Sickle SCAN (TM) Successfully Validated in Laboratory Testing
Dr. Kanter from the Medical University of South Carolina, Dr. Telen from Duke University Medical Center, Dr. Hoppe from Children's Hospital Oakland, and three of BioMedomics' key researchers, have successfully concluded a series of laboratory testing to evaluate and validate the diagnostic accuracy of Sickle SCAN (TM).
The Sickle SCAN™ test was created using advanced, qualitative lateral flow technology using capillary blood to identify the presence of hemoglobin A, S, and C allowing for detection of results with the naked eye.
In this study, laboratory testing using venous blood demonstrated 99 % sensitivity and 99 % specificity for the diagnosis of HbSS, HbAS, HbSC, HbAC, and HbAA. Seventy-one subjects underwent capillary blood sampling at the point of care for further validation. This test detected the correct A, S, and C presence with an overall diagnostic accuracy of 99 % at the bedside.
This study has shown the Sickle SCAN™ test's potential to significantly impact the diagnosis and treatment for sickle cell disease worldwide as well as enhance genetic counseling at the point of care. Further validation testing will be conducted in newborns in resource-poor settings in upcoming studies.
Details of the study has been published in BMC Medicine. To view or download the full article, please follow this link: http://www.biomedcentral.com/1741-7015/13/225