scholarly journals Estimation of indirect reference intervals for serum thyrotropin using hospital records

2017 ◽  
Vol 8 (3) ◽  
pp. 41-48 ◽  
Author(s):  
Kushal Bhattarai ◽  
Nilu Manandhar ◽  
Prabodh Shrestha ◽  
Sangita Thapa ◽  
Jharana Shrestha ◽  
...  
Keyword(s):  
Clinical Decision Making ◽  
Clinical Chemistry ◽  
Tertiary Care ◽  
Reference Intervals ◽  
Medical Sciences ◽  
Hospital Records ◽  
Clinical Databases ◽  
Test Kit ◽  
Indirect Reference ◽  
Serum Tsh

Background: Reference intervals of any biochemical analyte serve as an invaluable tool in clinical decision making. The IFCC (International Federation of Clinical Chemistry) guidelines for determining these values are not feasible in some hospital laboratory setting and have led to the development of alternative approaches.Aims and Objectives: To determine the indirect reference intervals for serum thyrotropin form the hospital records of individuals visiting a tertiary care center.Materials and Methods: In a hospital-record based, observational, cross-sectional study, data of serum TSH levels were collected from the hospital records of participants who underwent this test in the Central Clinical Laboratory, College of Medical Sciences and Teaching Hospital, Bharatpur, Chitwan, Nepal from July 2012 to June 2015. All the individuals, irrespective of their diagnoses of thyroid diseases and other possible comorbid conditions, were included in the study. Prior to the statistical analyses, partitioning was done in relation to gender, age, and ethnicity. The reference intervals for thyrotropin were established by non-parametric method.Results: Reference intervals for serum TSH best agreeing to those provided by the test kit suppliers were determined by combining the two strategies that used Tukey’s method of detection and removal of outliers, prior to the final analyses. Lower limit was best determined from the natural-log-transformed and upper limit from non-transformed TSH values with outliers removed by Tukey’s method in both. As such, for the cases with TSH in the range 0.02-98.8 mIU/L, the reference intervals were calculated as [0.31 (0.30-0.33) to 6.04 (5.97-6.12) mIU/L] and for the TSH in the range 0.102-9.99 mIU/L, [0.35 (0.34-0.37) to 5.81 (5.75-5.90) mIU/L].Conclusion: For establishing the indirect reference intervals from the hospital records, laboratory data can be combined with information stored in clinical databases for selecting subjects fulfilling stated clinical criteria.Asian Journal of Medical Sciences Vol.8(3) 2017 41-48

Establishment of Reference Intervals for Alkaline Phosphatase in Pakistani Children Using a Data Mining Approach

2019 ◽  
Vol 51 (5) ◽  
pp. 484-490 ◽  
Author(s):  
Sibtain Ahmed ◽  
Jakob Zierk ◽  
Aysha Habib Khan
Keyword(s):  
Data Mining ◽  
Alkaline Phosphatase ◽  
Clinical Decision Making ◽  
Clinical Chemistry ◽  
Age Groups ◽  
Clinical Decision ◽  
German Society ◽  
Reference Intervals ◽  
Photometric Method ◽  
Data Mining Approach

Abstract Objective To establish reference intervals (RIs) for alkaline phosphatase (ALP) levels in Pakistani children using an indirect data mining approach. Methods ALP levels analyzed on a Siemens Advia 1800 analyzer using the International Federation of Clinical Chemistry’s photometric method for both inpatients and outpatients aged 1 to 17 years between January 2013 and December 2017, including patients from intensive care units and specialty units, were retrieved. RIs were calculated using a previously validated indirect algorithm developed by the German Society of Clinical Chemistry and Laboratory Medicine’s Working Group on Guide Limits. Results From a total of 108,845 results, after the exclusion of patients with multiple specimens, RIs were calculated for 24,628 males and 18,083 females with stratification into fine-grained age groups. These RIs demonstrate the complex age- and sex-related ALP dynamics occurring during physiological development. Conclusion The population-specific RIs serve to allow an accurate understanding of the fluctuations in analyte activity with increasing age and to support clinical decision making.

