Comparison of test results obtained from lithium heparin gel tubes and serum gel tubes

2020 ◽  
Vol 45 (5) ◽  
pp. 575-586
Author(s):  
Şerif Ercan

AbstractObjectivesThere is currently trend that plasma might be alternative to serum due to some of its advantages. This study aimed to compare test results from heparinized plasma and serum.MethodsBlood samples from total of 40 participants (20 healthy, 20 hemodialysis patients) were drawn into serum gel tubes with clot activator and lithium heparin gel tubes. Twenty-eight clinical chemistry analytes were measured in serum and plasma samples. To determine whether difference between test results is clinically significant, total error (TE) was calculated and compared total allowable error (TEa) limits.ResultsTE of below 5% was calculated for amylase, AST, calcium, total cholesterol, chloride, CK, glucose, HDL-cholesterol, iron, LDH, LDL-cholesterol, magnesium, sodium, total bilirubin, uric acid and urea. Albumin, ALT, creatinine, CRP, lipase, phosphorus, potassium, total protein, and triglyceride had TE of 5–7%. TE of 7–10% were determined for ALP, direct bilirubin, and GGT. TE values were within TEa limits for all analytes.ConclusionsIt was concluded that results of 28 analytes measured in lithium heparin gel tubes are comparable to those of serum gel tubes. It is thought that several advantages including reduced turnaround time might be provided by using plasma instead of serum for these tests.

2001 ◽  
Vol 47 (4) ◽  
pp. 712-721 ◽  
Author(s):  
Thomas G Cole ◽  
Constance A Ferguson ◽  
David W Gibson ◽  
William L Nowatzke

Abstract Background: Risk of cardiovascular disease is assessed, in part, by laboratory measurement of the concentrations of several lipoproteins. β-Quantification is a method of lipoprotein measurement that uses ultracentrifugation to partially separate lipoprotein classes. Although β-quantification is used largely in clinical and basic research, methods have not been described to allow the analysis of a large number of small-volume specimens with a short turnaround time. We report two variations of the traditional 5-mL method used by the Lipid Research Clinics Program that overcome these shortcomings. Methods: Two lower-volume modifications of the traditional 5-mL β-quantification method were developed. The methods used either 1 or 0.23 mL of specimen and required substantially less time for analysis (20 and 6 h, respectively) than the 5-mL method (2.5 days). The goal was to develop ultracentrifugation methods such that the concentration of cholesterol in the bottom fraction, from which LDL-cholesterol concentration is calculated, agreed with the 5-mL method. Fresh serum specimens (n = 45) were analyzed by the three methods to determine comparability of the methods based on the recovery of cholesterol in the bottom fraction after ultracentrifugation. To evaluate intrarun precision, replicate specimens (n = 17) were analyzed in a single run for each method. This experiment also evaluated how quickly the fractions would remix after separation by ultracentrifugation. For the 1-mL method, accuracy of the measurement of LDL- and HDL-cholesterol concentrations and the interrun precision were established by analysis of frozen serum specimens provided by the CDC, which established target values for the pools using reference methods. Results: No clinically significant differences in cholesterol concentrations in the bottom fraction were observed for the 1- and 0.23-mL methods, which had mean biases of 0.8% and 1.5% relative to the 5-mL method, respectively. Intra- and interrun variability was acceptable for each method, e.g., <1.8% for cholesterol in the bottom fraction. Ultracentrifuged specimens were stable for at least 4 h with no evidence of contamination of cholesterol in the bottom fraction. For comparison specimens provided by the CDC, the 1-mL method met the accuracy and precision goals of the National Cholesterol Education Program for the measurement of HDL- and LDL-cholesterol concentrations (goals: total error <13% and <12%, respectively), with total errors of 6.45% and 5.43%, respectively. Conclusions: Both the 1- and 0.23-mL β-quantification methods are suitable substitutes for the traditional 5-mL method for use in clinical and basic research for the determination of LDL-cholesterol concentration. Both methods provide much higher throughput and require substantially less specimen volume. The 0.23-mL method can be performed in 1 day, but it is slightly less precise than the 1-mL method. In our laboratory setting, as many as 80 specimens are routinely processed per day using the 1-mL method.


2014 ◽  
Vol 60 (6) ◽  
pp. 855-863 ◽  
Author(s):  
Hedwig C M Stepman ◽  
Ulla Tiikkainen ◽  
Dietmar Stöckl ◽  
Hubert W Vesper ◽  
Selvin H Edwards ◽  
...  

