Establishment of reference intervals for immunoassay analytes of adult population in Saudi Arabia

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.

2020 ◽  
Author(s):  
Anna Ruzhanskaya ◽  
Kiyoshi Ichihara ◽  
Svetlana Evgina ◽  
Irina Skibo ◽  
Nina Vybornova ◽  
...  

AbstractObjectivesA multicenter study was organized to explore sources of variation (SVs) of reference values (RVs) for 24 major immunochemistry analytes and to determine reference intervals (RIs) for the Russian population.MethodsAccording to IFCC Committee on Reference Intervals and Decision Limits (C-RIDL) protocol, 793 healthy volunteers were recruited in St. Petersburg, Moscow, and Yekaterinburg. Serum samples were tested for five tumor markers, 19 hormones and related tests by Beckman Coulter’s UniCel DxI 800 immunochemistry analyzer. SVs were explored using multiple regression analysis and ANOVA. Standard deviation ratio (SDR) of 0.4 was used as primary guide for partitioning RIs by gender and age.ResultsSDR for between-city difference was <0.4 for all analytes. Secondary exclusion of individuals was done under the following conditions: for female sex-hormones, those with contraceptives (8%); for CA19-9, those supposed to have negative Lewis blood-group (10.5%); for insulin, those with BMI≥28 kg/m2 (29.9%); for the thyroid panel, those with anti-thyroid antibodies (10.3% in males; 24.5% in females). Gender-specific RIs were required for all analytes except CA19-9, CA15-3, thyroid-related tests, parathyroid hormone, and insulin. Age-specific RIs were required for α-fetoprotein and all sex-hormones except testosterone. RIs were generally derived by parametric method after Gaussian transformation using modified Box-Cox formula. Exceptions were growth hormone, estradiol, and progesterone, for which nonparametric method was required due to bimodal distribution and/or insufficient detection limit.ConclusionRIs for major hormones and tumor markers specific for the Russian population were derived based on the up-to-date internationally harmonized protocol by careful consideration of analyte-specific SVs.


Author(s):  
Anwar Borai ◽  
Kiyoshi Ichihara ◽  
Abdulaziz Al Masaud ◽  
Waleed Tamimi ◽  
Suhad Bahijri ◽  
...  

AbstractBackground:This study is a part of the IFCC-global study to derive reference intervals (RIs) for 28 chemistry analytes in Saudis.Method:Healthy individuals (n=826) aged ≥18 years were recruited using the global study protocol. All specimens were measured using an Architect analyzer. RIs were derived by both parametric and non-parametric methods for comparative purpose. The need for secondary exclusion of reference values based on latent abnormal values exclusion (LAVE) method was examined. The magnitude of variation attributable to gender, ages and regions was calculated by the standard deviation ratio (SDR). Sources of variations: age, BMI, physical exercise and smoking levels were investigated by using the multiple regression analysis.Results:SDRs for gender, age and regional differences were significant for 14, 8 and 2 analytes, respectively. BMI-related changes in test results were noted conspicuously for CRP. For some metabolic related parameters the ranges of RIs by non-parametric method were wider than by the parametric method and RIs derived using the LAVE method were significantly different than those without it. RIs were derived with and without gender partition (BMI, drugs and supplements were considered).Conclusions:RIs applicable to Saudis were established for the majority of chemistry analytes, whereas gender, regional and age RI partitioning was required for some analytes. The elevated upper limits of metabolic analytes reflects the existence of high prevalence of metabolic syndrome in Saudi population.


2016 ◽  
Vol 12 (27) ◽  
pp. 93 ◽  
Author(s):  
Al Hariri , Ahmed

Background: Vitamin D deficiency/insufficiency and anxiety are rapidly growing epidemics among Saudis. Objectives: This study aims to explore the degree and rates of anxiety among Saudis with vitamin D deficiency and insufficiency, to investigate the anxiety means differences between males and females with low vitamin D levels, and to investigate the anxiety means differences between the participants of the same gender in each of two groups, those with vitamin D deficiency and those with insufficiency. Methods: A cross-sectional study was carried out on 228 Saudi participants from two medical centres in Riyadh, Saudi Arabia. A structured questionnaire was used to measure anxiety, and the lab analysts at the two centres reported the participants’ vitamin D levels based on their blood tests. Results: The anxiety mean among Saudis with vitamin D deficiency was higher than among their peers with vitamin D insufficiency. Significant differences in anxiety means existed between males and females with vitamin D insufficiency by a large magnitude, and between males in both groups, with vitamin D deficiency and insufficiency, by a moderate magnitude. Conclusion: Although Saudi females were higher in their anxiety means in both groups, vitamin D deficiency and insufficiency, both anxiety and low vitamin D levels are continuous problems in Saudi Arabia. Hence, more could be done to foster awareness and to combat these issues through consuming vitamin D supplements and increasing food quality.


Food Research ◽  
2021 ◽  
Vol 5 (5) ◽  
pp. 34-41
Author(s):  
R.M. Alhomaid

One billion people globally have been affected by vitamin D deficiency and its associated diseases; therefore, the present study was aimed to estimate the knowledge, awareness and practices of vitamin D in the Qassim region of the adult population before and during the COVID-19 pandemic. A cross-sectional survey was conducted among 195 of the general adult population in the Qassim region, Saudi Arabia from 15th September 2020 to 25th October 2020. The results revealed that a high percentage of participants are cognizant of vitamin D (93.8%). Also, it appears that there was no association between knowledge and awareness of vitamin D and age, gender, education or social status. Around 82.6% of the participants know the sources of vitamin D and the majority of participants enjoy sun exposure (79%), where the most time exposed to the sun is early in the morning and after 3 pm, reported to at 43.6% and 52.3%, respectively. In addition, about 35% of participants increased their knowledge of vitamin D after the emergence of COVID-19. A high percentage of participants thought that vitamin D raising the body immunity against viral infection or improve immunity, in general, was at 67.7%, that thought that vitamin D prevents or increase resistance to COVID-19. From the foregoing results, it could be concluded that a high level of knowledge and awareness about vitamin D in adults living in the Qassim region and increased knowledge after the emergence of COVID-19 is the most important result of the current study.


