CAJ | 학술논문

目的：验证CardioChek PA床旁血脂检测仪测定全血总胆固醇（ total cholesterol， TC）、甘油三酯（ triglycer-ide， TG）和高密度脂蛋白胆固醇（high-density lipoprotein cholesterol， HDL-C）的准确度及其与全自动生化分析仪结果的可比性。方法使用同一批号试纸条分别在3台CardioChek PA血脂检测仪上连续检测低、中、高三个浓度水平全血20次，评价TC、 TG和HDL-C各项目的批内不精密度和仪器间总不精密度；在同一台仪器上使用三个批号的试纸条检测全血各10次，计算批内不精密度和总不精密度。筛选血脂浓度覆盖高、中、低三个水平的54名志愿者，清晨空腹采集末梢全血，在3台床旁血脂仪上测定血脂；同时采集静脉血，在4种不同的全自动生化分析仪检测血清TC、 TG及HDL-C。绘制Bland-Altman图，比较CardioChek PA与各生化分析仪测定结果的离散趋势；将CardioChek PA检测结果与不同生化分析系统及参考方法检测结果进行线性回归；计算CardioChek PA与不同生化分析系统的偏差及百分偏差，同时判定在医学决定水平处偏差是否符合相关要求。结果3台 CardioChek PA 仪器低、中、高水平的总不精密度 TC 分别为：2.69％、4.88％、3.51％， TG分别为5.51％、5.27％、4.96％， HDL-C分别为7.27％、6.84％、6.79％；相同仪器、不同批号试纸间总不精密度TC为4.70％， TG为7.66％， HDL-C为8.61％。 CardioChek PA检测系统与4种全自动生化仪分析比对结果显示： TC与各系统的偏差最小，在-2.21％～2.56％之间， HDL-C在-1.12％～5.57％之间， TG除与BeckmanDxC 800偏差较大外（25.85％），与其他3个系统的平均百分偏差在-4.55％～13.34％之间。医学决定水平偏差分析显示： TC在不同医学决定水平处的偏差在-3.27％～1.96％之间， TG 在-11.05％～13.06％之间， HDL-C 在-5.86％～11.56％之间，均满足美国国家胆固醇教育计划总允许误差标准（15％）。进一步的正确度验证结果显示：与参考方法比对， TC在医学决定水平处偏倚分别为1.96％和0.77％； HDL-C分别为2.34％和4.87％。结论 CardioChek PA床旁血脂检测仪准确度满足临床需求，适用于临床血脂异常筛查及治疗检测。目的：驗證CardioChek PA床徬血脂檢測儀測定全血總膽固醇（ total cholesterol， TC）、甘油三酯（ triglycer-ide， TG）和高密度脂蛋白膽固醇（high-density lipoprotein cholesterol， HDL-C）的準確度及其與全自動生化分析儀結果的可比性。方法使用同一批號試紙條分彆在3檯CardioChek PA血脂檢測儀上連續檢測低、中、高三箇濃度水平全血20次，評價TC、 TG和HDL-C各項目的批內不精密度和儀器間總不精密度；在同一檯儀器上使用三箇批號的試紙條檢測全血各10次，計算批內不精密度和總不精密度。篩選血脂濃度覆蓋高、中、低三箇水平的54名誌願者，清晨空腹採集末梢全血，在3檯床徬血脂儀上測定血脂；同時採集靜脈血，在4種不同的全自動生化分析儀檢測血清TC、 TG及HDL-C。繪製Bland-Altman圖，比較CardioChek PA與各生化分析儀測定結果的離散趨勢；將CardioChek PA檢測結果與不同生化分析繫統及參攷方法檢測結果進行線性迴歸；計算CardioChek PA與不同生化分析繫統的偏差及百分偏差，同時判定在醫學決定水平處偏差是否符閤相關要求。結果3檯 CardioChek PA 儀器低、中、高水平的總不精密度 TC 分彆為：2.69％、4.88％、3.51％， TG分彆為5.51％、5.27％、4.96％， HDL-C分彆為7.27％、6.84％、6.79％；相同儀器、不同批號試紙間總不精密度TC為4.70％， TG為7.66％， HDL-C為8.61％。 CardioChek PA檢測繫統與4種全自動生化儀分析比對結果顯示： TC與各繫統的偏差最小，在-2.21％～2.56％之間， HDL-C在-1.12％～5.57％之間， TG除與BeckmanDxC 800偏差較大外（25.85％），與其他3箇繫統的平均百分偏差在-4.55％～13.34％之間。醫學決定水平偏差分析顯示： TC在不同醫學決定水平處的偏差在-3.27％～1.96％之間， TG 在-11.05％～13.06％之間， HDL-C 在-5.86％～11.56％之間，均滿足美國國傢膽固醇教育計劃總允許誤差標準（15％）。進一步的正確度驗證結果顯示：與參攷方法比對， TC在醫學決定水平處偏倚分彆為1.96％和0.77％； HDL-C分彆為2.34％和4.87％。結論 CardioChek PA床徬血脂檢測儀準確度滿足臨床需求，適用于臨床血脂異常篩查及治療檢測。
목적：험증CardioChek PA상방혈지검측의측정전혈총담고순（ total cholesterol， TC）、감유삼지（ triglycer-ide， TG）화고밀도지단백담고순（high-density lipoprotein cholesterol， HDL-C）적준학도급기여전자동생화분석의결과적가비성。방법사용동일비호시지조분별재3태CardioChek PA혈지검측의상련속검측저、중、고삼개농도수평전혈20차，평개TC、 TG화HDL-C각항목적비내불정밀도화의기간총불정밀도；재동일태의기상사용삼개비호적시지조검측전혈각10차，계산비내불정밀도화총불정밀도。사선혈지농도복개고、중、저삼개수평적54명지원자，청신공복채집말소전혈，재3태상방혈지의상측정혈지；동시채집정맥혈，재4충불동적전자동생화분석의검측혈청TC、 TG급HDL-C。회제Bland-Altman도，비교CardioChek PA여각생화분석의측정결과적리산추세；장CardioChek PA검측결과여불동생화분석계통급삼고방법검측결과진행선성회귀；계산CardioChek PA여불동생화분석계통적편차급백분편차，동시판정재의학결정수평처편차시부부합상관요구。결과3태 CardioChek PA 의기저、중、고수평적총불정밀도 TC 분별위：2.69％、4.88％、3.51％， TG분별위5.51％、5.27％、4.96％， HDL-C분별위7.27％、6.84％、6.79％；상동의기、불동비호시지간총불정밀도TC위4.70％， TG위7.66％， HDL-C위8.61％。 CardioChek PA검측계통여4충전자동생화의분석비대결과현시： TC여각계통적편차최소，재-2.21％～2.56％지간， HDL-C재-1.12％～5.57％지간， TG제여BeckmanDxC 800편차교대외（25.85％），여기타3개계통적평균백분편차재-4.55％～13.34％지간。의학결정수평편차분석현시： TC재불동의학결정수평처적편차재-3.27％～1.96％지간， TG 재-11.05％～13.06％지간， HDL-C 재-5.86％～11.56％지간，균만족미국국가담고순교육계화총윤허오차표준（15％）。진일보적정학도험증결과현시：여삼고방법비대， TC재의학결정수평처편의분별위1.96％화0.77％； HDL-C분별위2.34％화4.87％。결론 CardioChek PA상방혈지검측의준학도만족림상수구，괄용우림상혈지이상사사급치료검측。
