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Abstract
Introduction: Health technology assessment (HTA) of medical devices is challenging. Despite being an area with technologies that can be expensive for the health system, little is said about HTA in relation to equipment and reagents for laboratory use. Objectives: To identify what has been published in the scientific literature, in the last ten years, about the HTA use in decision making in clinical laboratories. Methods: It consists of a systematic review in which PubMed and BVS/ Lilacs databases were used. After the initial screening, full texts were evaluated, followed by an assessment of the risks of bias and discussion of the results. Results: 15 articles were included in this systematic review. 80.0% were HTA reports and 20.0% were original articles; 86.7% were concentrated between 2014 and 2017; and the United Kingdom was the country with the most published data (66.7%). This review showed a high heterogeneity in terms of evaluated technology; the only technology that was evaluated in more than one study was the interferon-gamma release assay (IGRA). Three papers did not present technologies for comparison. Several included documents concluded that they did not find sufficient evidence or data proved to be with a high degree of uncertainty to make any recommendations. Conclusions: HTA in clinical laboratory is still a little explored niche, and much can be done to improve the service of clinical analysis.
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