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Title: Validation of the immunochromatographic strip for α-thalassemia screening: A multicenter study
Authors: Pranee Winichagoon
Pornnapa Kumpan
Paula Holmes
Jill Finlayson
Christopher Newbound
Arnold Kabral
Benjamin Li
Manit Nuinoon
Terry Fawcett
Chatchai Tayapiwatana
Watchara Kasinrerk
Suthat Fucharoen
Mahidol University
University of Western Australia
Keywords: Medicine
Issue Date: 1-Jun-2015
Citation: Translational Research. Vol.165, No.6 (2015), 689-695
Abstract: © 2015 Elsevier Inc. All rights reserved. α0-Thalassemia occurs from a deletion of 2 linked α-globin genes and interaction of these defective genes leads to hemoglobin (Hb) Bart's hydrops fetalis, the most severe and lethal thalassemia syndrome. Identification of α0-thalassemia carriers is thus essential for the prevention and control program. An immunochromatographic (IC) strip test was developed for rapid screening of α0-thalassemia by testing for Hb Bart's in the blood samples using a specific monoclonal antibody against Hb Bart's. To evaluate its sensitivity and specificity, the IC strip test was assessed in a cohort with various thalassemia genotypes from 4 different laboratories in Thailand and Australia. The result showed 97% sensitivity in α-thalassemia carriers with 2 α-globin genes deletion and Hb H disease. This is, in particular, the useful rapid screening test for regions where β-thalassemia and homozygous Hb E are also common. Similar hematologic and Hb data make it impossible to address the concomitant inheritance of α0-thalassemia in these samples without polymerase chain reaction (PCR)-based techniques, leading to misdiagnosis of the risk of having Hb Bart's hydrops fetalis. However, α-globin genotyping should be carried out in samples with positive IC strip as positive reactivity was also observed in homozygous α+-thalassemia carriers who have 2 trans α-globin gene deletions. These results indicate that in combination with red blood cell indices, the IC strip test could rule out mass populations for further α0-thalassemia detection by PCR-based analysis. The Alpha Thal IC strip also has the potential to replace testing for Hb H inclusion bodies, as it appears to be more sensitive, specific, and less labor intensive.
ISSN: 18781810
Appears in Collections:Scopus 2011-2015

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