Establishment of Reference Intervals of Serum Immunoglobulins in Healthy Korean Adults.
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ABSTRACT:
SUBMITTER: Jang JH
PROVIDER: S-EPMC8255343 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Appropriate reference intervals of serum insulin-like growth factor I (IGF-I) is important for diagnosing and monitoring patients with growth hormone-related diseases. To establish reference intervals, adult individuals (n=1,334, 680 men and 654 women) were divided into six age groups (20-29, 30-39, 40-49, 50-59, 60-69, ≥70). Serum IGF-I was measured by chemiluminescence immunoassay (Liaison). Concordance of patient classification based on reference intervals, manufacturer's intervals, and standard deviation score (SDS) was evaluated. New reference intervals had higher upper and lower limits than those specified by the manufacturer. The agreement between classification using new reference interval and the manufacturer's reference interval, and that using new reference interval and SDS was 75.0% (weighted kappa, 0.17), 91.9% (weighted kappa, 0.51) in men and 91.0% (weighted kappa, 0.41), 92.5% (weighted kappa, 0.53) in women, respectively. Reference intervals should be established not only based on age and sex, but also on ethnicity and assay method.
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Project description:ObjectivesAutomated haematology analysers measure various parameters of relevance to clinical research along with routine complete blood count (CBC)-related components. We aimed to establish ethnicity-specific and sex-specific reference intervals for 26 research-specific parameters as well as 18 routinely reported components using a large cohort of healthy Korean adults. The necessity of requiring separate sex-specific reference intervals for each parameter was also examined.DesignA retrospective database review.SettingSingle tertiary-care hospital of approximately 375 physicians and 530 nurses.ParticipantsThis study included 1383 reference individuals (840 men and 543 women).Primary and secondary outcome measuresFollowing the Clinical and Laboratory Standards Institute guidelines for establishing reference intervals, routine CBCs as well as research parameters were measured using an ADVIA 2120i instrument.ResultsAll the routine components except for mean platelet volume and per cent lymphocytes differed significantly between men and women. Most research parameters also differed between the sexes; the exceptions were large platelets, platelet dry mass distribution width, per cent basophil saturation, per cent peroxidase saturation and per cent abnormal peroxidase absorption. Despite these differences, separate reference intervals for men and women were required only for two research-specific parameters: 'percentage high cellular haemoglobin' and 'percentage of hyperchromic red blood cells (RBCs)'.ConclusionEven though most parameters showed significant differences between men and women, none of the evaluated parameters except two RBC-related factors required separate reference intervals for each sex.
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Project description:BackgroundSerum calcitonin measurement contains various clinical and methodological aspects. Its reference level is wide and unclear despite sensitive calcitonin kits are available. This study aimed to identify the specific reference range in the healthy Korean adults.MethodsSubjects were ≥20 years with available calcitonin (measured by a two-site immunoradiometric assay) data by a routine health checkup. Three groups were defined as all eligible subjects (group 1, n=10,566); subjects without self or family history of thyroid disease (group 2, n=5,152); and subjects without chronic kidney disease, autoimmune thyroid disease, medication of proton pump inhibitor/H2 blocker/steroid, or other malignancies (group 3, n=4,638).ResultsThis study included 6,341 male and 4,225 female subjects. Males had higher mean calcitonin than females (2.3 pg/mL vs. 1.9 pg/mL, P<0.001) in group 1. This gender difference remained similar in groups 2 and 3. Calcitonin according to age or body mass index was not significant in both genders. Higher calcitonin in smoking than nonsmoking men was observed but not in women. Sixty-nine subjects had calcitonin higher than the upper reference limit (10 pg/mL) and 64 of them had factors associated with hypercalcitoninemia besides medullary thyroid cancer. Our study suggests the reference intervals for men who were non, ex-, current smokers, and women (irrespective of smoking status) as <5.7, <7.1, <7.9, and <3.6 pg/mL, respectively.ConclusionSpecific calcitonin reference range should be provided considering for sex and smoking status. Taking account for several factors known to induce hypercalcitoninemia can help interpret the gray zone of moderately elevated calcitonin.
