TY - JOUR
T1 - High quality of SARS-CoV-2 molecular diagnostics in a diverse laboratory landscape through supported benchmark testing and External Quality Assessment
AU - Sluimer, John
AU - van den Akker, Willem M.R.
AU - Goderski, Gabriel
AU - Swart, Arno
AU - van der Veer, Bas
AU - Cremer, Jeroen
AU - Chung, Ngoc Hoa
AU - Molenkamp, Richard
AU - Voermans, Jolanda
AU - Guldemeester, Judith
AU - van der Eijk, Annemiek
AU - de Jong, Menno D.
AU - Mithoe, Glen
AU - Hermans, Mirjam H.A.
AU - de Beer, Jessica L.
AU - Wessels, Els
AU - von Wintersdorff, Christian
AU - Pas, Suzan
AU - Verweij, Jaco J.
AU - Melchers, Willem J.G.
AU - van de Bovenkamp, Jeroen H.B.
AU - Vahidnia, Ali
AU - Gard, Lilli
AU - Schuurman, Rob
AU - Wintermans, Bas
AU - Leversteijn-van Hall, Maurine
AU - Smits, Paul
AU - de Groot, Theun
AU - Deiman, Birgit A.L.M.
AU - Bart, Aldert
AU - van der Reijden, Wil
AU - Svraka-Latifovic, Sanela
AU - van der Zanden, Adri G.M.
AU - Thijsen, Steven
AU - Schubbert, Rainer
AU - Dreesens, Lisa L.
AU - van Duijn, Gert
AU - Ong, David S.Y.
AU - Oostra, Monique
AU - Bruisten, Sylvia
AU - van Trijp, Marijke
AU - Pettersson, Annika
AU - van Burgel, Nathalie D.
AU - Oudbier, Joke
AU - van der Linden, Michael
AU - van Rijn, Michiel
AU - Bos, Martine P.
AU - Rossen, John
AU - Schuurs, Theo A.
AU - Grosser, Roger
AU - Working Group SARS-CoV-2 Diagnostics The Netherlands
N1 - Funding Information:
The technicians of the RIVM (Lisa Wijsman, Sharon van den Brink, Barbara Favié, Annemarie van den Brandt) and Erasmus MC (Daphne Mulders) are thanked for skilfully evaluating the testing material. We would also like to thank Bart Haagmans (Erasmus MC) and Lia van der Hoek (Amsterdam University Medical Hospital) for supplying us with material with which our panels were made. We would also like to thank Pleunie van Alphen (PAMM), Greet Boland, Anne Wensing, Martin Rakke, Edwin Fries (UMCU), Roy Masius, Anne Vogel, Anco Molijn (Eurofins NMDL-LCPL), Roland Doorn (Tergooi MC, CBSL), Martijn Mostert (Diakonessenhuis Utrecht), Patricia Glasius (Noordwest Ziekenhuisgroep Alkmaar), Caroline M.A. Swanink, Angelino T. Tromp (Rijnstate Velp), Kelly Mertens, Nico van Lisdonk, Cindy Houwen (Star-SHL) and Stefan Küchler (SYNLAB Jena ONCOSCREEN) for their contributions to the datasets sent by the Working Group SARS-CoV-2 Diagnostics The Netherlands. This investigation was performed by order, and for the account, of the Ministry of Health, Welfare and Sport, project number V/190028/22/PR.
Publisher Copyright:
© 2024, The Author(s).
PY - 2024/12/1
Y1 - 2024/12/1
N2 - A 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.
AB - A 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.
U2 - 10.1038/s41598-023-50912-9
DO - 10.1038/s41598-023-50912-9
M3 - Article
SN - 2045-2322
VL - 14
JO - Scientific Reports
JF - Scientific Reports
IS - 1
M1 - 1378
ER -