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1.
Procedures involving phlebotomy are critical for obtaining diagnostic blood specimens and represent a well known and recognized problem, probably among the most important issues in laboratory medicine. The aim of this report is to show spurious hyperkalemia and hypocalcemia due to inadequate phlebotomy procedure. The diagnostic blood specimens were collected from a male outpatient 45 years old, with no clinical complaints. The tubes drawing order were as follows: i) clot activator and gel separator (serum vacuum tube), ii) K3EDTA, iii) a needleless blood gas dedicated-syringe with 80 I.U. lithium heparin, directly connected to the vacuum tube holder system. The laboratory testing results from serum vacuum tube and dedicated syringe were 4.8 and 8.5 mmol/L for potassium, 2.36 and 1.48 mmol/L for total calcium, respectively. Moreover 0.15 mmol/L of free calcium was observed in dedicated syringe. A new blood collection was performed without K3EDTA tube. Different results were found for potassium (4.7 and 4.5 mmol/L) and total calcium (2.37 and 2.38 mmol/L) from serum vacuum tube and dedicated syringe, respectively. Also free calcium showed different concentration (1.21 mmol/L) in this new sample when compared with the first blood specimen. Based on this case we do not encourage the laboratory managers training the phlebotomists to insert the dedicated syringes in needle-holder system at the end of all vacuum tubes. To avoid double vein puncture the dedicated syringe for free calcium determination should be inserted immediately after serum tubes before EDTA vacuum tubes.  相似文献   

2.

Background:

In vitro hemolysis can be induced by several biological and technical sources, and may be worsened by forced aspiration of blood in vacuum tubes. This study was aimed to compare the probability of hemolysis by drawing blood with a commercial evacuated blood collection tube, and S-Monovette used either in the “vacuum” or “aspiration” mode.

Materials and methods:

The study population consisted in 20 healthy volunteers. A sample was drawn into 4.0 mL BD Vacutainer serum tube from a vein of one upper arm. Two other samples were drawn with a second venipuncture from a vein of the opposite arm, into 4.0 mL S-Monovette serum tubes, by both vacuum an aspiration modes. After separation, serum potassium, lactate dehydrogenase (LD) and hemolysis index (HI) were tested on Beckman Coulter DxC.

Results:

In no case the HI exceed the limit of significant hemolysis. As compared with BD Vacutainer, no significant differences were observed for potassium and LD using S-Monovette with vacuum method. Significant increased values of both parameters were however found in serum collected into BD Vacutainer and S-Monovette by vacuum mode, compared to serum drawn by S-Monovette in aspiration mode. The mean potassium bias was 2.2% versus BD Vacutainer and 2.4% versus S-Monovette in vacuum mode, that of LD was 2.7% versus BD Vacutainer and 2.1% versus S-Monovette in vacuum mode. None of these variations exceeded the allowable total error.

Conclusions:

Although no significant macro-hemolysis was observed with any collection system, the less chance of producing micro-hemolysis by S-Monovette in aspiration mode suggest that this device may be used when a difficult venipuncture combined with the vacuum may increase the probability of spurious hemolysis.  相似文献   

3.

Background

It is still uncertain whether or not avoidance to let disinfectant alcohol dry at the site of venipuncture is a source of spurious hemolysis when drawing venous blood.

Methods:

In a consecutive series of 52 outpatients referred for routine laboratory testing, venous blood was drawn by direct venipuncture with (odd group) or without (pair group) wiping 70% isopropyl alcohol at the site of venipuncture. A 3.5 mL evacuated tube with clot activator and gel separator was drawn from a vein of the upper limb, serum was immediately separated with standard centrifugation and tested for potassium, lactate dehydrogenase (LD), aspartate aminotransferase (AST) and hemolysis index (HI) on Roche Cobas.

Results:

No specimen was discarded for unsatisfactory venipuncture. No differences for age and gender were observed between groups. As regards the four parameters investigated, no significant differences could be observed between patients in whom blood was drawn with or without letting the alcohol dry. It is also noteworthy that no sample in both groups exceeded the conventional sample rejection threshold of cell-free hemoglobin.

Conclusions:

The results of our prospective, randomized study attest that failure to wipe alcohol at the site of venipuncture should not be considered as a potential source of spurious hemolysis when drawing blood.  相似文献   

4.

