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

NCT03172221 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 880

Last updated 2023-11-30

No results posted yet for this study

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.

Conditions

  • Plasmodium Falciparum
  • Pregnancy Malaria
  • Diagnoses Disease

Interventions

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.

Sponsors & Collaborators

  • Universidad de Antioquia

    collaborator OTHER

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-25
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03172221 on ClinicalTrials.gov