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1.

Introduction:

The measurement of cardiospecific troponins is pivotal in the diagnostic and prognostic approach of patients with suspected acute myocardial infarction (AMI). However, no information is available on the commutability of results between the novel highly-sensitive (HS) troponin T (TnT) and I (TnI) immunoassays.

Materials and methods:

The study population consisted in 47 consecutive patients presenting at the emergency department (ED) of the Academic Hospital of Parma with suspected AMI. TnI was measured with the novel prototype Beckman Coulter HS-AccuTnI immunoassay on Access 2, whereas TnT was measured with the Roche HS-TnT immunoassay on Cobas.

Results:

Eight out of the 47 patients (17%) were finally diagnosed as having an AMI. The overall correlation between TnT and TnI for total patient group was acceptable (r = 0.944; P < 0.01). Nevertheless, when the analysis of data was carried out in separate groups according to the final diagnosis of AMI, two different equation results were obtained, i.e., HS-TnT = HS-AccuTnI × 0.349 + 20 (r = 0.823; P < 0.01) in non-AMI patients, and HS-TnT = HS-AccuTnI × 0.134 + 67 (r = 0.972; P < 0.01) in those with AMI.

Conclusions:

This study suggests the existence of two biological relationships between TnI and TnT in plasma, depending on the source of release from the myocardium. Moreover, the non-commutability of data between HS-TnT and HS-AccuTnI jeopardizes the clinical decision making, makes it impossible to calculate the delta or reference change value using the two biomarkers and to finally establish a reliable kinetics of troponin release from the injured myocardium.  相似文献   

2.

Introduction

The aim of the present study was to validate prothrombin time (PT) international normalized ratio (INR) results obtained using Steelex test reagents and a Steelex coagulometer (Steelex Scientific Instrument Company, Beijing, China), in comparison with use of a well-established standard test employing Pacific Hemostasis reagents (Fisher Diagnostics, Middletown, VA, USA) and Teco Coatron A4 coagulometer (Teco Medical Instruments GmbH, Neufahrn, Germany).

Materials and methods:

Between- and within-day coefficients of variation (CVs) of both assays were calculated using control samples provided by the test manufacturers. Samples from 90 subjects were collected and INR values were determined in a double-blind parallel manner employing both systems.

Results:

The within-day coefficients of variation (CVs) in INR estimates ranged from 2.6% (INR = 1.12) to 3.1% (INR = 2.51) for the Steelex system and from 2.1% (INR = 1.09) to 1.8% (INR = 2.8) for the Pacific test; the between-day values ran from 3.4% (INR = 1.16) to 7.9% (INR = 2.64) and from 3.3% (INR = 1.1) to 2.3% (INR = 2.7), respectively. Passing-Bablok fit of the of the Steelex and Pacific methods yielded the equation: Steelex INR = 0.85 (0.79–0.91) × Pacific INR + 0.12 (−0.02–0.21), whereas the CUSUM linearity P value was < 0.01. The mean bias as determined by the Bland-Altman test was −0.156 (−0.912–0.600).

Conclusion:

The results obtained using Steelex reagents and the M600H coagulometer are not equivalent to those obtained using Pacific Hemostasis reagents and a Teco Coatron A4 coagulometer, at least in the therapeutic range.  相似文献   

3.

Introduction

The determination of lipid biomarkers by capillary sampling may be useful in the screening, diagnosis and/or personal management of hyperlipidemia and cardiovascular risk. It remains unclear whether the use of the Accutrend® Plus system is appropriate. This study aimed to assess its reproducibility, accuracy and concordance for blood lipid profiling in adults.

Materials and methods:

Fasting capillary total cholesterol (TC) and triglyceride (TG) concentration on Accutrend® Plus were compared with their venous analogues obtained by a laboratory reference method in sixty-one adults (27 men and 34 women, aged 33.0 years). Supplementary capillary sampling was performed at two consecutive days taking into account macro-nutrient intake.