Introduction:

Blood collection through intravenous lines frequently causes spurious hemolysis. Due to specific structure, the tube holder Holdex® (Greiner Bio-One GmbH, Kremsmuenster, Austria) is supposed to prevent erythrocyte injury in samples collected from catheters, so that we planned a specific study to support this hypothesis.

Materials and methods:

Blood was collected from emergency department (ED) patients with 20-gauge catheter. In patients with odd order numbers, first and second tubes were collected with conventional holder (BD Vacutainer One Use Holder, Becton Dickinson, Milan, Italy) and the third with Holdex, whereas in even patients first and second tubes were drawn with Holdex and the third using BD Vacutainer One Use Holder. The first tube was discarded, whereas the second and third were centrifuged and serum was tested for potassium, lactate dehydrogenase (LD) and hemolysis index.

Results:

The final study population consisted in 60 ED patients. Concentrations of potassium (4.25 vs. 4.16 mmol/L; P = 0.031), LD (498 vs. 459 U/L; P = 0.039) and cell-free hemoglobin (0.42 vs. 0.22 g/L; P = 0.042) were higher in samples collected with BD Vacutainer One Use Holder than with Holdex. The mean bias of cell-free hemoglobin was −0.4 g/L in samples collected with Holdex. Although the frequency of samples with cell-free hemoglobin > 0.5 g/L was identical (17/60 vs. 17/60; P = 1.00), the frequency of those with concentrations >3.0 g/L was higher using BD Vacutainer One Use Holder than Holdex (4/60 vs. 0/60; P = 0.042).

Conclusions:

The use of Holdex for drawing blood from intravenous lines may be effective for reducing gross hemolysis.  相似文献   

5.

Introduction:

The contamination of serum or lithium heparin blood with ethylenediaminetetraacetic acid (EDTA) salts may affect accuracy of some critical analytes and jeopardize patient safety. The aim of this study was to evaluate the effect of lithium heparin sample contamination with different amounts of K2EDTA.

Materials and methods:

Fifteen volunteers were enrolled among the laboratory staff. Two lithium heparin tubes and one K2EDTA tube were collected from each subject. The lithium-heparin tubes of each subject were pooled and divided in 5 aliquots. The whole blood of K2EDTA tube was then added in scalar amount to autologous heparinised aliquots, to obtained different degrees of K2EDTA blood volume contamination (0%; 5%; 13%; 29%; 43%). The following clinical chemistry parameters were then measured in centrifuged aliquots: alanine aminotranspherase (ALT), bilirubin (total), calcium, chloride, creatinine, iron, lactate dehydrogenase (LD), lipase, magnesium, phosphate, potassium, sodium.

Results:

A significant variation starting from 5% K2EDTA contamination was observed for calcium, chloride, iron, LD, magnesium (all decreased) and potassium (increased). The variation of phosphate and sodium (both increased) was significant after 13% and 29% K2EDTA contamination, respectively. The values of ALT, bilirubin, creatinine and lipase remained unchanged up to 43% K2EDTA contamination. When variations were compared with desirable quality specifications, the bias was significant for calcium, chloride, LD, magnesium and potassium (from 5% K2EDTA contamination), sodium, phosphate and iron (from 29% K2EDTA contamination).

Conclusions:

The concentration of calcium, magnesium, potassium, chloride and LD appears to be dramatically biased by even modest K2EDTA contamination (i.e., 5%). The values of iron, phosphate, and sodium are still reliable up to 29% K2EDTA contamination, whereas ALT, bilirubin, creatinine and lipase appear overall less vulnerable towards K2EDTA contamination.  相似文献   

6.
IntroductionWe investigated the interference of haemolysis on ethanol testing carried out with the Synchron assay kit using an AU680 autoanalyser (Beckman Coulter, Brea, USA).Materials and methodsTwo tubes of plasma samples were collected from 20 volunteers. Mechanical haemolysis was performed in one tube, and no other intervention was performed in the other tube. After centrifugation, haemolysed and non-haemolysed samples were diluted to obtain samples with the desired free haemoglobin (Hb) values (0, 1, 2, 5, 10 g/L). A portion of these samples was then separated, and ethanol was added to the separated sample to obtain a concentration of 86.8 mmol/L ethanol. After that, these samples were diluted with ethanol-free samples with the same Hb concentration to obtain samples containing 43.4, 21.7, and 10.9 mmol/L. Each group was divided into 20 equal parts, and an ethanol test was carried out. The coefficient of variation (CV), bias, and total error (TE) values were calculated.ResultsThe TE values of haemolysis-free samples were approximately 2-5%, and the TE values of haemolysed samples were approximately 10-18%. The bias values of haemolysed samples ranged from nearly - 6.2 to - 15.7%.ConclusionsHaemolysis led to negative interference in all samples. However, based on the 25% allowable total error value specified for ethanol in the Clinical Laboratory Improvement Amendments (CLIA 88) criteria, the TE values did not exceed 25%. Consequently, ethanol concentration can be measured in samples containing free Hb up to 10 g/L.  相似文献   

