Improving Diagnostic Accuracy in Clinical Chemistry: Evaluation of Pre-Analytical and Analytical Errors in Resource-Limited Laboratories of Developing and Underdeveloped Countries

Abstract

Clinical chemistry laboratories generate a large share of the data on which clinical decisions ultimately rest, so the accuracy of that data has a direct bearing on patient safety. In resource-limited settings—those typical of low- and middle-income countries (LMICs), including many developing and underdeveloped nations—the diagnostic value of laboratory results is frequently undermined by pre-analytical and analytical errors that occur at rates well above those documented in better-resourced health systems. This critical review draws together published evidence from January 2010 to February 2026 to examine the nature, distribution, and consequences of these errors, and to weigh the evidence behind strategies proposed to reduce them. Pre-analytical errors, encompassing failures in patient preparation, specimen collection, labelling, transport, and storage, consistently make up the largest share of laboratory errors worldwide, and they are especially common in LMIC laboratories, where standardised phlebotomy practice, reliable cold-chain infrastructure, and electronic patient identification remain the exception rather than the rule. Analytical errors, for their part, stem from weak internal quality control, infrequent participation in external quality assurance schemes, calibration failures, unstable reagents, and gaps in staff competency. Both categories of error carry well-documented consequences, including misdiagnosis, delayed or inappropriate treatment, antimicrobial misuse, and excess mortality. Underlying these problems are structural factors that are not easily fixed in the short term: chronic underfunding, workforce shortages, unreliable electricity and water supplies, and weak regulatory oversight. The strategies considered here—staged implementation of quality management systems aligned with ISO 15189, targeted deployment of point-of-care testing, adoption of laboratory information systems, and training programmes tailored to local constraints—offer a realistic, if incremental, path forward. The synthesis presented is intended to inform laboratory policy, quality improvement programmes, and future research priorities in low-resource settings.