| Background and purposeIn order to realize the early detection and treatment of tumor diseases,it is necessary for people to enhance their health awareness and regularly examine the tumor markers related to tumor diseases.However,the current reference intervals for tumor markers are mainly derived from reagent manufacturers’ instructions,National Clinical Laboratory Operation Procedures,textbooks,etc.,and many of the data are based on studies of foreign populations,which may not be suitable for domestic populations.Due to the influence of race,age,gender,geographical location,test methods,test systems and other factors,test results are inconsistent.Therefore,the International Union of Clinical Chemistry(IFCC)recommends that all clinical laboratories establish a suitable reference interval for their own laboratory.Therefore,it is necessary to establish a reference interval suitable for tumor markers in this region,which is more conducive to clear diagnosis and effective treatment of the disease.In this study,combined with age,gender and other information,roche automatic immunoanalyzer Cobas E 601(electrochemical luminescence method)was used to detect the levels of serum lung cancer tumor markers CYFRA21-1,SCC and NSE in healthy people in Henan area.In accordance with the establishment of the reference interval for clinical laboratory test items in the health industry standard WS/T402-2012,the reference interval for lung cancer tumor markers CYFRA21-1,SCC and NSE in the physical examination population in Henan region is planned to be established.Materials and methods(1)From May 2018 to December 2020,patients with lung cancer tumor markers CYFRA21-1,SCC and NSE were selected from Zhengzhou Adican Medical Laboratory.(2)The lung cancer tumor markers CYFRA21-1,SCC and NSE were detected and analyzed by Roche CoBAS601 automatic immune analyzer in the physical examination population in Henan region.(3)Statistical processing:SPSS25.0 statistical software was used for graphic processing and statistical analysis.According to WS/T402-2012,the 95th percentile was taken as the upper limit of the normal reference interval.Comparisons between the two groups were performed using a nonparametric Mann-Whitney U test.Statistically significant differences are indicated by P<0.05.The reference interval for lung cancer tumor markers CYFRA21-1,SCC and NSE in the physical examination population in Henan region is planned to be established.ResultsDifferent gender and NSE levels between CYFRA21-1,SCC and age groups in Henan(P<0.05),and reference intervals were established based on age and gender groups.(1)CYFRA21-1 project the reference interval was 0～4.22ng/ml;The reference interval of male was 0～4.29ng/ml,and that of female was 0～4.11ng/ml.The 95th percentile of male group was higher than that of female group.The reference interval of 18～49 years old group was 0～3.83ng/ml,and the reference interval of≥50 years old group was 0～4.68ng/mL.The 95th percentile of 18～49 years old group was lower than that of≥50 years old group.The reference interval was 0～3.95ng/ml for men aged 18～49 years and 0～4.74 ng/ml for men aged ≥ 50 years.The reference interval was 0～3.67ng/ml for women aged 18～49 years and 0～4.63ng/ml for women aged≥50 years.The reference interval of northern Henan was 0～3.86 ng/mL,the reference interval of central Henan was 0～4.14 ng/ml,the reference interval of southern Henan was 0～4.30 ng/ml,the reference interval of western Henan was 0～5.35 ng/ml,the reference interval of eastern Henan was 0～4.28 ng/mL,and the upper limit of the reference interval of northern Henan was the lowest.The upper limit of reference interval was the highest in western Henan.(2)SCC project the reference interval was 0～2.25ng/ml;The reference interval for male was 0～2.46 ng/ml,and for female was 0～1.90 ng/ml.The 95th percentile of male group was higher than that of female group.The reference interval of 18～49 years old group was 0～2.30 ng/ml,and that of≥ 50 years old group was 0～2.17 ng/ml.The 95th percentile of 18～49 years old group was higher than that of ≥50 years old group;The reference interval was 0～2.46 ng/ml for men aged 18～49 years and 0～2.47ng/ml for men aged≥50 years.The reference interval was 0～2.01 ng/ml for women aged 18～49 years and 0～1.74 ng/ml for women aged≥50 years.The reference interval of northern Henan was 0～2.38ng/mL,the reference interval of central Henan was 0～2.13ng/ml,the reference interval of southern Henan was 0～2.33ng/ml,the reference interval of western Henan was 0～2.32ng/ml,the reference interval of eastern Henan was 0～2.44 ng/mL,and the upper limit of the reference interval of central Henan was the lowest.The upper limit of reference interval was the highest in eastern Henan.(3)NSE project the reference interval was 0～18.77 ng/ml;The reference interval for male was 0～19.68ng/ml,and for female was 0～17.42ng/ml.The 95th percentile of male group was higher than that of female group.The reference interval of 18～49 years old group was 0～18.45ng/ml,and that of≥50 years old group was 0～19.15ng/ml.The 95th percentile of 18～49 years old group was lower than that of≥50 years old group.The reference interval was 0～19.71ng/ml for men aged 18～49 years and 0～19.61 ng/ml for men aged≥50 years.The reference interval was 0～16.11ng/ml for women aged 18～49 years and 0～18.80ng/ml for women aged≥50 years.The reference interval of northern Henan was 0～19.3ng/mL,the reference interval of central Henan was 0～17.98ng/ml,the reference interval of southern Henan was 0～20.58ng/ml,the reference interval of western Henan was 0～2 0.25ng/ml,the reference interval of eastern Henan was 0～20.16ng/mL,and the upper limit of the reference interval of central Henan was the lowest.The upper limit of reference interval was the highest in southern Henan.Conclusions:The reference intervals of CYFRA21-1,SCC and NSE for healthy population in Henan province were preliminarily established,and the established reference intervals were different from those recommended by manufacturers.There were statistically significant differences among different genders and age groups,so a reference interval was established according to age and gender groups. |
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