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Introduction

The aim of our study was to investigate the extent to which Instructions to authors of the Croatian open access (OA) journals are addressing ethical issues. Do biomedical journals differ from the journals from other disciplines in that respect? Our hypothesis was that biomedical journals maintain much higher publication ethics standards.

Materials and methods

This study looked at 197 Croatian OA journals Instructions to authors to address the following groups of ethical issues: general terms; guidelines and recommendations; research approval and registration; funding and conflict of interest; peer review; redundant publications, misconduct and retraction; copyright; timeliness; authorship; and data accessibility. We further compared a subset of 159 non-biomedical journals with a subset of 38 biomedical journals. Content analysis was used to discern the ethical issues representation in the instructions to authors.

Results

The groups of biomedical and non-biomedical journals were similar in terms of originality (χ2 = 2.183, P = 0.140), peer review process (χ2 = 0.296, P = 0.586), patent/grant statement (χ2 = 2.184, P = 0.141), and timeliness of publication (χ2 = 0.369, P = 0.544). We identified significant differences among categories including ethical issues typical for the field of biomedicine, like patients (χ2 = 47.111, P < 0.001), and use of experimental animals (χ2 = 42.543, P < 0.001). Biomedical journals also rely on international editorial guidelines formulated by relevant professional organizations heavily, compared with non-biomedical journals (χ2 = 42.666, P < 0.001).

Conclusion

Low representation or absence of some key ethical issues in author guidelines calls for more attention to the structure and the content of Instructions to authors in Croatian OA journals.Key words: instructions to authors, publication ethics, publication standards, open access, OA, research integrity  相似文献   

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Introduction:

Continuing professional development (CPD) with corresponding crediting system is recognized as essential for the laboratory medicine specialists to provide optimal service for the patients. Article presents results of the survey evaluating current CPD crediting practice among members of European Federation of Clinical Chemistry and Laboratory Medicine (EFLM).

Materials and methods:

A questionnaire had been forwarded to presidents/national representatives of all EFLM members, with invitation to provide information about CPD programmes and crediting policies, as well as feedback on individual CPD categories, through scoring their relevance.

Results:

Complete or partial answers were received from 28 of 38 members. In 23 countries, CPD programmes exist and earn credits, with 19 of them offering access to non-medical scientists. CPD activities are evaluated in all participating countries, regardless to the existence of an official CPD programme. Among participating members with mandatory specialists’ licensing (22/28), CPD is a prerequisite for relicensing in 13 countries. Main categories recognized as CPD are: continuing education (24 countries), article/book (17/14 countries) authorship and distance learning (14 countries). The highest median score of relevance (20) is allocated to professional training, editor/authorship and official activities in professional organizations, with the first category showing the least variation among scores.

Conclusions:

Majority of EFLM members have developed CPD programmes, regularly evaluated and accompanied by crediting systems. Programmes differ in accessibility for non-medical scientists and impact on relicensing eligibility. Continuing education, authorship and e-learning are mainly recognized as CPD activities, although the professional training is appreciated as the most important individual CPD category.  相似文献   

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Introduction

Technological innovation requires the laboratories to ensure that modifications or incorporations of new techniques do not alter the quality of their results. In an ISO 15189 accredited laboratory, flexible scope accreditation facilitates the inclusion of these changes prior to accreditation body evaluation. A strategy to perform the validation of a biochemistry analyzer in an accredited laboratory having a flexible scope is shown.

Materials and methods:

A validation procedure including the evaluation of imprecision and bias of two Dimension Vista analysers 1500 was conducted. Comparability of patient results between one of them and the lately replaced Dimension RxL Max was evaluated. All studies followed the respective Clinical and Laboratory Standards Institute (CLSI) protocols. 30 chemistry assays were studied. Coefficients of variation, percent bias and total error were calculated for all tests and biological variation was considered as acceptance criteria. Quality control material and patient samples were used as test materials. Interchangeability of the results was established by processing forty patients’ samples in both devices.

Results:

27 of the 30 studied parameters met allowable performance criteria. Sodium, chloride and magnesium did not fulfil acceptance criteria. Evidence of interchangeability of patient results was obtained for all parameters except magnesium, NT-proBNP, cTroponin I and C-reactive protein.

