Molecular Genetic Testing in the United States: Comparison with International Practice
| Autor: | Ira M. Lubin, Joe Boone, Margaret M. McGovern, Elettra Ronchi, Rob Elles |
|---|---|
| Rok vydání: | 2008 |
| Předmět: |
Quality Control
medicine.medical_specialty Asia media_common.quotation_subject Accreditation Environmental protection Medical Laboratory Personnel medicine Humans Quality (business) Genetic Testing Genetics (clinical) media_common Protocol (science) Response rate (survey) Internet Informed Consent business.industry Data Collection Molecular genetic testing International Agencies United States Test (assessment) Europe Molecular Diagnostic Techniques Family medicine North America Laboratories business Quality assurance Confidentiality |
| Zdroj: | Genetic Testing. 12:187-193 |
| ISSN: | 1557-7473 1090-6576 |
| DOI: | 10.1089/gte.2007.0087 |
| Popis: | To compare data on the practices of molecular genetic testing (MGT) in laboratories in the United States with those in 18 other countries.A Web-based survey of MGT laboratory directors (n = 827; response rate 63%) in 18 countries on three continents was carried out, and the response from U.S. laboratories compared to all others. Quality assurance and reporting indices were developed and calculated for each responding laboratory.A comparison of U.S. results with all other countries identified differences in laboratory setting, personnel qualifications, and the specific tests being offered, but similar rates of adherence to MGT quality standards and reporting practices were found. The survey also documented substantial transborder flow of specimens, most commonly due to the lack of availability of the test in the United States or because the test was available only through a research protocol, highlighting the need for common reporting and practice guidelines for the international MGT community.The findings presented here provide further support for the need to consider the application of the Organisation for Economic Cooperation and Development (OECD) Guidelines and the establishment of compatible accreditation programs or equivalent mechanisms across national borders to ensure the quality of laboratory services and the clinical usefulness of molecular genetic test reports for referred specimens. |
| Databáze: | OpenAIRE |
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