Alpha-fetoprotein in plasma and serum of healthy adults: preanalytical, analytical and biological sources of variation and construction of age-dependent reference intervals

2001 ◽  
Vol 61 (3) ◽  
pp. 205-215 ◽  
Author(s):  
M. Christiansen, C. K. Høgdall, J.
2011 ◽  
Vol 26 (1) ◽  
pp. 65-71 ◽  
Author(s):  
Xue Qin ◽  
Liwen Lin ◽  
Zengnan Mo ◽  
Hui Lv ◽  
Yong Gao ◽  
...  

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.


2014 ◽  
Vol 29 (4) ◽  
pp. 436-439 ◽  
Author(s):  
Jie Zhang ◽  
Ying Zhao ◽  
Yu Chen

Objectives To determine the upper limits of the 95th percentile reference intervals (RIs) for the detection of the pro-gastrin releasing peptide (ProGRP) in plasma according to the Clinical and Laboratory Standards Institute (CLSI) C28-A3 guideline in a population of adult Chinese of Han ethnicity. Methods Plasma samples were collected from 578 healthy adults. Plasma ProGRP values were measured by chemiluminescent microparticle immunoassay (CMIA) on Abbot ARCHITECT i2000 system analyzers. Results Plasma ProGRP values did not conform to a Gaussian distribution, and thus non-parametric statistical methods were used to calculate RIs. Plasma ProGRP levels significantly increased with age, thus age-dependent RIs were determined. The upper limit of the 95th percentile RIs for plasma ProGRP was ≤57.26 pg/mL for young adults (18-50 years) and ≤81.42 pg/mL for old adults (>50 years). Conclusions By CMIA, we established distinct age-dependent RIs for plasma ProGRP in healthy adults of Chinese Han ethnicity, thus generating a valuable reference for future clinical and laboratory studies.


Author(s):  
Wataru Kikuchi ◽  
Kiyoshi Ichihara ◽  
Kazuo Mori ◽  
Yoshihisa Shimizu

Background Tartrate-resistant acid phosphatase 5b (TRACP5b) is a bone resorption marker that is mainly used in clinical management of osteoporosis. For proper interpretations of test results for serum TRACP5b, we explored their biological sources of variation, esp. age-related changes, and associations with other bone-related markers in healthy Japanese adults. Methods During the 2009 East-Southeast Asian multicentre study for determination of reference intervals, 72 major laboratory tests were measured by centralized assays in 3541 well-defined healthy volunteers. The current study included 1980 test results in Japanese subjects for five bone-related markers: TRACP5b, bone alkaline phosphatase, intact parathyroid hormone, calcium and inorganic phosphate. Information on sources of variation, including body mass index, smoking habits and ABO-blood group, were obtained from a health status questionnaire. Results Gender-specific profiles of age-related changes were observed for each parameter. Increased values starting from 40 years of age in females were most prominent for TRACP5b, followed by bone alkaline phosphatase and inorganic phosphate. TRACP5b in males decreased with body mass index, bone alkaline phosphatase and TRACP5b were higher in blood type-O subjects, especially in males. TRACPT5b was closely correlated with bone alkaline phosphatase, and moderately correlated with adjusted calcium and inorganic phosphate, especially in females aged ≥45 years. Reference intervals for each analyte were determined parametrically based on gender and age. Conclusions This study elucidated sources of variation of TRACP5b and related bone markers in healthy Japanese subjects and demonstrated a specific age profile for each marker. These results are of relevance for better clinical usage and interpretations of serum levels of bone markers.


2020 ◽  
Vol 58 (8) ◽  
pp. 1302-1313 ◽  
Author(s):  
Anwar Borai ◽  
Kiyoshi Ichihara ◽  
Abdulaziz Masaud ◽  
Waleed Tamimi ◽  
Suhad Bahijri ◽  
...  

AbstractBackgroundThis is a second part of report on the IFCC global multicenter study conducted in Saudi Arabia to derive reference intervals (RIs) for 20 immunoassay analytes including five tumor makers, five reproductive, seven other hormones and three vitamins.MethodsA total of 826 apparently healthy individuals aged ≥18 years were recruited in three clinical laboratories located in western, central and eastern Saudi Arabia using the protocol specified for the global study. All serum specimens were measured using Abbott, Architect analyzers. Multiple regression analysis (MRA) was performed to explore sources of variation of each analyte: age, body mass index (BMI), physical exercise and smoking. The magnitude of variation of reference values (RVs) attributable to sex, age and region was calculated by ANOVA as a standard deviation ratio (SDR). RIs were derived by the parametric (P) method.ResultsMRA revealed that region, smoking and exercise were not relevant sources of variation for any analyte. Based on SDR and actual between-sex differences in upper limits (ULs), we chose to partition RIs by sex for all analytes except for α-fetoprotein and parathyroid hormone (PTH). Age-specific RIs were required in females for ferritin, estradiol, progesterone, testosterone, follitropin, luteotropin and prolactin (PRL). With prominent BMI-related increase, RIs for insulin and C-peptide were derived after excluding individuals with BMI > 32 kg/m2. Individuals taking vitamin D supplements were excluded in deriving RIs for vitamin D and PTH.ConclusionsRIs of major immunoassay analytes specific for Saudi Arabians were established in careful consideration of various biological sources of variation.