Objective To validate the accuracy of CardioChek PA lipid point-of-care devices in determi-ning total cholesterol ( TC ) , triglyceride ( TG ) , and high-density lipoprotein cholesterol ( HDL-C ) in whole blood and the comparability with results determined by full-automatic biochemical analyzer .Methods We deter-mined the low, medium, and high levels of TG, TC, and HDL-C in whole blood with single reagent lot number 20 times using 3 different CardioChek PA devices to evaluate inter-run and devices'coefficient of variations ( CVs) , and used single CardioChek PA device with 3 reagent lot number to determine the whole blood 10 times for evaluating inter-run and total CVs .Fifty-four volunteers whose lipid profiles covered up high , medium, and low levels were recruited .Lipids in fasting periphery whole blood and venous serum were collected and deter -mined using 3 different CardioChek PA devices and 4 kinds of full-automatic biochemical analyzers , respectively . Bland-Altman plot was made to analyze the comparability of results from CardioChek PA and the full -automatic bi-ochemical analyzers .Linear regression was analyzed using results of CardioChek PA and full -automatic biochemi-cal analyzers .Bias and percentage bias were determined between CardioChek PA and different automatic bio -chemical analyzers; meanwhile, whether they satisfied the requirements of medical decision levels was deter -mined.Results The total CVs of TC in low , medium, and high levels in 3 different devices were 2.69%, 4.88%, and 3.51%, respectively;for TG, they were 5.51%, 5.27%and 4.96%;and for HDL-C, they were 7.27%, 6.84%and 6.79%.The total CVs of TC , TG, and HDL-C determined with the same device but dif-ferent reagent lot number were 4.70%, 7.66%, and 8.61%, respectively .Comparison of the results from Car-dioChek PA devices and the 4 kinds of full-automatic biochemical analyzers showed lowest deviation for TC with-2.21% 2.56%, and for HDL-C with -1.12% 5.57%;the deviation of TG results of BeckmanDxC 800 was relatively high with 25.85%, but in other 3 systems were -4.55% 13.34%.Deviation of TC , TG, and HDL-C in different medical decision levels were -3.27% 1.96%, -11.05% 13.06%, and -5.86% 11.56%, respectively , all of which could satisfy the requirements of the National Cholesterol Education Program ( NCEP) . Compared with reference methods , the biases of TC in medical decision levels were 1.96% and 0.77%; for HDL-C, they were 2.34%and 4.87%.Conclusion The accuracy of CardioChek PA lipid point-of-care device can satisfy the clinical requirements , and the device can be used in the screening and monitoring of dyslipidemia .