Results:

The day-to-day reproducibility of the Accutrend® Plus system proved to be high for TC (ICC = 0.85, P < 0.001), but moderate for TG (ICC = 0.68, P < 0.001). Strong correlations (r ≥ 0.80, P < 0.001) with the reference method were found for TC and TG. Mean difference (limits of agreement) were: 0.26 mmol/L (−0.95, 1.47) for TC, and −0.16 mmol/L (−1.29, 0.98) for TG. The concordance for subject classification according to the National Cholesterol Education Program (NCEP) guidelines was significant (P < 0.001), with substantial agreement for TC (κw = 0.67), and moderate agreement for TG (κw = 0.50).

Conclusions:

Day-to-day reproducibility of the Accutrend® Plus device for TC and TG is not optimal and lacks accuracy when compared to the reference laboratory method. The concordance between both methods for classifying subjects according to the NCEP is inadequate. Accutrend® Plus device should not be interchangeably used as a substitution for the standard laboratory methods in the diagnosis of hyperlipidemia.  相似文献   

4.

Introduction:

The aim of this study was to investigate whether serum levels of interleukin-1β (IL–1β) has any possible correlation on inflammatory parameters such as C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and fibrinogen concentration in patients with familial Mediterranean fever (FMF) patients during attack-free period.

Materials and methods:

The serum levels of IL-1β, as an indicator of cytokines status, and the acute phase response proteins, CRP, ESR and fibrinogen levels were evaluated in 35 attack-free patients with FMF and 25 healthy volunteers.

Results:

Serum IL-1β levels were significantly higher in patients with FMF than control subjects (P = 0.018). There was no statistically significant difference in the serum levels of ESR, CRP and fibrinogen between two groups (P = 0.181, P = 0.816, P = 0.686, respectively). There was a significant correlation between IL-1β and CRP (r = 0.513, P = 0.002) values of FMF group.

Conclusions:

In conclusion, our results confirm the presence of increased IL-1β levels in FMF patients during attack-free period. Serum IL-1β values seems to correlate with CRP levels. The elevation of IL-1β levels may be important in monitoring subclinical inflammation of attack free period in FMF patients.  相似文献   

5.

Introduction:

Metabolic syndrome (MetS) is a multifactorial disorder in which dyslipidemia plays an important role. Fatty acid-binding protein 2 (FABP 2) is responsible for transport of free fatty acids in the intestinal endothelium cells. FABP2-genetic variants might affect plasma lipid concentrations and intracellular lipid transport. The aim of this study was to investigate the association between FABP2 Ala54Thr genetic polymorphism and metabolic syndrome and some biochemical and anthropological parameters in elderly subjects.

Materials and methods:

This cross-sectional study included 140 men and 176 women older than 70 years. Fasting serum concentration of glucose, lipid parameters, total proteins and C-reactive protein were determined by standardized methods. Presence (MetS(+)) or absence (MetS(−)) of MetS was determined according to criteria of the International Diabetes Federation. FABP2 genetic polymorphism Ala54Thr (rs1799883) was genotyped with PCR-RFPL.

Results:

The genotype frequencies for Ala/Ala, Ala/Thr and Thr/Thr genotype were 60, 36 and 6 in MetS(−), and 131, 70 and 13 in MetS(+), respectively, without statistical significance (P = 0.567). Ala/Ala genotype was a subgroup of non-carriers, while Ala/Thr and Thr/Thr genotypes were Thr54-carriers. Median triglyceride concentration was significantly lower in carriers then in non-carriers for whole MetS(+) group (P = 0.050); there were no significant difference between men with MetS (P = 0.144), but there was a difference between women with MetS (P = 0.020). T-test showed that mean HDL cholesterol concentrations in MetS(+) group for Thr54-carriers was significantly higher in whole group (P = 0.001), and for both genders (men P = 0.039; women P = 0.004) as compared to non-carriers.

Conclusions:

FABP2 genetic polymorphism is associated with lower triglyceride and higher HDL-cholesterol concentrations in elderly subjects with MetS. This genetic variation might be a useful marker for understanding dyslipidemia in MetS.  相似文献   

6.

