G6PD deficiency Haematological Disorders
Conditions
Interventions
This is a multi-country, multicenter non-interventional, prospective, cross-sectional diagnostic accuracy study. Following consent, an optional screening test for G6PD activity may be conducted
only individuals testing deficient or intermediate on this test will be fully enrolled in the study. The optional screening test will be covered by study resources if performed.
At the point of care
Sponsors
Program for Appropriate Technology in Health
Eligibility
Sex/Gender
All
Age
2 Years to 100 Years
Inclusion criteria
Inclusion criteria: Diagnostic accuracy and repeatability: 1. Aged 2 years of age and older (for nested repeatability study: =18 years of age; for optional screening workflow: =18 years of age and testing deficient or intermediate on the G6PD screening test) 2. Willing and able to participate by providing informed consent (and assent, if applicable) and comply with study requirements Healthcare workers (usability) 1. 18 years of age and older 2. Considered an intended user of POC G6PD tests 3. Willing and able to provide informed consent and comply with study requirements
Exclusion criteria
Exclusion criteria: For diagnostic accuracy and repeatability: 1. Severe illness such that the treating provider deems study enrollment inappropriate 2. Prior participation in the study 3. Self-reported receipt of blood transfusion in the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy (positive percent agreement, negative percent agreement, positive predictive value, and negative predictive value) of the Wondfo G6PD Test for the classification of G6PD status in capillary blood samples at the point of care and in venous whole blood specimens, as compared to a reference spectrophotometry assay in the laboratory, will be conducted at a single timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of trained intended users who can accurately comprehend key messaging included in the Wondfo G6PD/Hb Test packaging and labelling measured using a label comprehension questionnaire following completion of training 2. Proportion of trained intended users who can accurately interpret the Wondfo G6PD/Hb Test result output measured using a test interpretation questionnaire following completion of training 3. Nested repeatability study: mean, SD, and % coefficient of variation for each instrument, and for the instruments combined of the test G6PD measurement at baseline 4. Nested repeatability study: mean, SD, and % coefficient of variation for each operator, and for both operators combined, of the test G6PD measurement at baseline | — |
Countries
Brazil, Thailand
Contacts
Public ContactStephanie Zobrist
Outcome results
None listed