Conclusions:

A laboratory having a well structured and documented validation procedure can opt to get a flexible scope of accreditation. In addition, performing these activities prior to use on patient samples may evidence technical issues which must be corrected to minimize their impact on patient results.  相似文献   

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Introduction:

We examined the cost-effectiveness of the three different D-dimer measurements in the screening of DVT in models with and without calculation of pre-test probability (PTP) score. Moreover, we calculated the minimal cost in DVT detection.

Material and methods:

In the group of 192 patients with clinically suspected acute DVT, we examined the three different D-dimer measurements (Innovance D-dimer, Hemosil D-dimer HS and Vidas D-dimer Exclusion II) in combination with and without PTP assessment.

Results:

The diagnostic alternative employing Vidas D-dimer Exclusion II assay without and with PTP calculation gave lower incremental cost-effectiveness ratio (ICER) than the alternative employing Hemosil D-dimer HS assay (0.187 Euros vs. 0.998 Euros per one additional DVT positive patient selected for CUS in model without PTP assessment and 0.450 vs. 0.753 Euros per one DVT positive patient selected for CUS in model with PTP assessment). According to sensitivity analysis, the Hemosil D-dimer HS assay was the most cost effective alternative when one patient was admitted to the vascular ambulance per day. Vidas D-dimer Exclusion II assay was the most cost effective alternative when more than one patient were admitted to the vascular ambulance per day. Cost minimisation analysis indicated that selection of patients according to PTP score followed by D-dimer analysis decreases the cost of DVT diagnosis.

Conclusions:

ICER analysis enables laboratories to choose optimal laboratory tests according to number of patients admitted to laboratory. Results support the feasibility of using PTP scoring and D-dimer measurement before CUS examination in DVT screening.  相似文献   

9.

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   

10.

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   

11.

Introduction

Vaspin (visceral adipose tissue-derived serpin) was first described as an insulin-sensitizing adipose tissue hormone. Recently its anti-inflammatory function has been demonstrated. Since no appropriate data is available yet, we sought to investigate the plasma concentrations of vaspin in sepsis.

Materials and methods

57 patients in intensive care, fulfilling the ACCP/SCCM criteria for sepsis, were prospectively included in our exploratory study. The control group consisted of 48 critically ill patients, receiving intensive care after trauma or major surgery. Patients were matched by age, sex, weight and existence of diabetes before statistical analysis. Blood samples were collected on the day of diagnosis. Vaspin plasma concentrations were measured using a commercially available enzyme-linked immunosorbent assay.

Results

Vaspin concentrations were significantly higher in septic patients compared to the control group (0.3 (0.1-0.4) ng/mL vs. 0.1 (0.0-0.3) ng/mL, respectively; P < 0.001). Vaspin concentration showed weak positive correlation with concentration of C-reactive protein (CRP) (r = 0.31, P = 0.002) as well as with SAPS II (r = 0.34, P = 0.002) and maximum of SOFA (r = 0.39, P < 0.001) scoring systems, as tested for the overall study population.

Conclusion

In the sepsis group, vaspin plasma concentration was about three-fold as high as in the median surgical control group. We demonstrated a weak positive correlation between vaspin and CRP concentration, as well as with two scoring systems commonly used in intensive care settings. Although there seems to be some connection between vaspin and inflammation, its role in human sepsis needs to be evaluated further.Key words: adipocytokine, inflammation, vaspin, CRP, intensive care  相似文献   

12.

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   

13.

Introduction

This study aimed to assess confidence level of healthcare professionals in venipuncture and their knowledge on the possible causes of in vitro hemolysis.

Materials and methods

A sample of 94 healthcare professionals (nurses and laboratory technicians) participated in this survey study. A four-section questionnaire was used as a research instrument comprising general information for research participants, knowledge on possible causes of in vitro hemolysis due to type of material used and venipuncture technique and specimen handling, as well as assessment of healthcare professionals’ confidence level in their own ability to perform first and last venipuncture.

Results

The average score on the knowledge test was higher in nurses’ than in laboratory technicians (8.11 ± 1.7, and 7.4 ± 1.5, respectively). The difference in average scores was statistically significant (P = 0.035) and Cohen’s d in the range of 0.4 indicates that there is a moderate difference on the knowledge test among the health care workers. Only 11/94 of healthcare professionals recognized that blood sample collection from cannula and evacuated tube is method which contributes most to the occurrence of in vitro hemolysis, whereas most risk factors affecting occurrence of in vitro hemolysis during venipuncture were recognized. There were no significant differences in mean score on the knowledge test in relation to the confidence level in venipuncture (P = 0.551).

