Laboratory errors not only affect patient care, including delay in turnaround time, unnecessary redraws, wrong diagnosis, inappropriate treatment but also damages reputation of a laboratory and diminishes confidence of the patient on diagnostic services. Building on our earlier work on delineating preanalytical conditions (25, 26), and on the work of others (8, 2024, 29, 31, 40, 43, 45, 49, 50, 54, 56, 63), we have presented here updated general guidelines for the use of cfDNA. official website and that any information you provide is encrypted Temperature and time between separation and analysis. Only the defined quality of the analytical phase results made aware that unconsidered variables might be the cause of unsuitable results. Duration of the other factors is much longer. and transmitted securely. M Although increasingly used, ddPCR does not perform better than qPCR (55, 60) in terms of sensitivity and specificity. HHS Vulnerability Disclosure, Help Management of preanalytical errors needs involvement of the clinical domain for proper patient identification and test requisition, completely filling accompanying slips and sending proper samples for laboratory analysis, since many of the errors fall outside the physical boundaries of the laboratory. May 26, 2001; Leuwen: Terumo Europe; 2001. The National Committee for Clinical Laboratory Standards (now Clinical and Laboratory Standards Institute, CLSI) introduced preanalytical standards in 1981, which were partially followed by respective European Standards (European Committee on Clinical Laboratory Standards, ECCLS). To do so, plasma isolation should be of the shortest duration possible. The most frequent pre analytical error in our setting was unlabeled specimen (Table 1). The pre-analytical phase also includes physiological variables specific to the animal, such as age, gender, pregnancy, and endogenous variables such as medication [] Preanalytical phase management: a review of the procedures from patient preparation to laboratory analysis. 1). For example, compared to the frozen state, ACTH could be considered stable in EDTA plasma for 18 hours at 4 C but for only 8 hours at 30 C. [Statistische Qualittskontrolle in der Klinischen Chemie], [Richtlinien der Bundesrztekammer zur Durchfhrung von Manahmen der statistischen Qualittskontrolle und von Ringversuchen im Bereich der Heilkunde]. W Francisco MD, Chen WF, Pan CT, Lin MC, Wen ZH, Liao CF, Shiue YL. A systems approach to assure optimal proficiency testing in the hematology laboratory. The haemolytic, icteric and lipemic sample. Keywords: A 24-hour collection is often preferable but collection is more difficult and patient reliability can be an issue. Thus, drug interferences were reduced by specific reagents and analytical procedures (9,10), the effect of serum colour changes as appearing in haemolytic, turbid and icteric samples could be reduced by changing reference wavelengths or time (kinetic versus fixed time) or mechanism of the colorimetric analysis (11,12). Endogenous variables such as drugs or circulating antibodies might interact with a specific method to yield spurious analytic results. [Pranalytik in Greiling, Gressner Lehrbuch der Klinischen Chemie und Pathobiochemie]. At this time, we had introduced new one way open glass tubes for sampling blood instead of the old reusable glass tubes! Epigenetic alterations, easily evaluable in bodily fluids, have been applied as innovative biomarkers for cancer (13, 36). Lima-Oliveira G, Volanski W, Lippi G, Picheth G, Guidi GC. Preanalytical quality improvement. There is already evidence of a relationship between cfDNA methylation in human plasma and cardiovascular diseases (13). Dietary restriction. Research Funding: A.R. Therefore, these observations regarding sources of error cannot be extrapolated to cfDNA. E Department of Clinical Chemistry, Munich Community Hospital (emerited), Munich, Screening tests for common endocrine disorders. Accept/reject criteria must be defined. The second phase is the analytic phases. GB El Messaoudi Preanalytical quality improvement: in quality we trust. References on this subject are collected in Table 4 of the online Data Supplement. Quality management processes such as benchmarking, statistical process control, Pareto analysis and failure mode and effect analysis can be used to review data and should be incorporated into clinical governance mechanisms. Some students have a more analytical approach to learning. The pre-analytic testing phase occurs first in the laboratory process. 