Reference Intervals for Serum Alpha-Fetoprotein and Carcinoembryonic Antigen in Chinese Han Ethnic Males from the Fangchenggang Area Male Health and Examination Survey

2011 ◽  
Vol 26 (1) ◽  
pp. 65-71 ◽  
Author(s):  
Xue Qin ◽  
Liwen Lin ◽  
Zengnan Mo ◽  
Hui Lv ◽  
Yong Gao ◽  
...  
Keyword(s):  
Carcinoembryonic Antigen ◽  
Reference Intervals ◽  
Alpha Fetoprotein ◽  
Male Health ◽  
Significant Difference ◽  
Reference Limits ◽  
Age Dependent ◽  
Serum Alpha Fetoprotein ◽  
Serum Cea ◽  
Normally Distributed

Objectives We calculated upper 95% reference limits for serum alpha-fetoprotein (AFP)and carcinoembryonic antigen (CEA) according to the CLSI/NCCLS C28-A3 guideline. Material and methods Serum samples from 1400 healthy male subjects were collected from the Fangchenggang Area Male Health and Examination Survey (FAMHES). Serum AFP and CEA values were measured by electrochemiluminescence immunoassay on COBAS 6000 system E601 (Elecsys module) immunoassay analyzers. Results Serum AFP and CEA values were not normally distributed but log normally distributed. The upper 95% reference limits of the reference intervals were ≤4.76 IU/mL (nonparametric) or ≤4.56 IU/mL (parametric) for AFP and ≤5.57 ng/mL (nonparametric) or ≤5.82 ng/mL (parametric) for CEA. The distribution of AFP levels was found to be consistent between the non-smoking and smoking (p=0.740) and non-drinking and drinking groups (p=0.698). The distribution of serum CEA levels was significantly higher in the smoking than the non-smoking group (p<105), whereas there was no significant difference in this respect between the non-drinking and drinking groups (p=0.147). A significant increase with age was found both for serum AFP and CEA levels, and the age-dependent reference intervals were calculated. Conclusions The reference intervals for serum AFP and CEA show a slight deviation compared to previously reported reference levels. Distinct reference intervals of serum CEA must be established for smoking and non-smoking populations. In addition, age-dependent reference intervals should be implemented in clinical laboratories.

scholarly journals Comparison of chemiluminescent microparticle immunoassay (CMIA) with electrochemiluminescence immunoassay (ECLIA) for Carcinoembryonic antigen (CEA)

2018 ◽  
Vol 8 (2) ◽  
pp. 94-100 ◽  
Author(s):  
Nafija Serdarevic ◽  
Jasmina Smajic
Keyword(s):  
Pancreatic Cancer ◽  
Carcinoembryonic Antigen ◽  
Correlation Coefficient ◽  
Therapy Monitoring ◽  
Reference Intervals ◽  
Serum Cea ◽  
Chemiluminescent Microparticle Immunoassay ◽  
Electrochemiluminescence Immunoassay ◽  
Mean Differences ◽  
Sera Samples

Introduction: Carcinoembryonic antigen (CEA) is used for monitoring of disease progression and treatment response in cancer patients. Our aim was to compare the performance of chemiluminescent microparticle immunoassay (CMIA) with electrochemiluminescence immunoassay (ECLIA) for CEA. Methods: A total of 115 samples were collected during routine diagnostic, prognostic and therapy monitoring procedures in patients with colorectal and pancreatic cancer. We used ARCHITECT i2000SR and Cobas E601 for CEA analysis in sera samples. Results: The correlation coefficient of 0.984 [95% CI: 0.972 to 0.991] for results obtained on both platforms was observed for CEA≤10 ng/mL group. Moreover, intercept of 0.9027 [95% CI: 0.705 to 1.099] and slope 0.8076 [95% CI: 0.765 to 0.8498]  (p < 0.0001) was observed in this group. In CEA >10 ng/mL group we observed slope = 1.1986  [95%CI: 1.1474 to 1.2498]  (p < 0.0001), intercept = -11.69 [-17.53 to - 5.84] and correlation coefficient of 0.985 [95% CI: 0.976 to 0.9914]. Mean differences between assays in group ≤10 ng/mL and >10 ng/mL were 0.2066 (95% CI: 0.0019 to 0.4113) and –2.66 (95% CI: -10.10 to 4.76) ng/mL, respectively. Conclusion: Although there were differences, based on 20 days precision tests, overall results showed a good analytical performance and correlation between CEA assays on ARCHITECT i2000SR and Cobas E601 platforms. Reference intervals appropriate for the method of CEA measurement should be used. The standardization and harmonization of serum CEA concentration assays are needed.