Conclusion

Confidence level at last venipuncture among both profiles of healthcare staff was very high, but they showed insufficient knowledge about possible factors affecting hemolysis due to materials used in venipuncture compared with factors due to venipuncture technique and handling of blood sample.Key words: hemolysis, patient safety, phlebotomy, medical staff, questionnaire, preanalytical phase  相似文献   

14.

Background:

A number of preanalytical activities strongly influence sample quality, especially those related to sample collection. Since blood drawing through intravenous catheters is reported as a potential source of erythrocyte injury, we performed a critical review and meta-analysis about the risk of catheter-related hemolysis.

Materials and methods:

We performed a systematic search on PubMed, Web of Science and Scopus to estimate the risk of spurious hemolysis in blood samples collected from intravenous catheters. A meta-analysis with calculation of Odds ratio (OR) and Relative risk (RR) along with 95% Confidence interval (95% CI) was carried out using random effect mode.

Results:

Fifteen articles including 17 studies were finally selected. The total number of patients was 14,796 in 13 studies assessing catheter and evacuated tubes versus straight needle and evacuated tubes, and 1251 in 4 studies assessing catheter and evacuated tubes versus catheter and manual aspiration. A significant risk of hemolysis was found in studies assessing catheter and evacuated tubes versus straight needle and evacuated tubes (random effect OR 3.4; 95% CI = 2.9–3.9 and random effect RR 1.07; 95% CI = 1.06–1.08), as well as in studies assessing catheter and evacuated tubes versus catheter and manual aspiration of blood (OR 3.7; 95% CI = 2.7–5.1 and RR 1.32; 95% CI = 1.24–1.40).

Conclusions:

Sample collection through intravenous catheters is associated with significant higher risk of spurious hemolysis as compared with standard blood drawn by straight needle, and this risk is further amplified when intravenous catheter are associated with primary evacuated blood tubes as compared with manual aspiration.  相似文献   

15.

Introduction

Over the last few years, many private companies are advertising direct-to-consumer genetic testing (DTC GT), mostly with no or only minor clinical utility and validity of tests and without genetic counselling. International professional community does not approve provision of DTC GT and situation in some EU countries has been analysed already. The aim of our study was to analyse current situation in the field of DTC GT in Slovenia and related legal and ethical issues.

Materials and methods

Information was retrieved through internet search, performed independently by two authors, structured according to individual private company and the types of offered genetic testing.

Results

Five private companies and three Health Insurance Companies offer DTC GT and it is provided without genetic counselling. Available tests include testing for breast cancer, tests with other health-related information (complex diseases, drug responses) and other tests (nutrigenetic, ancestry, paternity). National legislation is currently being developed and Council of Experts in Medical Genetics has issued an opinion about Genetic Testing and Commercialization of Genetic Tests in Slovenia.

Conclusions

Despite the fact that Slovenia has signed the Additional protocol to the convention on human rights and biomedicine, concerning genetic testing for health purposes, DTC GT in Slovenia is present and against all international recommendations. There is lack of or no medical supervision, clinical validity and utility of tests and inappropriate genetic testing of minors is available. There is urgent need for regulation of ethical, legal, and social aspects. National legislation on DTC GT is being prepared.Key words: Direct-to-consumer genetic testing, DTC, ethics in genetics, legislation  相似文献   

16.

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   

17.

Background

Short-chain acyl-CoA dehydrogenase deficiency (SCADD) is a rare inherited mitochondrial fatty acid oxidation disorder associated with variations in the ACADS (Acyl-CoA dehydrogenase, C-2 to C-3 short chain) gene. SCADD has highly variable biochemical, genetic and clinical characteristics. Phenotypes vary from fatal metabolic decompensation to asymptomatic individuals.

Subject and methods

A Romani boy presented at 3 days after birth with hypoglycaemia, hypotonia and respiratory pauses with brief generalized seizures. Afterwards the failure to thrive and developmental delay were present. Organic acids analysis with gas chromatography-mass spectrometry (GS/MS) in urine and acylcarnitines analysis with liquid chromatography-tandem mass spectrometry (LC-MS/MS) in dried blood spot were measured. Deoxyribonucleic acid (DNA) was isolated from blood and polymerase chain reactions (PCRs) were performed for all exons. Sequence analysis of all exons and flanking intron sequences of ACADS gene was performed.