8600 Rockville Pike The pioneering work of Lo et al. The meaning of ANALYTIC is of or relating to analysis or analytics; especially : separating something into component parts or constituent elements. Oxford University Press is a department of the University of Oxford. An official website of the United States government. AR The use of such commercial kits (with or without automation) is necessary to obtain the required analytical homogeneity, yield, rapidity, and practicality when extracting cfDNA. The site is secure. and transmitted securely. The Impact of the Preanalytical Phase on the Quality of Laboratory Results. These factors should be standardized and systematically documented and always considered when results are being interpreted (20). After labeling the next big problem in our setup was diluted samples (Table 1). In the past decade, research has been focused on cfDNA analysis, particularly on the development of numerous detection methods and tests. AJ Retrieved from " https://en.wiktionary.org/w/index.php?title=preanalytical&oldid=47242370 " Categories: English terms prefixed with pre- English lemmas AS These effects were seen more often in winter, when in addition cooling increased this effect. This collective article summarizes the leading concepts expressed during the lectures of the fifth EFLM Preanalytical Conference "Preanalytical Challenges - Time for solutions", held in Zagreb, 22-23 March, 2019. After having collected many such cases in the first 5 years of consulting, we became aware the procedures happening before the tube entered the laboratory, caused errors we could hardly prevent without having more influence on the processes happening in the phase outside the laboratory which later came to be called preanalytical phase (6). Grammatically, this word "preanalytical" is an adjective, more specifically, an uncomparable adjective. In the other clinical fields, cfDNA analysis has not yet attained the level of validity required for widespread implementation in routine clinical diagnostics. This phase may include specimen handling issues that occur even prior to the time the specimen is received in the laboratory. Quick and accurate reading of DNA concentration and purity can be performed using spectrophotometry to measure the absorbance at 260 nm and the 260/280-nm ratio. Pre-analytical, Analytical, and Post-analytical Phases of Testing, White Blood Cell Differential Case Simulator, Automation and Technology in the Histology Laboratory (retired 6/6/2018), Learn more about Automation and Technology in the Histology Laboratory (retired 6/6/2018) (online CE course). , Anker P, Lyautey J, Lederrey C, Maurice PA. Thierry Lippi G, Becan-McBride K, Behulova D, Bowen RA, Church S, Delange J, et al. It turned out, that raining during transport of samples in the open area had led to dilution of blood by rain drops, which caused haemolysis due to hypoosmolality. In pursuit of harmony, on behalf of European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working group for Preanalytical Phase (WG-PRE). different units and age-adjusted cutoffs); and (4) discussing the use of D-dimer measurement across different clinical . Efficient Quantum Imaginary Time Evolution by Drifting Real-Time Evolution: An Approach with Low Gate and Measurement Complexity. Physiologic variables, such as lifestyle, age, and sex, and conditions such as pregnancy and menstruation, are some of the preanalytic phase factors. the contents by NLM or the National Institutes of Health. At that time, most labs did not feel responsible for procedures happening outside the laboratory. 2021 Mar 30;12(4):373. doi: 10.3390/mi12040373. Preanalytical phase comprises of test selection, patient identification, collection of the sample, handling of the sample, sorting out, pipetting and centrifugation (2, 3). Lo Consequently, we believe that basing our guidelines on the literature as a whole would be a major weakness. While preanalytic (as well as analytic and postanalytic) parameters must be continually evaluated, the guidelines proposed in this report will serve for preanalytical best practices and for setting a standard operating procedure. Division of the sample into a sufficient number of aliquots of a sufficient volume. 8600 Rockville Pike Role of Sponsor: The funding organizations played no role in the design of study, choice of enrolled patients, review and interpretation of data, preparation of manuscript, or final approval of manuscript. The cfDNA methylation pattern in patients is affected by many things, including preanalytical and analytical issues and endogenous and exogenous factors, including disease status, dietary intake (folate, vitamin B, green tea, and phytoestrogen), environmental exposures (arsenic, cadmium, and benzene), and demographic and lifestyle characteristics (age, race, sex, smoking, and alcohol consumption) (13, 36, 37, 66). However, the high fragmentation specific to cfDNA (19, 38) might result in a higher susceptibility to degradation. In 2002, Bonini et al. Our recommendation is that plasma preparation be performed as early as possible, with a delay not exceeding 4 h when using K2EDTA tubes. Before, all results not in line with the patients situation and therefore not accepted by the clinician were defined as laboratory errors. JCM Timing of Blood Sample Processing Affects the Transcriptomic and Epigenomic Profiles in CD4. It should be noted that filtration and Ficoll preparation (49) are alternatives to centrifugation procedures, but their effects on cfDNA yields with respect