2021 ◽  
Author(s):  
Nadia Sabbah ◽  
Peter Wolf ◽  
Céline Piedvache ◽  
Séverine Trabado ◽  
Tristan Verdelet ◽  
...  

Context: Measurement of IGF-I is important in the management of patients with growth hormone disorders. Here we aim to establish normative data for two new IGF-I assay kits based on a large random sample of the French general adult population. Subjects and Methods: We measured IGF-I in 911 healthy adults (18–90 years) with two immunoassays (ROCHE Elecsys® and IMMULITE-2000 calibrated against the new IS 02/2547). We compared the data with those of the six immunoassays (iSYS, LIAISON XL, IMMULITE-2000 calibrated against the first IS 87/518, IGFI RIACT, Mediagnost ELISA, and Mediagnost RIA) that we reported previously. The pairwise concordance among the eight assays was assessed with Bland-Altman plots for both the IGF-1 raw data and the standard deviation scores (SDS), as well as with the percentage of observed agreement and the weighted Kappa coefficient for categorizing IGF-I SDS (ClinicalTrials.gov Identifier: NCT01831648). Results: The normative data included the range of values (2.5–97.5 percentiles) given by the two new IGF-I assays according to age group and sex. A formula for the SDS calculation is provided. For the previous six assays, the lower limits of the reference intervals of the two new assays were similar, but the upper limits varied markedly. The pairwise concordances were only moderate (kappa 0.57). Conclusions: Data obtained for these two new IGF-I immunoassays confirm that despite being obtained in the same large healthy population, the reference intervals of the eight commercial IGF-1 assay kits showed noteworthy differences. The agreement among the various methods was moderate to good.


PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0234284
Author(s):  
Anna Ruzhanskaya ◽  
Kiyoshi Ichihara ◽  
Svetlana Evgina ◽  
Irina Skibo ◽  
Nina Vybornova ◽  
...  

Objectives A multicenter study was organized to explore sources of variation (SVs) of reference values (RVs) for 22 major immunochemistry analytes and to determine reference intervals (RIs) for the Russian population. Methods According to IFCC Committee on Reference Intervals and Decision Limits (C-RIDL) protocol, 758 healthy volunteers were recruited in St. Petersburg, Moscow, and Yekaterinburg. Serum samples were tested for five tumor markers, 17 hormones and related tests by Beckman Coulter’s UniCel DxI 800 immunochemistry analyzer. SVs were explored using multiple regression analysis and ANOVA. Standard deviation ratio (SDR) of 0.4 was used as primary guide for partitioning RIs by gender and age. Results SDR for between-city difference was <0.4 for all analytes. Secondary exclusion of individuals was done under the following conditions: for female sex-hormones, those with contraceptives (8%); for CA19-9, those supposed to have negative Lewis blood-group (10.5% males and 11.3% females); for insulin, those with BMI≥28 kg/m2 (31%); for the thyroid panel, those with anti-thyroid antibodies (10.3% males; 24.5% females), for CEA those with smoking habit (30% males and 16% females). Gender-specific RIs were required for all analytes except CA19-9, CA15-3, thyroid-related tests, parathyroid hormone, and insulin. Age-specific RIs were required for alpha-fetoprotein, CEA, all sex-hormones for females, FSH and progesterone for both sexes. RIs were generally derived by parametric method after Gaussian transformation using modified Box-Cox formula. Exceptions were growth hormone, estradiol for females in postmenopause, and progesterone for females in premenopause, for which nonparametric method was required due to bimodal distribution and/or insufficient detection limit. Conclusion RIs for major hormones and tumor markers specific for the Russian population were derived based on the up-to-date internationally harmonized protocol by careful consideration of analyte-specific SVs.


2017 ◽  
Vol 87 (1-2) ◽  
pp. 37-48
Author(s):  
Riyadh A. Alzaheb ◽  
Norah Alatawi ◽  
Khawla A. Daoud ◽  
Naema Altawil

Abstract.Background: Establishing understanding of infants’ dietary intakes can support interventions to improve their diets and overall health. Because information on the dietary intakes of infants aged ≤12 months in Saudi Arabia is scarce, this study examined the diets of infants aged 6 and 12 months in Saudi Arabia and determined their main dietary sources of total energy and macronutrients. Methods: A crosssectional dietary survey employing a single 24-hour recall was performed between May and December 2015 with a sample of mothers of 278 healthy 6-month-old and 259 12-month-old infants. An analysis of the dietary intake data determined the nutrient intake adequacy and the percentage contributions of foods to energy and macronutrient intakes. Results: The respective mean daily energy intakes of the 6-month-old and 12-month-old infants in the study were 703 kcal and 929 kcal. Both age groups recorded adequate nutrient intakes, with the exception that the 6-month-olds’ mean vitamin D intake fell below the recommended Adequate Intake (AI), and the 12-month-olds’ intakes of omega-6 fatty acids and vitamin D were also below the AI, along with their iron intake which fell short of the Recommended Dietary Allowance (RDA). Conclusion: The data generated here will assist health professionals in planning interventions which aim to improve infants’ diets and to offer guidance to parents on the appropriate selection of food for their infants.


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