CAJ | 학술논문

目的：对D-二聚体定量检测的参考区间进行验证，并分析年龄和性别因素对参考区间的影响。方法明确参考个体入组标准，招募参考个体男性60例，女63例，按年龄分为3组：20～39岁组（男女各20名），40～59岁组（男性20名，女性23名），≥60岁组（男女各20名）。采集参考个体枸橼酸钠抗凝静脉血，分别使用三种不同品牌的血液凝固分析仪及配套试剂检测D-二聚体浓度水平。参照美国临床和实验室标准协会（clinical and laboratory standards institute，CLSI）C28-A3文件，对试剂厂商提供的D-二聚体参考区间进行验证，并采用非参数统计比较不同年龄和性别组间的差异。结果对于40岁以下健康人群，三种检测系统的参考区间均验证通过；对于40岁以上健康人群，A检测系统≥60岁组的验证结果未通过，C检测系统40～59岁组的验证结果未通过。各检测系统不同年龄组的检测结果比较显示D-二聚体浓度随年龄增长呈升高趋势，20～39岁年龄组与40～59岁组、20～39岁年龄组与≥60岁年龄组的 D-二聚体浓度水平的差异均具有统计学意义（P＜0.05）。各检测系统20～39岁组及40～59岁组男女间 D-二聚体浓度水平的差异具有统计学意义（P＜0.05），而≥60岁年龄组男女间D-二聚体浓度水平差异无统计学意义（P＞0.05）。结论 D-二聚体浓度水平与年龄和性别有关。对于40岁以下健康人群，三种检测系统的参考区间均通过验证，可直接采用；而对于40岁以上健康人群，部分检测系统的参考区间未通过验证，实验室应查找原因，必要时单独设置参考区间。
목적：대D-이취체정량검측적삼고구간진행험증，병분석년령화성별인소대삼고구간적영향。방법명학삼고개체입조표준，초모삼고개체남성60례，녀63례，안년령분위3조：20～39세조（남녀각20명），40～59세조（남성20명，녀성23명），≥60세조（남녀각20명）。채집삼고개체구연산납항응정맥혈，분별사용삼충불동품패적혈액응고분석의급배투시제검측D-이취체농도수평。삼조미국림상화실험실표준협회（clinical and laboratory standards institute，CLSI）C28-A3문건，대시제엄상제공적D-이취체삼고구간진행험증，병채용비삼수통계비교불동년령화성별조간적차이。결과대우40세이하건강인군，삼충검측계통적삼고구간균험증통과；대우40세이상건강인군，A검측계통≥60세조적험증결과미통과，C검측계통40～59세조적험증결과미통과。각검측계통불동년령조적검측결과비교현시D-이취체농도수년령증장정승고추세，20～39세년령조여40～59세조、20～39세년령조여≥60세년령조적 D-이취체농도수평적차이균구유통계학의의（P＜0.05）。각검측계통20～39세조급40～59세조남녀간 D-이취체농도수평적차이구유통계학의의（P＜0.05），이≥60세년령조남녀간D-이취체농도수평차이무통계학의의（P＞0.05）。결론 D-이취체농도수평여년령화성별유관。대우40세이하건강인군，삼충검측계통적삼고구간균통과험증，가직접채용；이대우40세이상건강인군，부분검측계통적삼고구간미통과험증，실험실응사조원인，필요시단독설치삼고구간。
Objective To verify the reference interval for D-dimer assay and analyze the influence of age and gender on the ref-erence interval.Methods Inclusion criteria for reference individuals were established.60 healthy males and 63 females were enrolled and divided to three groups by age,including 20 to 39 years old group (20 males and 20 females),40 to 59 years old group (20 males and 23 females)and above 60 years old group (20 males and 20 females).Blood samples were drawn in cit-rate sodium anticoagulated tubes and D-dimer concentration was determined by three different coagulation analyzers using o-riginal reagents.According to CLSI guideline C-28-A3,the reference interval for each measurement system from reagent manufacturer was verified and the difference of D-dimer concentration between different age-group and sex-group was ana-lyzed using non-parameters tests.Results All reference intervals were verified for people under age 40,while one reference interval cannot be verified for people from 40 to 59 years old as same as one for people above 60 years old.D-dimer concen-tration increased with age and there was significantly different between 20~39 years old group and 40~59 years old group or above 60 years old group(P<0.05).There was only a significant difference between sex-group for people under age 60(P<0.05).Conclusion D-dimer concentration was associated with age and sex.For people under age 40,the reference inter-val from reagent manufacture can be verified and directly used in laboratory,while for people above age 60,the reference in-terval from reagent manufacture cannot be verified.The cause should be investigated and a new reference interval should be established separately when necessary.