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1.
In the clinical laboratory setting, interferences can be a significant source of laboratory errors with potential to cause serious harm for the patient. After hemolysis, lipemia is the most frequent endogenous interference that can influence results of various laboratory methods by several mechanisms. The most common preanalytical cause of lipemic samples is inadequate time of blood sampling after the meal or parenteral administration of synthetic lipid emulsions. Although the best way of detecting the degree of lipemia is measuring lipemic index on analytical platforms, laboratory experts should be aware of its problems, like false positive results and lack of standardization between manufacturers. Unlike for other interferences, lipemia can be removed and measurement can be done in a clear sample. However, a protocol for removing lipids from the sample has to be chosen carefully, since it is dependent on the analytes that have to be determined. Investigation of lipemia interference is an obligation of manufacturers of laboratory reagents; however, several literature findings report lack of verification of the declared data. Moreover, the acceptance criteria currently used by the most manufacturers are not based on biological variation and need to be revised. Written procedures for detection of lipemia, removing lipemia interference and reporting results from lipemic samples should be available to laboratory staff in order to standardize the procedure, reduce errors and increase patient safety.  相似文献   

2.

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   

3.
IntroductionEpithelial cells (ECs) are structures regularly observed during urine microscopy analysis. The correct identification of EC subtypes can be useful since renal tubular epithelial cells (RTECs) are clinically relevant. We investigate the urinary ECs report and the judgement of its clinical importance by Brazilian laboratories.Materials and methodsA survey with four questions was made available to participants of the Urinalysis External Quality Assessment Program (EQAP) from Controllab. Laboratories composed 3 groups: (1) differentiating ECs subtypes: “squamous”, “transitional” and “RTECs”; (2) differentiating ECs subtypes: “squamous” or “non-squamous” cells; (3) without ECs subtype identification. Participants did not necessarily answer to all questions and the answers were evaluated both within the same laboratory’s category and within different categories of laboratories.ResultsA total of 1336 (94%) laboratories answered the survey; Group 1, 119/140 (85%) reported that ECs differentiation is important to the physician and 62% want to be evaluated by EQAP, while in Group 3, 455/1110 (41%) reported it is useful to them, however only 25% want be evaluated by EQAP. Group 2 laboratories 37/51 (73%) reported that the information is important, but only 13/52 (25%) are interested in an EQAP with differentiation of the 3 ECs subtypes.ConclusionMost of the laboratories do not differentiate ECs in the three subtypes, despite the clinical importance of RTECs. Education of laboratory staff about the clinical significance of urinary particles should be considered a key priority.  相似文献   

4.
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   

5.
IntroductionThe accurate estimation of low-density lipoprotein cholesterol (LDL) is crucial for management of patients at risk of cardiovascular events due to dyslipidemia. The LDL is typically calculated using the Friedewald equation and/or direct homogeneous assays. However, both methods have their own limitations, so other equations have been proposed, including a new equation developed by Sampson. The aim of this study was to evaluate Sampson equation by comparing with the Friedewald and Martin-Hopkins equations, and with a direct LDL method.Materials and methodsResults of standard lipid profile (total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL) and triglycerides (TG)) were obtained from two anonymized data sets collected at two laboratories, using assays from different manufacturers (Beckman Coulter and Roche Diagnostics). The second data set also included LDL results from a direct assay (Roche Diagnostics). Passing-Bablok and Bland-Altman analysis for method comparison was performed.ResultsA total of 64,345 and 37,783 results for CHOL, HDL and TG were used, including 3116 results from the direct LDL assay. The Sampson and Friedewald equations provided similar LDL results (difference ≤ 0.06 mmol/L, on average) at TG ≤ 2.0 mmol/L. At TG between 2.0 and 4.5 mmol/L, the Sampson-calculated LDL showed a constant bias (- 0.18 mmol/L) when compared with the Martin-Hopkins equation. Similarly, at TG between 4.5 and 9.0 mmol/L, the Sampson equation showed a negative bias when compared with the direct assay, which was proportional (- 16%) to the LDL concentration.ConclusionsThe Sampson equation may represent a cost-efficient alternative for calculating LDL in clinical laboratories.  相似文献   

6.

Introduction:

There are a number of pre-analytical and analytical factors, which cause false results in the complete blood count. The present case identifies cold agglutinins as the cause for the mismatch between hematocrit and hemoglobin values.

Materials and methods:

70-year old female patient had a history of cerebrovascular diseases and rheumatoid arthritis. During routine laboratory examination, the patient had normal leukocyte and platelet counts; however, the hemoglobin (Hb: 105 g/L) and hematocrit (HCT: 0.214 L/L) results were discordant. Hemolysis, lipemia and cold agglutinin were evaluated as possible reasons for the mismatch between hematocrit and hemoglobin values.

