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Clinical Chemistry and Laboratory... Nov 2018This document provides a joint recommendation for venous blood sampling of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for... (Review)
Review
This document provides a joint recommendation for venous blood sampling of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE) and Latin American Working Group for Preanalytical Phase (WG-PRE-LATAM) of the Latin America Confederation of Clinical Biochemistry (COLABIOCLI). It offers guidance on the requirements for ensuring that blood collection is a safe and patient-centered procedure and provides practical guidance on how to successfully overcome potential barriers and obstacles to its widespread implementation. The target audience for this recommendation are healthcare staff members directly involved in blood collection. This recommendation applies to the use of a closed blood collection system and does not provide guidance for the blood collection with an open needle and syringe and catheter collections. Moreover, this document neither addresses patient consent, test ordering, sample handling and transport nor collection from children and unconscious patients. The recommended procedure is based on the best available evidence. Each step was graded using a system that scores the quality of the evidence and the strength of the recommendation. The process of grading was done at several face-to-face meetings involving the same mixture of stakeholders stated previously. The main parts of this recommendation are: 1) Pre-sampling procedures, 2) Sampling procedure, 3) Post-sampling procedures and 4) Implementation. A first draft of the recommendation was circulated to EFLM members for public consultation. WG-PRE-LATAM was also invited to comment the document. A revised version has been sent for voting on to all EFLM and COLABIOCLI members and has been officially endorsed by 33/40 EFLM and 21/21 COLABIOCLI members. We encourage professionals throughout Europe and Latin America to adopt and implement this recommendation to improve the quality of blood collection practices and increase patient and workers safety.
Topics: Blood Specimen Collection; Chemistry, Clinical; Europe; Humans; Latin America; Medical Laboratory Science
PubMed: 30004902
DOI: 10.1515/cclm-2018-0602 -
Clinical Chemistry and Laboratory... Dec 2018Reference intervals are a vital part of the information supplied by clinical laboratories to support interpretation of numerical pathology results such as are produced... (Review)
Review
Reference intervals are a vital part of the information supplied by clinical laboratories to support interpretation of numerical pathology results such as are produced in clinical chemistry and hematology laboratories. The traditional method for establishing reference intervals, known as the direct approach, is based on collecting samples from members of a preselected reference population, making the measurements and then determining the intervals. An alternative approach is to perform analysis of results generated as part of routine pathology testing and using appropriate statistical techniques to determine reference intervals. This is known as the indirect approach. This paper from a working group of the International Federation of Clinical Chemistry (IFCC) Committee on Reference Intervals and Decision Limits (C-RIDL) aims to summarize current thinking on indirect approaches to reference intervals. The indirect approach has some major potential advantages compared with direct methods. The processes are faster, cheaper and do not involve patient inconvenience, discomfort or the risks associated with generating new patient health information. Indirect methods also use the same preanalytical and analytical techniques used for patient management and can provide very large numbers for assessment. Limitations to the indirect methods include possible effects of diseased subpopulations on the derived interval. The IFCC C-RIDL aims to encourage the use of indirect methods to establish and verify reference intervals, to promote publication of such intervals with clear explanation of the process used and also to support the development of improved statistical techniques for these studies.
Topics: Chemistry, Clinical; Humans; Reference Standards
PubMed: 29672266
DOI: 10.1515/cclm-2018-0073 -
Clinical Chemistry and Laboratory... Apr 2023
Topics: Humans; History, 20th Century; Chemistry, Clinical; Anniversaries and Special Events; Laboratories
PubMed: 36785890
DOI: 10.1515/cclm-2023-0143 -
European Heart Journal Jul 2016To critically evaluate the clinical implications of the use of non-fasting rather than fasting lipid profiles and to provide guidance for the laboratory reporting of...
Fasting is not routinely required for determination of a lipid profile: clinical and laboratory implications including flagging at desirable concentration cut-points-a joint consensus statement from the European Atherosclerosis Society and European Federation of Clinical Chemistry and Laboratory...
AIMS
To critically evaluate the clinical implications of the use of non-fasting rather than fasting lipid profiles and to provide guidance for the laboratory reporting of abnormal non-fasting or fasting lipid profiles.
