The effect of specimen processing delay on borate urine preservation. We can identify at least three main reasons why analytical method development is critical for any biotechnology Besides, the International Standards Organization (ISO) document 15189:2007 lists particular requirements for quality and competence (70). The acceptance of smaller urine specimens and the test protocol is determined by the individual laboratory. Soluble components released by cells in fresh urine may alter the physiochemical properties of the solution. Laboratory guidelines and standards in clinical and forensic toxicology. Preanalytical quality improvement: in quality we trust. Mid-stream urine was confirmed as the most appropriate sample, since the presence of contaminating elements, such as bacteria, analytes and formed particles are minimized (10). calls for serious efforts towards minimizing pre analytical errors as Informing the patient goes far beyond only explaining the practical aspects of urine sampling. of standards for the pre-analytical phase, which is considered Kouri TT, Gant VA, Fogazzi GB, Hofmann W, Hallander HO, Guder WG. Improving Treatment for Drug-Exposed Infants Treatment Improvement Protocol (TIP) Series 5. FOIA in research and clinical trials. In comparison with random urine testing, the examination of chemical analytes is more reliable when timed sampling is used, which is however prone to pre-analytical errors. The most studied The disruptive force generated by the vacuum on brittle figurated elements (e.g. Assessment of leukocytes gets doubtful when the analysis is performed more than 4 hours after sampling. False-positive results can also be caused by bacterial overgrowth due to delays in the transport of samples. A comment released together with observed (unchanged) dipstick test results pointing to the probable interference could be informative. 2017 Biomedical Research Network, LLC, All rights reserved. These transparent tubes preferably have a round bottom, which allow a better resuspension of the sediment following centrifugation (10). WebIn the brain to brain loop described by GeorgeLundberg,1 the preanalytical phase is dened as allparts of the total testing process (TTP) that occurfrom the conception of the requirement for the testthrough obtaining of the sample, transport to the labo-ratory and sample preparation, to the point where thesample is ready for analysis. 1999. As modern urinalysis (flow cytometry, automated microscopy) is characterized by a low CV, preanalytical aspects of urinalysis are of growing importance. Br J Haematol. Diabetes Technol Ther 21(7): 413-414. Stability of the urine metabolic profile at various storage temperatures was studied for different preanalytical treatments (prestorage centrifugation, filtration and addition of sodium azide). WebThe pre-analytical phase is a crucial part of the analysis and is equally important as the analytical component. Morphological studies showed a higher reproducibility when incubation time was 12 h. Therefore, using second morning urine specimens is sometimes recommended (urine samples voided 24 h after the first morning urine) (16). What are the 3 phase of the routine stool examination? WebPre-analytical and post-analytical errors also tend to be easier to count than analytical errors - it's not hard to keep track of which specimens were mislabeled, missing, or mishandled. captopril) or in (d) highly pigmented urine samples (34). Screening tests for occult blood can become false-positive by (a) certain oxidizing contaminants (hypochlorites when cleaning urine containers or in the presence of bacterial peroxidases by a high bacterial content) (37,38) or by (b) contamination with povidone-iodine (39), (c) menstrual blood, (d) semen or (e) myoglobinuria (34,40). Metabolites 3: 9(4). Moreover, automation allows a better standardization of particle analysis (4,49). Fassett RG, Horgan BA, Mathew TH. systematic reporting of pre-analytical quality indices will facilitate Grzych G, Pekar JD, Maboudou P (2019) Better Glucose Stability in Serum than in Plasma Samples after 12-h Stay at Room Temperature. The performance figure of bacteriuria depends on the operators skill, the bacterial species (bacilli or cocci), and on the interference caused by debris. Sample alkalinisation is consistent with shift variations for the He1 N-methylhistidine; also, changes in the chemical shifts of the resonances of xantine are observed with time. To reduce cross-reactivity and to increase drug specificity, many drug tests are routinely modified (56). and subsequent quality management using standardized protocols Koseoglu M, Hur A, Atay A, Cuhadar S (2011) Effects of hemolysis interference on routine biochemistry parameters. The introduction of new technologies and automation has improved the accuracy and productivity of the process (4). European urinalysis guidelines (10) have proposed to examine particles < 1 hour after