Abbott NxTekTM Malaria RDT WHO Prequalification Study

NCT05444790 | Completed

• 1 other identifier: MA016 Abbott
• Study Type: observational
• Target: 4,563
• Locations: 3 countries
• Sites: 3

Brief Summary

Since their introduction in the late 90's, rapid diagnostic tests (RDTs) have dramatically improved our ability to control malaria but proved insufficient to support elimination efforts because of their limited sensitivity, especially for P. vivax. 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 Abbott, FIND, PATH, and the Bill and Melinda Gates Foundation (BMGF) is addressing these limitations by developing two novel malaria RDTs with improved pLDH detection: a P. falciparum-specific test targeting both the HRP2 and PfLDH antigens on a single test line (NxTekTM Malaria P.f plus Rapid Diagnostic Test Device), and a P. falciparum/P. vivax combo test additionally targeting the PvLDH antigen on a second test line (NxTekTM Malaria P.f/P.v. plus Rapid Diagnostic Test Device). These new combo tests with improved pLDH detection may provide added value compared to currently available malaria RDTs, especially in settings where current tests prove to be insufficient due to hrp2 deletion or high burden of P. vivax malaria. Abbott, PATH, and FIND will conduct a prospective evaluation of NxTekTM Malaria P.f plus and NxTekTM Malaria P.f/P.v plus RDTs in malaria-endemic countries to assess their clinical performance for detection of malaria and usability in their intended-use settings. This is in support of a submission for WHO Prequalification.The purpose of this synopsis is to describe key points of alignment in study design and conduct across the portfolio of studies.

Conditions

Malaria; RDT; Diagnoses Disease

Keywords

Malaria, Diagnostics, RDT

Outcome Measures

Primary Outcomes (2)

• Point estimates of NxTekTM Malaria Pf Plus

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

  8 Months

• Point estimates of NxTekTM Malaria Pf/Pv Plus

  Point estimates of diagnostic accuracy characteristics (sensitivity, specificity, NPV, PPV) with 95% confidence intervals for NxTekTM Malaria Pf/Pv Plus 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.

  8 Months

Secondary Outcomes (3)

• Point estimates of comparator tests

  8 months

• Point estimates of index tests

  8 months

• User ability to read and interpret test

  8 months

Interventions

Rapid Diagnostic Test DIAGNOSTIC_TEST

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

Also known as: NxTekTM

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. By default, all such patients will be assessed for eligibility and, if appropriate, recruited in the study.

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
• Universidad Peruana Cayetano Heredia: collaborator

Study Sites (3)

Exeins Health Institute

Jakarta, 12870, Indonesia

Location

Universidad Peruana Cayetano Heredia

Lima, 15102, Peru

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: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 6, 2022
• Study Start: June 30, 2022
• Primary Completion: April 30, 2023
• Study Completion: July 30, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

SU (1); PE (1); ID (1)