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1.
IntroductionEvaluation of thyroid function is often requested and therefore defining paediatric reference intervals (RIs) is of vital importance. Currently, there is a distinct lack of paediatric RIs for thyroid function tests in Croatia. Thus, we established RIs for thyroid stimulating hormone (TSH), total triiodothyronine (TT3), total thyroxine (TT4), free triiodothyronine (FT3) and free thyroxine (FT4) in the Croatian paediatric population.Materials and methodsReference intervals were calculated from 397 apparently healthy children, aged from 2 days to < 19 years. Serum samples were analysed for thyroid function tests on the Abbott Architect i2000. Age- and sex-specific 95% RIs with 90% confidence intervals were established according to Clinical and Laboratory Standards Institute guidelines. To express the magnitude of sex and age variation, standard deviation ratio (SDR) was calculated using two-level nested ANOVA. The criterion for considering partitioning reference values was set to SDR > 0.3.ResultsAll thyroid function tests required age partitioning, confirmed by SDR above 0.3. There was no need for sex partitioning, confirmed by SDR below 0.3. Still, FT3 was partitioned due to visually noticeable sex related difference for the oldest group (12 years to < 19 years).ConclusionThis is the first study to establish RIs for thyroid function tests in the Croatian paediatric population. We propose RIs for widely used Abbott platform, thus giving laboratories method- and population-specific paediatric RIs for thyroid function tests that should improve clinical test interpretation.  相似文献   

2.
The reference intervals (RIs) of serum aminotransferases and Gamma-glutamyl transferase (GGT) have been established many years ago. Recent RIs are not available. The prospective study was conducted to re-evaluate the RIs of liver enzymes and the effect of demographic and anthropometric variables on them in western Indian population. A total of 1059 blood donors comprised the study population. Anthropometry and serum liver enzymes levels were measured. Subjects were categorized into normal weight and overweight by using body mass index (BMI) and waist circumference (WC). For RI determination, non-parametric methodology recommended by IFCC/CLSI was adopted. Mann–Whitney test and Spearman’s rank correlation were used for statistical analysis. Upper limit of normal reference value of liver enzymes were lower in female compared to male. (ALT—23.55 F vs 36.00 M, GGT—34.58 F vs 36.20 M) When RI of liver enzymes were calculated according to body mass index, the upper limit of normal of ALT and GGT were higher in overweight group compared to normal weight group. (ALT—38.00 vs 27.00 IU/L and GGT—37.59 vs 35.26 IU/L). In both male and female, liver enzymes correlated significantly with age. WC and BMI were positively correlated with AST, ALT and GGT in both subgroups and the correlation was stronger in male. Demographic factors should be considered for making liver enzyme tests more clinically relevant. Gender based partitioning should be adopted for serum alanine aminotransferase (ALT) and GGT reference values for Western Indian population.  相似文献   

3.
Reference intervals (RIs) of serum thyroid stimulating hormone (TSH) and free thyroxine (fT4) were determined in 402 healthy pregnant women by enzyme-linked immunosorbent assay (ELISA) technique after partitioning them into three trimesters. The reference population was chosen from a study population of 610 pregnant females by applying strict inclusion and exclusion criteria. The assays were done using proper quality control measures. RIs were calculated from the central 95 % of the distribution of TSH and fT4 values located between the lower reference limit of 2.5 percentile and upper reference limit of 97.5 percentile value 0.90 confidence intervals for the upper and lower reference limits were also determined. The reference intervals for TSH were 0.25–3.35 μIU/ml for the first trimester; 0.78–4.96 μIU/ml for the second trimester and 0.89–4.6 μIU/ml for the third trimester. Similarly, the reference intervals for fT4 for first, second and third trimesters were 0.64–2.0, 0.53–2.12 and 0.64–1.98 ng/dl respectively. The values thus obtained varied from those provided by the kit literature. In comparison to our derived reference intervals, the reference data from kit manufacturer under-diagnosed both subclinical hypo- and hyper-thyroidism within our pregnant reference population.  相似文献   

