Comparison The Reference Ranges of Medical Laboratory Solution Manufacturers with Local Reference Ranges in Zliten City: A survey study

Abstract

Most of medical laboratories in Libya rely entirely on the default normal ranges provided by international manufacturers, without verifying their suitability to the physiological and environmental characteristics of the local community. This field survey aimed to assess the application and use of commercial reference values within medical laboratories in the Zliten region, identify the diagnostic packages most affected by local variations, and determine the level of awareness and support among medical staff for establishing independent national reference values.  The study employed a descriptive-analytical approach. A scientific questionnaire and a field survey were designed, involving a purposive sample of 65 technicians working in medical laboratories (both public and private) in Zliten. The data underwent descriptive and inferential analysis using the Statistical Package for the Social Sciences (SPSS), specifically cross-reference analysis and Fisher's Exact Test to match the expected frequency distribution in the sample. The statistical results showed a 100% consensus among laboratories regarding their adherence to and full compliance with the technical manuals of international importing companies such as Roche, Abbott, and Mindray. Inferential analysis revealed a very strong correlation (p < 0.001) between the workplace and the sensitivity to detecting physiological deviations; private sector practitioners demonstrated a higher awareness of detecting these variations compared to the public sector, which is subject to intense operational pressure. The complete blood count (CBC) was the most frequently performed test for detecting deviations, at 61.5%, and 84.6% of participants attributed these variations to the prevailing dietary patterns and lifestyle habits in the region. Finally, the proposal to establish local reference values received overwhelming support, at 92.3%. The study concludes that reliance on international company standards creates a potential diagnostic gap that does not accurately reflect the true biological reality of Libyan citizens. The study strongly recommends, in general and specifically to decision-makers in the Zliten health sector, the urgent adoption and implementation of a national project aimed at developing and establishing independent local reference standards that ensure diagnostic accuracy and protect patient safety.