Evaluation of Low-cost Techniques for Detecting Sickle Cell Disease and β-thalassemia in Nepal and Canada

NACompletedINTERVENTIONAL
Enrollment

145

Participants

Timeline

Start Date

September 20, 2022

Primary Completion Date

March 30, 2023

Study Completion Date

March 30, 2023

Conditions
Sickle Cell DiseaseSickle Cell TraitBeta-ThalassemiaSickle Cell-Beta ThalassemiaSickle Cell-SS Disease
Interventions
DIAGNOSTIC_TEST

High performance liquid chromatography

High performance liquid chromatography (HPLC) using the D10 System by Bio-Rad Laboratories will be used as the gold standard test.

DEVICE

Automated sickling test

The standard sickling test using 2% sodium metabisulphite will be augmented using an automated microscope (such as Octopi) and machine learning, and will be used as one of the low-cost tests.

DIAGNOSTIC_TEST

HbS solubility test

Standard HbS solubility test currently used in Nepal (e.g. Sicklevue) will be used as one of the low-cost tests

DEVICE

HemoTypeSC

A point-of-care lateral flow assay, HemoTypeSC (https://www.hemotype.com/), will be used as one of the low-cost tests

DEVICE

Sickle SCAN

A point-of-care lateral flow assay, Sickle SCAN (https://www.biomedomics.com/products/hematology/sicklescan/), will be used as one of the low-cost tests

DEVICE

Gazelle Hb Variant Test

A portable electrophoresis machine, Gazelle diagnostic device (https://hemexhealth.com/), will be used as one of the low-cost tests

Trial Locations (3)

V6H 3N1

BC Children's Hospital, Vancouver

V6Z 1Y6

St. Paul's Hospital, Vancouver

Unknown

Mount Sagarmatha Polyclinic and Diagnostic Center, Nepalgunj

All Listed Sponsors
lead

University of British Columbia

OTHER