4.
IntroductionIndirect estimation of reference intervals (RIs) is straightforward and inexpensive procedure for determination of intra-laboratory RIs. We applied the indirect approach to assess RIs for haematological parameters in capillary blood of pre-school children, using results stored in our laboratory database.Materials and methodsWe extracted data from laboratory information system, for the results obtained by automatic haematology analyser in capillary blood of 154 boys and 146 girls during pre-school medical examination. Data distribution was tested, and logarithmic transformation was applied if needed. Reference intervals were calculated by the nonparametric percentile method.ResultsReference intervals were calculated for: RBC count (4.2-5.4 x1012/L), haemoglobin (114-146 g/L), MCH (25.0-29.4 pg), MCHC (321-368 g/L), RDW-SD (36.1-43.5 fL), WBC count (4.5-12.3 x109/L), neutrophils count (1.7-6.9 x109/L) and percentage (29.0-69.0%), lymphocytes count (1.6-4.4 x109/L) and percentage (21.9-60.7%), PLT (165-459 x109/L), MPV (8.1-11.4 fL) and PDW (9.2-14.4%). Gender specific RIs were calculated for monocytes count (male (M): 0.2-1.6 x109/L; female (F): 0.1-1.4 x109/L) and percentage (M: 2.5-18.3%; F: 1.8-16.7%), haematocrit (M: 0.34-0.42 L/L; F: 0.34-0.43 L/L), MCV (M: 73.4-84.6 fL; F: 75.5-84.2 fL) and RDW (M: 12.1-14.3%; F: 11.7-13.9%), due to observed gender differences in these parameters (P = 0.031, 0.028, 0.020, 0.012 and 0.001; respectively). Estimated RIs markedly varied from the literature based RIs that are used in the laboratory.ConclusionsIndirect method employed in this study enables straightforward assessment of RIs in pre-school children. Herein derived RIs differed from the literature-based ones, indicating the need for intra-laboratory determination of RIs for specific populations and sample types.  相似文献   

5.
The central role of the laboratory scientist is to aid the clinician, in interpreting observed values, by providing relevant reference values in a convenient and practical form. In India, reference values used in laboratories have been established in the western population. But these can be questioned due to differences in genetic load, lifestyle, and diet. This review highlights the approach for establishing reference values in our population using the IFCC guidelines and our observations from our data as compared to the reported values in our laboratory.  相似文献   

6.
IntroductionIntensive physical activity causes functional and metabolic changes in the athlete’s organism. The study aimed to verify the common national available reference intervals (RIs) for common inflammatory and screening coagulation tests in a population of healthy young female athletes.Materials and methodsOne hundred and twenty-one female athletes (age range: 16–34), from various sports disciplines (water polo, handball, volleyball, football, basketball), were included in the study. All participants completed the international physical activity short-form questionnaire. Blood samples were collected between 8–10 am, after an overnight fast, before any physical activity. Reference intervals were determined according to Clinical & Laboratory Standards Institute EP28-A3C Guidelines.ResultsCalculated RIs for white blood cell count (WBC), prothrombin time (PT), and activated partial thromboplastin time (APTT) ratio were in accordance with the common national RIs. Calculated RI for C-reactive protein (CRP) was lower (< 2.9 mg/L) than the proposed cut-off for a healthy population (< 5.0 mg/L). Reference interval for fibrinogen was higher (1.9–4.4 g/L), than the available RIs (1.8–3.5 g/L). D-dimer cut-off value was set at 852 µg/L fibrinogen equivalent units (FEU), higher than the proposed 500 µg/L FEU for venous thromboembolism (VTE) exclusion.ConclusionsThe applicability of the available RIs for WBC count, PT, and APTT-ratio was confirmed. However, RIs for CRP and fibrinogen differed significantly than the available common national RIs for the healthy non-athletes’ population. A higher cut-off for D-dimers should be extensively verified before implementation for VTE diagnosis exclusion in a group of healthy young female athletes.  相似文献   

7.
Clinical reference intervals among Indian population are poorly defined. Therefore, there is an urgent need to establish local clinical laboratory reference intervals for healthy Indian population. The present study aimed to identify the 95 % reference interval for hematological and biochemical parameters in apparently healthy Indian population. We undertook a multicentric cross-sectional study conducted at Apollo Hospitals Educational and Research Foundation across India. Of which 10,665 reference individuals identified as healthy by physicians. The 95 % of the reference distribution was estimated using 2.5th and 97.5th percentile reference limits. The 95 % reference intervals for hemoglobin (Males: 12.3–17 g/dL; Females: 9.9–14.3 g/dL), platelet count (Males: 1.3–3.8; Females: 1.3–4.2 Lakhs/µL), erythrocyte sedimentation rate (Males: 2–22; Females: 4–55 mm/h), serum uric acid in males: 3.5–8.2 mg/dL, gamma glutamyl transferase (Males: 13–61 U/L), fasting blood glucose (Males: 78–110 mg/dL), total cholesterol (Males: 115–254 mg/dL), low density lipoprotein (Males: 60–176 mg/dL) and triglycerides (Males: 55–267 mg/dL, Females: 52–207 mg/dL) were different from currently used reference values. Additionally need for gender based partitioning were observed for triglycerides and gamma glutamyl transferase. The observed findings are of clinical significance and it needs to be validated with additional community based studies.  相似文献   