Results:

First blood sample was slightly hemolysed. Redrawn sample without hemolysis or lipemia was analyzed but the mismatch became even more distinct (Hb: 104 g/L and HCT: 0.08 L/L). In this sample, the titration of the cold agglutinin was determined and found to be positive at 1:64 dilution ratios. After an incubation of the sample at 37°C for 2 hours, reversibility of agglutination was observed.

Conclusion:

We conclude that cold agglutinins may interfere with the analysis of erythrocyte and erythrocyte-related parameters (HCT, MCV, MCH and MCHC); however, Hb, leukocyte and platelet counts are not affected.  相似文献   

7.
IntroductionThe interest in quality management tools/methodologies is gradually increasing to ensure quality and accurate results in line with international standards in clinical laboratories. Six Sigma stands apart from other methodologies with its total quality management system approach. However, the lack of standardization in tolerance limits restricts the advantages for the process. Our study aimed both to evaluate the applicability of analytical quality goals with Roche Cobas c 702 analyser and to determine achievable goals specific to the analyser used.Materials and methodsThe study examined under two main headings as Sigmalaboratory and Sigmaanalyser. Sigmalaboratory was calculated using internal and external quality control data by using Roche Cobas c 702 analyser for 21 routine biochemistry parameters and, Sigmaanalyser calculation was based on the manufacturer data presented in the package inserts of the reagents used in our laboratory during the study. Sigma values were calculated with the six sigma formula.ResultsConsidering the total number of targets achieved, Sigmaanalyser performed best by meeting all CLIA goals, while Sigmalaboratory showed the lowest performance relative to biological variation (BV) desirable goals.ConclusionsThe balance between the applicability and analytical assurance of “goal-setting models” should be well established. Even if the package insert data provided by the manufacturer were used in our study, it was observed that almost a quarter of the evaluated analytes failed to achieve even “acceptable” level performance according to BV-based goals. Therefore, “state-of-the-art” goals for the Six Sigma methodology are considered to be more reasonable, achievable, and compatible with today’s technologies.  相似文献   

8.
IntroductionAn appropriate management of anaemia laboratory tests is crucial for a correct diagnosis and treatment. A non-sequential “shotgun” approach (where every anaemia related test is ordered) causes workload and cost increases and could be potentially harmful. We have implemented a Decision Support System through our laboratory information system (LIMS) based on reflexive algorithms and automatic generation of interpretative reports specifically in diagnosis of anaemia for primary care patients.Materials and methodsWhen a request contained an “Anaemia Suspicion Study” profile, more than twenty automatic reflexive rules were activated in our LIMS based upon laboratory results. These rules normally involved the addition of reflexive tests. A final report was automatically generated for each interpretation which was always reviewed for their validity by two staff pathologists. We measured the impact of this system in the ordering of most common anaemia related tests and if a proper treatment was established based on the interpretive report.ResultsFrom all the studies performed, only 12% were positive being “iron deficiency” and “anaemia of chronic disease” the most frequent causes, 62% and 17%, respectively. Proper treatment was established in 88% of these anaemic patients. Total iron, transferrin, ferritin, folate and vitamin B12 demand decreased substantially after implementation representing a cost reduction of 40% only for these five tests.ConclusionsOur system has easily improved patient outcomes, advising on individual clinical cases. We have also noticeably reduced the number of over-requested tests and laboratory costs.  相似文献   

9.
We describe a case of severe hypervitaminosis D and mild hypercalcaemia in a 68-year-old woman who presented with fatigue and weight loss. Her 25-hydroxy vitamin D (25OHD) was > 400 nmol/L (50-150) and corrected serum calcium was 2.83 mmol/L (2.1-2.6). Her intact parathyroid hormone (PTH) was 4.9 pmol/L (2.0-9.5). Further investigation revealed an IgM kappa paraprotein, and a bone marrow aspirate confirmed a diagnosis of lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia (LPL/WM). As the vitamin D level was discordant with the patient’s other results and presentation, the presence of an assay interferent was suspected. A 1-in-2 dilution of the sample returned a 25OHD result of 84 nmol/L in keeping with the presence of an interferent. Testing for rheumatoid factor was negative. The sample was treated with an antibody blocking reagent (Scantibodies) and results were not consistent with heterophile antibody interference. The sample was then analysed using liquid chromatography tandem mass spectrometry (LC-MS/MS), which returned a 25OHD result of 82 nmol/L. Testing on an alternative immunoassay platform produced a 25OHD result of 75 nmol/L. Reapeted testing on the original platform following reduction of the monoclonal paraprotein with chemotherapy, returned a result of 64 nmol/L. The patient’s mild hypercalcaemia persisted following resolution of the monoclonal paraprotein, in keeping with a diagnosis of primary hyperparathyroidism. This case highlights the potential for paraproteins to cause assay interference, and the importance of considering interference when results are incongruous with the clinical presentation.  相似文献   

10.

