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

Sturgeon, C., Butler, S.A., Gould, F., Johnson, S., Rowlands, S., Stenman, U-H. and Grenache, D.G., 2021. Recommendations for validation testing of home pregnancy tests (HPTs) in Europe. Clinical Chemistry and Laboratory Medicine, 59 (5), 823-835.

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DOI: 10.1515/cclm-2020-1523

Abstract

Home pregnancy tests (HPTs) available in Europe include accuracy and other performance claims listed on their packaging. Due to the lack of guidance on the standardisation of such products, it is often difficult to replicate these claims when tested on a clinical sample, whether in a laboratory setting or by lay users. The In Vitro Diagnostic Regulation is a set of requirements that mandate comprehensive validation data on human pregnancy tests and other in vitro devices. It is due to replace the current European Directive (98/79/EC) and fully implemented in Europe by 2022. In June 2019, a panel of seven experts convened to discuss the validation studies required to provide the information needed to meet the new regulation for HPTs in Europe and proposed 15 recommendations for best practice. Defining best practice at all stages of validation of these important tests may ensure that tests marketed in Europe are fit for purpose, enabling lay users to be confident of the high quality of the HPT results they obtain. The panelists believe that the recommendations proposed here for the validation of HPTs may constructively contribute to improved standardisation of validation procedures in Europe.

Item Type:Article
ISSN:1437-4331
Additional Information:The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2020-1523).
Uncontrolled Keywords:European Directive ; home pregnancy tests ; human chorionic gonadotrophin ; in vitro diagnostic regulation ; validation testing
Group:Faculty of Health & Social Sciences
ID Code:35164
Deposited By: Unnamed user with email symplectic@symplectic
Deposited On:08 Feb 2021 12:14
Last Modified:27 May 2021 07:54

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