RapiGEN BIOCREDIT Malaria Ag RDTs WHO Prequalification Study

NCT05085301 | Completed

• 1 other identifier: MA016 RapiGEN
• Study Type: observational
• Target: 674
• Locations: 2 countries
• Sites: 2

Brief Summary

Since their introduction in the late 90's, rapid diagnostic tests (RDTs) have markedly improved our ability to control malaria; yet they have inherent limitations which include low sensitivity in Plasmodium vivax detection and inability to detect hrp2/3 gene deleted Plasmodium falciparum parasites. In addition, the spread of P. falciparum parasites lacking hrp2 gene jeopardizes the long-term use of P. falciparum-specific HRP2-based RDTs. A partnership between RapiGEN, FIND, and the Bill and Melinda Gates Foundation (BMGF) is addressing these limitations by developing five novel malaria RDTs with improved pLDH and HRP2 detection. RapiGEN has also developed three novel malaria RDTs - BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH), BIOCREDIT Malaria Ag Pf (pLDH/HRP2) and BIOCREDIT Malaria Ag Pf (pLDH) - to address these drawbacks. The BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) is a combo test that detects P. falciparum and P. vivax on a single device. BIOCREDIT Malaria Ag Pf (pLDH/HRP2) targets both PfLDH and HRP2 antigens in P. falciparum; and BIOCREDIT Malaria Ag Pf (pLDH) has improved detection of pLDH in P. falciparum. In countries with circulation of hrp2/3 deleted P. falciparum malaria parasites or high P. vivax burden, these improved RDTs may be invaluable in malaria elimination. This study is a prospective and retrospective evaluation of RapiGEN's BIOCREDIT Malaria Ag RDTs in malaria-endemic countries to assess their clinical performance for detection of malaria. The purpose of this study is to provide a high level outline of the study design and conduct to support the collation of a data package for WHO Pre-Qualification proposed study.

Conditions

Malaria; Diagnoses Disease; RDT

Outcome Measures

Primary Outcomes (2)

• Point estimates of BIOCREDIT Malaria Ag Pf

  Point estimates of diagnostic accuracy characteristics (sensitivity, specificity, NPV, PPV) with 95% confidence intervals for BIOCREDIT Malaria Ag Pf (pLDH/HRP2) and BIOCREDIT Malaria Ag Pf (pLDH) using the reference test (nPCR) as standard of truth for the detection of P. falciparum infections in patients with symptoms suggestive of malaria

  2 months

• Point estimate of BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH)

  Point estimates of diagnostic accuracy characteristics (sensitivity, specificity, NPV, PPV) with 95% confidence intervals for BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) using the reference test as standard of truth for the detection of P. falciparum and P.vivax infections in patients with symptoms suggestive of malaria

  2 months

Secondary Outcomes (2)

• Point estimates of comparator tests

  2 months

• Frequencies of hrp2/3 gene deletions

  2 months

Interventions

Rapid diagnostic test DIAGNOSTIC_TEST

The performance of three index tests and two comparator tests will be compared to reference tests and gold standard microscopy.

Also known as: BIOCREDIT

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptoms suggestive of malaria seeking clinical care in health facilities. All patients will be assessed for eligibility of enrollment and those who full filled the criteria will be recruited in the study after signing an informed consent.

You may qualify if:

• Aged 5 years old or older
• Presenting at the study site with fever or a history of fever during the preceding 48 hours
• Freely agreeing to participate by providing informed consent (and assent, if applicable)

You may not qualify if:

• Presence of symptoms and signs of severe illness and/or central nervous system infections as defined by WHO guidelines

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• University of Khartoum: collaborator
• Eijkman Institute for Molecular Biology: collaborator

Study Sites (2)

Eijkman Institute for Molecular Biology

Jakarta, 10430, Indonesia

Location

Institute of Endemic Diseases, Medical Campus

Khartoum, Sudan

Location

MeSH Terms

Conditions

Malaria

Interventions

Rapid Diagnostic Tests

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Point-of-Care Testing; Point-of-Care Systems; Patient Care Management; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: December 1, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

SU (1); ID (1)