METHODS AND RESULTS
Extensive observational data, in which random non-fasting lipid profiles have been compared with those determined under fasting conditions, indicate that the maximal mean changes at 1-6 h after habitual meals are not clinically significant [+0.3 mmol/L (26 mg/dL) for triglycerides; -0.2 mmol/L (8 mg/dL) for total cholesterol; -0.2 mmol/L (8 mg/dL) for LDL cholesterol; +0.2 mmol/L (8 mg/dL) for calculated remnant cholesterol; -0.2 mmol/L (8 mg/dL) for calculated non-HDL cholesterol]; concentrations of HDL cholesterol, apolipoprotein A1, apolipoprotein B, and lipoprotein(a) are not affected by fasting/non-fasting status. In addition, non-fasting and fasting concentrations vary similarly over time and are comparable in the prediction of cardiovascular disease. To improve patient compliance with lipid testing, we therefore recommend the routine use of non-fasting lipid profiles, while fasting sampling may be considered when non-fasting triglycerides >5 mmol/L (440 mg/dL). For non-fasting samples, laboratory reports should flag abnormal concentrations as triglycerides ≥2 mmol/L (175 mg/dL), total cholesterol ≥5 mmol/L (190 mg/dL), LDL cholesterol ≥3 mmol/L (115 mg/dL), calculated remnant cholesterol ≥0.9 mmol/L (35 mg/dL), calculated non-HDL cholesterol ≥3.9 mmol/L (150 mg/dL), HDL cholesterol ≤1 mmol/L (40 mg/dL), apolipoprotein A1 ≤1.25 g/L (125 mg/dL), apolipoprotein B ≥1.0 g/L (100 mg/dL), and lipoprotein(a) ≥50 mg/dL (80th percentile); for fasting samples, abnormal concentrations correspond to triglycerides ≥1.7 mmol/L (150 mg/dL). Life-threatening concentrations require separate referral when triglycerides >10 mmol/L (880 mg/dL) for the risk of pancreatitis, LDL cholesterol >13 mmol/L (500 mg/dL) for homozygous familial hypercholesterolaemia, LDL cholesterol >5 mmol/L (190 mg/dL) for heterozygous familial hypercholesterolaemia, and lipoprotein(a) >150 mg/dL (99th percentile) for very high cardiovascular risk.
CONCLUSION
We recommend that non-fasting blood samples be routinely used for the assessment of plasma lipid profiles. Laboratory reports should flag abnormal values on the basis of desirable concentration cut-points. Non-fasting and fasting measurements should be complementary but not mutually exclusive.
Topics: Atherosclerosis; Cardiovascular Diseases; Chemistry, Clinical; Cholesterol; Consensus; Fasting; Humans; Lipid Metabolism; Lipids; Risk Factors; Triglycerides
PubMed: 27122601
DOI: 10.1093/eurheartj/ehw152 -
Clinical Chemistry and Laboratory... Apr 2023Lot-to-lot verification is an integral component for monitoring the long-term stability of a measurement procedure. The practice is challenged by the resource... (Review)
Review
Lot-to-lot verification is an integral component for monitoring the long-term stability of a measurement procedure. The practice is challenged by the resource requirements as well as uncertainty surrounding experimental design and statistical analysis that is optimal for individual laboratories, although guidance is becoming increasingly available. Collaborative verification efforts as well as application of patient-based monitoring are likely to further improve identification of any differences in performance in a relatively timely manner. Appropriate follow up actions of failed lot-to-lot verification is required and must balance potential disruptions to clinical services provided by the laboratory. Manufacturers need to increase transparency surrounding release criteria and work closer with laboratory professionals to ensure acceptable reagent lots are released to end users. A tripartite collaboration between regulatory bodies, manufacturers, and laboratory medicine professional bodies is key to developing a balanced system where regulatory, manufacturing, and clinical requirements of laboratory testing are met, to minimize differences between reagent lots and ensure patient safety. has served as a fertile platform for advancing the discussion and practice of lot-to-lot verification in the past 60 years and will continue to be an advocate of this important topic for many more years to come.
Topics: Humans; Quality Control; Reagent Kits, Diagnostic; Chemistry, Clinical; Laboratories
PubMed: 36420533
DOI: 10.1515/cclm-2022-1126 -
Clinical Chemistry and Laboratory... Jul 2022
Topics: Chemistry, Clinical; Humans; Laboratories
PubMed: 35822713
DOI: 10.1515/cclm-2022-0627 -
Biochemia Medica 2011Hemolysis is still the most common reason for rejecting samples, while reobtaining a new sample is an important problem. The aim of this study was to investigate the...
INTRODUCTION
Hemolysis is still the most common reason for rejecting samples, while reobtaining a new sample is an important problem. The aim of this study was to investigate the effects of hemolysis in different hemolysis levels for mostly used biochemical parameters to prevent unnecessary rejections.