Abstract BACKGROUND External quality assessment (EQA) with commutable samples is essential for assessing the quality of assays performed by laboratories, particularly when the emphasis is on their standardization status and interchangeability of results. METHODS We used a panel of 20 fresh-frozen single-donation serum samples to assess assays for the measurement of creatinine, glucose, phosphate, uric acid, total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides. The commercial random access platforms included: Abbott Architect, Beckman Coulter AU, Ortho Vitros, Roche Cobas, Siemens Advia, and Thermo Scientific Konelab. The assessment was done at the peer group level and by comparison against the all-method trimmed mean or reference method values, where available. The considered quality indicators were intraassay imprecision, combined imprecision (including sample–matrix interference), bias, and total error. Fail/pass decisions were based on limits reflecting state-of-the-art performance, but also limits related to biological variation. RESULTS Most assays showed excellent peer performance attributes, except for HDL- and LDL cholesterol. Cases in which individual assays had biases exceeding the used limits were the Siemens Advia creatinine (−4.2%), Ortho Vitros phosphate (8.9%), Beckman Coulter AU triglycerides (5.4%), and Thermo Scientific Konelab uric acid (6.4%), which lead to considerable interassay discrepancies. Additionally, large laboratory effects were observed that caused interlaboratory differences of >30%. CONCLUSIONS The design of the EQA study was well suited for monitoring different quality attributes of assays performed in daily laboratory practice. There is a need for improvement, even for simple clinical chemistry analytes. In particular, the interchangeability of results remains jeopardized both by assay standardization issues and individual laboratory effects.


Diagnostics ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 1019
Author(s):  
Kyungjin Hong ◽  
Gabriella Iacovetti ◽  
Ali Rahimian ◽  
Sean Hong ◽  
Jon Epperson ◽  
...  

Blood sample collection and rapid separation—critical preanalytical steps in clinical chemistry—can be challenging in decentralized collection settings. To address this gap, the Torq™ zero delay centrifuge system includes a lightweight, hand-portable centrifuge (ZDrive™) and a disc-shaped blood collection device (ZDisc™) enabling immediate sample centrifugation at the point of collection. Here, we report results from clinical validation studies comparing performance of the Torq System with a conventional plasma separation tube (PST). Blood specimens from 134 subjects were collected and processed across three independent sites to compare ZDisc and PST performance in the assessment of 14 analytes (K, Na, Cl, Ca, BUN, creatinine, AST, ALT, ALP, total bilirubin, albumin, total protein, cholesterol, and triglycerides). A 31-subject precision study was performed to evaluate reproducibility of plasma test results from ZDiscs, and plasma quality was assessed by measuring hemolysis and blood cells from 10 subject specimens. The ZDisc successfully collected and processed samples from 134 subjects. ZDisc results agreed with reference PSTs for all 14 analytes with mean % biases well below clinically significant levels. Results were reproducible across different operators and ZDisc production lots, and plasma blood cell counts and hemolysis levels fell well below clinical acceptance thresholds. ZDiscs produce plasma samples equivalent to reference PSTs. Results support the suitability of the Torq System for remotely collecting and processing blood samples in decentralized settings.


2016 ◽  
Vol 62 (7) ◽  
pp. 930-946 ◽  
Author(s):  
Børge G Nordestgaard ◽  
Anne Langsted ◽  
Samia Mora ◽  
Genovefa Kolovou ◽  
Hannsjörg Baum ◽  
...  

Abstract 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, whereas fasting sampling may be considered when non-fasting triglycerides are >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 for the risk of pancreatitis when triglycerides are >10 mmol/L (880 mg/dL), for homozygous familial hypercholesterolemia when LDL cholesterol is >13 mmol/L (500 mg/dL), for heterozygous familial hypercholesterolemia when LDL cholesterol is >5 mmol/L (190 mg/dL), and for very high cardiovascular risk when lipoprotein(a) >150 mg/dL (99th percentile). CONCLUSIONS 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 cutpoints. Non-fasting and fasting measurements should be complementary but not mutually exclusive.


Jurnal BIOMA ◽  
2015 ◽  
Vol 11 (2) ◽  
pp. 131
Author(s):  
Pratiwi Widyamurti ◽  
Rusdi Rusdi ◽  
Sri Rahayu

ABSTRACT Increased blood pressure more than 140/90 mmHg taken from three measurement in 24 hours can be diagnosed as hypertension. Abnormality of lipid values condition was found at many hypertensive. Based on this reason examination of lipid profile in hypertensive and normotensive should be done. The aim of this research was to measure and compare lipid profile on blood serum in hypertensive    and normotensive. Lipid profile was measured by Konelab 20XT clinical chemistry analyzer. Ex     Post Facto used as method and Cross-sectional used as design. A total of 50 blood samples collected from Hypertensive (N1=25) and normotensive (N2=25) from June to August 2014. SPSS 16.0 was used to analyze the data, T-test was used to compare value of LDL cholesterol, HDL cholesterol and total cholesterol while U Mann-Whitney test was used to compare value of triglyceride. The result      of this research showed that the mean value of triglyceride was 146.56 mg/dL in hypertensive and 143.92 mg/dL in normotensive (p=0.11). The mean value of LDL cholesterol was 129.80 mg/dL in hypertensive and 136.72 mg/dL in normotensive (p=0.62). The mean value of HDL cholesterol was  38.80 mg/dL in hypertensive and 45.04 mg/dL in normotensive (p=0.1). The mean value of total cholesterol was 201.04 mg/dL in hypertensive and 221.88 mg/dL in normotensive (p=0.25). In conclusion, there was no different of lipid profile on blood serum in hypertensive and normotensive.  Keywords: hypertension, lipid profile, normotensive


