Abstract
Introduction
Sickle cell disease is a multifactorial haemoglobinopathy that causes various abnormalities in affected individuals. Several diagnostic methods exist, but most require sophisticated techniques that are not available in Congolese diagnostic centres involved in this activity. Considering the number of affected individuals in Africa, particularly in the Democratic Republic of Congo (The Democratic Republic of the Congo) (50 million people affected), and the precarious financial situation of our countries, it is essential to develop low-cost techniques to facilitate access to screening for our populations.
Purpose
This study aimed to validate the rapid "Sickle SCAN" method, manufactured by ZENTECH, as a tool for rapid diagnostic testing.
Methods
We assessed a single validation criterion: selectivity. This was done using samples with known haemoglobin status. The results of the Sickle SCAN test obtained from 290 subjects were compared with those obtained through isoelectric focusing, the reference method, using the Chi-square test. The duration for trait appearance was also evaluated.
Results
The Sickle SCAN test demonstrated 100% selectivity. Statistical analysis using the Chi-square test confirmed that the results from isoelectric focusing were identical to those obtained using the Sickle SCAN method. This test can also be applied to samples collected on blotting paper. The interpretation time should not exceed 2 minutes, contrary to the manufacturer's claims.
Conclusion
The Sickle SCAN rapid screening test, manufactured by ZENTECH, produced satisfactory results and is suitable for use by the Congolese population to screen for sickle cell disease. This test has the advantages of being accessible, available, and easy to use.
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