Maternal Age-Dependent and Sex-Related Changes of Gestational Serum Alpha-Fetoprotein

1995 ◽  
Vol 10 (6) ◽  
pp. 368-372 ◽  
Author(s):  
Maria Szabó ◽  
Lajos Veress ◽  
Ákos Münnich ◽  
Zoltán Papp
Keyword(s):  
Maternal Age ◽  
Alpha Fetoprotein ◽  
Age Dependent ◽  
Serum Alpha Fetoprotein

scholarly journals First-Trimester Reference Intervals for Thyroid Function Testing among Women Screened at a Tertiary Care Hospital in India

2021 ◽  
Author(s):  
Rachita Nanda ◽  
Prasanta Kumar Nayak ◽  
Suprava Patel ◽  
Eli Mohapatra ◽  
Sarita Agrawal
Keyword(s):  
Statistical Analysis ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
First Trimester ◽  
Reference Intervals ◽  
Reference Ranges ◽  
Care Hospital ◽  
Maternal Weight ◽  
Significant Difference ◽  
Normally Distributed

Abstract Objectives Due to differences in the method of assay and population-specific factors, each laboratory needs to establish its own gestation-specific reference intervals (GRIs) for thyroid hormones. Materials and Methods Three-hundred forty-one women with less than 14 weeks gestation were screened at a tertiary care hospital in Chhattisgarh, India. Serum levels of thyroid-stimulating hormone (TSH), free thyroxine (fT4), and thyroid peroxidase antibody (anti-TPO) were measured using an ADVIA Centaur XP immunoassay.GRIs (2.5th and 97.5th percentiles) were determined for TSH and fT4. TSH and fT4 concentrations were converted to multiples of the median (MoM) values. Effect of maternal age, gestational age, and maternal weight was analyzed. Statistical Analysis Quantitative variables were expressed as means and standard deviations (SD), and qualitative variables were expressed as frequencies and percentages. Normality of the data was checked using the Kolmogorov–Smirnov test. Values that were normally distributed were expressed only as means and SD. Those that were not normally distributed were expressed as medians and interquartile range. For all statistical analysis, p < 0.05 was considered as statistically significant. Results First-trimester GRI was 0.245 to 4.971 mIU/L for TSH, 10.2 to 18.9 pmol/L for fT4, and 27.0 to 56.89 kIU/L for anti-TPO. There was no significant difference in the mean serum TSH (p = 0.920), fT4 (p  = 0.714), or anti-TPO (p = 0.754) values among women in 4 to 7th week and 7 to 14th week of gestation. The 1st and 99th centile MoMs were 0.03 and 4.09 for TSH and 0.66 and 1.39 for fT4. There was a significant positive correlation between the maternal weight and TSH MoM values (p = 0.027, r = 0.120). Conclusion These laboratory- and first-trimester-specific GRI for TSH and fT4 shall help in proper diagnosis and treatment of subclinical thyroid dysfunctions. TSH and fT4 MoM values can be used to indicate high or low values in a quantitative manner independent of the reference ranges and may be used by other laboratories.

scholarly journals Comparison of an ELISA with a RIA Method for Serum Alpha-Fetoprotein Determination in Screening for Fetal Neural Tube Defects

1986 ◽  
Vol 23 (3) ◽  
pp. 334-339 ◽  
Author(s):  
R D Barlow ◽  
S G Thompson ◽  
H S Cuckle ◽  
N J Wald ◽  
A Voller
Keyword(s):  
Neural Tube ◽  
Neural Tube Defects ◽  
Alpha Fetoprotein ◽  
Enzyme Linked Immunosorbent Assay ◽  
Antenatal Screening ◽  
Elisa Method ◽  
Suitable Alternative ◽  
Significant Difference ◽  
Serum Alpha Fetoprotein ◽  
Gestational Week

An enzyme-linked immunosorbent assay (ELISA) was evaluated for serum alpha-fetoprotein determination in the antenatal screening for fetal open neural tube defects. The ELISA was used concurrently with an existing radioimmunoassay (RIA) method until serum specimens from 5000 pregnant women, between 15 and 20 weeks gestation, had been tested. The accuracy of the ELISA was similar to that of the RIA; the median AFP values by gestational week obtained with the ELISA were, on average, 2 KIU/L higher than the corresponding RIA values; the 10th and 90th percentiles, in terms of multiples of the median (MoM), were very similar. The precision of the two methods was also similar. The ELISA method yielded 1·8% results from unaffected pregnancies above 2·5 MoM compared with 1·4% by RIA, a small but statistically significant difference ( P=0·03). Both methods detected the same affected pregnancies identified during this period; five open neural tube defects, three with exomphalos and three intra-uterine deaths. The ELISA method was simple, required about one quarter less operator time than the RIA and enabled results to be generated in one day rather than the two days required by RIA. The ELISA method is a suitable alternative to RIA for routine use in screening for fetal neural tube defects.