8.
Hyperhomocysteinemia has been shown to be an independent risk factor for cardiovascular disease as well as retinal vascular occlusion. Because of the epidemiological, dietary, genetic and environmental diversity among the different countries, each country should establish the reference interval of homocysteine of their own population for recommending appropriate medical decision limits. Hence a total of 1,288 apparently healthy subjects including 636 male and 652 female were enrolled in the present study to determine the reference intervals of homocysteine in an Indian population. Results of the study were presented as mean, standard deviation, median and 2.5th and 97.5th percentile with the 0.90 confidence interval of each percentile values of homocysteine along with decade-wise changes.  相似文献   

9.
Quality indicators (QIs) measure the extent to which set targets are attained and provide a quantitative basis for achieving improvement in care and, in particular, laboratory services. A body of evidence collected in recent years has demonstrated that most errors fall outside the analytical phase, while the pre- and post-analytical steps have been found to be more vulnerable to the risk of error. However, the current lack of attention to extra-laboratory factors and related QIs prevent clinical laboratories from effectively improving total quality and reducing errors. Errors in the pre-analytical phase, which account for 50% to 75% of all laboratory errors, have long been included in the ‘identification and sample problems’ category. However, according to the International Standard for medical laboratory accreditation and a patient-centered view, some additional QIs are needed. In particular, there is a need to measure the appropriateness of all test request and request forms, as well as the quality of sample transportation. The QIs model developed by a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is a valuable starting point for promoting the harmonization of available QIs, but further efforts should be made to achieve a consensus on the road map for harmonization.  相似文献   

10.
In this paper we would like to briefly introduce readers to the situation in the field of laboratory medicine in Bosnia and Herzegovina, with a focus on training in the field of medical biochemistry. As in some of neighboring countries, term Medical biochemist is the usual name for the Clinical biochemist or Clinical chemist in Bosnia and Herzegovina. Despite the difficult period through which the profession had passed in the last two decades, laboratory work, particularly clinical biochemistry, has managed to retain the necessary quality and keep pace with the developed world. In post war period, Society of Medical Biochemists of Bosnia and Herzegovina held regular meetings each year as a part of "life long learning" process, where both scientific and vocational lecturers presented their work. A single law on the state level would provide us with more defined and precise answers, such as: who can get a specialization, how long should last the training for medical biochemistry specialists (duration in years). This law should be in consent with the program described in EC4 or other documents given by the EFCC (European Federation of Clinical Chemistry and Laboratory Medicine) and IFCC (International Federation of Clinical Chemistry and Laboratory Medicine).  相似文献   

11.
The incidence of cardiovascular and cerebrovascular disease is steadily increasing in South East Asian countries including Indian sub continent. Many lipids, apolipoproteins and Lp (a) except HDL-C and apo A-I, A-II are implicated as risk factors for coronary artery disease and cerebrovascular disease. There is great need to have national guidelines for each country like the ATP III guidelines recommended for U.S. population. For recommending appropriate medical decision limits, it is mandatory that each country establishes reference intervals pertaining to their population due to dietary, genetic and environmental diversity. In the present study, reference intervals for serum lipids, apolipoproteins and Lp (a) were established in a total of 1923 healthy Indian reference individuals comprising 1161 healthy men and 762 healthy women from Andhra Pradesh. For each analyte viz., serum total cholesterol, HDL-C, LDL-C, triglycerides, Lp (a), Apo A-I, Apo A-II, B, C-II, C-III and E, mean, two SD, median, confidence limits of mean, different percentile values are presented. The study also includes decade wise changes in each analyte and comparison of lipids, lipoproteins and Lp (a) among few populations covering U.S., India, Japan, Sweden, Finland and China. Reference Intervals for all lipid and lipoprotein parameters will immensely help in assessing associated risk for cardiovascular and cerebrovascular diseases in India. Additionally, the results will be beneficial in formulating our own guidelines pertaining to Indian population.  相似文献   