7.

Introduction:

Sample type recommended by the manufacturer for the digoxin Abbott assay is either serum collected in glass tubes or plasma (sodium heparin, lithium heparin, citrate, EDTA or oxalate as anticoagulant) collected in plastic tubes. In our hospital samples are collected in plastic tubes. Our hypothesis was that the serum sample collected in plastic serum tube can be used interchangeably with plasma sample for measurement of digoxin concentration. Our aim was verification of plastic serum tubes for determination of digoxin concentration.

Materials and methods:

Concentration of digoxin was determined simultaneously in 26 venous blood plasma (plastic Vacuette, LH Lithium heparin) and serum (plastic Vacuette, Z Serum Clot activator; both Greiner Bio-One GmbH, Kremsmünster, Austria) samples, on Abbott AxSYM analyzer using the original Abbott Digoxin III assay (Abbott, Wiesbaden, Germany). Tube comparability was assessed using the Passing Bablok regression and Bland-Altman plot.

Results:

Serum and plasma digoxin concentrations are comparable. Passing Bablok intercept (0.08 [95% CI = −0.10 to 0.20]) and slope (0.99 [95% CI = 0.92 to 1.11]) showed there is no constant or proportional error.

Conclusion:

Blood samples drawn in plastic serum tubes and plastic plasma tubes can be interchangeably used for determination of digoxin concentration.  相似文献   

8.
IntroductionThe aim of this study was to screen practices used in verification procedures for methods/analysers among medical biochemistry laboratories (MBLs) in Croatia. We hypothesized that these procedures differ widely from laboratory to laboratory and wanted to gather specific data on steps used in the verification workflow.Materials and methodsIn order to obtain data, an online survey was conducted. The survey, divided in two sections, contained 29 questions and statements addressing general characteristics and specific steps of the verification workflow of each individual MBL. The survey was disseminated among managers of all MBLs in Croatia.ResultsA total of 108/196 (55%) laboratories participated in the survey. Forty nine MBLs were excluded from the second part of the survey: 14 have not implemented verification procedures, and 35 MBLs due to the absence of answers. The most relevant results of the second part of the survey showed that: 18/59 (0.31) of the responding MBLs have difficulties when defining acceptance criteria, 27/59 (0.46) used the Clinical and Laboratory Standards Institute protocol for precision estimation; the majority of MBLs used a median of 20 samples for method/analyser comparisons and estimated bias using internal quality control samples; reference intervals provided by external sources are mainly adopted; 60% of MBLs do not include linearity verification in their protocol and do not use the national document for the estimation of measurement uncertainty.ConclusionsHeterogeneous verification protocols are routinely utilized across Croatian MBLs which clearly confirms that a national document might help in the harmonization of verification procedures.  相似文献   

9.

Introduction

Glycolysis affects glucose determination in vitro. The placement of sample tubes in ice-water slurry with plasma separation within 30 minutes is recommended, or alternatively the use of a glycolysis inhibitor. The aim of our two-steps study was to evaluate which Terumo tube is best for glucose determination in routine clinical setting.

Materials and methods

In the first study, blood from 100 volunteers was collected into lithium heparin (LH), NaF/Na heparin (FH) and NaF/citrate buffer/Na2EDTA (FC-Mixture) tubes. LH sample was treated as recommended and considered as reference, while FH and FC-Mixture samples were aliquoted, maintained at room temperature (RT) for 1, 2 and 4 hours; centrifuged and plasma analysed in triplicate. In the second study, samples from 375 volunteers were collected in LH, FH and FC-Mixture tubes and held at RT before centrifugation from 10 to 340 minutes, depending on each laboratory practice. Samples were analysed in one analytical run.