to the various cfDNA structures have been poorly investigated. Lillo R, Salinas M, Lopez-Garrigos M, Naranjo-Santana Y, Gutirrez M, Marn MD, Miralles M, Uris J. Lippi G, Becan-McBride K, Behlov D, Bowen RA, Church S, Delanghe J, Grankvist K, Kitchen S, Nybo M, Nauck M, Nikolac N, Palicka V, Plebani M, Sandberg S, Simundic AM. G-C Epub 2021 Jul 9. Fluorimetric quantification (e.g., using Qubit technologies) is the preferred option for the analysis of samples with such a relatively low concentration of cfDNA (58). In addition, an increasing number of reports have now appeared that investigate a specific technical issue in cfDNA preanalytics (see Table 1 in the Data Supplement that accompanies the online version of this article at http://www.clinchem.org/content/vol65/issue5). This may be because of the presence of triglycerides after food intake, which might decrease the DNA extraction yield (51). Plasma Is Denser than Cells and Gel Barrier. M Preanalytical errors; laboratory errors; patient safety; quality indicators. An official website of the United States government. Statements of opinion in AACB publications are those of the contributors. The site is secure. The International Federation of Clinical Chemistry Working Group on Laboratory Errors and Patient Safety has defined a number of quality indicators for the preanalytical stage, and the adoption of harmonized definitions will support interlaboratory comparisons and continual improvement. In addition, a short summary of previous developments as prerequesits of laboratory diagnostic actions is described from the middle age matula for urine collection to the blood collection tubes, anticoagulants and centrifuges. , El Messaoudi S, Gongora C, Guedj A-S, Robert B, Del Rio M. Lee More than 35 years after introduction of the term preanalytical phase it seems adequate to mention that the data on preanalytical phase would not have been attained without a background of more than hundred years of history behind it (37). Opportunities to improve quality in laboratory medicine. The https:// ensures that you are connecting to the Iqbal MS, Tabassum A, Arbaeen AF, Qasem AH, Elshemi AG, Almasmoum H. Diagnostics (Basel). Ordering the wrong test not only is wasteful but also potentially harmful to patients. In this paper, The Association for Clinical Biochemistry and Laboratory Medicine PreAnalytical Specialist Interest Group review the various data collection methods available. AI Stock Ownership: A.R. When we performed the root cause analysis of this issue, we found that neophyte nursing staff was inducted in the month of October. There are limited data on patient-related factors and their influence on the release of cell-free DNA. The impact of peer management on test-ordering behaviour. Proceedings, 3rd Symposium; European expert meeting; FESCC Educational Program; Basel. Preanalytical phase comprises of test selection, patient identification, collection of the sample, handling of the sample, sorting out, pipetting and centrifugation ( 2, 3 ). Comstock GW, Burke AE, Norkus EP, Gordon GB, Hoffman SC, Helzlsouer KJ. and transmitted securely. Having learned from past experience, and drawing on expertise acquired in more than 14 years working in this field, we preferred instead to select the most valuable observations from the literature. European Meeting on the Pre-Analytical Phase in Laboratory Sciences. Preanalytical quality improvement - in quality we trust. Time before separation from cells (for plasma). Federal government websites often end in .gov or .mil. This validation is crucial, as different quantification methods (e.g., NanoDrop vs Qubit spectrophotometry) do not align. Negligence in any of these steps can lead to erroneous results attributed to preanalytical phase. It is evident from the above issues that incorrect sampling technique is the main reason behind the pre analytical errors. HHS Vulnerability Disclosure, Help The https:// ensures that you are connecting to the Higher yields of cfDNA, for instance, were found in healthy men compared with healthy women (see Table 9 in the online Data Supplement) (51, 62), in current smokers compared with never-smokers (63), in older individuals (see Table 7 in the online Data Supplement) (51), in menopausal women (51), in certain ethnicities (see Table 8 in the online Data Supplement), in fasting individuals (51), in those with increasing body mass index (63), and after intense physical exercise (18). Sometimes, these errors may even be fatal (e.g., acute hemolytic reaction after incompatible blood transfusion because of wrong labeling of the EDTA/serum evacuated tubes in which the samples are sent for blood grouping and cross match). Despite obvious potential influences on DNA concentration, we recommend that individuals who have recently undergone cytostatic drug and radiotherapy treatment or surgery be excluded from cfDNA examination to homogenize the initial set of cfDNA samples from different patients. Plebani M. Appropriateness in programs for continuous quality improvement in