Introduction:

We present our work of monitoring 202 different patients with markedly elevated serum index for lipemia whereby serum samples were clear. We tried to clarify the cause of occurrence of these indices which were detected in the years 2006–2010 on Siemens Dimension analyzers.

Materials and methods:

In samples with unusual lipemia index we measured the concentration of lipids (total cholesterol, triglycerides, HDL and LDL cholesterol, Lp(a), ApoA1, ApoB), total proteins and checked for possible interferents (rheumatoid factor, immunoglobulins). We performed serum protein and immuno- electrophoresis. We investigated the repeatability of unusual lipemia indices during the day and after different time periods and we compared them on four different analyzers (RXL Max, Vista, Hitachi 911 and former Olympus AU640).

Results:

In 87% of 202 samples we found a monoclonal or biclonal peak in serum protein electrophoresis. Different types of paraproteins were confirmed with immunofixation electrophoresis. In the remaining 13%, polyclonal elevated concentrations of immunoglobulins were measured. Other parameters had no influence on appearing of these indices. The repeatability of indices was good during the first day of measurements (P values > 0.05) and markedly lower in the next days or after 3 and 12 months (P values < 0.05). The indices were elevated only on Dimension analyzers, but not on Hitachi and former Olympus analysers.

Conclusion:

A markedly elevated lipemia index in a clear serum sample measured on Siemens analyzers Dimension indicates a high possibility for the presence of a paraprotein in the sample.  相似文献   

11.
IntroductionThe current study aimed to assess the interference of in vitro haemolysis on complete blood count (CBC) using Abbott Alinity hq system, and to determine which haemolysis levels affect the reliability of sample results.Materials and methodsBlood samples obtained from 25 volunteers in K3-EDTA tubes were divided into four aliquots. The first aliquot was not subjected to any intervention. The second, third and fourth aliquots were passed through a fine needle 2, 4 and 6 times, respectively. Complete blood count was performed by multi-angle polarized scatter separation technology and haemolysis index (HI) was assessed from the plasma samples separated by centrifugation. Five groups were formed according to the HI values. The percentage biases between the results of non-haemolysed and haemolysed groups were compared with the desirable bias limits from The European Federation of Clinical Chemistry and Laboratory Medicine database and reference change values (RCVs).ResultsIn groups 1 to 4, the effects of haemolysis on CBC parameters were acceptable comparing to the analytical bias except for lymphocytes (7.26%-7.42%), MCH (2.59%), and MCHC (0.47%-2.81%). Results of group 5 (gross haemolysis) showed decreases in HCT(- 4.56%), RBC (- 4.07%) count and increase in lymphocyte (11.60%) count higher than the analytical performance specifications. Moreover, variations in MCH (4.65%) and MCHC (5.24%) were exceeding the RCVs.ConclusionsGross haemolysis (haemoglobin concentration > 10 g/L) is likely to produce unreliable CBC results on non-pathological samples. Further studies including pathological specimens are needed.  相似文献   

12.
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   

13.

Introduction

Postmenopausal women have higher risk of cardiovascular disease. One of the contributing factors could be reduced activity of anti-atherogenic enzyme paraoxonase 1 (PON1). The aim of this study was to examine differences in the lipid status, paraoxonase and arylesterase PON1 activities and PON1 phenotype in women with regular menstrual cycle and in postmenopausal women.

Materials and methods:

The study included 51 women in reproductive age (25 in follicular and 26 in luteal phase of the menstrual cycle) and 23 women in postmenopause. Lipid parameters in sera were determined using original reagents and according to manufacturer protocol. PON1 activity in serum was assessed by spectrophotometric method with substrates: paraoxon and phenylacetate. PON1 phenotype was determined by double substrate method.

