Evaluation of a Point-of-Care Test for G6PD Detection in India

Not Applicable

Conditions: Health Condition 1: A00-B99- Certain infectious and parasitic diseases

Recruitment & Eligibility

Inclusion Criteria

Diagnostic accuracy study

-Individuals attending the health care facility

-Age greater than equal to 8 years

-Body temperature greater than equal 37.5 ? C (axillary) or with a history of fever in the last 48 hours (self-report)

- Willing to provide written informed consent/ written assent

Usability assessment study

-18 years of age or older

-Considered an intended user of point-of-care G6PD deficiency test

-Study staff member responsible for operation and use of the POC tests

-Willing and able to provide informed consent and comply with study requirements

Exclusion Criteria

Diagnostic accuracy participants

- Considered by the on-duty doctor to be too sick to undergo recruitment

- Less than 8 years of age

- Unwilling to provide informed consent

- Received a blood transfusion in the past three months

- Children who have a LAR to provide consent other than Parents

- Previously participated in the same study

Usability study

- Unwilling to provide informed consent.

Primary Outcome Measures

Name	Time	Method
Estimates of diagnostic performance (positive percent agreement, negative percent agreement, positive predictive value (PPV), and negative predictive value (NPV) of the Wondfo G6PD/Hb test classification of G6PD status compared to the reference assay in venous blood. <br/ ><br> <br/ ><br>Overall percentage agreement between the Wondfo G6PD/Hb test and the reference hemoglobin assay for the classification of anemia status in capillary and venous whole blood specimens.Timepoint: Outcome assessments will be done at the completion of study enrollments.

Secondary Outcome Measures

Name	Time	Method
Diagnostic performance (positive percent agreement, negative percent agreement, PPV, & NPV) of the SD Biosensor STANDARD G6PD test classification of G6PD status compared to the reference assay. <br/ ><br> <br/ ><br>Diagnostic performance (positive percent agreement, negative percent agreement, PPV, & NPV) of the SD Biosensor STANDARD G6PD test classification of anemia status compared to hemoglobin reference assay. <br/ ><br> <br/ ><br>Percent of trained health workers who can accurately comprehend key messaging included in the Wondfo G6PD/Hb test packaging & labels. <br/ ><br> <br/ ><br>Percent of trained health workers who can accurately run & interpret the Wondfo G6PD/Hb test & SD Biosensor STANDARD G6PD test result outputs.Timepoint: Outcome assessments will be done at the completion of study enrollments.