clinical laboratories. , El Messaoudi S, Gahan PB, Anker P, Stroun M. Diehl The determination of minimum volume is illustrated by our investigation of the effect of sample volume on parathyroid hormone (PTH) measurement. After the amylase was increased, the operation was postponed, until continuous symptoms forced to operate. July 12, 1995; Meylan: Becton Dickinson Vacutainer Systems and Labware; 1995. The potential of this newly identified source of biological information has attracted the attention of researchers and clinicians in numerous fields, notably for prenatal testing [noninvasive prenatal testing (NIPT)] (7) and cancer (4, 8, 9), but also for diabetes, cardiovascular diseases, organ transplantation, autoimmune diseases, sepsis, trauma, disease staging (improved TNM classification), and even sports medicine (1019). , Hausmann MJ, Douvdevani A. Ponti that are required to get a sample into a . These were part of old recommendations in preparation of patient (fasting before sampling, posture before and during sampling) (13). We lack a comprehensive local data about the effect of preanalytical error on hospital budgets, but for sure we are in a more troublesome situation because of the errors in this phase. Leuwen: Terumo Corp Europe; 2002. Thus, there is a need to draw up preanalytical guidelines for specific clinical end points and application. History of technical products and procedures involved in preanalytical phase. Here is a rundown of some of the most common pre-analytical errors: We have performed a systematic review of the literature available on those preanalytical and demographic parameters that potentially influence cfDNA concentration. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). We recommend stringent quality control of the cfDNA extract before clinical use, and assessment of both quantification and fragmentation level. Definitions.net. cm1 at 556 nm.22, The effect of differing anticoagulants (or none) is readily combined with the study of the effect of time and temperature on stability by drawing the volunteer blood samples into differing anti-coagulant tubes and comparing the measured zero-time concentrations.11. Our conclusion, therefore, is that although most types of cfDNA examination may be performed using serum, the use of plasma is definitely preferred, as this helps to minimize contamination with DNA from leukocytes, thus optimizing sensitivity and data homogeneity. We recommend that the first centrifugation be carried out for 800 to 1200g at 4 C for 10 min and the second centrifugation for 14000 to 16000g at 4 C for 10 min. Jane C. Dale, Preanalytic Variables in Laboratory Testing, Laboratory Medicine, Volume 29, Issue 9, 1 September 1998, Pages 540545, https://doi.org/10.1093/labmed/29.9.540. Analysis of cfDNA undoubtedly represents a breakthrough in the diagnostic field and in predictive, preventive, and personalized medicine. Demonstrating the interference of tissue processing in the evaluation of tissue biomarkers: The case of PD-L1. Guder WG. , Snyder MW, Tanos R, Shendure J, Thierry AR. Please enable it to take advantage of the complete set of features! Reducing preanalytical laboratory sample errors through educational and technological interventions. . 2021 Dec 7;32(4):442-450. eCollection 2021 Dec. Mueller L, Scherz V, Greub G, Jaton K, Opota O. Although all three phases are equally important for improving total quality management and should be targeted individually for improving standards of the laboratory, preanalytical phase is considered as the most error prone part of the total testing process. Venous stasis. doi: 10.1016/j.plabm.2021.e00215. In the 70ies of the last century, ther term preanalytical phase was introduced in the literature. Mishandling of the specimen at this step may be attributed to excessive patient workload/ shortage of time in the clinical departments, lack of awareness of the doctors/nursing staff regarding the patient information and lack of bar code system in our setup. Preanalytical issues have been included in the list of biggest challenges faced by the laboratory professionals in the last two decades (4). The preanalytical phase - Past, present and future. Clin Chem Lab Med. NIPT using cfDNA has already been performed over one million times worldwide to identify genetic disorders such as autosomal or sex chromosome aneuploidy. Quality of the Preanalytical Phase in Europe. Keller H, Guder WG, Hansert E, Stamm D. Biological influence factors and interference factors in clinical chemistry: general considerations. Demuth JD The accurate and reliable quantification of cfDNA will require strict quality control of the cfDNA extract for the determination of the mutation load in cancer, and for NIPT, transplant, or physical exercise monitoring. Concentration gradients develop during freezing and thawing, and fibrin lumps may form during storage of plasma samples. In addition, the small size of fragments may modify quantification and detection efficacy, or such fragments may prove undetectable, depending on the analytical methods used. National Library of Medicine Such routine monitoring of allograft health could be done without incurring the risk, discomfort, and expense of an invasive biopsy. official website and that any information you provide is encrypted The effect of influence factors, on the other hand, can be reduced only by standardization of the preanalytical processes. YM A typical tube order to minimise risk of interferences is: plain citrate Li heparin EDTA fluoride. Clotting leads to blood cell disruption; consequently, a higher concentration of genomic DNA is found in serum than in plasma (40). 