Validation of a Point-care Device (Truenat Malaria Pv/Pf/mixed Pv-Pf) using a molecular method (Q-PCR) for detecting malaria

POCTRN – Point-of-Care Technologies for Nutrition, Infection and Cancer for Global Health (PORTENT) Study: Phase 1. Evaluation and selection of a total of five (05) Point-of-Care Devices for Nutrition, Infection, and Cancer for Global Health for validation over a 5-year period. Phase 2: Evaluation and Validation of Point-of-Care Device Number 01 - Truenat® Malaria Pv-Pf (a new Q-PCR device for malaria testing by MolBio) over a 1-year period.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061505

Enrollment

560

Registered

2024-01-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B509- Plasmodium falciparum malaria, unspecified Health Condition 2: B519- Plasmodium vivax malaria without complication

Interventions

Intervention1: Validation of Truenat® Malaria Pv-Pf (a new Q-PCR device for malaria testing by MolBio): Truenat® Malaria Pv-Pf device will be validated against reference standard tests for detecting P

Eligibility

Inclusion criteria

Inclusion criteria: Patients: Where the health care providers want to rule out malaria in the patient visiting the clinical site and are willing to consent to participate in the study Healthy individuals from clinical sites and community who are willing to consent to participate in the study to identify the true negative

Exclusion criteria

Exclusion criteria: Patients with the following condition/s a) Participant who is terminally ill/ needs emergency care. b) Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study or the participant’s ability to participate in the study.

Design outcomes

Primary

Measure	Time frame
Clinically evaluate the Truenat malaria testing kits for diagnosis of sub-microscopic infections in field conditions following are the outcome measures. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the new test will be reported compared to the standard test. The Mc Nemar chi-square test will be used to test the proportion of positives between the new test and the standard test. Agreement between the two tests will be assessed using Kappa statistics along with prevalence-adjusted weighted Kappa. P-value less than 5% will be considered statistically significant.Timepoint: Individuals will be tested only once at the time of recruitment in the study.	—

Measure

Time frame

Clinically evaluate the Truenat malaria testing kits for diagnosis of sub-microscopic infections in field conditions following are the outcome measures. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the new test will be reported compared to the standard test. The Mc Nemar chi-square test will be used to test the proportion of positives between the new test and the standard test. Agreement between the two tests will be assessed using Kappa statistics along with prevalence-adjusted weighted Kappa. P-value less than 5% will be considered statistically significant.Timepoint: Individuals will be tested only once at the time of recruitment in the study.

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Secondary

Measure	Time frame
NoneTimepoint: Nil	—

Countries

India

Contacts

Public ContactDr Abijeet Waghmare

St. Johns Research Institute

mary.dias@stjohns.in08049467100

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026