Use of total patient data for indirect estimation of reference intervals for 40 clinical chemical analytes in Turkey

2006 ◽  
Vol 44 (7) ◽  
Author(s):  
Yesim Ozarda Ilcol ◽  
Diler Aslan
Keyword(s):  
Binding Capacity ◽  
Clinical Chemistry ◽  
Reference Intervals ◽  
Thyroid Stimulating Hormone ◽  
Patient Data ◽  
Clinical Chemical ◽  
Laboratory Results ◽  
Total Triiodothyronine ◽  
Iron Binding Capacity ◽  
Indirect Reference

AbstractIn the present study we used patient data to calculate laboratory-specific indirect reference intervals. These values were compared with reference intervals obtained for a healthy group according to recommendations of the International Federation of Clinical Chemistry and Laboratory Medicine and manufacturer suggestions. Laboratory results (422,919 records) from all subjects of 18–45years of age over a 1-year period were retrieved from our laboratory information system and indirect reference intervals for 40 common analytes were estimated using a modified Bhattacharya procedure. Indirect reference intervals for most of the biochemical analytes were comparable, with small differences in lower [alkaline phosphatase (ALP) (male), alanine aminotransferase (ALT), creatine kinase, iron (male), total iron-binding capacity, folic acid, calcium (female), lactate dehydrogenase (LDH), lipoprotein (a) [Lp(a)], thyroid-stimulating hormone (TSH), total triiodothyronine (TClin Chem Lab Med 2006;44:867–76.

scholarly journals Application of the TML method to big data analytics and reference interval harmonization

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Mary Kathryn Bohn ◽  
Khosrow Adeli
Keyword(s):  
Clinical Chemistry ◽  
A Priori ◽  
Big Data Analytics ◽  
Reference Interval ◽  
German Society ◽  
Reference Intervals ◽  
Indirect Methods ◽  
Advantages And Disadvantages ◽  
Result Interpretation ◽  
Indirect Reference

Abstract Significant variation in reported reference intervals across healthcare centers and networks for many well-standardized laboratory tests continues to exist, negatively impacting patient outcomes by increasing the risk of inappropriate and inconsistent test result interpretation. Reference interval harmonization has been limited by challenges associated with direct reference interval establishment as well as hesitancies to apply currently available indirect methodologies. The Truncated Maximum Likelihood (TML) method for indirect reference interval establishment developed by the German Society of Clinical Chemistry and Laboratory Medicine (DGKL) presents unique clinical and statistical advantages compared to traditional indirect methods (Hoffmann and Bhattacharya), increasing the feasibility of developing indirect reference intervals that are comparable to those determined using a direct a priori approach based on healthy reference populations. Here, we review the application of indirect methods, particularly the TML method, to reference interval harmonization and discuss their associated advantages and disadvantages. We also describe the CSCC Reference Interval Harmonization Working Group’s experience with the application of the TML method in harmonization of adult reference intervals in Canada.

Age-specific thyroid hormone and thyrotropin reference intervals for a pediatric and adolescent population

2012 ◽  
Vol 50 (5) ◽  
Author(s):  
Eduardo A. Chaler ◽  
Romina Fiorenzano ◽  
Carla Chilelli ◽  
Vanessa Llinares ◽  
Giselle Areny ◽  
...  
Keyword(s):  
Thyroid Hormones ◽  
Clinical Chemistry ◽  
Laboratory Data ◽  
Age Groups ◽  
Reference Value ◽  
Reference Intervals ◽  
Reference Distribution ◽  
Free T4 ◽  
Reference Change Value ◽  
Serum Tsh

AbstractEstablishment of reliable reference intervals remains valuable for confirming validity and advancing standardization across methods and populations. Moreover, knowledge of the measurement uncertainty (U) and of the reference change value (RCV) has important applications in clinical chemistry.Starting from the information available in the laboratory data base (29,901 subjects) an initial selection was carried out by eliminating all subjects with a clinical or laboratory pathological report; data from 7581 0- to 20-year-old subjects (53.87% girls) remained in the study. These subjects, divided into nine age groups, were used to define reference distribution percentiles (2.5th, 50th and 97.5th) of serum thyrotropin (TSH), triiodothyronine (T3), thyroxine (T4), and free T4 (fT4), as well as U and RCV of these assays.In early infancy, T4 and fT4 values were higher than in the older age groups. Serum T4 95th percentile reference value, useful for the diagnosis of hyperthyroidism, was 142.9 in 20-year-old boys and 230.4 nmol/L in early infants and serum T3 95th percentile was 2.6 and 3.5 nmol/L, respectively, while fT4 2.5th percentile reference value, useful for the diagnosis of hypothyroidism, was 9.6 and 13.0 pmol/L, respectively. Serum TSH 97.5th percentile showed less age variation, 4.38–4.88 mIU/L. Performance of the four assays resulted in approximately 20% Us, reflecting simple and complex imprecision, trueness, analytical and functional sensitivity. RCV of serum TSH (58.6%) was larger than for thyroid hormones (28.3%–34.7%), probably due to the high biological variation of this hormone.We have established reference interval for TSH and thyroid hormones, as well as Us for assessing reliability of measurements, and RCVs to alert users on the presence of clinical significant changes.

scholarly journals Reference intervals for 26 common biochemical analytes in term neonates in Jilin Province, China