Introduction:

Zonulin is a eukaryotic protein structurally similar to Vibrio cholerae’s zonula occludens toxin. It plays an important role in the opening of small intestine tight junctions. The loss of gut wall integrity during sepsis might be pivotal and has been described in various experimental as well as human studies. Increased levels of zonulin could be demonstrated in diseases associated with increased intestinal inflammation, such as celiac disease and type 1 diabetes. We therefore investigated the role of plasma levels of zonulin in patients with sepsis as a non-invasive marker of gut wall integrity.

Materials and methods:

Plasma level of zonulin was measured in 25 patients with sepsis, severe sepsis or septic shock according to ACCP/SCCM criteria at the first day of diagnosed sepsis. 18 non-septic post-surgical ICU-patients and 20 healthy volunteers served as control. Plasma levels were determined by using commercially available ELISA kit. Data are given as median and interquartile range (IQR).

Results:

Significantly higher plasma concentration of zonulin were found in the sepsis group: 6.61 ng/mL (IQR 3.51–9.46), as compared to the to the post-surgical control group: 3.40 ng/mL (IQR 2.14–5.70) (P = 0.025), as well as to the healthy group: 3.55 ng/mL (IQR 3.14–4.14) (P = 0.008).

Conclusion:

We were able demonstrate elevated levels of plasma zonulin, a potential marker of intestinal permeability in septic patients. Increased zonulin may serve as an additional mechanism for the observed increased intestinal permeability during sepsis and SIRS.  相似文献   

7.

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   

8.

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   

9.

Introduction:

The enzyme 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) catalyzes the conversion of the hormonally inactive cortisone to active cortisol, thus facilitating glucocorticoid receptor activation in target tissues. Increased expression of 11β-HSD1 in adipose tissue has been associated with obesity and insulin resistance. In this study, we investigated the association of two 11β-HSD1 gene (HSD11B1) polymorphisms with the metabolic syndrome (MetS) and its characteristics in the Bosnian population.

Materials and methods:

The study included 86 participants: 43 patients diagnosed with MetS and 43 healthy controls. Subjects were genotyped for two HSD11B1 gene polymorphisms: rs846910: G>A and rs45487298: insA, by the high resolution melting curve analysis. Genotype distribution and an influence of genotypes on clinical and biochemical parameters were assessed.

Results:

There was no significant difference in the mutated allele frequencies for the two HSD11B1 gene polymorphisms between MetS patients and controls. In MetS patients, no significant associations between disease-associated traits and rs45487298: insA were found. Regarding rs846910: G>A variant, heterozygous patients (G/A) had significantly lower systolic (P = 0.017) and diastolic blood pressure (P = 0.015), lower HOMA-IR index (P = 0.011) and higher LDL-cholesterol levels (P = 0.049), compared to the wild-type homozygotes. In the control group, rs45487298: insA polymorphism was associated with lower fasting plasma insulin levels (P = 0.041), lower homeostasis model assessment insulin resistance (HOMA-IR) index (P = 0.041) and lower diastolic blood pressure (P = 0.048). Significant differences between rs846910: G>A genotypes in controls were not detected. Haplotype analysis confirmed the association of rs45487298: insA with markers of insulin resistance in the control subjects.

Conclusions:

Our results indicate that a common rs45487298: insA polymorphism in HSD11B1 gene may have a protective effect against insulin resistance.  相似文献   

10.

Introduction:

Studies about vitamin D [25(OH)D] stability in plasma are limited and preanalytical variables such as tube type may affect results. We aimed to evaluate effect of storage conditions, sample type and some preanalytical variables on vitamin D concentration.

Materials and methods:

Blood samples from 15 healthy subjects were centrifuged at different temperatures and stored under different conditions. Serum and plasma 25(OH)D difference, effect of centrifugation temperature and common storage conditions were investigated.

Results:

There was no difference between serum and plasma vitamin D concentration. Centrifugation temperature had no impact on vitamin D concentration. 25(OH)D is stable under common storage conditions: 4 hours at room temperature, 24 hours at 2–8 °C, 7 days at −20 °C, 3 months at −80 °C.

Conclusion:

Vitamin D does not require any special storage conditions and refrigeration. Both serum and plasma can be used for measurement.  相似文献   

11.