Results:

Compared to the women in follicular and luteal phase, postmenopausal women have significantly higher concentration of triglyceride [0.9 (0.7–1.3), 0.7 (0.6–1.0) vs. 1.5 (0.9–1.7) mmol/L; P = 0.002], cholesterol [5.10 (4.78–6.10), 5.05 (4.70–5.40) vs. 6.30 (5.73–7.23) mmol/L; P < 0.001], LDL [3.00 (2.56–3.63), 3.00 (2.70–3.70) vs. 3.90 (3.23–4.50) mmol/L; P < 0.001], and apolipoprotein B [0.88 (0.75–1.00), 0.79 (0.68–1.00) vs. 1.07 (0.90–1.24) mmol/L; P = 0.002]. PON1 basal [104 (66–260), 106 (63–250) vs. 93 (71–165) U/L; P = 0.847] and salt-stimulated paraoxonase activity [210 (131–462), 211 (120–442) vs. 180 (139–296) U/L; P = 0.857] as well as arylesterase activity [74 (63–82), 70 (54–91) vs. 70 (60–81) kU/L; P = 0.906] and PON1 phenotype (P = 0.810) were not different in the study groups.

Conclusion:

There are no differences in PON1 activity and PON1 phenotype between women with regular menstrual cycle and postmenopausal women.  相似文献   

14.

Introduction

Centrifugation is an essential step for plasma preparation to remove residual elements in plasma, especially platelets and platelet-derived microparticles (PMPs). Our working hypothesis was that centrifugation as a preanalytical step may influence some coagulation parameters.

Materials and methods

Healthy young men were recruited (N = 17). For centrifugation, two protocols were applied: (A) the first centrifugation at 2500 x g for 15 min and (B) at 2500 x g for 20 min at room temperature with a light brake. In protocol (A), the second centrifugation was carried out at 2500 x g for 15 min, whereas in protocol (B), the second centrifugation involved a 10 min spin at 13,000 x g. Thrombin-antithrombin (TAT) and plasmin-antiplasmin (PAP) complexes concentrations were determined by enzyme-linked immunosorbent assays. PMPs were stained with CD41 antibody and annexin V, and analyzed by flow cytometry method. Procoagulant activity was assayed by the Calibrated Automated Thrombogram method as a slope of thrombin formation (CAT velocity).

Results

Median TAT and PAP concentrations did not differ between the centrifugation protocols. The high speed centrifugation reduced the median (IQR) PMP count in plasma from 1291 (841-1975) to 573 (391-1010) PMP/µL (P = 0.001), and CAT velocity from 2.01 (1.31-2.88) to 0.97 (0.82-1.73) nM/min (P = 0.049). Spearman’s rank correlation analysis showed correlation between TAT and PMPs in the protocol A plasma which was (rho = 0.52, P < 0.050) and between PMPs and CAT for protocol A (rho = 0.74, P < 0.050) and protocol B (rho = 0.78, P < 0.050).

Conclusion

Centrifugation protocols do not influence the markers of plasminogen (PAP) and thrombin (TAT) generation but they do affect the PMP count and procoagulant activity.Key words: cell-derived microparticles, blood coagulation tests, centrifugation, preanalytical phase  相似文献   

15.
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   

16.
IntroductionIntensive physical activity causes functional and metabolic changes in the athlete’s organism. The study aimed to verify the common national available reference intervals (RIs) for common inflammatory and screening coagulation tests in a population of healthy young female athletes.Materials and methodsOne hundred and twenty-one female athletes (age range: 16–34), from various sports disciplines (water polo, handball, volleyball, football, basketball), were included in the study. All participants completed the international physical activity short-form questionnaire. Blood samples were collected between 8–10 am, after an overnight fast, before any physical activity. Reference intervals were determined according to Clinical & Laboratory Standards Institute EP28-A3C Guidelines.ResultsCalculated RIs for white blood cell count (WBC), prothrombin time (PT), and activated partial thromboplastin time (APTT) ratio were in accordance with the common national RIs. Calculated RI for C-reactive protein (CRP) was lower (< 2.9 mg/L) than the proposed cut-off for a healthy population (< 5.0 mg/L). Reference interval for fibrinogen was higher (1.9–4.4 g/L), than the available RIs (1.8–3.5 g/L). D-dimer cut-off value was set at 852 µg/L fibrinogen equivalent units (FEU), higher than the proposed 500 µg/L FEU for venous thromboembolism (VTE) exclusion.ConclusionsThe applicability of the available RIs for WBC count, PT, and APTT-ratio was confirmed. However, RIs for CRP and fibrinogen differed significantly than the available common national RIs for the healthy non-athletes’ population. A higher cut-off for D-dimers should be extensively verified before implementation for VTE diagnosis exclusion in a group of healthy young female athletes.  相似文献   