voiding at ambient temperature or < 4 hours if refrigerated to avoid material lysis. In the inverse situation, an excessive amount of preservative may inhibit bacterial growth. Correlation between protein:creatinine ratio and 24-hour protein excretion may not be accurate for proteinuria levels > 1 g/L. Addition of variable commercially available baby soaps to drug-free urine resulted in a measurable response in THC immunoassays. Spectral variations were followed after urine processing or thawing. designs in metabolomics studies that carefully consider patient The preanalytical phase, including biological collection, identification, storage and specimen transport, preparation for analyses of the specimen (e.g. towards ensuring overall quality management of laboratory Quality improvements in the preanalytical phase: Focus on urine specimen workflow | Medical Laboratory Observer. analytical aspects and issues making it the new major challenge in medical laboratory. Besides the influence of clarity and colour of the urine samples, a number of substances can interfere with dipstick tests, according to the type of test strip. The European Workplace Drug Testing Society (58), the Substance Abuse and Mental Health Services (59), the Swiss Working Group for Drugs of Abuse Testing Guidelines (60), the Joint Technical Committee (61) and the United Kingdom (62) proposed some criteria for urine validity testing based on several parameters: urinary creatinine concentration, specific gravity, nitrite, pH and presence of exogenous or endogenous substances. What would be the pre-analytical phase in doing Kato technique? Ideally, preservatives are present in a lyophilized form. Grzych G, Pekar JD, Durand G, Deckmyn B, Maboudou P, et al. In function of the required testing, a difference in preservative demands is requested. A wide range of variables that affect the result for a patient from whom a specimen of The pre- preanalytical phase has been described as the stage in which the requesting physician formulates the appropriate question upon which the test request is based and selects the tests to be undertaken.9 Plebani10 on the other hand de-scribes the pre-preanalytical phase as being all the steps that occur This broadly includes: For each of these steps, there are several opportunities for factors to affect the accuracy of the analysis itself. At this moment, only particle analysis will result in true identification of casts. Automated flow cytometry compared with an automated dipstick reader for urinalysis. Standardization of urine sediment examination consisting of urine volume, speed and time of centrifugation, concentration of urine or sediment volume, volume of sediment examined and result reporting are essential to ensure accuracy and precision of urine microscopic examination. An advantage of using a counting chamber is a larger urine volume that can be examined, allowing a more precise analysis. The most distant from nonprecentrifuged samples are the samples precentrifuged at a speed in the 1,0003,000 RCF range, while samples precentrifuged at 11,000 RCF are slightly closer to the aliquots that do not undergo any precentrifugation. In addition to experimental considerations to limiting sources Mixtures of drug-free urine with various products that commonly contact newborns were tested using immunoassays. Eisinger SW, Schwartz M, Dam L, Riedel S. Evaluation of the BD Vacutainer Plus Urine C&S Preservative Tubes Compared With Nonpreservative Urine Samples Stored at 4{degrees}C and Room Temperature. In healthy subjects, two consecutive samples of the first morning micturition were collected by a vacuum system, the first from the first-void and the second from the mid-stream. Urinalysis plays a key role as an aid in the differential diagnosis of many renal and urologic diseases. Although it cannot be considered as good laboratory practice, in some laboratories dip slides are put in a urine containing test tube while using the same sample for other types of analyses. Point-of-care analyses are not subject to this delay, but may as well be affected by various analytical issues. Delanghe JR. New screening diagnostic techniques in urinalysis. Alkaline urine, glucose and urea can decrease the sensitivity of the analysis (10). Fundamentals of Urine and Body Fluid Analysis. In addition, coloured urine (bilirubinuria and beet ingestion) can result in a positive reaction. influence laboratory results. OMICS J Integr Biol 21(9): 499-508. Carlson DA, Statland BE. Delanghe J, Langlois M. Pre-analytical effects of vacuum aspiration on urinalysis. In addition, coloured urine and prophobilinogen can result in false-positive reactions. Int J Clin Pract 63(8): 1259-1262. However, differentiation appears to be easier through a thin liquid film, obtained by a glass slide. strenuous physical exercise) and vaginal contamination (e.g. Falsely negative urinary leukocyte counts due to delayed examination. Metabolites 