Reference Range Research Articles

Reference intervals of Cyfra21-1 and CEA in healthy adult Han Chinese population

ObjectiveThis study aimed to establish the reference intervals of Cyfra21-1 and CEA for the local screening populations using a chemiluminescence method. MethodsA total of 4845 healthy adults and 190 lung cancer patients were included from the First Hospital of Hebei Medical University. The levels of Cyfra21-1 and CEA were measured to establish the local reference intervals. ResultsThe upper limit reference intervals for Cyfra21-1 and CEA were determined as 3.19 ng/ml and 3.13 ng/ml, respectively. Notably, both Cyfra21-1 and CEA levels were found to be higher in males than in females. Additionally, both biomarkers showed an increasing trend with age.In terms of diagnostic efficacy, the receiver operating characteristic (ROC) curve areas for Cyfra21-1, CEA, and their combination in lung cancer were 0.86, 0.73, and 0.91, respectively. ConclusionOur study revealed that the reference intervals of Cyfra21-1 and CEA in the local population differed from the established reference intervals. Furthermore, both biomarkers exhibited gender-dependent variations and demonstrated a positive correlation with age. Combining the two biomarkers showed potential for improving the diagnosis rate of lung cancer.

A multicenter nationwide reference intervals study for common biochemical analytes in Nepalese apparently healthy adult population

A multicenter nationwide reference intervals study for common biochemical analytes in Nepalese apparently healthy adult population

First trimester specific reference interval of TSH, FT3, FT4 in population of Oran (Algeria)

First trimester specific reference interval of TSH, FT3, FT4 in population of Oran (Algeria)

Serum 25-OH vitamin D concentrations – Are different reference intervals depending on the season in Croatia required?

Serum 25-OH vitamin D concentrations – Are different reference intervals depending on the season in Croatia required?

The performance of unsupervised machine learning method in the indirect reference interval estimation of selected biochemical analytes

The performance of unsupervised machine learning method in the indirect reference interval estimation of selected biochemical analytes

A comprehensive analysis of the immune system in healthy Vietnamese people

Lifestyle, diet, socioeconomic status and genetics all contribute to heterogeneity in immune responses. Vietnam is plagued with a variety of health problems, but there are no available data on immune system values in the Vietnamese population. This study aimed to establish reference intervals for immune cell parameters specific to the healthy Vietnamese population by utilizing multi-color flow cytometry (MCFC). We provide a comprehensive analysis of total leukocyte count, quantitative and qualitative shifts within lymphocyte subsets, serum and cytokine and chemokine levels and functional attributes of key immune cells including B cells, T cells, natural killer (NK) cells and their respective subpopulations. By establishing these reference values for the Vietnamese population, these data contribute significantly to our understanding of the human immune system variations across diverse populations. These data will be of substantial comparative value and be instrumental in developing personalized medical approaches and optimizing diagnostic strategies for individuals based on their unique immune profiles.

A novel statistical approach for the verification of reference intervals from real-world data

A novel statistical approach for the verification of reference intervals from real-world data

Python-powered analysis: Establishing creatinine reference intervals in a specialized kidney institute of Pakistan

Python-powered analysis: Establishing creatinine reference intervals in a specialized kidney institute of Pakistan

Establishment of reference intervals for serum and salivary cortisol in Kano, Nigeria

Establishment of reference intervals for serum and salivary cortisol in Kano, Nigeria

Reference intervals for TSH, fT4 and fT3 established with newly developed AI-based method

Reference intervals for TSH, fT4 and fT3 established with newly developed AI-based method

A multicenter nationwide reference intervals study for common biochemical analytes in nepalese apparently healthy population using Beckman Coulter (AU480) analyzer

A multicenter nationwide reference intervals study for common biochemical analytes in nepalese apparently healthy population using Beckman Coulter (AU480) analyzer

Pediatric indirect reference intervals for hemogram parameters derived from hospital data

Pediatric indirect reference intervals for hemogram parameters derived from hospital data

Performance verification and reference interval establishment of serum/plasma aldosterone by a novel “sandwich” chemiluminescent immunoassay

Performance verification and reference interval establishment of serum/plasma aldosterone by a novel “sandwich” chemiluminescent immunoassay

