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

Phase 2

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

Registration Number: CTRI/2024/01/061505

Lead Sponsor: ational Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinically evaluate the Truenat malaria testing kits for diagnosis of sub-microscopic infections in field conditions following are the outcome measures. <br/ ><br>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.

Secondary Outcome Measures