Results

In the first study, FH glucose concentrations were 5.15 ± 0.66 mmol/L, 5.05 ± 0.65 mmol/L and 5.00 ± 0.65 mmol/L (P < 0.001) in tubes stored at RT for 1, 2 and 4 hours, respectively. Mean biases in all time points exceeded the analytical goal for desirable bias based on biological variation criteria. FC-Mixture glucose concentrations were 5.48 ± 0.65 mmol/L, 5.46 ± 0.6 mmol/L and 5.46 ± 0.64 mmol/L in tubes stored at RT for 1, 2 and 4 hours, respectively. Mean biases for FC-Mixture glucose in all time points reached optimal analytical goals. In the second study, the biases for LH and FH glucose compared to reference FC-Mixture glucose exceeded the preset analytical goals, regardless of the blood collection to centrifugation time interval.

Conclusions

FC-mixture tubes glucose concentrations were preserved up to 4h storage at RT. We confirmed that NaF alone does not allow immediate glycolysis inhibition in real life pre-centrifugation storage conditions (up to 340 minutes). FC-Mixture should be used exclusively for glucose determination in laboratories unable to implement the recommended blood samples’ treatment.Key words: glucose, pre-analytical phase, sodium fluoride, citrate acidification, stability  相似文献   

10.
IntroductionBased on the hypothesis that there is a substantial rate of adults with prediabetes and undiagnosed diabetes mellitus (DM), our aim was to perform haemoglobin A1c (HbA1c)-based screening in a cohort of Croatian adults and estimate the prevalence of prediabetes and undiagnosed DM according to American Diabetes Association criteria.Materials and methodsThis multi-center, cross-sectional study performed in six Croatian hospitals included 5527 patients aged 40 to 70 years admitted to the Emergency Department or undergoing a primary care check-up. Haemoglobin A1c was measured from leftover whole blood samples using the enzymatic method on either Alinity c or Architect c-series analyser (Abbott Laboratories, Chicago, USA). Haemoglobin A1c between 39-47 mmol/mol was classified as prediabetes, while ≥ 48 mmol/mol as undiagnosed DM.ResultsAfter exclusion of 435 patients with known DM, the final cohort included 5092 patients (median age 57; 56% males). A total of 882 (17.3%) patients had HbA1c values between 39 and 47 mmol/mol. There were 214 (4.2%) patients with HbA1c ≥ 48 mmol/mol. Prediabetes prevalence ranged from 14.2% to 20.5%, while undiagnosed DM from 3.3% to 7.3%, with statistically significant differences among settings (P < 0.001). Age-stratified analysis showed that prediabetes and undiagnosed DM prevalence increase with age (P < 0.001), being 25.4% and 5.8%, respectively, in patients aged 60 to 70 years.ConclusionUnderlying impairment of glucose metabolism was identified in about one in five adults, with significant number of patients with already overt DM. These results should serve as a starting point for further steps directed towards promotion of preventive measures for DM in Croatia.  相似文献   

11.

Introduction:

Preanalytical variables account for most of laboratory errors. There is a wide range of factors that affect the reliability of laboratory report. Most convenient sample type for routine laboratory analysis is serum. BD Vacutainer® Rapid Serum Tube (RST) (Becton, Dickinson and Company, Franklin Lakes, NJ, USA) blood collection tube provides rapid clotting time allowing fast serum separation. Our aim was to evaluate the comparability of routine chemistry parameters in BD Vacutainer® RST blood collection tube in reference with the BD Vacutainer® Serum Separating Tubes II Advance Tube (SST) (Becton, Dickinson and Company, Franklin Lakes, NJ, USA).

Materials and methods:

Blood specimens were collected from 90 participants for evaluation on its results, clotting time and stability study of six routine biochemistry parameters: glucose (Glu), aspartate aminotransferase (AST), alanine aminotransferase (ALT), calcium (Ca), lactate dehidrogenase (LD) and potassium (K) measured with Olympus AU2700 analyzer (Beckman Coulter, Tokyo, Japan). The significance of the differences between samples was assessed by paired t-test or Wilcoxon Matched-Pairs Rank test after checking for normality.

