title: Assessing the accuracy of a point-of-care analyzer for hyperlipidaemia in western Kenya.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Duke Global Health Institute, Duke University, Durham, NC, USA.
authors.forename: Paul H
authors.initials: PH
authors.lastname: Park
authors.affiliation: Department of Family Medicine, School of Medicine, College of Health Sciences, Moi University, Eldoret, Kenya.
authors.forename: Patrick
authors.initials: P
authors.lastname: Chege
authors.affiliation: College of Pharmacy, Purdue University, West Lafayette, IN, USA.
authors.forename: Isabel C
authors.initials: IC
authors.lastname: Hagedorn
authors.affiliation: Department of Family Medicine, School of Medicine, College of Health Sciences, Moi University, Eldoret, Kenya.
authors.forename: Arthur
authors.initials: A
authors.lastname: Kwena
authors.affiliation: Duke Global Health Institute, Duke University, Durham, NC, USA.|Duke Clinical Research Institute, Duke University, Durham, NC, USA.|Division of Cardiology, Duke University Hospital, Durham, NC, USA.
authors.forename: Gerald S
authors.initials: GS
authors.lastname: Bloomfield
authors.affiliation: College of Pharmacy, Purdue University, West Lafayette, IN, USA.
authors.forename: Sonak D
authors.initials: SD
authors.lastname: Pastakia
mesh_terms: D000328:Adult; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D006801:Humans; D006949:Hyperlipidemias / Q000097:blood / Q000175:diagnosis*; D007630:Kenya; D000067716:Point-of-Care Testing / Q000592:standards*; D015203:Reproducibility of Results; D014280:Triglycerides / Q000097:blood
chemical_list: D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D014280:Triglycerides; D002784:Cholesterol
keywords: Hiperlipidemias; cardiovascular diseases; developing countries; enfermedades cardiovasculares; estudios de validación; hyperlipidaemias; hyperlipidémies; maladies cardiovasculaires; pays en développement; países en vías de desarrollo; point-of-care technology; prueba de diagnóstico en el punto de atención; technologie au point des soins; validation des études; validation studies