Evaluation of the point of care Afinion AS100 analyser in a community setting

Abstract

Background A 'one stop shop' model for multifactorial risk factor management in a culturally sensitive environment may improve cardiovascular disease and diabetes prevention. A full biochemical profile for cardiovascular disease risk assessment includes a lipid profile, glucose, glycated haemoglobin and urine albumin creatinine ratio measurements. This may require the use of more than one point of care testing instrument. Methods Individuals who attended a community cardiovascular disease risk screening or an audit programme of the diabetic care pathway in the community were sampled. Bland-Altman and Deming regression plots were used to assess agreement between methods for total cholesterol, high-density lipoprotein cholesterol, triglycerides, glycated haemoglobin and urine albumin creatinine ratio. Results There was good agreement between the Afinion AS100 analyser, Cholestech LDX and the laboratory methods for total cholesterol, high-density lipoprotein cholesterol and triglycerides ( n = 232). The Afinion AS100 agreed well with the laboratory method for glycated haemoglobin ( n = 255) and urine albumin creatinine ratio ( n = 176). There was statistically significant bias ( p = 0.03 to <0.0001) for several measurements. However, these were judged not to be clinically relevant. Specifically for the total cholesterol and high-density lipoprotein cholesterol values, we obtained good agreement (weighted kappa: 0.91 and 0.94 for the Afinion AS100 vs. Cholestech LDX and Afinion AS100 vs. laboratory method, respectively) for cardiovascular disease risk calculation using QRISK2. Conclusions Point of care testing can support a 'one stop shop' approach by providing rapid, reliable results. The Afinion AS100 analyser provides a multi-analyte platform and compares well with laboratory-based methods and another well-established point of care testing analyser.

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

“…Our study is one of two suggesting that the Afinion is an acceptable POC tool for the measurement of lipids. Our findings support those of Jain et al, [5] who compared the Afinion with the Cholestech LDX for the measurement of TC, HDL-C and triglyceride levels. The Afinion was shown to meet the performance criteria recommended by the National Education Cholestrol Program in the UK for TC and HDL-C measurements.…”

“…In the present study, the researchers also found that the Afinion detected HbA1c levels that were above target levels. Similar findings were reported by Jain et al, [5] with the Afinion being shown to overestimate HbA1c levels for certain samples. However, similar to the present study, the overestimation did not affect the overall diagnostic performance of the instrument.…”

“…[4] Measurement of HbA1c levels using POC tests provides rapid results, improving patient management. [4][5][6] Findings from a randomised controlled trial of POC testing in an Australian setting showed that POC tests of samples from patients with established hyperlipidaemia or established type 1 or type 2 DM, or taking anticoagulant therapy, had the same clinical effectiveness as testing in a pathology laboratory. [7] Reports have also shown that access to a POC test is associated with improved treatment adherence.…”

“…At high HbA1c levels, the DCA tended to read lower than HPLC, but the Afinion's accuracy did not vary according to HbA1c. [18] Jain et al [5] evaluated the performance of the Afinion in a DM and CVD screening programme. In this study, the Afinion and the reference laboratory method identified similar numbers of new patients with suspected DM.…”

“…The Afinion is still recommended as a useful screening instrument for DM in a community setting, but diagnosis needs to be confirmed by an NGSP-certified method. [5] In SA, since the prevalence of familial hypercholesterolaemia is as high as 1 in 100 in some communities, ideally everyone should undergo a full lipogram, or at minimum TC/LDL-C measurement, at least once in young adulthood (from 20 years of age). [3] Although the measurement of lipids in the blood is a widely accepted biochemical marker for cardiovascular risk assessment and management in primary healthcare, [19,20] testing performed in hospital laboratories may result in excess travel for the patient, sample loss and repeat clinic visits.…”