12.
IntroductionIt is often quoted that 70% of clinical decisions are based on laboratory results, but the evidence to substantiate this claim is lacking. Since clinical guidelines aim to document best-practice decision making for specific disease conditions, inclusion of any laboratory test means that the best available evidence is recommending clinicians use it. Cardiovascular disease (CVD) is the world’s most common cause of mortality, so this study reviewed all CVD guidelines published by five national/international authorities to determine what proportion of them recommended laboratory testing.Materials and methodsFive leading CVD guidelines were examined, namely the European Society of Cardiology (ESC), the UK National Institute for Health and Clinical Excellence (NICE), the American College of Cardiology (ACC), the Australian Heart Foundation (AHF) and the Cardiac Society of Australia and New Zealand (CSANZ).ResultsA total of 101 guidelines were reviewed. Of the 33 individual ESC guidelines relating to CVD, 24/33 made a direct reference to the use of clinical laboratory tests in either diagnosis or follow-up treatment. The same applied to 15/20 of NICE guidelines, 24/32 from the ACC and 15/16 from the AHF/CSANZ. Renal function and blood count testing were the most recommended (39 and 26 times), with lipid, troponin and natriuretic peptide measurement advocated 25, 19 and 19 times respectively.ConclusionsThis study has shown that laboratory testing is advocated by between 73% and 94% of individual CVD guideline recommendations from five national/international authorities. This provides an index to assess the potential value of laboratory medicine to healthcare.  相似文献   

13.
In a contemporary clinical laboratory it is very common to have to assess the agreement between two quantitative methods of measurement. The correct statistical approach to assess this degree of agreement is not obvious. Correlation and regression studies are frequently proposed. However, correlation studies the relationship between one variable and another, not the differences, and it is not recommended as a method for assessing the comparability between methods.
In 1983 Altman and Bland (B&A) proposed an alternative analysis, based on the quantification of the agreement between two quantitative measurements by studying the mean difference and constructing limits of agreement.
The B&A plot analysis is a simple way to evaluate a bias between the mean differences, and to estimate an agreement interval, within which 95% of the differences of the second method, compared to the first one, fall. Data can be analyzed both as unit differences plot and as percentage differences plot.
The B&A plot method only defines the intervals of agreements, it does not say whether those limits are acceptable or not. Acceptable limits must be defined a priori, based on clinical necessity, biological considerations or other goals.
The aim of this article is to provide guidance on the use and interpretation of Bland Altman analysis in method comparison studies.Key words: Bland-Altman, agreement analysis, laboratory research, method comparison, correlation of data  相似文献   

14.
Reference intervals in clinical chemistry are commonly based on results of measurements in reference western population or are taken from the western literature. Reference Values are thought to aid physicians to interpret results of measurements and, should be representative of a defined group of individuals. This group should be as similar as possible to the patients under investigation. The reference population in this, study has been recruited from the individuals attending the Health Plan Clinic who fulfill the defined inclusion and exclusion criteria as well as defined partition criteria. The samples were sorted based on the decision by the physician. The emerging group of individuals was considered as a reference population for the hospital patients and the results of measurements in this study was evaluated statistically, to stress on the urgent need to establish the in-house reference values. The reference limits are defined as the central 95 percentile of the population after eliminating the outliers. The lower, reference limit is the 2.5 percentile while the upper reference limit constituted the 97.5 percentile for the population.  相似文献   

15.
Reference Intervals denote normative values related to laboratory parameters/analytes used by diagnostic centers for clinical diagnosis. International guidelines recommend that every country must establish reference intervals for healthy individuals belonging to a group of homogeneous population. Considering enormous racial and ethnic diversity of Indian population, it is mandatory to establish reference intervals specific to Indian population. The overview on reference interval describes why the national organizations in India need to initiate nationwide efforts to establish its own laboratory standards for apparently healthy reference individuals belonging to our polygenetic, polyethnic, polyracial, multilinguistic and multicultural predominantly rural and appreciable urban Indian population with varied dietary habits.  相似文献   

16.

Introduction

Presepsin, the circulating soluble form of CD14 subtype (sCD14-ST) is a new emerging early marker for sepsis. Various cutoff levels of presepsin have been proposed, to discriminate between systemic bacterial and nonbacterial infectious diseases. The aim of this work was to define the reference interval for presepsin according to the CLSI C28-A3c approved guideline.

Materials and methods

Reference individuals (N = 200; 120 females) aged 18-75 years (median 39 years), free from inflammatory diseases, were selected for the study. Presepsin concentrations were measured by a commercially available chemiluminescent enzyme immunoassay (PATHFASTTM, Mitsubishi Chemical Europe GmbH, Düsseldorf, Germany). Reference limits were calculated using the non-parametric percentile method.

Results

Overall, the reference limits for the presepsin were 55–184 pg/mL (90% confidence intervals, CI, were 45 to 58 and 161 to 214, respectively). There were no significant differences between males and females and the presepsin concentrations were not even particularly influenced by age. The upper reference limit for the presepsin is much lower than every cut-off limit so far proposed, both for sepsis and also for systemic inflammatory response syndrome.