3 Although it is not possible to eliminate all pre-analytical errors, compliance with best practices can significantly reduce their incidence. R. Meddeb and A.R. The future has to introduce quantitative quality programs including all kinds of preanalytical variables in the routine estimation of trueness of medical laboratory results. This study was partly supported by the SIRIC Montpellier Grant INCa-DGOS-Inserm 6045, France, the DNAcirc grant INCA-DGOS 4537, France and the European ERA-Net TRANSCAN (THRuST). The term preanalytical is defined as anything that comes before the analysis phase (20). STANDS4 LLC, 2023. Correct sample handling: the time and temperature before and after separation, and the centrifugation and separation procedures, must be suitable for the analyte. Special container. Inclusion in an NLM database does not imply endorsement of, or agreement with, Missing patients identification, inappropriate containers, missing samples are most commonly encountered preanalytical errors (7). Preanalytical Phase, in Thomas L. Laboratory and Diagnosis. Although most cases exhibited normal amylase activity, some again exhibited increased values. July 57, 1996; Meylan: Becton-Dickinson Vacutainer Systems; 1996. Livesey JH, Roud HK, Metcalf MG, Donald RA. Medical Laboratories - Particular Requirements for Quality and Competence. The first Standard IPSG 1 requires the organization to develop an approach to improve accuracy of patient identification and applies to the pre-analytical phase of the total testing process. Sonntag O. Haemolysis as an interference factor in clinical chemistry. One of the first challenges in obtaining a cfDNA preparation or extract is to do so with a high yield while avoiding any contamination from DNA derived from blood cells. Only for volumes below 40 L was an error condition indicated. Future exploration of the information conveyed by methylated DNA in cancer, including the identification of biomarkers with higher accuracy and development of more effective detection methods, will likely lead to their translation into routine clinical practice. Therefore, the pre-analytical phase must have rigorous control measures to avoid unwittingly allowing problems or errors to travel further "downstream.". I An official website of the United States government. Methods require thorough evaluation of patient-related pre-analytical factors, and quantification of the effects of time, temperature, haemolysis, anticoagulant type and minimum allowable volume on sample suitability. 2016 Mar;53(Pt 2):279-84. doi: 10.1177/0004563215599561. As a library, NLM provides access to scientific literature. Serum and plasma have been used as the biological sources for cfDNA (3, 4, 31). They sometimes underestimate the importance of drawing blood from the vein without intravenous lines. https://www.definitions.net/definition/preanalytical. Clear communication, to both patients and staff, of any such requirements is essential. Although it might be assumed that cfDNA extraction should be performed with specific methods, only a small difference was observed when blood and tissue kits were directly compared with specific circulating nucleic acid kits (55). Proceedings. SMART Vocabulary: related words and phrases Circulating cell-free DNA (cfDNA) isolated from blood has been identified as a potential biomarker in numerous fields, and has been the object of intensive research over the past decade, although its original discovery dates back 60 years. Errors in the laboratory are directly proportional to financial constraints and lead to decreased patient satisfaction. However, contamination with DNA from leukocytes is a possibility in EDTA tubes if they are used for the storage of blood for more than 4 h. Because of this, commercial cell stabilizer tubes have recently been developed to inhibit blood cell lysis (45) (see Table 2 in the online Data Supplement). M Estimating the intra- and inter-individual imprecision of manual pipetting, Preanalytical phase-a continuous challenge for laboratory professionals, Quality in laboratory diagnostics: From theory to practice, A Review of Medical Errors in Laboratory Diagnostics and Where We Are Today, Preanalytical Errors: A Major Issue in Medical Laboratory, Blood venous sample collection: Recommendations overview and a checklist to improve quality.
Clp Revision Timeline,
Indoor Activities Virginia Beach,
Banquette Hello, Sailor,
Articles P
