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目的:在临床开展血清胃蛋白酶原Ⅰ和Ⅱ(PGⅠ/PGⅡ)检测前,对PGⅠ/PGⅡ试剂盒在全自动生化分析仪上检测性能进行评价。方法:以厂家配套的高、低值浓度样品为样本,进行批内精密度和批间精密度验证。以厂家配套的质控标准品为样本,进行正确度验证。将质控标准品稀释,PGⅠ范围为2.5~160.0 ng/mL,PGⅠI范围为2.0~70.0 ng/mL,将结果做回归与相关分析。以厂商提供干扰物进行抗干扰能力验证。结果:PGⅠ和PGⅡ的低值浓度样品批内精密度的分别为3.23%CV和2.93%CV,批间精密度分别为2.87%CV和2.80CV%。PGⅠ和PGⅡ的高值浓度样品批内精密度的分别为1.75%CV和2.60%CV,批间精密度分别为1.75%CV和2.46%CV。PGⅠ和PGⅡ准确度偏倚均在±5%以内。在PGⅠ范围为2.5~160.0 ng/mL,线性系数r=0.999;PGⅡ范围为2.0~70.0 ng/mL,线性系数r=0.996,均到达要求。结论:免疫比浊法PGⅠ/PGⅡ检测试剂盒在日立7600-010全自动生化分析仪上检测性能符合临床要求。
OBJECTIVE: To evaluate the detection performance of PGⅠ / PGⅡ on automatic biochemical analyzer before clinical serum pepsinogen Ⅰ and Ⅱ (PGⅠ / PGⅡ) test. Methods: Samples of high and low concentration samples matched by manufacturers were used for the in-batch and inter-batch precision verification. To manufacturers supporting quality control standards for the sample, the correct degree of validation. The quality control standards were diluted with PGⅠ in the range of 2.5-160.0 ng / mL and PGⅠI in the range of 2.0-70.0 ng / mL. The results were analyzed by regression and correlation analysis. Provide interference with manufacturers to verify the anti-interference ability. Results: The intra-assay precision of PGⅠ and PGⅡ were 3.23% CV and 2.93% CV respectively, with the inter-assay precision of 2.87% CV and 2.80% CV. The intra-assay precision of PGⅠ and PGⅡ were 1.75% CV and 2.60% CV respectively, with the inter-assay precision of 1.75% CV and 2.46% CV, respectively. The accuracy of PGⅠ and PGⅡ was within ± 5%. In the PG Ⅰ range of 2.5 ~ 160.0 ng / mL, linear coefficient r = 0.999; PG Ⅱ range of 2.0 ~ 70.0 ng / mL, the linear coefficient r = 0.996, meet the requirements. Conclusion: Immunoturbidimetry PG Ⅰ / PG Ⅱ detection kit in Hitachi 7600-010 automatic biochemical analyzer performance in line with clinical requirements.