In Search of Normality for Vitamin K1: Establishing Age-Dependent Reference Intervals in the Danish Population

2020 ◽  
Vol 5 (3) ◽  
pp. 531-543
Author(s):  
Ida Boegh Andersen ◽  
Claus Lohman Brasen ◽  
Anne Schmedes ◽  
Ivan Brandslund ◽  
Jonna Skov Madsen
Keyword(s):  
Vitamin K ◽  
Serum Vitamin ◽  
Reference Intervals ◽  
Specific Reference ◽  
Vitamin K1 ◽  
Serum Samples ◽  
Lower Serum ◽  
Limit Of Quantitation ◽  
Significant Difference ◽  
Age Dependent

Abstract Background A growing body of evidence suggests that vitamin K has beneficial effects on human health, especially cardiovascular and bone health. Vitamin K1 (phylloquinone), the predominant form of vitamin K in blood, is regarded as an indicator of vitamin K status, but to our knowledge no reference intervals (RIs) have been established for vitamin K1. Methods In this population-based study, vitamin K1 was measured in serum from 3808 Caucasian individuals without diabetes from 26 to 78 years of age. The need for gender- and age-partitioned vitamin K1 reference intervals was evaluated using Lahti’s method, and exclusion criteria were defined to obtain as healthy a study group as possible. The excluded subgroups were tested for differences in mean serum vitamin K1 levels. Serum vitamin K1 levels were quantified using an in-house newly developed, validated, and highly sensitive online SPE-LC-MS/MS method with a limit of quantitation of (LOQ) 0.05 nmol/L. Results The reference interval for serum vitamin K1 was 0.22 to 3.95 nmol/L for individuals aged 26 to 44 years and 0.35 to 3.70 nmol/L for individuals aged 45 to 78. Similar age-specific reference intervals were established for vitamin K1-triglyceride ratio being 0.20 to 3.16 and 0.31 to 3.44, respectively. No significant difference was found between genders. Serum vitamin K1 was detectable in all serum samples. Individuals with known comorbidity were found to have significantly lower serum vitamin K1 compared to those without comorbidity. Current smokers had lower serum vitamin K1 compared to nonsmokers. Conclusion Age-dependent reference intervals were established for serum vitamin K1 and vitamin K1-triglyceride ratio in a well-defined, healthy Caucasian population. Lower serum vitamin K1 levels were found in individuals with known comorbidity, suggesting an association between serum vitamin K1 and disease status. Further studies are needed to determine an optimal serum vitamin K1 level.

Serum and Saliva Levels of Cancer Antigen 15-3, Carcinoembryonic Antigen, Estradiol, Vaspin, and Obestatin as Biomarkers for the Diagnosis of Breast Cancer in Postmenopausal Women

2020 ◽  
Vol 51 (6) ◽  
pp. 620-627
Author(s):  
Hyder Farahani ◽  
Jamal Amri ◽  
Mona Alaee ◽  
Fathollah Mohaghegh ◽  
Mohammad Rafiee
Keyword(s):  
Breast Cancer ◽  
Carcinoembryonic Antigen ◽  
Correlation Coefficients ◽  
Control Group ◽  
Case Group ◽  
Cancer Antigen ◽  
Healthy Women ◽  
Significant Difference ◽  
Serum Cea ◽  
Control Study

Abstract Objective To find suitable biomarkers for diagnosis of Breast cancer in serum and saliva; also, to examine the correlation between salivary and serum concentrations of suitable biomarkers. Methods This case-control study included 30 women with breast cancer as a case group and 30 healthy women as a matched control group. Blood and saliva specimens were collected from all participants. We evaluated serum and salivary cancer antigen 15-3 (CA15-3), carcinoembryonic antigen (CEA), estradiol, vaspin, and obestatin concentrations. Mann-Whitney U testing and Spearman correlation coefficients were used for statistical analysis. Results Serum and salivary concentrations of estradiol were significantly higher in patients with breast cancer (BC) than in healthy women (P &lt; .05). Also, serum CEA and salivary obestatin concentrations were significantly higher in BC patients than in the control group (P &lt; .05). However, there was no significant difference between other parameters in patients with BC and controls. We observed a positive correlation between serum and salivary concentrations of CA15-3, as well as a negative correlation between serum and salivary concentrations of vaspin and obestatin. Conclusion The results of this study demonstrated that concentrations of CEA and estradiol in serum, obestatin in serum and saliva, and estradiol in saliva were significantly different between the 2 groups.

scholarly journals Clinical Utility of Alpha Fetoprotein and HCCR-1, Alone or in Combination, in Patients with Chronic Hepatitis, Liver Cirrhosis and Hepatocellular Carcinoma

