Evaluation of Analytical Performance of Rapid Diagnostic Test Kits for Blood Groupings
DOI:
https://doi.org/10.26437/ajar.v10i2.808Keywords:
Blood group.detection. performance. rapid diagnostic test. rhesus factor.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.
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