MATERIALS AND METHODS
Sixteen healthy volunteers were enrolled in the study. Four hemolysis levels were constituted according to hemoglobin concentrations and they were divided into five groups: Group I: 0-0.10 g/L, Group II:0.10-0.50 g/L, Group III: 0.51-1.00 g/L, Group IV: 1.01-2.50 g/L, Group V: 2.51-4.50 g/L. Lysis was achieved by mechanical trauma.
RESULTS
Hemolysis interference affected lactate dehydrogenase (LD) and aspartate aminotransferase (AST) almost at undetectable hemolysis by visual inspection (plasma hemoglobin < 0.5 g/L). Clinically meaningful variations of potassium and total bilirubin were observed in moderately hemolyzed samples (hemoglobin > 1 g/L). Alanine aminotransferase (ALT), cholesterol, gamma glutamyltransferase (GGT), and inorganic phosphate (P) concentrations were not interfered up to severely hemolyzed levels (hemoglobin: 2.5-4.5 g/L). Albumin, alkaline phosphatase (ALP), amylase, chloride, HDL-cholesterol, creatine kinase (CK), glucose, magnesium, total protein, triglycerides, unsaturated iron binding capacity (UIBC) and uric acid differences were statistically significant, but remained within the CLIA limits.
CONCLUSION
To avoid preanalytical visual inspection for hemolysis detection, improper sample rejection, and/or rerun because of hemolysis, it is recommended in this study that, routine determination of plasma or serum free hemoglobin concentrations is important. For the analytes interfered with hemolysis, new samples have to be requested.
Topics: Blood Chemical Analysis; Blood Physiological Phenomena; Blood Specimen Collection; Chemistry, Clinical; Hemolysis; Humans
PubMed: 22141211
DOI: 10.11613/bm.2011.015 -
Archives of Pathology & Laboratory... Feb 2017
Topics: Chemistry, Clinical; Humans; Pathology, Clinical
PubMed: 28029803
DOI: 10.5858/arpa.2016-0176-ED -
PloS One 2022Laboratory medicine plays a critical role in the modern healthcare system, and it is reported to influence 60-70% of clinical decision makings. The quantitative...
Laboratory medicine plays a critical role in the modern healthcare system, and it is reported to influence 60-70% of clinical decision makings. The quantitative laboratory test results are interpreted by comparing to the Reference Intervals (RIs) and therefore the use of appropriate RIs is critical. Clinical laboratories in Bhutan have been randomly using RIs from textbooks and manufacturer's package inserts without even verifying their applicability and therefore lessening their contribution to clinical decision makings. To improve the healthcare service delivery in Bhutan, this study aims to establish routine clinical chemistry and haematological test RIs for healthy adults in the Bhutanese population. Out of 1150 (male, n = 570; female, n = 580) healthy Bhutanese adults listed for the study through a simple random sampling technique, 1002 (male, n = 405; female, n = 597) individuals were assessed and 815 (male, n = 372; female, n = 443) individuals were enrolled in the study. An adequate volume of venous blood was drawn from these participants with the use of standard phlebotomy technique for clinical chemistry and haematological analysis. The laboratory data were analysed with the use of statistical methods recommended by the International Federation of Clinical Chemistry and Laboratory Medicine and Clinical and Laboratory Standards Institute. After excluding the test results indicating underlying pathology and statistically detected outliers, a maximum of 775 (male, n = 346; female, n = 429) and 784 (male, n = 351; female, n = 433) individuals test values were eligible for clinical chemistry and haematology RIs establishment respectively. Statistically, there were no significant differences between age groups of same-sex for both test categories; however, significant differences between sex were observed for various test parameters in both test categories. Our RIs are generally comparable to other published literature. The established RIs are applicable to all the adult Bhutanese population; however, clinical laboratories should validate the transference of these RIs before using them for clinical purposes.
Topics: Adult; Bhutan; Chemistry, Clinical; Female; Hematologic Tests; Humans; Male; Reference Standards; Reference Values
PubMed: 36048813
DOI: 10.1371/journal.pone.0273778 -
Clinical Chemistry and Laboratory Medicine: progress and new challenges for our 50-year-old journal.Clinical Chemistry and Laboratory... Jan 2013
Topics: Anniversaries and Special Events; Chemistry, Clinical; Clinical Laboratory Techniques; Clinical Medicine; Journal Impact Factor; Periodicals as Topic; Publishing
PubMed: 23093279
DOI: 10.1515/cclm-2012-0449