2011 ◽  
Vol 30 (6) ◽  
pp. 307-315 ◽  
Author(s):  
Peng Jirun ◽  
Guoxin Zhang ◽  
Hyun Kee Kim ◽  
Seon-Ah Ha ◽  
Jin Zhongtian ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Liver Cirrhosis ◽  
Chronic Hepatitis ◽  
Normal Subjects ◽  
Alpha Fetoprotein ◽  
Combined Use ◽  
Significant Difference ◽  
Serum Alpha Fetoprotein ◽  
Immunohistochemical Studies ◽  
A Prospective Study

Serum alpha fetoprotein (AFP) is the most widely used tumor marker in detecting patients with hepatocellular carcinoma (HCC). However, it has been indicated that HCCR-1 (human cervical cancer oncogene 1) might be supplementary to AFP in the detection. We conducted a prospective study in 120 normal and 524 liver disease patients to evaluate the significance of simultaneous measurement of 2 tumor markers (AFP and HCCR-1) in the diagnosis of HCC through the cohort study in Korea and China. We also performed immunohistochemical studies using 25 normal subjects (N), 32 liver cirrhosis (LC) and 116 HCC tissues. The sensitivities of AFP (20 ng/mL) and HCCR-1 (10 ng/mL) in HCC were 55.8% (164/294) and 44.2% (130/294), respectively. When AFP was combined with HCCR-1, sensitivities increased to 4.2% (N), 12.7% (chronic hepatitis; CH), 50.0% (LC), and 77.2% (HCC), respectively. Although there was no significant difference in the diagnostic rate for HCC between AFP and HCCR-1, many cases for AFP-negative HCC were positive for HCCR-1 and vice versa. Moreover, the combined use of AFP and HCCR-1 improved the diagnostic rate to 70.8% in small HCC (< 2 cm) and 81.6% in large HCC (≥ 2 cm), respectively. AFP and HCCR-1 are independent markers. Our result suggests that the HCCR-1 could be an useful biomarker for HCC while the diagnostic rate could be significantly improved in the combined use of HCCR-1 and AFP.

scholarly journals The establishment of serum 25-hydroxyvitamin D reference intervals in children aged 0–14 years in Zigong area, China

2021 ◽  
Vol 40 (1) ◽  
Author(s):  
Jianhong Yu ◽  
Xiaoping He ◽  
Shengwei Huang
Keyword(s):  
Age Groups ◽  
Reference Interval ◽  
Reference Intervals ◽  
Healthy Children ◽  
Hydroxyvitamin D ◽  
Significant Difference ◽  
Different Seasons ◽  
25 Hydroxyvitamin D ◽  
Apparently Healthy ◽  
Normally Distributed

Abstract Objective To establish the reference interval of serum 25-hydroxyvitamin D (25(OH)D) in apparently healthy children in Zigong, China, using an indirect method to provide a basis for proper clinical diagnosis and treatment. Methods A total of 1851 apparently healthy children of the Children’s Health Care Department in Zigong First People’s Hospital between January 2016 and December 2020 were included in the study. The Kolmogorov–Smirnov test was used to analyze the data for normality, and the non-normally distributed data were transformed into approximately normal distribution by Blom's normal rank transformation, and the transformed data were excluded from outliers by the quartile spacing method, and the data were stratified and analyzed according to sex, age, and season. The data were stratified according to sex, age, and season, and the area between the 2.5% and 97.5% percentile points was used as the reference interval. Results The serum 25(OH)D data were non-normally distributed. The data were normally distributed after Blom’s normality rank transformation, and 92 cases of outliers were excluded from the transformed data according to the interquartile spacing method. The differences in serum 25(OH)D levels between sex were not statistically significant (P > 0.05), and there was no need to establish reference intervals based on sex. There was no statistically significant difference in serum 25-hydroxyvitamin D levels between winter and spring, and also no difference between summer and autumn (P > 0.05), and the levels were lower in winter-spring than in summer-autumn. Comparison between age groups showed that there was no statistically significant difference in serum 25(OH)D levels between the < 6 months group and the 6 ~ 11 months group, and between the 6 ~ 9 years group and the 10 ~ 14 years group (P > 0.05); serum 25(OH)D levels decreased with increasing age. There was an interactive effect of season and age group on 25(OH)D levels, and the corresponding reference intervals were established according to different seasons and age groups. In summer and autumn, the reference intervals of serum 25(OH)D for < 1 year, 1 ~ 2 years, 3 ~ 5 years, and 6 ~  14 years were 39.86 ~ 151.43, 31.54 ~ 131.65, 22.05 ~ 103.75, and 15.36 ~ 85.53 ng/ml and 24.42 ~ 144.20, 31.54 ~ 131.65, 16.80 ~ 165.68, and 15.46 ~ 85.54 ng/ml in winter and spring, respectively. Conclusion Reference intervals for serum 25(OH)D in children of different seasons and ages in Zigong, China, were established to provide a reference for clinical disease diagnosis, treatment, and prognosis determination.

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