定量测定HCG的斑点金免疫渗滤试验的临床评价

Clinical evaluation of the dot gold immunofiltration assay for quantitative determination of HCG

目的 评价斑点金免疫渗滤试验 (DGIFA)定量测定血清和尿液人绒毛膜促性腺激素 (HCG)的可靠性。方法 分别用化学发光免疫分析法 (CLIA)和DGIFA定量测定HCG试剂盒 (HCG DOT)及DGIFA定量仪测定 4 0份血清样品的HCG含量 ,分别用胶体金免疫层析定性试验 (GICA)和HCG DOT及DGIFA定量仪测定2 70份尿液样品的HCG水平 ;作回收试验和不精密度试验。结果 CLIA和DGIFA定量测定血清样品HCG的相关性好 ;GICA检测阴性的 16 2份尿液样品用HCG DOT测定有 9份为背景红色所致的假阳性 ,1份为血尿导致的假阳性 ,另 2份为阳性 ;GICA检测阳性的 95份和可疑阳性的 13份尿液样品用HCG DOT测定 ,结果均为阳性 ;HCG DOT定量测定高、低浓度HCG血清样品和HCG尿液样品的变异系数 (CV)分别为 5 .38%、4 .13%和 4 .73%、6 .0 1% ;HCG DOT定量测定血清和尿液的HCG回收率分别为 94 .7%和 89.9%。结论 DGIFA定量测定尿液HCG ,对尿液GICA结果可疑者可在妊娠早期作出明确的判断 ;DGIFA定量检测血清和尿液HCG的精密度良好 ,回收率较高 ,适合门急诊应用。

Objective To evaluate the reliability of the dot gold immunofiltration assay (DGIFA) for quantitative determination of human chorionic gonadotropin (HCG) in serum or urine. Methods The HCG contents in 40 serum samples were determined by chemiluminescence immunoassay (CLIA) and DGFIA. The HCG levels in 270 urine samples were determined by a qualitative gold immunochromatography assay (GICA) HCG reagent kit and the quantitative DGFIA HCG reagent with the coresponding reader (HCG-DOT). The recovery test and the imprecision test were carried out. Results The correlativity of HCG contents in serum determined by CLIA and DGIFA was satisfied; 9 and 1 urine samples in the 162 negative urine samples detected by GICA were false positive due to red background or blood and hematuria by HCG-DOT respectively, another 2 urine samples were positive; 95 positive and 13 doubtful positive urine samples detected by GICA were all positive by HCG-DOT. The CV of quantitative DOT-HCG in determination high and low HCG contents serum samples were 5.38% and 4.13% respectively. The CV of urine samples determination were 4.73% and 6.01% respectively. The recovery rates of quantitative determination of serum and urine samples by HCG-DOT were 94.7% and 89.9% respectively. Conclusions Quantitative determination of HCG contents in urine by DGIFA can help firmly diagnose earlier pregnancy. The precision and recovery rate of quantitatie determination of HCG contents in serum and urine by DGIFA are satisfied. The reagents and instrument are suitable for clinical use.