2018 ◽  
Vol 4 (2) ◽  
pp. 49
Author(s):  
Perdina Nursidika ◽  
Wikan Mahargyani ◽  
Fitri Kurnia Anggraeni

Total cholesterol is the composition of many substances including cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol. Cholesterol examination is one of the most frequent tests required in the laboratory to monitor vascular and cardiovascular diseases. Most clinical pathology laboratories use photometer to perform clinical chemistry checks. Cholesterol testing can also be done with Point of Care Testing (POCT) which has a working principle of biosensor technology. This research method is experimental, using 40 samples that can represent normal and pathological levels. All samples will be checked for total cholesterol with a photometer of CHOD-PAP method and 3 POCT Lipid Pro. The results showed linear regression y = 0.955x + 1.8325 with R2 of 0.9955. The linear regression value is calculated by Total Error (TE), while the Total Error Allowable (TEa) cholesterol is 10%. The bias value is 0.31%, TE for normal level = 5.92% and TE for high pathological level = 3.00%, it can be stated the result of examination can be compared or accepted. The% TE value obtained is less than the TEa value of cholesterol. It can be concluded that the total cholesterol results examined by the photometer and LipidPro are comparable. For further research it is advisable to use a total cholesterol sample that has a value of more than 400 mg/dL.


2017 ◽  
Vol 43 (1) ◽  
pp. 9-14
Author(s):  
Giray Bozkaya ◽  
Murat Aksit ◽  
Merve Zeytinli Aksit

AbstractAim:Emergency department laboratories, besides from giving accurate results, should be quick enough in order not to delay patient care. Giving fast results doesn’t mean to ignore quality, rather it should always be improved to prevent erroneous results. Six sigma is a modern assessment of quality which is used to determine the analytical performance. Our aim was to evaluate the analytical performance of clinical chemistry tests in our emergency department laboratory by using sigma metrics.Materials and methods:Our study was performed by using the internal and external quality assessment data of 13 clinical chemistry tests of emergency laboratory. Sigma levels were calculated using bias, coefficient of variation and total allowable error (TEa) ratios of CLIA, Ricos, Rilibak and Turkey.Results:Sigma levels of various tests (CK, amylase, ALT, AST, urea, creatinine, total bilirubin, sodium and chloride) were found to be ≥6 according to different TEa’s, whereas the performance of sodium, potassium and chloride were unsatisfactory, according to TEa’s of CLIA, Ricos and Rilibak.Conclusion:Since most of our sigma values were found to be over 3, the analytical performance of clinical chemistry tests was thought to be acceptable and our laboratory can be regarded as a qualified emergency laboratory.


2018 ◽  
Vol 64 (9) ◽  
pp. 1380-1393 ◽  
Author(s):  
Aasne K Aarsand ◽  
Jorge Díaz-Garzón ◽  
Pilar Fernandez-Calle ◽  
Elena Guerra ◽  
Massimo Locatelli ◽  
...  

Abstract BACKGROUND The European Federation of Clinical Chemistry and Laboratory Medicine European Biological Variation Study (EuBIVAS) has been established to deliver rigorously determined data describing biological variation (BV) of clinically important measurands. Here, EuBIVAS-based BV estimates of serum electrolytes, lipids, urea, uric acid, total protein, total bilirubin, direct bilirubin, and glucose, as well as their associated analytical performance specifications (APSs), are presented. METHOD Samples were drawn from 91 healthy individuals (38 male, 53 female; age range, 21–69 years) for 10 consecutive weeks at 6 European laboratories. Samples were stored at −80 °C before duplicate analysis of all samples on an ADVIA 2400 (Siemens Healthineers). Outlier and homogeneity analyses were performed, followed by CV-ANOVA on trend-corrected data, when relevant, to determine BV estimates with CIs. RESULTS The within-subject BV (CVI) estimates of all measurands, except for urea and LDL cholesterol, were lower than estimates available in an online BV database, with differences being most pronounced for HDL cholesterol, glucose, and direct bilirubin. Significant differences in CVI for men and women/women <50 years of age were evident for uric acid, triglycerides, and urea. The CVA obtained for sodium and magnesium exceeded the EuBIVAS-based APS for imprecision. CONCLUSIONS The EuBIVAS, which is fully compliant with the recently published Biological Variation Data Critical Appraisal Checklist, has produced well-characterized, high-quality BV estimates utilizing a stringent experimental protocol. These new reference data deliver revised and more exacting APS and reference change values for commonly used clinically important measurands, thus having direct relevance to diagnostics manufacturers, service providers, clinical users, and ultimately patients.