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kaijin Wang ◽  
Xuetong Zhu ◽  
Qi Zhou ◽  
Jiancheng Xu
Keyword(s):  
Lactate Dehydrogenase ◽  
Clinical Decision Making ◽  
Reference Intervals ◽  
Individual Characteristics ◽  
Integrated System ◽  
Delivery Mode ◽  
Related Factor ◽  
Term Neonates ◽  
Age Related ◽  
Laboratory Test Results

Abstract Background Biochemical analytes provide information for neonatal disease management and therapy, and population-based reference intervals (RIs) are essential to accurately interpret laboratory test results. This study aimed to establish local RIs for biochemical assays in term neonates. Methods A total of 195 healthy term neonates from birth to 3rd day were recruited as reference individuals prospectively. Analytes of 26 common biochemistries were measured using the VITROS 5600 Integrated System. The 3-level nested ANOVA was performed to assess the need for partitioning RIs of each analyte, and RIs were derived by a nonparametric method or robust method. Multiple regression analysis was used to evaluate specific correlations between the analytes and individual characteristics including age, gender, gestational age, birthweight and delivery mode. Results There were no between-sex differences in all analytes, whereas there were significant between-day-age differences in 6 analytes. Small between-delivery-mode differences were observed in the results for potassium, phosphorus, and urea. The major related factor of most analytes was postnatal age. During the first 3 days, values of iron, lipids and lipoproteins increased; creatinine, urea, uric acid, creatine kinase and lactate dehydrogenase decreased; other analytes showed slight changes or relatively stable trends. Reference limits of some analytes, particularly lactate dehydrogenase and alkaline phosphatase, were significantly different from adult and pediatric groups. Conclusions RIs of 26 common biochemical analytes are established for term neonates aged 0 to 3 days in northeast China. Additionally, it is suggested that age-related changes should be valued in the clinical decision-making process for newborns.

Pediatric reference interval verification for endocrine and fertility hormone assays on the Abbott Alinity system

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Mary Kathryn Bohn ◽  
Siobhan Wilson ◽  
Alexandra Hall ◽  
Khosrow Adeli
Keyword(s):  
Clinical Decision Making ◽  
De Novo ◽  
Reference Interval ◽  
Clinical Decision ◽  
Reference Intervals ◽  
Healthy Children ◽  
Confidence Limits ◽  
Test Results ◽  
Serum Samples ◽  
Abbott Architect

Abstract Objectives The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) has developed an extensive database of reference intervals (RIs) for several biomarkers on various analytical systems. In this study, pediatric RIs were verified for key immunoassays on the Abbott Alinity system based on the analysis of healthy children samples and comparison to comprehensive RIs previously established for Abbott ARCHITECT assays. Methods Analytical performance of Alinity immunoassays was first assessed. Subsequently, 100 serum samples from healthy children recruited with informed consent were analyzed for 16 Alinity immunoassays. The percentage of test results falling within published CALIPER ARCHITECT reference and confidence limits was determined. If ≥ 90% of test results fell within the confidence limits, they were considered verified based on CLSI guidelines. If <90% of test results fell within the confidence limits, additional samples were analyzed and new Alinity RIs were established. Results Of the 16 immunoassays assessed, 13 met the criteria for verification with test results from ≥ 90% of healthy serum samples falling within the published ARCHITECT confidence limits. New CALIPER RIs were established for free thyroxine and prolactin on the Alinity system. Estradiol required special considerations in early life. Conclusions Our data demonstrate excellent concordance between ARCHITECT and Alinity immunoassays, as well as the robustness of previously established CALIPER RIs for most immunoassays, eliminating the need for de novo RI studies for most parameters. Availability of pediatric RIs for immunoassays on the Alinity system will assist clinical laboratories using this new platform and contribute to improved clinical decision-making.

Risk Stratification of Patients Undergoing Primary Pci for Stemi Using Dynamic Timi Risk Score at A Tertiary Care Cardiac Center

2021 ◽  
Vol 15 (11) ◽  
pp. 3252-3256
Author(s):  
Jehangir Hasan ◽  
Muhammad Hashim Kalwar ◽  
Javed Khurshed Shaikh ◽  
Syed Mohammad Haleem ◽  
Muhammad Hassan Butt ◽  
...  
Keyword(s):  
Risk Score ◽  
Clinical Decision Making ◽  
Tertiary Care ◽  
Case Series ◽  
Primary Pci ◽  
St Segment Elevation ◽  
Case Series Study ◽  
Femoral Route ◽  
Timi Risk Score ◽  
Cardiac Center