Results:

Clotting process was significantly shorter in the RSTs compared to SSTs (2.49 min vs. 19.47 min, respectively; P < 0.001). There was a statistically significant difference between the RST and SST II tubes for glucose, calcium and LD (P < 0.001). Differences for glucose and LD were also clinically significant. Analyte stability studies showed that all analytes were stable for 24 h at 4 °C.

Conclusions:

Most results (except LD and glucose) from RST are comparable with those from SST. In addition, RST tube provides shorter clotting time.  相似文献   

12.

Background

Due to the high prevalence of hemolysis in specimens received from the emergency department (ED), several strategies have been proposed to improve sample quality, but none of these seem effective to overcome the problem. In a preliminary study we showed that the use of S-Monovette blood collection system was effective to lower the risk of hemolysis in venous blood samples collected from intravenous catheters. This study was hence aimed to verify whether the replacement of a conventional vacuum system with S-Monovette may be effective to reduce the burden of hemolysis in the daily practice of a large urban ED.

Materials and methods

The study was divided in two observational periods of 4 months each. In the former period, blood was collected from intravenous catheters using BD Vacutainer SST II Plus plastic serum tubes, whereas in the latter period the blood was drawn from intravenous catheters using S-Monovette blood tubes in aspiration mode. Sample hemolysis was automatically assessed in all serum samples by photometrical measurement.

Results

The total number of hemolysed serum specimens was 624/14155 (4.41%) in the first phase of the study, and 342/13319 (2.57%) in the second phase of the study (P < 0.001).

Conclusion

Results of our study confirm that the introduction of the Sarstedt S-Monovette blood tubes has reduced the hemolysis rate in the emergency department compared to the previously used BD Vacutainer® SST II Plus plastic serum tubes.Key words: preanalytical phase, hemolysis, blood specimen collection, catheter, emergency department  相似文献   

13.
IntroductionKidney stone formers can have higher oxalate and phosphate salt amounts in their urine than healthy people and we hypothesized that its acidification may be useful. The study aims to compare results of urine concentrations of calcium, magnesium, and inorganic phosphorus in the midstream portion of first voided morning urine samples without (FMU) and with post-collection acidification (FMUa) in kidney stone patients.Materials and methodsThis is a prospective single center study. A total of 138 kidney stone patients with spot urine samples were included in the study. Urine concentrations of calcium, magnesium and inorganic phosphorus were measured with and without post-collection acidification. Acidification was performed by adding 5 µL of 6 mol/L HCl to 1 mL of urine.ResultsThe median age (range) of all participants was 56 (18-87) years. The median paired differences between FMU and FMUa concentrations of calcium, magnesium, and inorganic phosphorus were: - 0.040 mmol/L, 0.035 mmol/L, and 0.060 mmol/L, respectively. They were statistically different: P < 0.001, P < 0.001, P = 0.004, respectively. These differences are not clinically significant because biological variations of these markers are much higher.ConclusionsNo clinically significant differences in urinary calcium, magnesium, and inorganic phosphorus concentrations between FMU and FMUa in patients with kidney stones were found.  相似文献   

14.
IntroductionThe COVID-19 pandemic has posed several challenges to clinical laboratories across the globe. Amidst the outbreak, errors occurring in the preanalytical phase of sample collection, transport and processing, can further lead to undesirable clinical consequences. Thus, this study was designed with the following objectives: (i) to determine and compare the blood specimen rejection rate of a clinical laboratory and (ii) to characterise and compare the types of preanalytical errors between the pre-pandemic and the pandemic phases.Materials and methodsThis retrospective study was carried out in a trauma-care hospital, presently converted to COVID-19 care centre. Data was collected from (i) pre-pandemic phase: 1st October 2019 to 23rd March 2020 and (ii) pandemic phase: 24th March to 31st October 2020. Blood specimen rejection rate was calculated as the proportion of blood collection tubes with preanalytical errors out of the total number received, expressed as percentage.ResultsTotal of 107,716 blood specimens were screened of which 43,396 (40.3%) were received during the pandemic. The blood specimen rejection rate during the pandemic was significantly higher than the pre-pandemic phase (3.0% versus 1.1%; P < 0.001). Clotted samples were the commonest source of preanalytical errors in both phases. There was a significant increase in the improperly labelled samples (P < 0.001) and samples with insufficient volume (P < 0.001), whereas, a significant decline in samples with inadequate sample-anticoagulant ratio and haemolysed samples (P < 0.001).ConclusionIn the ongoing pandemic, preanalytical errors and resultant blood specimen rejection rate in the clinical laboratory have significantly increased due to changed logistics. The study highlights the need for corrective steps at various levels to reduce preanalytical errors in order to optimise patient care and resource utilisation.  相似文献   

