Good correlation between the Afinion AS100 analyser and the ABX Pentra 400 analyser for the measurement of glycosylated haemoglobin and lipid levels in older adults in Durban, South Africa

摘要

BACKGROUND: The Afinion AS100 analyser is a small bench-top, multi-assay, point-of-care (POC) analyser that is able to measure glycated haemoglobin (HbA1c) and lipid levels. OBJECTIVE: To assess performance of the Afinion analyser compared with a reference laboratory test for the measurement of HbA1c and lipid levels. METHOD: The study involved men and women enrolled in a cross-sectional study, Sexual health, HIV infection and comorbidity with non-communicable diseases among Older Persons (SHIOP), which was conducted from February to May 2016. Whole blood was drawn aseptically by a trained study nurse into a serum separator gel tube and an ethylenediaminetetra-acetic acid (EDTA) tube. The EDTA whole blood was used to measure HbA1c levels, and serum to measure total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglyceride levels. Lin's correlation coefficient was used to assess the agreement between the Afinion and ABX Pentra 400 analysers for each marker. RESULTS: A total of 435 older individuals were included in the study. The proportion of HbAlc results that were correctly classified by the Afinion analyser was 92.2%. Bland-Altman analysis and linear regression analysis showed a very good agreement (correlation concordance 0.89) between the two analysers for the measurement of HbAlc. The two-way scatter plot for TC showed a substantial correlation (0.80). However, a total of 69 cholesterol results that were within the normal range on the Pentra were misclassified as abnormal on the Afinion. The readings obtained for HDL-C levels with the Afinion were shown to be slightly overestimated when compared with the Pentra. However, correlation for HDL-C on the two analysers was 0.93, indicating an almost perfect agreement. Seventy-four LDL-C results were erroneously classified as abnormal on the Afinion but were within the normal range on the Pentra, resulting in a substantial correlation of 0.75. An excellent agreement was observed between triglyceride measurements (0.99). CONCLUSION: This study supports the use of the Afinion AS100 analyser in POC testing for the measurement of HbAlc, triglycerides and HDL-C in a South African setting.