Background:

Presently the necessity of fasting time for coagulation tests is not standardized. Our hypothesis is that this can harm patient safety. This study is aimed at evaluating whether a light meal (i.e. breakfast) can jeopardize laboratory coagulation tests.

Materials and methods:

A blood sample was firstly collected from 17 fasting volunteers (12 h). Immediately after blood collection, the volunteers consumed a light meal. Then samples were collected at 1, 2 and 4 h after the meal. Coagulation tests included: activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen (Fbg), antithrombin III (AT), protein C (PC) and protein S (PS). Differences between samples were assessed by Wilcoxon ranked-pairs test. The level of statistical significance was set at P < 0.05. Mean % differences were determined and differences between and baseline and 1, 2 and 4h samples were compared with reference change value (RCV).

Results:

A significantly higher % activity of AT was observed at 1 h and 4 h after meal vs. baseline specimen [113 (104–117) and 111 (107–120) vs. 109 (102–118), respectively; P = 0.029 and P = 0.016]. APTT at 2 h was found significantly lower than baseline samples [32.0 (29.9–34.8) vs. 34.1 (32.2–35.2), respectively; P = 0.041]. The results of both Fbg and PS tests were not influenced by a light meal. Furthermore, no coagulation tests had significant variation after comparison with RCV.

Conclusion:

A light meal does not influence the laboratory coagulation tests we assessed, but we suggest that the laboratory quality managers standardize the fasting time for all blood tests at 12 hours, to completely metabolize the lipids intake.  相似文献   

12.

Introduction:

We have previously shown that the concentrations of D-dimer are significantly elevated in saliva compared with plasma. Saliva offers several advantages compared with blood analysis. We hypothesised that human saliva contains plasminogen activator inhibitor-1 (PAI-1) and that the concentrations are not affected by the time of saliva collection. The aim was to adopt and validate an immunoassay to quantify PAI-1 concentrations in saliva and to determine whether saliva collection time has an influence in the measurement.

Materials and methods:

Two saliva samples (morning and afternoon) from the same day were collected from healthy subjects (N = 40) who have had no underlying heart conditions. A customized AlphaLISA® immunoassay (PerkinElmer®, MA, USA) was adopted and used to quantify PAI-1 concentrations. We validated the analytical performance of the customized immunoassay by calculating recovery of known amount of analyte spiked in saliva.

Results:

The recovery (95.03%), intra- (8.59%) and inter-assay (7.52%) variations were within the acceptable ranges. The median salivary PAI-1 concentrations were 394 pg/mL (interquartile ranges (IQR) 243.4–833.1 pg/mL) in the morning and 376 (129.1–615.4) pg/mL in the afternoon and the plasma concentration was 59,000 (24,000–110,000) pg/mL. Salivary PAI-1 did not correlate with plasma (P = 0.812).

Conclusions:

The adopted immunoassay produced acceptable assay sensitivity and specificity. The data demonstrated that saliva contains PAI-1 and that its concentration is not affected by the time of saliva collection. There is no correlation between salivary and plasma PAI-1 concentrations. Further studies are required to demonstrate the utility of salivary PAI-1 in CVD risk factor studies.  相似文献   

13.

Background

Numerous data suggest that aerobic-type exercise improves lipoprotein-lipid profiles, cardiorespiratory fitness and body composition in young women. The aim of this study was to evaluate the biological response to high-low impact aerobic fitness among young women.

Materials and methods

Thirty-four young women aged 22 (19-24) years were divided into three groups: underweight (N = 10), normal weight (N = 12) and overweight (N = 12). Aerobic capacity, anthropometry and body composition together with complete blood count and lipid profile were determined before and after completion of a 12-week-long training period.

Results

The training programme caused a significant decrease in weight (by 4.3 kg, P = 0.003), body mass index (by 1.3 kg/m2, P = 0.003), free fat mass (by 2.1 kg, P = 0.002), total body water (by 0.4 kg, P = 0.036), percentage of fat (by 3 percent points, P = 0.002), all analyzed skinfolds thicknesses, as well as the lipid profile in overweight group, and no changes in normal weight group. Significant changes in weight (by 4.2 kg, P = 0.005), body mass index (by 0.9 kg/m2, P = 0.005), crus skinfold thickness (by 3.3 mm, P = 0.028), and in maximum oxygen uptake (by 2.49 mL/kg/min; P = 0.047) were observed among underweight women. No change in total blood count was observed in all groups.