17.
IntroductionThe detection and prevention of errors in the postanalytical phase can be done through the harmonization and standardization of constituent parts of this phase of laboratory work. The aim was to investigate how well the ongoing management of the postanalytical phase corresponds to the document “Post-analytical laboratory work: national recommendations” in Croatian medical biochemistry laboratories (MBLs).Materials and methodsAll 195 MBLs participating in the national external quality assessment scheme, were invited to undertake a part in a survey. Through 23 questions the participants were asked about management of the reference intervals (RI), delta check, reflex/reflective testing, postanalytical quality indicators and other parts of the postanalytical phase recommended in the national recommendations. The results are presented in numbers and percentages.ResultsOut of 195 MBLs, 119 participated in the survey, giving a response rate of 61%. Not all of the respondents provided answers to all the questions. Delta check has not been used in 59% (70/118) of the laboratories. Only 22/113 (20%) laboratories use reflex and/or reflective testing. In 53% of the laboratories, critical results were reported within 30 minutes of the confirmation of the results. In 34% (40/118) of the laboratories, turnaround time and reporting of critical results are two most often monitored postanalytical quality indicators.ConclusionThe results showed the critical results reporting and monitoring of postanalytical quality indicators are in the line with the recommendations. However, the management of RI verification, the use of delta check and reflex/reflective testing still must be harmonized among Croatian MBLs.  相似文献   

18.
19.
IntroductionTotal bilirubin tests are highly demanded in clinical laboratories. Since icteric index (I-index) has zero cost, we aimed to evaluate its clinical utility and cost-effectiveness to determine if total bilirubin is necessary to be tested. We took into account if haemolysis could interfere to icteric index determination.Material and methodsRetrospectively we reviewed I-index results in two cohorts (43,372 and 8507 non-haemolysed and haemolysed samples, respectively). All determinations were done using Alinity c chemistry analysers (Abbott Diagnostics). Receiver operating characteristic (ROC) curve was used to determine the optimal index cut-off to discriminate between normal and abnormal bilirubin concentration (20.5 µmol/L).ResultsThe ROC curve analysis suggested 21.4 µmol/L as the optimal I-index cut-off but differences in sensitivity and specificity were detected between patient derivation. For rejecting purpose, 15.4 µmol/L and 17.1 µmol/L I-index thresholds were selected based on patient derivation (inpatients and emergency room; and primary care and outpatients, respectively) with 97% sensitivity and 0.25% false negative results. Sensitivity was much lower in haemolysed samples. We selected 34.2 µmol/L I-index as threshold to detect hyperbilirubinemia with 99.7% specificity and 0.26% false positive results, independent of haemolysis. With the icteric index cut-offs proposed, we would save 66% of total bilirubin requested and analyse total bilirubin in around 2% of samples without total bilirubin requested.ConclusionsThis study supports the use of I-index to avoid bilirubin determination and to identify patients with hyperbilirubinemia. This work considers that the economic and test savings could help to increase the efficiency in clinical laboratories.  相似文献   

20.

Introduction

Extremely high glucose concentrations have been shown to interfere with creatinine assays especially with Jaffe method in peritoneal dialysate. Because diabetes is the fastest growing chronic disease in the world, laboratories study with varying glucose concentrations. We investigated whether different levels of glucose spiked in serum interfere with 21 routine chemistry and thyroid assays at glucose concentrations between 17-51 mmol/L.

Materials and methods

Baseline (group I) serum pool with glucose concentration of 5.55 (5.44-5.61) mmol/L was prepared from patient sera. Spiking with 20% dextrose solution, sample groups were obtained with glucose concentrations: 17.09, 34.52, and 50.95 mmol/L (group II, III, IV, respectively). Total of 21 biochemistry analytes and thyroid tests were studied on Abbott c8000 and i2000sr with commercial reagents. Bias from baseline value was checked statistically and clinically.

Results

Creatinine increased significantly by 8.74%, 31.66%, 55.31% at groups II, III, IV, respectively with P values of < 0.001. At the median glucose concentration of 50.95 mmol/L, calcium, albumin, chloride and FT4 biased significantly clinically (-0.85%, 1.63%, 0.65%, 7.4% with P values 0.138, 0.214, 0.004, < 0.001, respectively). Remaining assays were free of interference.

Conclusion

Among the numerous biochemical parameters studied, only a few parameters are affected by dramatically increased glucose concentration. The creatinine measurements obtained in human sera with the Jaffe alkaline method at high glucose concentrations should be interpreted with caution. Other tests that were affected with extremely high glucose concentrations were calcium, albumin, chloride and FT4, hence results should be taken into consideration in patients with poor diabetic control.Key words: assay interference, glucose interference, preanalytical phase, creatinine, Jaffe kinetic assay, thyroid function tests  相似文献   

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