EVALUATION OF ANALYTICAL PERFORMANCE OF RAPID DIAGNOSTIC TEST KITS FOR BLOOD GROUPINGS

Abstract

Purpose: This study aimed to determine the analytical performance of ABO and Rh D rapid diagnostic test kits as a substitute for the conventional tube method. Design/Methodology/Approach: 161 participants who visited the Koforidua Technical University Clinic Laboratory were recruited from August to September 2022. The rapid diagnostic ABO and Rh D test kits were used to determine the ABO and Rh D blood groups of the study participants. The concordance rate, kappa analysis and Receiver Operating Characteristics (ROC) were performed. Findings: The strength of agreement of the two diagnostic methods in detecting ABO and Rh D blood type using Kappa analyses was excellent (k꞊1.00; standard error꞊0.00; P-value=0.001). All diagnostic performance statistics of the RDT were not different from the tube method being the standard. Research Limitation: This research focused on the analytical performance of the rapid test kits but not on different brands of the test kits for their comparative studies. Practical Implication: This paper could potentially ensure reliable results, facilitate certification, and enable test kits to be accepted in the market. Social Implication: This study will assist policy-makers in increasing access to healthcare to enable testing in resource-limited settings and improving health outcomes as timely diagnosis and management facilitate better patient outcomes. Originality/ Value: This study is based on providing reliable information on portable and point of-care diagnostic testing outside conventional laboratory settings for timely diagnosis.