Conclusion

Twelve-week-long fitness training programme of two alternating styles (low and high impact) has a beneficial effect on overweight young women.Key words: body composition, physical fitness, overweight, women  相似文献   

14.

Introduction:

Non insulin dependent diabetes mellitus is the most common type of diabetes. Genetic factors, lipid profiles, hypertension are potential risk factors for diabetes mellitus. Adenosine binding cassette transporter proteins 1 (ABCA1) plays a role in cholesterol metabolism, especially high density lipoprotein (HDL-cholesterol). There are multiple mechanisms by which HDL-cholesterol can be atheroprotective, it is clear that the relative activity of ABCA1 plays a major role. We aimed to investigate association of ABCA1 C69T gene polymorphism with lipid levels in Turkish type 2 diabetic patients.

Materials and methods:

After isolation of DNA by ethanol precipitation we determined ABCA1 gene polymorphism by using polimerase chain reaction - restriction fragment lenght polymorphism (PCR-RFLP) method in 107 type 2 diabetic patients and 50 healthy controls.

Results:

We have observed that the frequency of TT genotype is significantly higher in healthy controls compared to patients (14% vs. 3%; P = 0.008). Also frequency of T allele was higher in controls than in patients (34% vs. 21%; P = 0.020; OR (95% CI) = 0.52 (0.30–0.88)). There was no association of lipid levels and ABCA1 C69T polymorphism subgroups.

Conclusion:

We have found significantly higher frequency of both T allele and genotype in control group when compared to patients that made us think that T allele may be a protective factor against diabetes mellitus. But, we could not find a relationship between genotypes and lipid concentrations in our two groups. Larger studies will help us to understand the relationship between ABCA1 C69T genotype and lipid parameters in diabetes mellitus.  相似文献   

15.

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   

16.

Introduction:

This study aimed to assess whether heart fatty acid-binding protein (H-FABP) and glycogen phosphorylase isoenzyme BB (GPBB) could be used for the accurate diagnosis of acute myocardial infarction (AMI) in acute coronary syndrome (ACS) patients.

Materials and methods:

The study included 108 ACS patients admitted to a coronary unit within 3 h after chest pain onset. AMI was distinguished from unstable angina (UA) using a classical cardiac troponin I (cTnI) assay. H-FABP and GPBB were measured by ELISA on admission (0 h) and at 3, 6, 12, and 24 h after admission; their accuracy to diagnose AMI was assessed using statistical methods.

Results:

From 92 patients with ACS; 71 had AMI. H-FABP and GPBB had higher peak value after 3 h from admission than cTnI (P = 0.001). Both markers normalized at 24 h. The area under the receiver operating characteristic curves was significantly greater for both markers in AMI patients than in UA patients at all time points tested, including admission (P < 0.001). At admission, the H-FABP (37%) and GPBB (40%) sensitivities were relatively low. They increased at 3 and 6 h after admission for both markers and decreased again after 24 h. It was 40% for H-FABP and approximately 2-times lower for GPBB (P < 0.01). In AMI patients, both biomarkers had similar specificities, positive- and negative-predictive values, positive and negative likelihood ratios, and risk ratios for AIM.

Conclusion:

H-FABP and GPBB can contribute to early AMI diagnosis and can distinguish AMI from UA.  相似文献   

17.

Introduction:

ISO 15189 was a new standard published in 2003 for accrediting medical laboratories. We believe that some requirements of the ISO 15189 standard are especially difficult to meet for majority of laboratories. The aim of this article was to present the frequency of nonconformities to requirements of the ISO 15189 accreditation standard, encountered during the assessments of medical laboratories in Hong Kong, during 2004 to 2009.

Materials and methods:

Nonconformities reported in assessments based on ISO 15189 were analyzed in two periods – from 2004 to 2006 and in 2009. They are categorized according to the ISO 15189 clause numbers. The performance of 27 laboratories initially assessed between 2004 and 2006 was compared to their performance in the second reassessment in 2009.