2019 ◽  
Vol 152 (Supplement_1) ◽  
pp. S24-S24
Author(s):  
Megan Brown ◽  
Jennifer Colby ◽  
Matthew Feldhammer ◽  
James Nichols

Abstract Our objective was to define the performance of automated chemistry platforms at two large academic medical centers by calculating and comparing sigma metrics for 28 analytes. Performance characteristics of chemistry assays on two Roche Cobas analyzers and four Abbott Architect analyzers were estimated using 12 months of Bio-Rad quality control (QC) data at two concentrations. Method imprecision was calculated as the cumulative QC coefficient of variation (CV) across analyzers at each QC concentration and percent bias was calculated by comparison of analyzer QC mean to peer group means. Sigma values were calculated for each method as [(TEa – Bias%)/CV%] using allowable total error (TEa) from two sources: the CLIA evaluation limits and desirable biological variation. Average sigma values were generated for each site and graded as optimal, >6 sigma; good, 5 to 6 sigma; marginal, 3 to 5 sigma; or poor, <3 sigma. Analysis of NIST SRM1950 standards for a subset of analytes allowed an estimation of absolute bias. Sigma metrics were highly comparable across both study sites. Considering CLIA TEa, just over half (Roche 57%; Abbott 54%) of the 28 analytes met the six-sigma standard of performance. The highest performing groups to meet or exceed the six-sigma standard were lipids (cholesterol, LDL, HDL, and triglycerides) and enzymes (ALP, ALT, AST, CK, GGT, LDH, and lipase). Electrolytes (Na, K, Cl, Mg) and metabolites (total bilirubin, BUN, CO2) failed to meet six-sigma. Notably, there were dramatic differences in sigma values calculated using CLIA and Ricos TEa criteria. Almost 40% of the analytes had at least one QC that performed poorly using Ricos criteria. Only 4 of the 28 assays (CK, GGT, lipase, and triglycerides) demonstrated optimal performance at both study sites using Ricos and CLIA criteria. Overall, 11 analytes at each institution exhibited unacceptable performance using Ricos criteria as opposed to only two analytes with the CLIA TEa limits. Analysis of NIST SRM1950 at both study sites gave comparable sigmas for all analytes except total bilirubin, cholesterol, Mg, and total protein. Neither Abbott nor Roche analyzers met six-sigma quality standards for all analytes tested. Overall assay performance across these two platforms at two major academic medical centers was almost identical. CLIA TEa and RICOS TEa criteria are significantly different, with wider limits of acceptability for CLIA. Variations between individual analyzers and manufacturers and limitations in automation would make tailored QC rules based on sigma metrics difficult to implement in a high-volume laboratory.


1999 ◽  
Vol 82 (4) ◽  
pp. 273-282 ◽  
Author(s):  
Aafje Sierksma ◽  
Jan A. Weststrate ◽  
Gert W. Meijer

In a 9-week study seventy-six healthy adult volunteers with an average age of 44 (sd11) years, with baseline plasma total cholesterol levels below 8 mmol/l, received in a balanced, double-blind, crossover design, a total of three different table spreads for personal use. Two spreads were fortified either with free (non-esterified) vegetable-oil sterols, mainly from soyabean oil (31 g sterol equivalents/kg; 0·8 g/d) or sheanut-oil sterols (133 g sterol equivalents/kg; 3·3 g/d). One spread was not fortified (control). Average intake of spread was 25 g/d for 3 weeks. None of the spreads induced changes in blood clinical chemistry or haematology. Plasma total- and LDL-cholesterol concentrations were statistically significantly reduced by 3·8% and 6% (both 0·19 mmol/l) respectively, for the spread enriched with free soyabean-oil sterols compared with the control spread. The spread enriched with sheanut-oil sterols did not lower plasma total- and LDL-cholesterol levels. None of the plant-sterol-enriched spreads affected plasma HDL-cholesterol concentrations. Plasma-lipid-standardized concentrations of α- plus β-carotene were not statistically significantly affected by the soyabean-oil sterol spread in contrast to lipid-standardized plasma lycopene levels which showed a statistically significant decrease (9·5%). These findings indicate that a daily intake of free soyabean-oil sterols as low as 0·8 g added to a spread is effective in lowering blood total- and LDL-cholesterol levels with limited effects on blood carotenoid levels. The lowering in total- and LDL-cholesterol blood levels due to consumption of the vegetable-oil-sterol-enriched spread may be helpful in reducing the risk of CHD for the population.


Sign in / Sign up

Export Citation Format

Share Document