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Article: Development and validation of a ζ-globin-specific ELISA for carrier screening of the (--SEA) α thalassaemia deletion

TitleDevelopment and validation of a ζ-globin-specific ELISA for carrier screening of the (--SEA) α thalassaemia deletion
Authors
Issue Date2009
Citation
Journal of Clinical Pathology, 2009, v. 62, n. 2, p. 147-151 How to Cite?
AbstractAims: The Southeast Asian (SEA) deletion (--SEA) represents the most common determinant causing α thalassaemia in Southeast Asian countries. The embryonic ζ-globin chain has been defined as a marker for the detection of this deletion in adults. The aim of this study was to develop an appropriate low-cost ELISA for ζ-globin chain detection as a routine screening test for (--SEA) a thalassaemia deletion. Methods: A sandwich ELISA system for ζ-globin chains was established with a pair of ζ-globin-specific monoclonal antibodies prepared in-house, and locally made products. Against a gap-PCR method that was taken as the standard, this assay was validated in a cohort study testing a total of 526 individuals comprising patients scheduled for haemoglobinopathy diagnostic analysis and normal individuals. Routine screening of the (--SEA) deletion in 300 random student volunteers was conducted using the assay. Results: While the cut-off point was set at a percentage positive value of 30, the sensitivity and specificity of this ELISA method were 100% and 99.24%, respectively. The mean intra-assay and inter-assay coefficients of variation among the different concentrations in the optimised ELISA conditions were 2.1-11.4% and 4.3-13.2%, respectively. Seventeen of the 300 volunteers sampled were determined by the ELISA to have the (--SEA) deletion; these results were in 100% agreement with the gap-PCR results. Conclusions: This study validates the ELISA method described here as a simple, rapid and cost-effective assay that is potentially adaptable for application in large-scale population screening for this prevalent disorder in SEA areas such as southern China.
Persistent Identifierhttp://hdl.handle.net/10722/207910
ISSN
2023 Impact Factor: 2.5
2023 SCImago Journal Rankings: 0.934
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorTang, L-
dc.contributor.authorZhu, P-
dc.contributor.authorZhou, WJ-
dc.contributor.authorZheng, J-
dc.contributor.authorZhou, YQ-
dc.contributor.authorFu, N-
dc.contributor.authorXu, XM-
dc.date.accessioned2015-01-26T11:46:42Z-
dc.date.available2015-01-26T11:46:42Z-
dc.date.issued2009-
dc.identifier.citationJournal of Clinical Pathology, 2009, v. 62, n. 2, p. 147-151-
dc.identifier.issn0021-9746-
dc.identifier.urihttp://hdl.handle.net/10722/207910-
dc.description.abstractAims: The Southeast Asian (SEA) deletion (--SEA) represents the most common determinant causing α thalassaemia in Southeast Asian countries. The embryonic ζ-globin chain has been defined as a marker for the detection of this deletion in adults. The aim of this study was to develop an appropriate low-cost ELISA for ζ-globin chain detection as a routine screening test for (--SEA) a thalassaemia deletion. Methods: A sandwich ELISA system for ζ-globin chains was established with a pair of ζ-globin-specific monoclonal antibodies prepared in-house, and locally made products. Against a gap-PCR method that was taken as the standard, this assay was validated in a cohort study testing a total of 526 individuals comprising patients scheduled for haemoglobinopathy diagnostic analysis and normal individuals. Routine screening of the (--SEA) deletion in 300 random student volunteers was conducted using the assay. Results: While the cut-off point was set at a percentage positive value of 30, the sensitivity and specificity of this ELISA method were 100% and 99.24%, respectively. The mean intra-assay and inter-assay coefficients of variation among the different concentrations in the optimised ELISA conditions were 2.1-11.4% and 4.3-13.2%, respectively. Seventeen of the 300 volunteers sampled were determined by the ELISA to have the (--SEA) deletion; these results were in 100% agreement with the gap-PCR results. Conclusions: This study validates the ELISA method described here as a simple, rapid and cost-effective assay that is potentially adaptable for application in large-scale population screening for this prevalent disorder in SEA areas such as southern China.-
dc.languageeng-
dc.relation.ispartofJournal of Clinical Pathology-
dc.titleDevelopment and validation of a ζ-globin-specific ELISA for carrier screening of the (--SEA) α thalassaemia deletion-
dc.typeArticle-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1136/jcp.2008.059477-
dc.identifier.pmid19181632-
dc.identifier.scopuseid_2-s2.0-61449163023-
dc.identifier.volume62-
dc.identifier.issue2-
dc.identifier.spage147-
dc.identifier.epage151-
dc.identifier.eissn1472-4146-
dc.identifier.isiWOS:000262918400008-
dc.identifier.issnl0021-9746-

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