Population and method specific establishment of ACTH reference interval

Population and method specific establishment of ACTH reference interval

Determination of reference intervals and decision limits for thyroid stimulating hormone and Thyroxine on cord blood samples

Determination of reference intervals and decision limits for thyroid stimulating hormone and Thyroxine on cord blood samples

Single-Dose Oral Toxicity Study of Chloroform Extract of Kaffir Lime (Citrus hystrix DC.) Leaves in Wistar Rats (Rattus norvegicus Berkenhout, 1769)

Leaves of kaffir lime (Citrus hystrix) are commonly used as a seasoning in various Indonesian and Southeast Asian dishes. Phytochemical studies reported various secondary metabolites that possess medicinal properties. Before exploring their potential as therapeutic agent, a series of toxicity studies must be conducted to assess the toxicity and safety levels. This research aimed to study the single-dose acute oral toxicity of chloroform extract of kaffir lime leaves (CECHL) in female Wistar rats (Rattus norvegicus) as experimental animals. The procedure followed OECD Test Guideline No.420 with the dose 2000 mg/kg bw for 14 days (Sighting study). Parameters consisted of mortality, clinical signs of sublethal effect based on changes in general appearance and daily activity/behavior, hematological profile, and blood clinical biochemistry. Neither mortality nor sublethal effects were found during the experiment. All blood parameter values (erythrocytes, leukocytes, thrombocytes, ALT, AST, creatinine, BUN, glucose, cholesterol, and triglycerides) were within reference interval, indicating that CECHL is not harmful to normal physiology. In conclusion, single-dose oral administration of CECHL is safe, no-observed-adverse-effect-level (NOAEL) at dose 2000 mg/kg bw or included in Category 5 based on the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).

Quantitative detection of mpox antigen using time-resolved fluorescence immunochromatography.

Recently, concern has been raised about the spread of human mpox virus, and the demand for rapid detection reagents for mpox virus has increased. This study aims to establish a time-resolved fluorescence immunochromatography (TRFICO) method for qualitative/quantitative detection of mpox virus. A double-antibody sandwich TRFICO method was optimized and established using mpox recombinant fusion antigen and its paired monoclonal antibody. The test performance of the method was evaluated using mpox fusion antigen and control serum, including sensitivity, linearity range, specificity, precision, and reference interval. We successfully established a TRFICO method for qualitative/quantitative detection of mpox antigen, its linearity range 0-100ng/mL, analytical sensitivity 0.017ng/mL, and reference intervals greater than 0.045ng/mL. No cross-reaction was detected with various poxvirus and clinical negative controls, with good specificity. All average recoveries of the intra- and inter-batch ranged from 81.33% to 97.83%, and all CVs were below 10%. Additionally, the TRFICO strips can be stably stored at 37°C for 7days without significant changes in the fluorescence intensity. This TRFICO method, with high sensitivity, linearity range, specificity, precision, and stability with 16-min detection time, provides a new option for qualitative/quantitative and convenient testing of mpox virus.

Reference intervals for bone marrow cells in juvenile and young adult cats bone marrow cytology.

The current bone marrow (BM) reference intervals (RI) are based on a limited number of cats. Age-related changes in BM variables might be important, possibly affecting the interpretation of the results. Establish BM cytologic reference intervals (RIs) and association of age and sex on these findings, in healthy juvenile and young adult cats. BM aspirates of cats deemed healthy based on history and clinical, CBC, serum chemistry findings, and negative retrovirus serology were obtained and examined cytologically. The examination included a 1000-nucleated differential cell count and cell morphologic assessment. RIs were calculated using parametric, robust, and nonparametric methods. The cytologic findings were examined for associations with sex and age. The study included 40 cats (females, 22 [55%]; males, 18 [45%]) with a median age of 1.5 years (range 0.5-5). Most calculated RIs were similar to those previously reported. BM plasma cell and monocyte counts were weakly and positively correlated with age (rs, .312 and .373, respectively; P < .05). Metarubricytes were higher in females (mean, 25.1%; SD, 6.0%) than males (mean, 21.2%; SD, 6.0%; P < .05). The BM differential cell counts determined in this study can serve as RIs for cats aged 0.5-5 years.

Population Pharmacokinetics of Lamotrigine and Its N2-Glucuronide Metabolite in Chinese Patients with Epilepsy.