Results

Organic acids analysis revealed increased concentration of ethylmalonic acid. Acylcarnitines analysis showed increase of butyrylcarnitine, C4-carnitine. C4-carnitine was 3.5 times above the reference range (<0.68 µmol/L). Confirmation analysis for organic acids and acylcarnitine profile was performed on the second independent sample and showed the same pattern of increased metabolites. Sequence analysis revealed 3-bp deletion at position 310-312 in homozygous state (c.310_312delGAG). Mutation was previously described as pathogenic in heterozygous state, while it is in homozygous state in our patient.

Conclusions

In our case clinical features of a patient, biochemical parameters and genetic data were consistent and showed definitely SCAD deficiency.Key words: SCAD deficiency, short chain acyl-CoA dehydrogenase deficiency, screening, acylcarnitine, polymorphism, genetic  相似文献   

18.

Introduction

Poor harmonization of critical results management is present in various laboratories and countries, including Croatia. We aimed to investigate procedures used in critical results reporting in Croatian medical biochemistry laboratories (MBLs).

Materials and methods

An anonymous questionnaire, consisting of 24 questions/statements, related to critical results reporting procedures, was send to managers of MBLs in Croatia. Participants were asked to declare the frequency of performing procedures and degree of agreement with statements about critical values reporting using a Likert scale. Total score and mean scores for corresponding separate statements divided according to health care setting were calculated and compared.

Results

Responses from 111 Croatian laboratories (48%) were analyzed. General practice laboratories (GPLs) more often re-analyzed the sample before reporting the critical result in comparison with the hospital laboratories (HLs) (score: 4.86 (4.75-4.96) vs. 4.49 (4.25-4.72); P = 0.001) and more often reported the critical value exclusively to the responsible physician compared to HLs (4.46 (4.29-4.64) vs. 3.76 (3.48-4.03), P < 0.001). High total score (4.69 (4.56-4.82)) was observed for selection of the critical results list issued by the Croatian Chamber of Medical Biochemistry (CCMB) indicating a high harmonization level for this aspect of critical result management. Low total scores were observed for the statements regarding data recording and documentation of critical result notification.

Conclusions

Differences in practices about critical results reporting between HLs and GPLs were found. The homogeneity of least favorable responses detected for data recording and documentation of critical results notification reflects the lack of specific national recommendations.Key words: critical results, laboratory testing, quality indicators, survey, post-analytical phase  相似文献   

19.

Introduction

Sparse data are available about the effect of therapy methods on antibody levels in patients with liver failure. The aim of this study was to determine serum immunoglobulin concentrations in patients with chronic hepatic failure (CHF), acute- (ALF), or acute-on-chronic liver failure (ACLF) and to evaluate the impact of MARS treatment or liver transplantation (LT) on antibody levels.

Materials and methods

We followed ten patients with ALF, twelve with ACLF and 18 with CHF. Eight patients with ALF and seven with ACLF underwent MARS therapy, whereas the rest received LT. 13 healthy volunteers served as controls. Serum antibody concentrations were measured using ELISA-technique.

Results

Median serum levels of IgA, IgG and IgM were significantly increased in patients with CHF compared to ALF or controls (P < 0.02, P < 0.01, and P < 0.01). IgM and IgG concentrations were also significantly elevated in patients with CHF compared to ACLF (IgM, 3.7 vs. 1 g/L, P < 0.001; IgG, 8.7 vs. 3.1 g/L, P = 0.004). Immediately after LT a significant decrease of IgA (6.9 vs. 3.1 g/L, P = 0.004), IgG (8.7 vs. 5.1 g/L, P = 0.02) and IgM (3.7 vs. 1.8 g/L, P = 0.001) was detected in patients with CHF and antibody levels further decreased the days after LT reaching levels comparable to healthy individuals. MARS treatment had no apparent effect on the immunoglobulin profile in patients with ALF or ACLF.

Conclusion

We provide evidence that LT reverses hypergammaglobulinemia in patients suffering from CHF within one day, which could be explained to a reconstituted hepatic antibody clearance, whereas MARS treatment has no immediate effect on immunoglobulin levels.Key words: antibodies, immunoglobulins, liver failure, liver transplantation, artificial liver support system, molecular adsorbent recirculating system  相似文献   

20.

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   

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