Med. Weter. 82 (3), 111-127, 2026
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| ABDÜLKERİM DENİZ, AYTAÇ PEKMEZCİ |
| Methods for the validation and verification of the diagnostic performance ... |
| Studies on the validation and diagnostic accuracy of portable electronic point-of-care analyzers (POCAs) are now widespread. These are easy-to-use, portable devices that can provide reliable and rapid on-site diagnosis in humans and animals once their accuracy has been proven. Various POCAs have been tested for analyzing the concentrations of beta-hydroxybutyrate (BHB), calcium (Ca), and glucose in blood to diagnose subclinical ketosis and hypocalcemia, which are metabolic diseases in dairy cows that significantly impact the agricultural economy. The biological, external, and qualitative factors that affect the validation and diagnostic accuracy of POCAs include the anatomical site of blood sampling, the use of anticoagulants, the type of blood sample, measurement conditions (such as environmental and human factors), the precision of the analyzers, as well as statistical analysis and its interpretation. Studies on the diagnostic accuracy and validation of POCAs require appropriate methods and statistical analyses of data. POCAs can be compared with the gold standard reference method in terms of agreement and diagnostic performance based on certain key parameters, such as mean bias, limits of bias, total error, coefficient of variation between tests, systematic constant and proportional error, area under the curve, specificity, sensitivity, positive predictive value, and negative predictive value. However, some inconsistencies and variations have been noted, as data reporting and interpretation differ from one study to another. This critical narrative review article provides an insight into the methods used to validate and verify the diagnostic accuracy of portable electronic POCAs by considering factors that influence the results of the analyses, such as external, biological, methodological, and statistical factors. It also summarized the results of studies on the validation and diagnostic accuracy of POCAs by analyzing BHB, Ca, and glucose in the blood of dairy cows for the diagnosis of subclinical ketosis and hypocalcemia. |
| Key-words: point-of-care analyzers, subclinical ketosis, subclinical hypocalcemia, validation, diagnostic accuracy |