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Project description:Amyloid ? (A?) peptides are important components of plaques in patients with Alzheimer's disease (AD). Recent studies suggest that a low plasma ratio of A?42 to A?40 may precede the development of the sporadic form of AD. The aim of this study was to establish reference intervals for plasma A? in Korean adults. A total of 370 apparently healthy individuals (181 males and 189 females aged 40-69 yr) without cognitive impairment were enrolled. Plasma concentrations of A?40 and A?42 were measured by using a human amyloid ? assay kit (Immuno-Biological Laboratories, Japan). Reference intervals were established according to the "CLSI guidelines for defining, establishing, and verifying reference intervals in the clinical laboratory". There was no need to partition the data with respect to gender or age group. The 95th percentile reference intervals for A?40 and A?42 were 127-331 pg/mL and 2.31-19.84 pg/mL, respectively. The reference interval for the A?42/A?40 ratio was 0.011-0.092. Plasma A? concentrations obtained in this study could be used as reference intervals for clinical purposes.
| S-EPMC5011114 | biostudies-other
Project description:BackgroundReference intervals defined for adults or children of other ethnicities cannot be applied in the evaluation of Korean pediatric patients. Pediatric reference intervals are difficult to establish because children are in their growing stage and their physiology changes continuously. We aimed to establish reference intervals for routine laboratory tests for Korean pediatric patients through retrospective multicenter data analysis.MethodsPreoperative laboratory test results from 1,031 pediatric patients aged 0 month-18 years who underwent minor surgeries in four university hospitals were collected. Age- and sex-specific reference intervals for routine laboratory tests were defined based on the Clinical and Laboratory Standards Institute (CLSI) EP28-A3c guidelines.ResultsThe pediatric reference intervals determined in this study were different from existing adult reference intervals and pediatric reference intervals for other ethnicities. Most tests required age-specific partitioning, and some of those required sex-specific partitioning for at least one age-partitioned subgroup. Erythrocyte sedimentation rate, monocyte percentage, basophil percentage, activated partial thromboplastin time, glucose, cholesterol, albumin, bilirubin, chloride, and C-reactive protein did not show any difference between age- or sex-partitioned subgroups.ConclusionsWe determined Korean pediatric reference intervals for hematology, coagulation, and chemistry tests by indirect sampling based on medical record data from multiple institutions. These reference intervals would be valuable for clinical evaluations in the Korean pediatric population.
| S-EPMC7591287 | biostudies-literature
Project description:IntroductionThe Platelet Function Analyzer-100 (PFA-100) is a point of care instrument that simulates plug formation under high shear flow. The PFA-100 measures the time required to occlude the aperture in a biochemically active cartridge and is expressed in a term of closure time (CT). In Algeria, the reference values used in clinical laboratories are of Western origin. However, ethnic, genetic, dietary environmental, and diet differences between populations may affect reference intervals. We established the reference intervals of PFA-100 closure times in healthy Algerian adults according to the International Federation of Clinical Chemistry method, and we compared them with those of Western and Asian countries.Material and methodsWe enrolled 303 healthy blood donors in the study. 218 subjects met inclusion criteria. We analyzed the blood sample on the PFA-100 for CT with both the collagen epinephrine and collagen ADP cartridges.ResultsThe reference intervals of PFA-100 collagen epinephrine CT and PFA-100 collagen ADP CT were 91-207 seconds and 71-144 seconds, respectively. Compared to Western and Asian populations, there were significant differences. The upper limits of CTs were higher for Algerians in this study. Our findings show that many healthy Algerians would be incorrectly identified as having a primary hemostasis abnormality according to the reference intervals of the manufacturer and scientific literature.ConclusionThis report provides the first reference intervals for PFA-100 CTs in healthy Algerian adults. These results improve the accuracy of diagnosis and patient care in Algeria.
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Project description:BackgroundErythrocyte sedimentation rate (ESR) is a new reporting parameter of the BC-720 auto hematology analyzer; however, no biological reference interval for healthy adults has been established for this parameter.MethodsOutpatients or hospitalized patients with ESR test orders were selected. The ESR was measured by the standard method of ESR (Westergren) recommended by the International Council for Standardization in Hematology (ICSH), the BC-720 hematology analyzer, and the LBY-XC40B auto ESR analyzer. The data were statistically analyzed and compared among different methods. The repeatability and carryover rate (CR) of the BC-720 were assessed in randomly selected samples for each range segment. Blood Samples from three hospitals in China were collected, and the reference interval of the BC-720 ESR was determined.ResultsThe ESR results measured by the BC-720 correlated well with the Westergren method (r=0.957, y = 0.359 + 1.016x), and there was no significant difference between these two methods (P>0.05). The correlation between LBY-XC40B auto ESR analyzer and Westergren was y = 1 + 1.25x and r=0.856. The BC-720 ESR has good repeatability [standard deviation (SD) ≤1 mm/h, coefficient of variation (CV) ≤5%], and the CR was less than 1%. The 95th percentile of the biological reference interval for BC-720 ESR is 15 mm/h for men and 24 mm/h for women.ConclusionsThe Mindray BC-720 ESR showed high accuracy and good repeatability, which provided a faster, safer, and more reliable method to measure ESR. The reference intervals for BC-720 ESR could guide better clinical decisions for the laboratories utilizing this new method.
