Comparison of the Automatic Non-invasive Express Screening Analyser (ANESA)® for Clinical Analytical Parameters

Abstract

Background: The objective we evaluated the reliability of some haematological and biochemical parameters performed by a non-invasive auto-analyser (ANESA) with those obtained by the standard method of venipuncture (reference method) in patients who went to the clinical analysis laboratory (Municipal-Hospital of Badalona, Spain). Methods: A transversal, comparative and parallel (paired) study was carried out. Two methods of study were practiced for the same subject: a) the reference method of venipuncture (conventional clinical analysis) and b) placement of sensors (comparison method: ANESA device). Consecutive patients older than 18 years, who met certain criteria for inclusion were included in the study during an 8 week period in 2014. The parameters studied were: haemogram (7), glucose, lipids (4), transaminases (2), bilirubin, creatinine and urea. Statistical analysis compared averages for paired groups and reliability of the obtained observations (method: intraclass-correlation coefficient (ICC); individual differences: Bland–Altman method), p<0.05. Results: A total of 195 patients were involved, with an average age of 50.8 years; 65.2% were women. In paired comparisons, cholesterol (185.4 vs. 179.8; difference: 5.6 mg/dL; p=0.005), cLDL (95.9 vs. 100.5; difference: −4.6 mg/dL; p=0.002) and bilirubin (0.6 vs. 0.5; difference: 0.1 mg/dL; p<0.001) obtained more modest results. Erythrocytes, haemoglobin, haematocrit, platelets, leukocytes, glucose, cHDL, triglycerides, ALT, AST, creatinine and urea reached an ICC>0.90. Lipid parameters (cholesterol: ICC=0.728; cLDL: ICC=0.817) obtained a moderate correlation, whereas lymphocytes (ICC=0.551) and monocytes (ICC=0.546) reached discrete results. Conclusions: Despite of the study limitations, the automatic non-invasive analyser (ANESA) is shown as a reliable and promising screening method in usual clinical practice for most of the analyzed parameters as an alternative to standard blood extraction. However, more studies are required to strengthen the consistency of the results.