| Objective:1.Verify the analytical performance of the tumor-specific protein 70 by ELISA quantitative detection.2.Explore the clinical value of serum SP70 as a new tumor marker for early diagnosis of non-small cell lung cancer.3.By comparing and analyzing the expression level of serum SP70 in patients with non-small cell lung cancer in Xuanwei area and non-Xuanwei area,explore whether the expression of serum SP70 in Xuanwei area has special research value.Methods:1.According to the EP15-A,EP6-A,CLSI C28-A2 documents approved by the American Association of Clinical Laboratory Standards(CLSI),the precision,accuracy,linear range and reference of the tumor-specific protein 70 ELISA quantitative detection kit Interval was verified.In addition,the detection limit was also verified by testing 20 blank samples.2.The serum SP70 antigen of 463 clinical samples was detected using the tumor specific protein 70 ELISA quantitative detection kit verified by analytical performance,including 181 cases of non-small cell lung cancer confirmed by pathology(89 cases of lung cancer in Xuanwei area),92 cases of lung cancer in non-Xuanwei area),20 cases of small cell lung cancer,129 cases of benign lung disease(65 cases of benign lung disease in Xuanwei area,64 cases of benign lung disease in non-Xuanwei area),133 cases of healthy physical examination(67 cases Health examinations in Xuanwei area,66 cases of health examinations in non-Xuanwei area).3.We detected the level of lung cancer-related tumor markers CEA and CYFRA21-1 by electrochemiluminescence method.The correlation with SP70 and three indexes of SP70,CEA and CYFR211 in non-small cell lung cancer was analyzed by drawing ROC curve to show the value of joint diagnosis.Results:1.Precision verification results:The measured intra-and inter-variation coefficients of variation were less than the manufacturer’s claimed coefficients of variation,and the verification was passed;the accuracy verification results:the bias of the test results in high and low concentration standards and the "marked value" were 2.6%and 4.1%,respectively,which is less than 15%of the manufacturer’s allowable range;the detection limit verification:the actual detection limit was 0.86 ng/mL,which is less than the manufacturer’s claimed value of 1ng/mL;the reference interval verification results:only 2 cases of 20 healthy people were higher than the reference interval provided by the manufacturer.So it can be accepted;the linear range verification:the first-order polynomial fitting equation was Y=1.275X-3.845,r2=0.9889.The P value of the second and third polynomial coefficients were all>0.05,and the linear range was 1.39-28.90ng/mL.2.The ELISA results showed that the serum SP70 level in the non-small cell lung cancer group was higher than that in the small cell lung cancer group,benign lung disease group and healthy physical examination group.The concentrations were 11.52ng/mL(8.65,14.73)、8.24ng/mL(6.46,11.07)、7.01ng/mL(4.77,10.05)、6.75ng/mL(4.66,8.78).The difference was statistically significant(P<0.05);the serum SP70 level in the late group(stage Ⅲ/Ⅳ)was higher than the early group(stage Ⅰ/Ⅱ).The concentrations were 14.73ng/mL(13.04,20.27)、8.86ng/mL(6.72,10.41).The difference was statistically significant(P<0.05);the transfer group was higher than the non-transfer Group.The concentrations were 12.66 ng/mL(10.41,16.15)、5.60 ng/mL(4.74,6.76).The difference was statistically significant(P<0.05);there was no significant difference in serum SP70 levels between non-small cell lung cancer group in Xuanwei area and non-Xuanwei,with concentrations of 10.49ng/mL(7.31,14.12)、12.54ng/mL(10.08,15.36),respectively.there was no statistically significant difference(P>0.05)3.The results of SP70,CEA and CYFR211 combined with ROC curve showed that the cut-off point of SP70 for diagnosis of non-small cell lung cancer was 8.821ng/mL,AUC was 0.796,sensitivity was 76%,and specificity was 72%;The combined diagnostic efficiency of the three indicators of CYFR211 is higher than that of SP70,CEA and CYFR211(AUC is 0.904,0.796,0.740,0.792)Conclusion:1.The precision,accuracy,detection limit,reference interval,and linear range of the tumor-specific protein 70 ELISA quantitative detection kit are consistent with the manufacturer’s declaration.It can meet the needs of clinical testing.2.Serum SP70 has a higher detection level in patients with non-small cell lung cancer,and it is significant increasing in the early stage,indicating that SP70 is a potential new serum tumor marker for the early diagnosis of non-small cell lung cancer.Early detection,diagnosis,and treatment have important clinical significance.At the same time,the combined application of the three indicators of SP70,CEA,and CYFR211 has better diagnostic efficacy,which is significantly better than the three methods of SP70,CEA,and CYFR211 alone;Lung cancer has unique research value,and the most common pathological type is non-small cell lung cancer.However,because of its pathological nature,it is still non-small cell lung cancer.There is no difference in serum SP70 between non-small cell lung cancer in Xuanwei and non-Xuanwei areas It can be accepted.At the same time,through this study,it shows that serum SP70 is a potential new tumor marker for early diagnosis of non-small cell lung cancer,and its application can help early detection,diagnosis,and treatment of non-small cell lung cancer in this area to reduce its high case fatality rate. |
PDF Full Text Request