8(1): 6. the contents by NLM or the National Institutes of Health. Several reports highlight contamination of the sample by glycine (2), iodine (30), caffeine (31) and other constituents of the test strip, which leads to unnecessary further investigation. Lee JE, Kim YY (2017) Impact of Preanalytical Variations in Blood-Derived Biospecimens on Omics Studies: Toward Precision Biobanking? In contrast, false-negative results can be found when the examination is delayed, when urine specimens are not well mixed before testing or when using formalin as preservative. In comparison with bacterial cultures, the analytical sensitivity for bacteria is poor at lower counts. Several specimen tampering methods have been used to avoid detection: substitution of urine by another fluid, adulteration by addition of a foreign material, dilution of the urine sample by adding water. diagnosis [8,9]. In summary, measurement of pre analytical errors Background and objectives: All three phases of laboratory testing are equally important for improving total quality management, but the pre-analytical phase is the For reducing the risk of errors and contamination, commercially available vacuum systems have been developed, allowing direct sample aspiration into a secondary container. Based on a work at www.biomedres.us. Clin Chem Lab Med CCLM. Bright-field microscopy, phase-contrast microscopy or polarized light microscopy are used with low- and high-power magnification. the analytical and post analytical phases. WebIt has been suggested that up to 70% of all medical decisions are based on some kind of pathology and/or laboratory result. Frozen storage at temperatures above 80 C (particularly at 20 C) produces various modifications to the albumin molecule (21). It should be stressed that an appropriate collection, handling and testing of urine samples are necessary to avoid false-positive, false-negative and inconclusive test results (56). Some may be suitable as screening methods for larger laboratories if specificity, sensitivity, or both are high enough. Urinalysis by use of multi-test reagent strips: two dipsticks compared. Pre analytical phase is The analytical phase involves the actual running of the test, while the post-analytical phase includes recording the results, interpreting the results, reporting Until the development of such a preservative, clinical labs need to prepare two aliquots. A concentrated sample using a glass slide is proposed if manual evaluation is requested. indicators of the pre analytical phase is necessary for streamlining However, preservatives may affect some chemical properties and alter the appearance of particles. More specifically, the effect of possible biological confounders such as dietary intake, diuresis, exercise and other interferents, should be emphasized. Expert Solution Want to see the full answer? Next to the use of a primary urine container, it is recommended to split the original urine sample into various smaller aliquots for morphological, microbiological and chemical analyses, decreasing the risk of contamination. Abstract Objective The objective of this study was to determine the magnitude of pre-analytical, analytical and post-analytical laboratory errors in hematology tests. Vacuum aspiration is responsible for a significant reduction of hyaline and cellular cast counts (respectively at least 58% and 51%) in comparison with conventional test tubes (4). casts) is generally underestimated and insufficiently examined. WebAbstract. Clin Chem Lab Med CCLM 56(12): 2125-2131. As most drugs are characterized by a predominantly renal excretion, urine is the preferred specimen for inexpensive, noninvasive and quick substance abuse tests (56). (2019) The Effect of Pre-Analytical Conditions on Blood Metabolomics in Epidemiological Studies. Continuous tracking and To rule out transient hematuria, the urinalysis should be repeated on different occasions in asymptomatic patients with a positive dipstick result for hematuria and an otherwise normal urinalysis. Pre Table 1A and and1B1B give an overview of the stability of different particles and test strip parameters (22). However, in the last few years, there is growing awareness about pre As more effort needs to be spent in the preanalytical phase for the further reduction of errors (9), in the present paper we give an overview of the preanalytical challenges of urinalysis. The authors declare that they have no competing interests. Preanalytical errors may not only impact on patient care and contribute to incorrect diagnosis, they may also contribute to increased healthcare costs. When deciding the best procedure, one should take into consideration the patients characteristics (suspected microorganisms or presence of a urinary catheter). In clinical chemistry, collection tubes contain additives that could