Department of Clinical Chemistry, New Cross Hospital, Wolverhampton, West Midlands, UK.
Department of Clinical Chemistry, New Cross Hospital, Wolverhampton, West Midlands, UK Research Institute, Healthcare Sciences, Wolverhampton University, Wolverhampton, West Midlands, UK.
J Clin Pathol. 2014 Jun;67(6):535-9. doi: 10.1136/jclinpath-2013-202123. Epub 2014 Apr 7.
Lipid point-of-care testing (POCT) analysers are being used to screen target populations to identify individuals at high risk of developing cardiovascular disease (CVD) as part of the National Health Service (NHS) Health Checks programme. We evaluated the performance of the Cholestech LDX and CardioChek PA POCT analysers against laboratory methods in CVD risk assessment.
Ten-year QRISK2, Joint British Societies' II (JBSII), and Framingham CVD risk scores were calculated for subjects recruited from Wolverhampton City PCT community NHS Health Check clinics. CVD risk scores derived using POCT capillary whole blood total cholesterol and HDL-cholesterol measurements were compared with those derived from the laboratory analysis of paired venous serum samples. Data from subjects with diabetes, overt CVD, and those who did not meet the risk algorithm age criteria were excluded.
All subjects classified as high risk (risk score >20%) by the three risk algorithms on the basis of the laboratory results were correctly identified by the LDX. One (2.2%) and four (7.0%) moderate-risk subjects were misclassified by the LDX as high risk, using the JBSII and Framingham risk algorithms, respectively. The CardioChek identified all subjects classed as high risk by QRISK2, but failed to identify 6/31 (19.4%) and 3/19 (15.8%) of subjects classed as high risk by the Framingham and JBSII algorithms, respectively. The CardioChek, however, did not misclassify any moderate-risk subjects as high risk.
Identification of subjects at risk of CVD depends on the cardiovascular risk algorithm and also on the performance of the POCT device.
作为国民保健服务(NHS)健康检查计划的一部分,正在使用脂质即时检验(POCT)分析仪对目标人群进行筛查,以识别出患心血管疾病(CVD)风险较高的个体。我们评估了 Cholestech LDX 和 CardioChek PA POCT 分析仪在 CVD 风险评估中的性能,与实验室方法进行了比较。
对从伍尔弗汉普顿市社区国民保健服务 NHS 健康检查诊所招募的受试者,计算了 10 年 QRISK2、联合英国协会 II(JBSII)和弗雷明汉 CVD 风险评分。使用 POCT 毛细血管全血总胆固醇和 HDL-胆固醇测量值推导的 CVD 风险评分与从实验室分析配对静脉血清样本中推导的评分进行了比较。排除了患有糖尿病、明显 CVD 以及不符合风险算法年龄标准的受试者的数据。
基于实验室结果,所有三种风险算法均将高风险(风险评分>20%)的受试者正确地识别为 LDX。使用 JBSII 和弗雷明汉风险算法,LDX 将一名(2.2%)和四名(7.0%)中度风险受试者错误地分类为高风险。CardioChek 识别了所有被 QRISK2 分类为高风险的受试者,但未能识别出 Framingham 和 JBSII 算法分别分类为高风险的 6/31(19.4%)和 3/19(15.8%)的受试者。然而,CardioChek 并未将任何中度风险受试者错误地分类为高风险。
识别 CVD 风险患者取决于心血管风险算法,还取决于 POCT 设备的性能。