15.
IntroductionMost laboratories routinely determine haemolysis, icterus and lipemia indices to identify lipemic samples and reject potentially affected results. Hypertriglyceridemia is the most common cause of lipemia and severe hypertriglyceridemia (≥ 11.3 mmol/L) is a major risk factor of acute pancreatitis.Laboratory analysisA 56-year-old woman attended the outpatient clinic for a follow-up visit 1 month after a kidney transplantation. Her immunosuppressive therapy consisted of corticosteroids, cyclosporine, and mycophenolic acid. The routine clinical chemistry sample was rejected due to extreme lipemia. The comment “extreme lipemic sample” was added on the report, but the requesting physician could not be reached. The Cobas 8000 gave a technical error (absorption > 3.3) for the HIL-indices (L-index: 38.6 mmol/L) which persisted after high-speed centrifugation. The patient was given a new appointment 2 days later. The new sample was also grossly lipemic and gave the same technical error (L-index: 35.9 mmol/L).What happenedThe second sample was manually diluted 20-fold after centrifugation to obtain a result for triglycerides within the measuring range (0.10–50.0 mmol/L). Triglycerides were 169.1 mmol/L, corresponding to very severe hypertriglyceridemia. This result was communicated to the nephrologist and the patient immediately recalled to the hospital. She received therapeutic plasma exchange the next day and did not develop acute pancreatitis.Main lessonThis case illustrates the delicate balance between avoiding the release of unreliable results due to lipemia and the risk of delayed diagnosis when results are rejected. Providing an estimate of the degree of hypertriglyceridemia might be preferable to rejecting the result.  相似文献   

16.

Introduction

The collected and shipped blood samples are exposed to a various extra-analytical factors prior to analysis. The aim of the study was to determine the stability of analytes in serum gel tubes and plain tubes exposed to a range of storage temperatures and times after centrifugation.

Materials and methods:

Fifteen healthy volunteers were recruited and venous blood was collected into four tubes, two with and two without gel separator. Analyzing the baseline samples in 30 min, all were stored at 4ºC or 24ºC for 6, 12, 18, 24, 30, 36, 48 and 72 hours and 1 week. Sixteen biochemical anaytes were measured on each sample. Variations remained under the desirable bias considered as clinically insignificant.

Results:

On day three, most analytes remained stable including albumin, protein, creatinine, cholesterol, triglycerides, gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), alanine aminotransferase (ALT), creatine kinase (CK), lactate dehydrogenase (LD) regardless of tube types. Glucose concentration decreased markedly (P = 0.001) beginning from the first hours of storage in plain serum. The stability maximized for the analytes including glucose, total bilirubin, urea nitrogen (BUN), uric acid stored at 4 ºC in gel tubes. Aspartate aminotransferase (AST) activity increased significantly (P = 0.002) up to 48-h, however bias was not significant clinically. High density lipoprotein (HDL) concentration was stable in gel tubes at 24 ºC, in plain tubes at 4 ºC stored up to 36-h.

Conclusion:

Serum gel or non-gel tubes might be used interchangeably for 11 analytes chilled or at 24 ºC, whereas some restrictions must be applied for glucose, AST, BUN, HDL, and uric acid.  相似文献   

17.
Abstract

This paper describes the ActionWorkflow? approach to workflow management technology: a design methodology and associated computer software for the support of work in organizations. The approach is based on theories of communicative activity as language/action, developed in a series of systems for coordination among users of networked computers. This article describes the approach, gives an example of its application, and shows the architecture of a workflow management system based on it.  相似文献   