http://creativecommons.org/licenses/by-nc-nd/3.0/, http://dx.doi.org/10.1016/j.cll.2007.12.011, http://dx.doi.org/10.1016/j.clinbiochem.2012.02.029, http://dx.doi.org/10.1146/annurev.me.19.020168.002243, http://dx.doi.org/10.3109/00365519709060028, http://dx.doi.org/10.1016/S0009-8981(00)00256-4, http://dx.doi.org/10.1373/clinchem.2008.106567, http://dx.doi.org/10.1053/j.ajkd.2007.11.039, http://dx.doi.org/10.1309/AJCP5ON9JHXVNQOD, http://dx.doi.org/10.1258/acb.2009.009001, http://dx.doi.org/10.1016/S0022-3476(78)80179-6, http://dx.doi.org/10.1016/j.pcl.2006.02.004, http://dx.doi.org/10.1136/bmj.313.7048.25, http://dx.doi.org/10.3109/00365518009095576, http://dx.doi.org/10.1016/S0140-6736-(82)92451-5, http://dx.doi.org/10.1016/j.cca.2006.03.015, http://dx.doi.org/10.1016/j.cca.2007.05.012, http://www.ncbi.nlm.nih.gov/books/NBK64750/, http://www.gpo.gov/fdsys/pkg/FR-2004-04-13/pdf/04-7984.pdf/, http://faculty.ksu.edu.sa/18856/454/AGSA%20%20Drugs%20of%20Abuse%20Testing%20Guidelines.pdf, http://www.sai-global.com/pdftemp/previews/osh/as/as4000/4300/4308.pdf/, http://dx.doi.org/10.1007/s00769-006-0131-y, http://dx.doi.org/10.1097/FTD.0b013e3181c0eee0, http://dx.doi.org/10.1007/s10858-011-9489-1, http://dx.doi.org/10.1007/s11306-006-0042-2. Manual microscopy and flowcytometry show a good agreement, except for casts and yeast-like cells, where flow cytometry is inferior. EDTA contamination leads to false elevation of potassium, Hence, a sediment method can never be considered as reference of quantitative urinary particle counting (10). such as metabolomics. Mayo S, Acevedo D, Quiones-Torrelo C, Cans I, Sancho M. Clinical laboratory automated urinalysis: comparison among automated microscopy, flow cytometry, two test strips analyzers, and manual microscopic examination of the urine sediments. Influence of preservatives on test strip reactions. European Confederation of Laboratory Medicine European urinalysis guidelines. Urine stability for metabolomic studies: effects of preparation and storage. A wide range of variables that affect the result for a patient from whom a specimen of False-negative results are reported in diluted urine or in the presence of slightly elevated proteinuria other than albuminuria (globulin, immunoglobulin, light chains) (10,34). Firstly, extended to the field of research given the increase in clinical omics Red blood cells with a normal morphology usually originate from the lower urinary tract (16). The correct preservative to specimen ratio should be respected when samples are preserved for transport and analysis (8). Unless urine samples are investigated within 4 hours from micturition (at 4 C) or within 30 min at 20 C, preservatives should be added. However, contamination with strong oxidizing cleaning agents peroxide or hydrochloric acid can result in a false-positive reaction. In addition, high quality pipettes and standardized microscope slides with calibrated volumes for analysis of urine sediment are essential. The preanalytic phase is an important component of total laboratory quality. In parallel, a correlation between NGAL and the bacterial count has been reported. Image analysis of native urine specimens was a first technological breakthrough, which allowed analysis of much larger number of particles, resulting in improved results. On the other hand, it's hard to track analytical error rates. As an example of the importance of interferents, the influence of commercially available baby soaps on tetrahydrocannabinol (THC) immunoassays can be mentioned. WebThe pre-analytical phase consists of all steps from preparing the patient for collection of the specimen to processing of the specimen prior to the analytical step. WebThe pre-analytic phase of the Total Testing Process (T.T.P) begins with the encounter between the clinician and the patient,and includes verification of identity, specimen Due to the presence of alkaline medication or stale urine, highly buffered alkaline urine (pH 9) may result in false-positive test strip results for proteinuria. The use of metabolomics particularly warrants Urine culture transport tubes: effect of sample volume on bacterial toxicity of the preservative. Due to the presence of surfactants with the THC assay, soap and wash products used for newborn and infant care can potentially cause false positive screening test results, leading to involvement by social services or false child abuse allegations (12). Although the 24-hour urine collection is the reference method for quantification of stable chemical analytes, contamination, incorrect collection and incorrect calculation of urinary volume can cause preanalytic errors. Acta Clin Belg 65(5): 311-318. Nevertheless, the lion share of errors in laboratory diagnostics (and in urinalysis in particular) falls outside the analytical phase; both preanalytical and postanalytical steps are much more vulnerable (7). Because of the growing importance of (micro)albuminuria in the diagnosis of kidney disease, more attention has been paid to the particular preanalytical