Results:

For management requirements, nonconformities were most frequently reported against quality management system, quality and technical records and document control; whereas for technical requirements, they were reported against examination procedures, equipment, and assuring quality of examination procedures. There was no major difference in types of common nonconformities reported in the two study periods. The total number of nonconformities reported in the second reassessment of 27 laboratories in 2009 was almost halved compared to their initial assessments. The number of significant nonconformities per laboratory significantly decreased (P = 0.023).

Conclusion:

Similar nonconformities were reported in the two study periods though the frequency encountered decreased. The significant decrease in number of significant nonconformities encountered in the same group of laboratories in the two periods substantiated that ISO15189 contributed to quality improvement of accredited laboratories.  相似文献   

18.

Introduction

Although prostatitis is a common male urinary tract infection, clinical diagnosis of prostatitis is difficult. The developmental mechanism of prostatitis is not yet unraveled which led to the elaboration of various biomarkers. As changes in asparagine-linked-(N-)-glycosylation were observed between healthy volunteers (HV), patients with benign prostate hyperplasia and prostate cancer patients, a difference could exist in biochemical parameters and urinary N-glycosylation between HV and prostatitis patients. We therefore investigated if prostatic protein glycosylation could improve the diagnosis of prostatitis.

Materials and methods

Differences in serum and urine biochemical markers and in total urine N-glycosylation profile of prostatic proteins were determined between HV (N = 66) and prostatitis patients (N = 36). Additionally, diagnostic accuracy of significant biochemical markers and changes in N-glycosylation was assessed.

Results

Urinary white blood cell (WBC) count enabled discrimination of HV from prostatitis patients (P < 0.001). Urinary bacteria count allowed for discriminating prostatitis patients from HV (P < 0.001). Total amount of biantennary structures (urinary 2A/MA marker) was significantly lower in prostatitis patients compared to HV (P < 0.001). Combining the urinary 2A/MA marker and urinary WBC count resulted in an AUC of 0.79, 95% confidence interval (CI) = (0.70–0.89) which was significantly better than urinary WBC count (AUC = 0.70, 95% CI = [0.59–0.82], P = 0.042) as isolated test.

Conclusions

We have demonstrated the diagnostic value of urinary N-glycosylation profiling, which shows great potential as biomarker for prostatitis. Further research is required to unravel the developmental course of prostatic inflammation.Key words: diagnostic marker, prostatitis, urinary asparagine-linked glycosylation  相似文献   

19.

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   

20.

Introduction

Urinary tract infection (UTI) is one of the most common types of infection. Currently, diagnosis is primarily based on microbiologic culture, which is time- and labor-consuming. The aim of this study was to assess the diagnostic accuracy of urinalysis results from UriSed (77 Electronica, Budapest, Hungary), an automated microscopic image-based sediment analyzer, in predicting positive urine cultures.

Materials and methods:

We examined a total of 384 urine specimens from hospitalized patients and outpatients attending our hospital on the same day for urinalysis, dipstick tests and semi-quantitative urine culture. The urinalysis results were compared with those of conventional semi-quantitative urine culture.

Results:

Of 384 urinary specimens, 68 were positive for bacteriuria by culture, and were thus considered true positives. Comparison of these results with those obtained from the UriSed analyzer indicated that the analyzer had a specificity of 91.1%, a sensitivity of 47.0%, a positive predictive value (PPV) of 53.3% (95% confidence interval (CI) = 40.8–65.3), and a negative predictive value (NPV) of 88.8% (95% Cl = 85.0–91.8%). The accuracy was 83.3% when the urine leukocyte parameter was used, 76.8% when bacteriuria analysis of urinary sediment was used, and 85.1% when the bacteriuria and leukocyturia parameters were combined. The presence of nitrite was the best indicator of culture positivity (99.3% specificity) but had a negative likelihood ratio of 0.7, indicating that it was not a reliable clinical test.

Conclusions:

Although the specificity of the UriSed analyzer was within acceptable limits, the sensitivity value was low. Thus, UriSed urinalysis results do not accurately predict the outcome of culture.  相似文献   

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