Author:
Sluimer John,van den Akker Willem M. R.,Goderski Gabriel,Swart Arno,van der Veer Bas,Cremer Jeroen,Chung Ngoc Hoa,Molenkamp Richard,Voermans Jolanda,Guldemeester Judith,van der Eijk Annemiek,de Jong Menno D.,Mithoe Glen,Hermans Mirjam H. A.,de Beer Jessica L.,Wessels Els,von Wintersdorff Christian,Pas Suzan,Verweij Jaco J.,Melchers Willem J. G.,van de Bovenkamp Jeroen H. B.,Vahidnia Ali,Gard Lilli,Schuurman Rob,Wintermans Bas,Leversteijn-van Hall Maurine,Smits Paul,de Groot Theun,Deiman Birgit A. L. M.,Bart Aldert,van der Reijden Wil,Svraka-Latifovic Sanela,van der Zanden Adri G. M.,Thijsen Steven,Schubbert Rainer,Dreesens Lisa L.,van Duijn Gert,Ong David S. Y.,Oostra Monique,Bruisten Sylvia,van Trijp Marijke,Pettersson Annika,van Burgel Nathalie D.,Oudbier Joke,van der Linden Michael,van Rijn Michiel,Bos Martine P.,Rossen John,Schuurs Theo A.,Grosser Roger,Smit Pieter,Nijhuis Roel H. T.,Rozemeijer Wouter,van de Laar Thijs,Scheepers Theodoor M. M.,Smeets Leonard C.,Flipse Jacky,de Leeuw Bertie,Dijkman Remco,van Maarseveen Noortje,Koppelman Marco,Postma Bent,van Hannen Erik J.,Thai Khoa,Braun Kathrin,Schepers Raf J. F.,Henning Jana,van Hees Eva R.,Tacken Mirriam G. J.,Mol Jaqueline,Heddema Edou R.,Eggink Dirk,Presser Lance D.,Meijer Adam,
Abstract
AbstractA two-step strategy combining assisted benchmark testing (entry controls) and External Quality Assessments (EQAs) with blinded simulated clinical specimens to enhance and maintain the quality of nucleic acid amplification testing was developed. This strategy was successfully applied to 71 diagnostic laboratories in The Netherlands when upscaling the national diagnostic capacity during the SARS-CoV-2 pandemic. The availability of benchmark testing in combination with advice for improvement substantially enhanced the quality of the laboratory testing procedures for SARS-CoV-2 detection. The three subsequent EQA rounds demonstrated high quality testing with regard to specificity (99.6% correctly identified) and sensitivity (93.3% correctly identified). Even with the implementation of novel assays, changing workflows using diverse equipment and a high degree of assay heterogeneity, the overall high quality was maintained using this two-step strategy. We show that in contrast to the limited value of Cq value for absolute proxies of viral load, these Cq values can, in combination with metadata on strategies and techniques, provide valuable information for laboratories to improve their procedures. In conclusion, our two-step strategy (preparation phase followed by a series of EQAs) is a rapid and flexible system capable of scaling, improving, and maintaining high quality diagnostics even in a rapidly evolving (e.g. pandemic) situation.
Funder
Ministerie van Volksgezondheid, Welzijn en Sport
Publisher
Springer Science and Business Media LLC