Dual Analyte Immunoassay in Neural Tube Defect and Down's Syndrome Screening: Results of a Multicentre Clinical Trial
| Autor: | H M Barbour, J Doran, Peter J. Wood, Rob Anderson, D. J. Worthington, R Wilmot, E.J. Coombes, J A Crossley, James N. Macri, E Berry, Kevin Spencer, D A Aitken, M Stroud |
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| Rok vydání: | 1993 |
| Předmět: |
Adult
030213 general clinical medicine Analyte medicine.medical_specialty Adolescent Clinical Biochemistry Enzyme immunoassay method 030209 endocrinology & metabolism Chorionic Gonadotropin Immunoenzyme Techniques 03 medical and health sciences 0302 clinical medicine Bias Pregnancy Prenatal Diagnosis Humans Medicine Neural Tube Defects Chromatography S syndrome Neural tube defect medicine.diagnostic_test business.industry Early gestation Reproducibility of Results General Medicine Middle Aged medicine.disease Surgery Clinical trial Technical performance Immunoassay Female alpha-Fetoproteins Down Syndrome business Biomarkers |
| Zdroj: | Annals of Clinical Biochemistry: International Journal of Laboratory Medicine. 30:394-401 |
| ISSN: | 1758-1001 0004-5632 |
| Popis: | We report a multicentre clinical field trial of a novel dual analyte enzyme immunoassay method for the simultaneous measurement of alpha-fetoprotein (AFP) and free β-human choriogonadotropin (hCG) in the same microtitre well. The assay was shown to have good technical performance in the hands of all trial centres, with between assay coefficients of variation better than 10% for both analytes across the whole of the assay ranges. The method compared well with single analyte measuring procedures and produced acceptable performance as judged by external quality assurance criteria. Recovery of added analyte and analyte dilution curves also showed acceptable performance. In clinical evaluation of a large set of neural tube defect cases, good clinical discrimination from unaffected cases was observed using APP. With over 150 Down's syndrome cases, the combination of AFP and free (3 hCG confirmed the high detection rates achievable using this marker combination, with detection rates in excess of 70% in early gestation. We conclude that the combination of clinically superior markers coupled with technologically innovative assay design will lead to more efficient Down's screening programmes. |
| Databáze: | OpenAIRE |
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