Lamotrigine is a new antiepileptic drug with substantial interindividual variability in its pharmacokinetics and therapeutic responses. This study aimed to develop population pharmacokinetic (PPK) models of lamotrigine and its N2-glucuronide metabolites for model-informed individualized therapy. A total of 353 plasma concentrations from Chinese patients with epilepsy receiving oral lamotrigine were used to develop a population PPK model using a nonlinear mixed effects modeling method. One- and two-compartment models were applied to the nonmetabolite and metabolite model, respectively. Forward addition and backward elimination were used to establish the final model. Model validation was performed using standard goodness-of-fit, bootstrap, visual predictive checks, and normalized prediction distribution errors. Finally, simulations were performed to propose lamotrigine dosages in different situations to achieve trough concentrations within the reference interval (2.5-15 mg/L). For both final population PPK models, coadministration with valproic acid (VPA) or enzyme inducer, and body weight significantly affected lamotrigine clearance. The final models for lamotrigine clearance were and for nonmetabolite and metabolite models, respectively. The precision of the PPK parameters was acceptable, and the models exhibited good predictability. Monte Carlo simulations revealed that the lamotrigine dosage administered to patients combined with an enzyme inducer must be tripled that administered with VPA to reach the target trough concentration. Variability in the pharmacokinetics of lamotrigine is large. Coadministration of VPA or an enzyme inducer and body weight are the most important factors in lamotrigine clearance in Chinese patients with epilepsy. The developed population PPK models might support further optimization of lamotrigine dosing regimens.

The Invstigation of Lipid Profile in Saudi Healthy Population and the Effects of Lifestyle

In this study differences in the response of plasma total cholesterol, triglycerides, Low Density Lipoprotein Cholesterol and High Density Lipoprotein Cholesterol were investigated in normal healthy Saudi population according to sex, age and lifestyle (rural and urban). This study was carried out for a total of (873) subjects (475 males and 398 females). Each of these two sex groups is classified into six subgroups according to ages ([0-14],[15-24],[25-40],[41-55],[56-69],[70+]). For the all tested people the blood was drawn after overnight fasting period (12-14hrs) using heparinized tubes. For all the required parameters (total cholesterol, triglycerides, LDL-C, HDL-C) enzymatic colorimetric method is used and the mean values were obtained accordingly. For plasma total cholesterol, triglycerides, HDL-C and LDL-C, the results showed lower Total Cholesterol, Triglycerides and Low Density Lipoprotein Cholesterol levels through childhood group (0-14) in both males and females. However HDL-C remains high in children with similar values as in adults in both males and females between city and village population. Neonatal and children plasma contains proportionately higher HDL-C than that of adult, decreases during adolescence to a constant value and remains constant up to the age of 55 years in both sexes, then it starts to rise to a constant level and remain constant throughout life. For both males and females at birth and through early years of life (infants and children) there were no considerable differences in all parameters (T.C, HDL-C, LDL-C, TG) tested and that is may be due to absolute and close similarity of dietary habits and lifestyle between villagers and city populations for infants and children respectively. These levels increase with increasing of age for both sexes depending deeply upon the diet, and the increase of total cholesterol is significant or close to significant up to the age of 69 years in males, then it starts to fall, but it continued to rise in women. Similarly LDL-C level increases up to the age of 69 in males and then it remains constant through all the rest of the life, but for females it continues on increasing throughout life. Triglyceride levels increase up to the age of 55 in males where it started to fall throughout life, whereas in females it follow the same manner as T.C and LDL-C since it increases throughout life. The increasing of LDL-C is quite obvious throughout life in females, whereas it remains constant after the age of 69 in males. On the other hand it seems that differences of dietary habits and lifestyle are much more effective in the adult groups of age (15-24), (25-40), (41-55), (56-69), (70+), since there are significant or nearly significant differences between villagers and city populations in plasma total cholesterol, LDL-C, HDL-C and triglycerides. It is quite obvious that the variability in plasma lipids and lipoproteins (T.C, TG, HDL-C and LDL-C) among populations precludes the establishment of universally acceptable limits. What may be considered "normal" for one populations group may not necessarily be applicable to another. Even within a country, these reference intervals may vary from a city to a village due to differences in dietary habits and lifestyle and also markedly age and sex.