2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Agata Sobczyńska-Malefora ◽  
Dominic J. Harrington ◽  
Kieran Voong ◽  
Martin J. Shearer

5-Methyltetrahydrofolate (5-MTHF) is the predominant form of folate and a strong determinant of homocysteine concentrations. There is evidence that suboptimal 5-MTHF availability is a risk factor for cardiovascular disease independent of homocysteine. The analysis of folates remains challenging and is almost exclusively limited to the reporting of “total” folate rather than individual molecular forms. The purpose of this study was to establish the reference intervals of 5-MTHF in plasma and red cells of healthy adults who had been prescreened to exclude biochemical evidence of functional deficiency of folate and/or vitamin B12. Functional folate and vitamin B12status was assessed by respective plasma measurements of homocysteine and methylmalonic acid in 144 healthy volunteers, aged 19–64 years. After the exclusion of 10 individuals, values for 134 subjects were used to establish the upper reference limits for homocysteine (13 μmol/L females and 15 μmol/L males) and methylmalonic acid (430 nmol/L). Subjects with values below these cutoffs were designated as folate and vitamin B12replete and their plasma and red cell 5-MTHF reference intervals determined,N=126: 6.6–39.9 nmol/L and 223–1041 nmol/L, respectively. The application of these intervals will assist in the evaluation of folate status and facilitate studies to evaluate the relationship of 5-MTHF to disease.


Author(s):  
Johannes J.M.L. Hoffmann ◽  
Karin C.A.M. Nabbe ◽  
Nicole M.A. van den Broek

AbstractRed blood cell distribution width (RDW) was recently shown to be age-dependent when using Sysmex XE-2100 hematology analyzers. As measuring RDW is subject to technology, we have investigated if this relation also exists when using a different hematology analyzer, Abbott CELL-DYN Sapphire. In addition, as RDW is generally expressed relative to mean red blood cell volume (MCV), we have explored how MCV influences the age-dependency of RDW.We measured RDW and MCV in a large cohort and calculated RDW-SD (the “absolute” RDW), which does not contain MCV. For establishing reference intervals we used Bhattacharya statistics.In our study cohort of 8089 individuals we found a strong association between RDW and age, but not with gender. Also MCV showed an age-related increase over the entire age range. The conventional RDW increased by 6% from the youngest to oldest age class, whereas RDW-SD increased by nearly 15%. This difference was caused by a mean age-related increase in MCV of 6.6%. Age-dependent reference intervals were established for RDW, RDW-SD and MCV.The age-dependency of RDW seems to be a universal biological feature rather than related with a single type of hematology analyzer. As not only RDW, but also MCV increases with age, we propose that future studies on the prognostic significance of RDW take its age-dependency into account and focus on RDW-SD as a potential marker of adverse events in many clinical conditions.


2020 ◽  
Vol Volume 13 ◽  
pp. 1249-1254
Author(s):  
Dana Ahmed Abdullah ◽  
Gizing Anwar Mahmood ◽  
Heshu Sulaiman Rahman

Author(s):  
Lennart Friis-Hansen ◽  
Linda Hilsted

Abstract: The aim of the present study was to establish Nordic reference intervals for thyreotropin (TSH) and the thyroid hormones in heparinized plasma.: We used 489 heparinized blood samples, collected in the morning, from the Nordic NOBIDA reference material, from healthy adults without medication. TSH, thyroxine, free thyroxine, triiodothyronine, free triiodothyronine, and thyroglobulin antibodies (Tg-ab) were measured using assays for Roche Modular E170: The measured concentrations for the thyroid hormones, but not TSH, followed a Gaussian distribution. There were more TPO-ab and Tg-ab positive women than men. After exclusion of the TPO-ab and the Tg-ab positive individuals, the reference interval TSH was 0.64 (0.61–0.72) to 4.7 (4.4–5.0) mIU/L. The exclusion of these ab-positive samples also minimized the differences in TSH concentrations between the sexes and the different Nordic countries. For the thyroid hormones, there were only minor differences between the reference intervals between the Nordic populations and between men and women. These reference intervals were unaffected by removal of the TPO-ab and TG-ab positive samples.: The upper limit of the TSH reference interval in our study is high compared to some other recent reports. This could be due to blood sampling in the morning. Furthermore, the Roche platform gives slightly higher results than other platforms. The number and distribution of the samples in the NOBIDA material makes it suitable for the determination of hormone Nordic reference intervals.Clin Chem Lab Med 2008;46:1305–12.


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