aspects of this analyte. Figure 1: Summary of pre analytical phase and the main variables that may affect laboratory results. There appears to be a variable loss of these figurated elements in manual methods due to the many intermediate steps involved (centrifugation, decantation and resuspension of the specimen). The pre-analytical phase encompasses everything that happens to a sample prior to its analysis. Additional requirements may be needed in function of diagnostic procedures (e.g. Urine toxicology specimens should be stored at a temperature of 28 C for five days, minimizing deterioration and protecting samples from tampering. Relative losses due to centrifugation of red and white blood cells vary between 20 and 80% (10). Vitamin C intake, proteinuria (> 5 g/L), glucosuria (> 20 g/L), 1% boric acid, trypsin inhibitor, oxalate or mercuric salts may decrease the sensitivity of the test (10,34,41). Scand J Clin Lab Invest 79(5): 283-287. Overall prevalence of subjects with cellular elements count exceeding upper reference limits was also higher in first-voided than in mid-stream samples. Need multiple seats for your university or lab? Guy M, Borzomato JK, Newall RG, Kalra PA, Price CP. First, pre-analytical phase in which requirement for a test is determined, the test is ordered and the patient is identified. Dinda AK, Saxena S, Guleria S, Tiwari SC, Dash SC, Srivastava RN, et al. Improvements in both reliability and standardization of analytical techniques, reagents and instrumentation have contributed to a remarkable 10-fold reduction in the analytical error rate over the last 30 years. Finally, level 4 stands for best methods (primary reference measurement procedures = reference and definitive methods). A lower sensitivity is sometimes seen after the intake of a high amount of ascorbic acid, after the intake of captopril, in urine samples with a high concentration of proteins or nitrites or with a high specific gravity (10,34). [14,19], sample preparation, centrifugation conditions, transport The quality of the reported results could also be influenced by variables in specimen processing. In addition, the temperature can affect the sensitivity of glucose due to its effect on the enzyme reaction. Urinalysis and other tests of renal function. Addition of additives is to be avoided since the required concentrations will generate NMR signals covering the resonance of metabolites and may affect the original NMR profiles. Best viewed in drugs, diseases). False-positive reactions can be induced by indican and metabolites of etodolac, by the intake of phenazopyridine or large doses of chlorpromazine or phenazopyridine. Clinical and Laboratory Standards Institute. The albumin: creatinine ratio (or protein:creatinine ratio) on a random urine sample, which is not influenced by variation in water intake and rate of diuresis, is a recommended alternative (27). analytical phase of urinalysi s. Need for the test, moting of the pre analytical procedu res by the lab- nal qual ity assess ment progra m are a lso important (10, 51). as feeding state [1] or gender [2]. Received 2013 Sep 30; Accepted 2013 Nov 20. WebPreanalytical errors (PAEs) are errors which occurprior to the analytical stage in the total testing process(TTP) and can occur both before and after receipt ofspecimens in the laboratory. Interpretation of test results is only possible when these conditions are fulfilled. Finally, over-the-counter (OTC) drugs, prescribed medications and some foodstuff, which are chemically related to drugs of abuse, can also be detected by urinary drug tests (56). Fogazzi GB, Cameron JS, Ritz E, Ponticelli C. The history of urinary microscopy to the end of the 19th century. Tube additives can also contaminate the sample. Mid-stream vs. first-voided urine collection by using automated analyzers for particle examination in healthy subjects: an Italian multicenter study. The pre-analytic testing phase occurs first in the laboratory process. In contrast to casts, epithelial cells and leukocytes, the stabilization of erythrocytes is extremely difficult, probably due to cellular shrinkage following the addition of formaldehyde solutions (25). collection, transport and storage protocols along with downstream If a mild precentrifugation (1,0003,000 RCF) is applied, cellular components are spun down. Caleffi A, Manoni F, Alessio MG, Ottomano C, Lippi G. Quality in extra-analytical phases of urinanalysis. the quality management process. This phase may include specimen handling issues that occur even prior to the time the Hara F, Shiba K. Nonspecific binding of urinary albumin on preservation tube. To improve the optimal urine quality management in routine clinical laboratories, the CLSI develops best practices in clinical and laboratory testing by using a core set of quality system essentials and promotes the use of these standards worldwide (13).
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