• Last updated: 2023-11-30

Locations

2 sites across 1 country: Colombia