Objective: To determine the frequency of severity based on dynamic TIMI scoring among STEMI patients undergoing primary PCI at a tertiary care Cardiac center. Subject and Methods: This case series study was carried out on 171 patients admitted with acute STEMI undergoing PPCI at the department of cardiology NICVD, Karachi for six months from February 1st to July 30th, 2018. After the selection of patients, they were shifted to the Cath lab, the arterial sheath was passed through the femoral route only although the radial route is also present but to reduce the bias we choose the same femoral route only. Angiography was done and the area of occlusion identified was ballooned/stented by the interventional cardiologist having experience of at least 03 years. The study parameters of dynamic TIMI risk score points were recorded on a predesigned proforma. Results: The mean age of the patients of the study subjects was 59.89±12.67, Distribution of gender was stated, 133(77.78%) patients were male and (22.22%) were female. Outcome dynamic TIMI risk score severity was stated, 86(50.29%) patients had a low risk, 62(36.26%) patients had a moderate risk, 23(13.45%) patients had a high risk. Conclusion: When used in STEMI patients, this new approach shows the ever-changing risks and could be helpful in clinical decision-making as well as risk assessment. Keywords: ST-segment elevation myocardial infarction; Primary percutaneous coronary intervention, TIMI

Annual biological variation and personalized reference intervals of clinical chemistry and hematology analytes

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Shuo Wang ◽  
Min Zhao ◽  
Zihan Su ◽  
Runqing Mu
Keyword(s):  
Clinical Chemistry ◽  
Population Based ◽  
Reference Intervals ◽  
Biological Variation ◽  
Annual Data ◽  
Healthy Individuals ◽  
Reference Change Value ◽  
Index Of Individuality ◽  
Personalized Diagnosis

Abstract Objectives A large number of people undergo annual health checkup but accurate laboratory criterion for evaluating their health status is limited. The present study determined annual biological variation (BV) and derived parameters of common laboratory analytes in order to accurately evaluate the test results of the annual healthcare population. Methods A total of 43 healthy individuals who had regular healthcare once a year for six consecutive years, were enrolled using physical, electrocardiogram, ultrasonography and laboratory. The annual BV data and derived parameters, such as reference change value (RCV) and index of individuality (II) were calculated and compared with weekly data. We used annual BV and homeostatic set point to calculate personalized reference intervals (RIper) which were compared with population-based reference intervals (RIpop). Results We have established the annual within-subject BV (CVI), RCV, II, RIper of 24 commonly used clinical chemistry and hematology analytes for healthy individuals. Among the 18 comparable measurands, CVI estimates of annual data for 11 measurands were significantly higher than the weekly data. Approximately 50% measurands of II were <0.6, the utility of their RIpop were limited. The distribution range of RIper for most measurands only copied small part of RIpop with reference range index for 8 measurands <0.5. Conclusions Compared with weekly BV, for annual healthcare individuals, annual BV and related parameters can provide more accurate evaluation of laboratory results. RIper based on long-term BV data is very valuable for “personalized” diagnosis on annual health assessments.

scholarly journals Tubercular mastitis: An institutional experience from a tertiary care centre of northern India

2017 ◽  
Vol 8 (3) ◽  
pp. 72-75
Author(s):  
Amit Gupta ◽  
Lovenish Bains ◽  
Deepshikha Yadav ◽  
Prashant Durgapal ◽  
Manish Kumar Agrawal
Keyword(s):  
Tertiary Care ◽  
Needle Aspiration ◽  
Care Centre ◽  
Medical Sciences ◽  
Tertiary Care Centre ◽  
Aspiration Cytology ◽  
Northern India ◽  
Institutional Experience ◽  
Needle Aspiration Cytology ◽  
High Index Of Suspicion

Background: Tuberculous mastitis (TM) is a rare extra pulmonary presentation of tuberculosis. It may be problematic to distinguish from carcinoma breast, a condition with which it may coexist.  Fine needle aspiration cytology (FNAC) / biopsy are indispensable for diagnosis and tuberculosis culture when positive may be very valuable to guide antimicrobial therapy.Aims and Objectives:  To disseminate the message to the concerned expertise that it can present a diagnostic problem on radiological and microbiological investigations, and thus a high index of suspicion is needed.Materials and Methods: 19 cases of tubercular mastitis between  January 2012 to March 2014 were identified and included in the present study. Cytology and biopsy alongwith AFB stain was done for confirmation.Results: Age ranged between 23- 55 years (median 33 years). Axillary nodes were palpable in 9 (47.3%) patients. Acid Fast Bacilli stain which was positive in only 3 patients. All the 19 patients were started on antitubercular treatment.Conclusion: This study highlights the importance of early diagnosis and aggressive medical and if required surgical management to cure this disease.Asian Journal of Medical Sciences Vol.8(3) 2017 72-75

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