Evaluation of the Quality of Commercial Control Materials and Homemade Lyophilized on Clinical Chemistry Parameters with the Sigma Metric Method
Downloads
Control materials are used to maintain the accuracy of testing procedures and the quality of laboratory results. However, commercial control materials are often considered less economical, so an alternative is needed, namely lyophilized human serum. Sigma metric helps improve laboratory operational costs efficiency through control settings and Westgard rule recommendations involving the Total Error Allowable (TEa) value, bias value (d%), and coefficient of variation (CV%). This study aims to determine the quality of commercial control materials and homemade lyophilized materials for blood glucose, uric acid, total cholesterol, and triglyceride parameters based on sigma values. This study used a comparative cross-sectional design. The samples included commercial control materials from one of the primary-level laboratories in Bangkalan District and homemade lyophilized samples from human serum collections. Data Analysis was conducted by statistically comparing the bias value and descriptively comparing the sigma value of commercial control material and homemade lyophilized. The results showed no significant difference in bias value between commercial control material and homemade lyophilized material for all parameters (significance value > α 0,05). The sigma values of commercial control material for blood glucose, uric acid, total cholesterol, and triglyceride parameters were 2.81 (poor), 2.41 (poor), 3.10 (marginal), and 2.14 (poor). The sigma values of the homemade lyophilized were 2.12 (poor), 1.76 (unacceptable), 3.36 (marginal), and 2.08 (poor). Based on the sigma values, the homemade lyophilized material was better for total cholesterol parameters, while the commercial control material was better for blood glucose, uric acid, and triglyceride parameters. It can be concluded that homemade lyophilized can be used as an alternative to commercial control materials, especially for total cholesterol parameters. These findings support the cost efficiency of laboratory operations through the development of more economical homemade lyophilized products that are suitable for use in laboratories.
Copyright (c) 2025 Maulida Azmi Wimasni Inah, Masdiva Putri Hidayah, Anik Handayati, Museyarohr, Lully Hanni Endarini, Edy Haryanto,(Author)
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-ShareAlikel 4.0 International (CC BY-SA 4.0) that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