18.
IntroductionTwo new formulas, the Martin-Hopkins and the Sampson formula, were recently developed to overcome shortcomings of the Friedewald formula for calculating LDL-cholesterol. We aimed to compare the concordance of the two formulas with apolipoprotein B (apoB), a surrogate marker of the number of LDL particles.Materials and methodsIn a study of serum lipid data of 1179 patients who consulted the AZ St-Jan Hospital Bruges for cardiovascular risk assessment, the correlation and concordance of the Friedewald, Martin-Hopkins and Sampson formulas with apoB concentration, measured by immunonephelometry, were determined and compared.ResultsThe Martin-Hopkins formula showed significantly higher correlation coefficient than the Friedewald formula with apoB in the entire dataset and in patients with low LDL-cholesterol < 1.8 mmol/L. Both Martin-Hopkins and Sampson formulas yielded > 70% concordance of LDL-cholesterol with regard to treatment group classification based on population-equivalent thresholds of apoB in hypertriglyceridemic patients (2-4.5 mmol/L), with the highest concordance (75.6%) obtained using Martin-Hopkins formula vs. 60.5% with Friedewald formula.ConclusionThe Martin-Hopkins (and, to a lesser extent, Sampson) formula is more closely associated with the number of LDL particles than Friedewald formula. This, in combination with literature evidence of lesser accuracy of the Friedewald formula, is an argument to switch from Friedewald to a modified, improved formula.  相似文献   

19.
IntroductionIt is common for patients to switch between several healthcare providers. In this context, the long-term follow-up of medical conditions based on laboratory test results obtained from different laboratories is a challenge. The measurement uncertainty in an inter-laboratory context should also be considered in data mining research based on routine results from randomly selected laboratories. As a proof-of-concept study, we aimed at estimating the inter-laboratory reference change value (IL-RCV) for exemplary analytes from publicly available data on external quality assessment (EQA) and biological variation.Materials and methodsExternal quality assessment data of the Reference Institute for Bioanalytics (RfB, Bonn, Germany) for serum creatinine, calcium, aldosterone, PSA, and of whole blood HbA1c from campaigns sent out in 2019 were analysed. The median CVs of all EQA participants were calculated based on 8 samples from 4 EQA campaigns per analyte. Using intra-individual biological variation data from the EFLM database, positive and negative IL-RCV were estimated with a formula based on log transformation under the assumption that the analytes under examination have a skewed distribution.ResultsWe estimated IL-RCVs for all exemplary analytes, ranging from 13.3% to 203% for the positive IL-RCV and - 11.8% to - 67.0% for the negative IL-RCV (serum calcium - serum aldosterone), respectively.ConclusionExternal quality assessment data together with data on the biological variation – both freely available – allow the estimation of inter-laboratory RCVs. These differ substantially between different analytes and can help to assess the boundaries of interoperability in laboratory medicine.  相似文献   

20.
This study reports the utilization of serum fructosamine and blood glucose for the screening of gestational diabetes mellitus (GDM). Blood samples from 165 pregnant women were analyzed for fasting blood glucose (FBG), random blood glucose (RBG) and serum fructosamine. The actual fructosamine levels were corrected for serum protein (c-Fruct) for more precise presentation. Two cut-off values of FBG (>5.3 mmol/L and >7.0 mmol/L) and RBG (>7.8 mmol/L and >11.0 mmol/L) were used to classify hyperglycemic subjects for subsequent evaluation. The average values±standard deviations for FBG, RBG and cFruct were 5.865±1.95, 7.767±3.21 and 2.387±0.47 mmol/L, respectively. FBG levels were significantly correlated with RBG (Pearson correlation=0.597, P<0.001). Significant correlations were also observed between cFruct and FBG (Pearson correlation=0.673, P<0.001) or RBG (Pearson correlation=0.641, P<0.001). Out of 165 subjects, 24 (14.5%) cases were classified as hyperglycemic on the basis of FBG>7.0 mmol/L or RBG>11.0 mmol/L; use of lower cut-off values resulted higher frequencies of hyperglycemia. Whereas, a combined criteria of FBG>5.3 mmol/L and cFruct >2.5 mmol/L predicted 35 patients as the most probable hyperglycemic as compared to 32 patients identified using the criteria of RBG >7.8 mmol/L and cFruct >2.5 mmol/L. These criteria were associated with 4.8% and 3.6% false-positivity at the expense of 3.6% and 3.0% false-negative outcomes, respectively. The levels of FBG, RBG and cFruct were significantly higher in hyperglycemic groups (irrespective of grouping criteria) as compared to the respective normal groups. In conclusion, these findings clearly indicate that the paired values of cFruct with FBG or RBG could help in filtering high-risk individuals for OGTT and therefore avoiding a unnecessary OGTT.  相似文献   

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