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Project description:Background Clinical chemistry reference intervals are important tools for health evaluation, diagnosis, prognosis and monitoring adverse events. Currently used reference intervals in most African countries including Ethiopia are mainly derived from Western populations, despite studies reporting differences that could lead to incorrect clinical decisions. The aim of this study was to establish reference intervals for commonly used clinical chemistry parameters for healthy adults in Northeast Ethiopia. Methods A community based cross-sectional study was conducted among 328 apparently healthy adults between the ages of 18 and 57 years. Blood samples were collected for clinical chemistry analysis using Dirui CS-T240 auto-analyzer and serological testing to screen the population. Medians and 95% reference intervals were computed using non-parametric method according to the Clinical and Laboratory Standards Institute guideline. The Mann–Whitney U test was used to compare reference values between males and females. Results Reference intervals established were: ALT 11.2–48.0 U/L, AST 16–60 U/L, ALP 53–342.3 U/L, total protein 5.4–8.9 mg/dL, total bilirubin 0.1–1.23 mg/dL, glucose 65–125 mg/dL, total cholesterol 69–213 mg/dL, triglycerides 46–207 mg/dL, creatinine 0.3–1.2 mg/dL and urea 9.5–46.3 mg/dL. Significant sex-differences were observed for ALT, AST, ALP, total cholesterol, triglycerides, creatinine and urea. We found that the established reference intervals substantially differ from the reference ranges currently in use. Up to 43.1% of apparently healthy adults are considered as having abnormal test values on the bases of the currently in use reference ranges. If the reference values from the United States based intervals were applied to the study population, 81.8% would have been classified as having abnormal laboratory test results. Conclusions Local population-specific reference intervals were established for commonly used clinical chemistry parameters in adult population of Northeast Ethiopia. Although further study is needed, these reference intervals may have the potential to facility the decision-making process based on laboratory test results in this population.
| S-EPMC9629653 | biostudies-literature
Project description:The function of lymphocytes is the key to reflect the immune status of hosts. Evaluation of lymphocyte function is a useful tool to monitor the effect of immunosuppressive treatment and predict the prognosis of immune-mediated diseases (e.g., cancer, autoimmune diseases, and infectious diseases). As the lymphocytes have various activities, such as activation, cytotoxicity, and cytokine secretion, it is a challenge to evaluate the function of lymphocytes in clinical practice and the reference intervals (RIs) of lymphocyte function are rarely reported. The present study showed that the secretion of IFN-? was well correlated with the activation, chemotaxis, and cytotoxicity of CD4+, CD8+ T cells, and NK cells, which suggests that IFN-? production can be used as a symbol of lymphocyte function. We therefore created a simple method to detect the function of CD4+, CD8+ T cells, and NK cells simultaneously according to IFN-? secretion by using whole blood instead of peripheral blood mononuclear cells. We further established the RIs of lymphocyte function (CD4+ T cells: 15.31-34.98%; CD8+ T cells: 26.11-66.59%; NK cells: 39.43-70.79%) in healthy adults. This method showed good reproducibility for the evaluation of lymphocyte function. The established RIs were suitable for use in other centers based on the validation data. We also validated the RIs in individuals with different immune status, and the results showed that kidney transplant recipients and infants (0-1 year) had a decreased lymphocyte function, whereas T cells in systemic lupus erythematosus patients exhibited an opposite trend. Overall, we have successfully established the RIs of lymphocyte function in healthy adults in a simple way, which might be of important clinical value in the diagnosis, monitoring, and prognosis of immune-related diseases.
| S-EPMC5808316 | biostudies-literature
Project description:BackgroundNonesterified fatty acids (NEFAs) are an important energy substrate in mammals. Measurement of the NEFA concentration in blood serum is common practice and enables reliable detection of a negative energy balance in several species. This parameter can be used to detect subclinical metabolic diseases or to optimise feeding to prevent severe negative energy balance. Since no reference values for dogs have been published, the aim of this study was to establish such values.MethodsBlood serum from 85 healthy dogs was examined with a multiparameter clinical chemistry analyser. Given that NEFA values are not usually normally distributed, reference intervals (RIs) were calculated nonparametrically using bootstrapping (5000 replicates) for the 90% confidence intervals.ResultsThe examined cohort had a median age of 62.16 months (2-180 months) and a median weight of 19.2 kg (3.0-55.0 kg) and comprised 27 (31.8%) males and 58 (68.2%) females, with 32 (37.6%) neutered or spayed. The fasting time was 5.9 h (range 0-23 h). The tested confounders age, sex, neuter status, bodyweight and body condition score did not significantly affect the NEFA concentrations.ConclusionsThe NEFA RI for dogs in this study was 0.2-1.47 mmol/L. The results may be used to adjust food composition and amount in healthy dogs or to detect metabolic disorders. Further research on NEFA metabolism in dogs maintained in standardised conditions and in specific nutritional situations or with particular diseases is warranted.
| S-EPMC9313937 | biostudies-literature