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Evaluation of a Point-of-Care Testing Analyzer for Measuring Peripheral Blood Leukocytes
Published on: March 22, 2022
Assessing the accuracy of a point-of-care analyzer for hyperlipidaemia in western Kenya
Paul H Park1, Patrick Chege2, Isabel C Hagedorn3
1Duke Global Health Institute, Duke University, Durham, NC, USA.
Insights
The CardioChek PA device is inaccurate for measuring cholesterol levels in Kenya, misclassifying patients and posing risks. Validation of diagnostic tools is crucial before widespread use in new settings.
Area of Science:
- Clinical diagnostics
- Point-of-care testing
- Public health in low- and middle-income countries
Background:
- Hyperlipidaemia prevalence is increasing in low- and middle-income countries.
- Point-of-care devices like CardioChek PA aim to improve diagnostics by providing rapid results.
- Validation of such devices in local settings is essential.
Purpose of the Study:
- To assess the accuracy of the CardioChek PA device for lipid measurement in Kenya.
- To compare CardioChek PA results against the gold standard laboratory testing.
- To evaluate the risk of misclassification due to device inaccuracy.
Main Methods:
- 246 adult subjects in Webuye, Kenya, provided two blood samples.
- Lipid levels were measured simultaneously using CardioChek PA and laboratory methods.
- Accuracy was assessed using US National Institutes of Health (NIH) per cent bias parameters.
Main Results:
- CardioChek PA showed significant inaccuracy for LDL cholesterol (-25.9% bias), HDL cholesterol (-8.2% bias), and total cholesterol (-15.9% bias).
- Patients at higher risk were more likely to be misclassified into lower risk categories.
- The device did not meet NIH accuracy recommendations for key lipid parameters.
Conclusions:
- The CardioChek PA device is inaccurate and unsuitable for clinical use in Kenya.
- Findings underscore the necessity of validating diagnostic tools in their intended settings before implementation.
- Potential utility does not negate the need for rigorous local validation.
Objectives:
The prevalence of hyperlipidaemia, along with other non-communicable diseases, is on the rise in low- and middle-income countries. CardioChek PA is a point-of-care lipid measuring device, which seeks to overcome laboratory-based diagnostic barriers by providing immediate results without dependency on significant laboratory infrastructure. However, it has not been validated in Kenya. In this study, we assess the accuracy of CardioChek PA with respect to the gold standard laboratory-based testing.
Methods:
In Webuye, Kenya, two blood samples were collected from 246 subjects to simultaneously measure the lipid levels via both CardioChek PA and the gold standard. All subjects were adults, and geographic stratified sampling methods were applied. Statistical analysis of the device's accuracy was based on per cent bias parameters, as established by the United States National Institutes of Health (NIH). The NIH recommends that per cent bias be ≤±3% for low-density lipoprotein (LDL) cholesterol, ≤±5% for high-density lipoprotein (HDL) cholesterol, ≤±5% for total cholesterol (TC) and ≤±4% for triglycerides (TG). Risk group misclassification rates were also analysed.
Results:
The CardioChek PA analyzer was substantially inaccurate for LDL cholesterol (-25.9% bias), HDL cholesterol (-8.2% bias) and TC (-15.9% bias). Moreover, those patients at higher risk of complications from hyperlipidaemia were most likely to be misclassified into a lower risk category.
Conclusion:
CardioChek PA is inaccurate and not suitable for our clinical setting. Furthermore, our findings highlight the need to validate new diagnostic tools in the appropriate setting prior to scale up regardless of their potential for novel utility.
