Recommendations for validation testing of home pregnancy tests (HPTs) in Europe.

Sturgeon, Catharine; Butler, Stephen A; Gould, Fiona; Johnson, Sarah; Rowlands, Sam; Stenman, Ulf-Håkan; Grenache, David G

Sturgeon, Catharine; Butler, Stephen A; Gould, Fiona; Johnson, Sarah; Rowlands, Sam; Stenman, Ulf-Håkan; Grenache, David G.

Afiliación

Sturgeon C; Department of Laboratory Medicine, UK National External Quality Assessment Service (UK NEQAS), Edinburgh, UK.
Butler SA; SAB Scientific Consultancy Ltd, Flitton, Bedfordshire, UK.
Gould F; Alere International, Bedford, UK.
Johnson S; Clinical Affairs, SPD Development Company Limited, Bedford, UK.
Rowlands S; Department of Medical Sciences & Public Health, Bournemouth University, Bournemouth, UK.
Stenman UH; Department of Clinical Chemistry and Haematology, University of Helsinki, Helsinki, Finland.
Grenache DG; TriCore Reference Laboratories, Albuquerque, NM, USA.

Clin Chem Lab Med ; 2021 Jan 26.

Article en En | MEDLINE | ID: mdl-33544509

Palabras clave

European Directive; home pregnancy tests; human chorionic gonadotrophin; in vitro diagnostic regulation; validation testing

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Guideline Idioma: En Revista: Clin Chem Lab Med Asunto de la revista: QUIMICA CLINICA / TECNICAS E PROCEDIMENTOS DE LABORATORIO Año: 2021 Tipo del documento: Article País de afiliación: Reino Unido

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