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目的:探讨甲胎蛋白(AFP)两种检测方法(酶免法和免疫层析法)的临床实用价值。方法:随机采集临床血液样本460份,分别用EIA(酶免法)和IND(免疫层析法)检测AFP,经统计学分析,计算其敏感性、临床符合率和影响因素,评价两种方法的临床实际应用价值。结果:460例患者临床血液样本两法检测AFP结果,灵敏度(最低可检出限浓度)均为20μg/L。可测范围EIA法为20μg/L~10000μg/L,IND法为20μg/L~30000μg/L,均可满足临床诊断要求。临床阴性符合率:EIA法为96.3%,IND为100%;临床阳性符合率:EIA法为89.1%,IND为97.3%,两者比较差异有显著性(P<0.05)。两法对0μmol/L~684μmol/L胆红素均无交叉反应。结论:IND法与EIA比较,具有操作简便,快速(10min~15min出结果)等优点,更符合临床实际推广应用。
Objective: To investigate the clinical value of two detection methods of AFP (enzyme immunoassay and immunochromatography). Methods: A total of 460 clinical blood samples were randomly collected. AFP was detected by EIA (enzyme immunoassay) and IND (immunochromatography). The sensitivity, clinical coincidence rate and influencing factors were calculated by statistical analysis. Two methods The clinical practical value. Results: AFP was detected by two methods in clinical blood samples of 460 patients. The sensitivity (the lowest detectable concentration) was 20μg / L. The measurable range of EIA method is 20μg / L ~ 10000μg / L, IND method is 20μg / L ~ 30000μg / L, can meet the clinical diagnosis requirements. The clinical negative coincidence rate was 96.3% in EIA and 100% in IND. The clinical positive coincidence rate was 89.1% in EIA and 97.3% in IND, the difference was significant (P <0.05). There was no cross reaction between 0μmol / L ~ 684μmol / L bilirubin in the two methods. Conclusion: Compared with EIA, IND method has the advantages of simple and rapid operation (10min ~ 15min out of results), and more in line with the actual application of clinical practice.