Performance evaluation of immunoassay methods using innovative Westgard method decision chart/six sigma: metric tool

Ani Toboc; Cristina Stan; Andrada-Cătălina Stănescu; Mihai Ionică

doi:10.1117/12.2324859

31 December 2018 Performance evaluation of immunoassay methods using innovative Westgard method decision chart/six sigma: metric tool

Ani Toboc, Cristina Stan, Andrada-Cătălina Stănescu, Mihai Ionică

Author Affiliations +

Proceedings Volume 10977, Advanced Topics in Optoelectronics, Microelectronics, and Nanotechnologies IX; 109773L (2018) https://doi.org/10.1117/12.2324859
Event: Advanced Topics in Optoelectronics, Microelectronics and Nanotechnologies IX, 2018, Constanta, Romania

Abstract

Our research team is seeking to implement new ways to validate the performance of the biomedical optoelectronic analytical instruments used in Doping Control Laboratory (DCL). The compliance of the instrumental method with international standard of laboratory (ISL) and technical documents (TD) of World Anti-Doping Agency (WADA) is critical in quality assurance, providing precise and accurate results.

The performance level achieved using the innovative method “decision chart” based on “six sigma metric” tool applied to the immunoassay analyses of luteinizing (LH) and chorionic gonadotropin (hCG) hormones, proves the excellent respectively good quality of the testing process, which meet our set goal - performance higher than 4-sigma level.

Using six sigma metric tool, our laboratory was able not only to evaluate performance of our instrumental methods, but also to implement changes to our quality control (QC) charts, to reduce number of internal QCs and calibration expenses as well as reducing troubleshooting.

In order to establish a continuous quality control improvement, verifying the implementation of our quality goals, the quality manager can evaluate analytical performance based on analytical QC data and update the Westgard quality charts.

Citation Download Citation

Ani Toboc, Cristina Stan, Andrada-Cătălina Stănescu, and Mihai Ionică "Performance evaluation of immunoassay methods using innovative Westgard method decision chart/six sigma: metric tool", Proc. SPIE 10977, Advanced Topics in Optoelectronics, Microelectronics, and Nanotechnologies IX, 109773L (31 December 2018); https://doi.org/10.1117/12.2324859

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