Conclusion

Specific decision levels are required to define the diagnostic and prognostic roles of presepsin in different settings of inflammatory and infectious diseases. Reference values can help to distinguish and quickly rule out healthy subjects or patients with other pathologies.Key words: CD14 Antigen, presepsin, reference values, male, female, Clinical and Laboratory Standard Institute  相似文献   

17.
Reference intervals for pubertal characteristics are influenced by genetic, geographic, dietary and socioeconomic factors. Therefore, the aim of this study was to establish age-specific reference intervals of glucose and lipid levels among local school children. This was cross-sectional study, conducted among Saudi school children. Fasting blood samples were collected from 2149 children, 1138 (53%) boys and 1011 (47%) girls, aged 6 to 18 years old. Samples were analyzed on the Architect c8000 Chemistry System (Abbott Diagnostics, USA) for glucose, cholesterol, triglycerides, HDL and LDL. Reference intervals were established by nonparametric methods between the 2.5th and 97.5th percentiles. Significant differences were observed between boys and girls for cholesterol and triglycerides levels in all age groups (P < 0.02). Only at age 6–7 years and at adolescents, HDL and LDL levels were found to be significant (P < 0.001). No significant differences were seen in glucose levels except at age 12 to 13 years. Saudi children have comparable serum cholesterol levels than their Western counterparts. This may reflect changing dietary habits and increasing affluence in Saudi Arabia. Increased lipid screening is anticipated, and these reference intervals will aid in the early assessment of cardiovascular and diabetes risk in Saudi pediatric populations.  相似文献   

18.

Introduction:

Capillary sampling is increasingly used to obtain blood for laboratory tests in volumes as small as necessary and as non-invasively as possible. Whether capillary blood sampling is also frequent in Croatia, and whether it is performed according to international laboratory standards is unclear.

Materials and methods:

All medical laboratories that participate in the Croatian National External Quality Assessment Program (N = 204) were surveyed on-line to collect information about the laboratory’s parent institution, patient population, types and frequencies of laboratory tests based on capillary blood samples, choice of reference intervals, and policies and procedures specifically related to capillary sampling. Sampling practices were compared with guidelines from the Clinical and Laboratory Standards Institute (CLSI) and the World Health Organization (WHO).

Results:

Of the 204 laboratories surveyed, 174 (85%) responded with complete questionnaires. Among the 174 respondents, 155 (89%) reported that they routinely perform capillary sampling, which is carried out by laboratory staff in 118 laboratories (76%). Nearly half of respondent laboratories (48%) do not have a written protocol including order of draw for multiple sampling. A single puncture site is used to provide capillary blood for up to two samples at 43% of laboratories that occasionally or regularly perform such sampling. Most respondents (88%) never perform arterialisation prior to capillary blood sampling.

Conclusions:

Capillary blood sampling is highly prevalent in Croatia across different types of clinical facilities and patient populations. Capillary sampling procedures are not standardised in the country, and the rate of laboratory compliance with CLSI and WHO guidelines is low.  相似文献   

19.
During post-analytical phase, critical value notification to responsible caregiver in a timely manner has potential to improve patient safety which requires cooperative efforts between laboratory personnel and caregivers. It is widely accepted by hospital accreditors that ineffective notification can lead to diagnostic errors that potentially harm patients and are preventable. The objective of the study was to assess the variables affecting critical value notification, their role in affecting it’s quality and approaches to improve it. In the present study 1,187 critical values were analysed in the Clinical Chemistry Laboratory catering to tertiary care hospital for neuropsychiatric diseases. During 25 months of study period, we evaluated critical value notification with respect to clinical care area, caregiver to whom it was notified and timeliness of notification. During the study period (25 months), the laboratory obtained 1,279 critical values in clinical chemistry. The analytes most commonly notified were sodium and potassium (20.97 & 20.8 % of total critical results). Analysis of critical value notification versus area of care showed that critical value notification was high in ICU and emergency area followed by inpatients and 64.61 % critical values were notified between 30 and 120 min after receiving the samples. It was found that failure to notify the responsible caregiver in timely manner represent an important patient safety issue and may lead to diagnostic errors. The major area of concern are notification of critical value for outpatient samples, incompleteness of test requisition forms regarding illegible writing, lack of information of treating physician and location of test ordering and difficulty in contacting the responsible caregiver.  相似文献   

20.
课题组 《软科学》2004,18(2):48-51
攀西地区是我国西部资源最富集地区之一,潜伏着巨大的潜在经济价值。本文以西部大开发为背景,从分析攀西资源开发状况入手,探索加快攀西区域经济发展的政策,为各级政府决策提供参考。  相似文献   

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