| Zugriffsnummer | 46331 |
| Dokumenttyp | Zeitschriftenartikel |
| Peer Review | mit Peer Review |
| Sprache | Englisch |
| Titel | The performance of human cytomegalovirus digital PCR reference measurement procedure in seven external quality assessment schemes over four years |
| Autor(in); Institution |
Milavec, M.; Department of Biotechnology and Systems Biology, National Institute of Biology, Ljubljana, SLOVENIA
Pavsic, J.; Department of Biotechnology and Systems Biology, National Institute of Biology, Ljubljana, SLOVENIA
Bogozalec Kosir, A.; Department of Biotechnology and Systems Biology, National Institute of Biology, Ljubljana, SLOVENIA
Jones, G.; National Measurement Laboratory (NML), LGC, Teddington, UNITED KINGDOM
O'Sullivan, D.; National Measurement Laboratory (NML), LGC, Teddington, UNITED KINGDOM
Devonshire, A.; National Measurement Laboratory (NML), LGC, Teddington, UNITED KINGDOM
Van Heuverswyn, F.; European Commission, Joint Research Centre (JRC), Geel, BELGIUM
Karczmarczyk, M.; European Commission, Joint Research Centre (JRC), Geel, BELGIUM
Neeb, Jannika; 8.3, Biomedizinische Optik, PTB-Berlin
Plauth, Annabell; 8.3, Biomedizinische Optik, PTB-Berlin
Corbisier, P.; European Commission, Joint Research Centre (JRC), Geel, BELGIUM
Schimmel, H.; European Commission, Joint Research Centre (JRC), Geel, BELGIUM
Kummrow, Andreas; 8.3, Biomedizinische Optik, PTB-Berlin
Neukammer, Jörg; 8.3, Biomedizinische Optik, PTB-Berlin
Foy, C.; National Measurement Laboratory (NML), LGC, Teddington, UNITED KINGDOM
Kammel, M.; INSTAND, Gesellschaft zur Foerderung der Qualitaetssicherung in medizinischen Laboratorien e.V., Düsseldorf, GERMANY
Zeichhardt, H.; INSTAND, Gesellschaft zur Foerderung der Qualitaetssicherung in medizinischen Laboratorien e.V., Düsseldorf, GERMANY
Grunert, H.P.; GBD Gesellschaft fuer Biotechnologische Diagnostik mbH, Berlin, GERMANY
Huggett, J.; National Measurement Laboratory (NML), LGC, Teddington, UNITED KINGDOM
|
| Quelle/Jahr | Methods: 201 (2022), 65 - 73 |
| ISSN | 1046-2023 (PRINT) ; 1095-9130 (ONLINE) |
| DOI | |
| Verlag | Amsterdam: Elsevier |
| Freie Schlagworte | Digital PCR ; Human immunodeficiency virus type 1 ; External quality assessment ; Reverse transcriptase digital PCR |
| Zusammenfassung | A candidate digital PCR (dPCR)-based reference measurement procedure for quantification of human cytomegalovirus (hCMV) was evaluated in 10 viral load comparison schemes (seven external quality assessment (EQA) and three additional training schemes) organized by INSTAND e.V. over four years (between September 2014 and March 2018). Four metrology institutes participated in these schemes using the same extraction method and dPCR measurement procedure for the hCMV specific target sequence of UL54 gene. The calibration independent reference measurement procedure results from the metrology institutes were compared to the results of the clinical diagnostic laboratories applying hCMV qPCR measurement procedures calibrated to reference materials. While the criteria for the acceptable deviation from the target value interval for INSTAND’s EQA schemes is from −0.8 log10 to +0.8 log10, the majority of dPCR results were between −0.2 log10 to +0.2 log10. Only 4 out of 45 results exceeded this interval with the maximum deviation of −0.542 log10. In the training schemes containing samples with lower hCMV concentrations, more than half of the results deviated less than ±0.2 log10 from the target value, while more than 95% deviated less than ±0.4 log10 from the target value. Evaluation of intra- and inter-laboratory variation of dPCR results confirmed high reproducibility and trueness of the method. This work demonstrates that dPCR has the potential to act as a calibration independent reference measurement procedure for the value assignment of hCMV calibration and reference materials to support qPCR calibration as well as ultimately for routine hCMV load testing. |
| Kostenfreier Zugang | Open Access Hybrid |
| Rechteinformation | CC BY 4.0 ; Creative Commons Attribution 4.0 License |
| Themenbereich der Metrologie | Metrologie in der Medizin |
Zitierung
Milavec, M., Pavsic, J., Bogozalec Kosir, A., Jones, G., O'Sullivan, D., Devonshire, A., Van Heuverswyn, F., Karczmarczyk, M., Neeb, J., Plauth, A., Corbisier, P., Schimmel, H., Kummrow, A., Neukammer, J., Foy, C., Kammel, M., Zeichhardt, H., Grunert, H., & Huggett, J. (2022). The performance of human cytomegalovirus digital PCR reference measurement procedure in seven external quality assessment schemes over four years. Methods, 201, 65–73. https://doi.org/10.1016/j.ymeth.2021.03.016