Aim: For the accreditation of a medical laboratory, it is necessary to evaluate the quality indicators (QI) used to evaluate pre-analytical process performance and establish an infrastructure to prevent errors arising from outside the laboratory. We aimed to present the quality indicators to prove the pre-analytical process performance of a medical (clinical) laboratory that has a large workforce prepared for medical laboratory accreditation.Methods: The sample rejection criteria were defined for the pre-analytical process. QIs, which are the requirements of the ISO15189 standard, was determined. QIs were estimated both as percentages and process Sigma levels. Pareto charts presented the distribution of errors.Results: QI values calculated as “%” and “Sigma” levels consistently demonstrated performances. According to 80% cumulated percentages, the Pareto charts rankings were “haemolysed,” “coagulated,” “barcode error,” and “insufficient” samples. In addition, when Pareto charts were evaluated, it was seen that the first 2 reasons in the 6-month period were “hemolysis” and “clotted samples” in all months. Still, the third most common reason was found to vary between “barcode error” and “insufficient” samples.Conclusion: Because of the consistency between % and sigma values, QIs can be presented with one of these in showing laboratory pre-analytical processes. However, sigma values give a more general view, and performance can be easily monitored between months. Pareto charts help illustrate error distribution and provide information for continuous improvement in laboratory-related healthcare.

Objectives: Microribonucleic acids (microRNA/miRNA/miR-) are predicted to be useful in the early diagnosis, monitoring, and treatment of diabetic nephropathy (DN). We aimed to investigate the relationship of DN to miR-21-3p, miR-29a-3p, miR-29b-3p, miR-29c-3p, miR-126 -3p, miR-1291-3p, miR-137, miR-192-5p, miR-212-3p, and miR-320c. Methods: There were 50 healthy controls and 100 patients with type 2 diabetes mellitus (T2DM). The diabetic patients were divided into three subgroups: normal to mildly increased (A1, n=51), moderately increased (A2, n=25), and severely increased (A3, n=24) albuminuria. The biochemical measurements were analysed using Roche Cobas 8000. The plasma miRNAs were analysed using RT-qPCR based on SYBR green chemistry. Results: The relative expression of miR-21-3p was significantly lower in the (A3 p=0.005, 6.6-fold decrease) and DN (A1 + A3) (p=0.005, 6.6-fold decrease) groups compared to the controls. The relative expression of miR-192-5p was also significantly lower in the DN group (p=0.027, 2.4-fold decrease) compared to the controls. The area under curve value was 0.726 for miR-21-3p and 0.717 for miR-192-5p for distinguishing the DN group from the controls. Conclusions: The decreased expressions of miR-21-3p and miR-192-5p are associated with the development of DN and may be potential biomarkers for the early diagnosis of DN.

INTRODUCTION:GFR is estimated by using creatinine and cystatin C to determine renal dysfunction. Our aim was to evaluate estimated GFR (eGFR) based on cystatin C in type 2 diabetic patients with diabetic nephropathy (DN).METHODS:Study group included 52 controls (46% male, age: 54.5±12.4) and 101 diabetic patients (46.5% male, age: 58.2±11). The diabetics were divided into three subgroups according to 24-hour urine albumin: normal to mildly increased (A1) (n=51), moderately increased (A2) (n=25), severely increased (A3) (n=25) albuminuria. Creatinine clearance (CrCl) was determined. Correlations between CrCl and eGFRs estimated according to the CKD-EPI, MDRD, and Cockcroft-Gault (CG) formulas, and ROC curves were evaluated. Data were analyzed using SPSS 22.0.RESULTS:Only CKD-EPI-cys eGFR was significantly lower in the A1 group than the controls (p=0.021). All GFRs were lower in the A3 group than the control (CKD-EPI-cr, MDRD, CKD-EPI-cys, CKD-EPI-cr-cys: p=0.0001, CG and CrCl: p=0.001) and A1 (for all GFRs p=0.0001) groups. CKD-EPI-cr (p=0.004), MDRD (p=0.01), CG (p=0.037), CKD-EPI-cys (p=0.033), and CKD-EPI-cr-cys (p=0.016) eGFRs in the A2 group were significantly different from the A1 group. All eGFRs showed a moderate correlation with CrCl in the A1group (CKD-EPI-cr and CKD-EPI-cr-cys: r=0.49, p=0.0001, MDRD: r=0.44, p=0.001, CG r=0.48, p=0.0001: CKD-EPI-cys r=0.40, p=0.004). The area under the CKD-EPI-cys ROC curve was the highest and found to be 0.847 (95%CI 0.763-0.931, p=0.0001).CONCLUSIONS:Our results showed that the CKD-EPI-cys eGFR can be useful in detecting the early stage of DN and more predictive than the others for prediction of DN.

Background: Vitamin B12 deficiency is still an important nutritional problem worldwide. There is no consensus on the reference intervals (RIs) for vitamin B12. In order to establish vitamin B12 RIs, we used the database obtained from a primary healthcare organization and estimated region-specific intervals. Methods: Vitamin B12 results were collected from our laboratory information system (LIS) between January 2014 and July 2014. We excluded the results of the individuals who had megaloblastic and microcytic anemia. After outlier detection and exclusion, we estimated the RIs of the "1-12, 13-18, 19-64 and 65+" age groups according to the International Federation of Clinical Chemistry (IFCC) method. Statistical differences were examined between groups. Results: The reference limits and 90% confidence-intervals (CIs) (n = 14,748, 3790 male, age: 1-96; 10,958 female, age: 1-115) were estimated with 90% CIs as 106 (104-107)-393 (391-395) pmol/L. We also estimated the reference limits of the "1-12, 13-18, 19-64 and 65+" age groups to be 127-459, 108-398, 106-384 and 104-426 pmol/L, respectively. There was no difference between genders in all age groups. Conclusions: Both the lower and upper limits of the estimated RIs were found to be lower than the reference limits recommended by the manufacturer. Our findings revealed that the RIs of vitamin B12 should be given for the "1-12, 13-18, 19-64 and 65 +" age groups separately. The big data obtained from laboratories should be used for the determination of its population health status. As our population is composed of outpatients, the estimated vitamin B12 RIs may establish the basic information for the examination of our population for vitamin B12 deficiency.

Background There is increasing requests of Vitamin D test in many clinical settings in recent years. However, immunoassay performance is still a controversial topic. Several diagnostic manufacturers have launched automated 25-hydroxyvitamin D (25-OH D) immunoassays in the past decade. We compared the performance of Abbott Architect 25-OH D Vitamin immunoassay with liquid chromatography-tandem mass spectrometry systems (LCMS/MS) to evaluate immunoassay performance, especially in deficient groups. Methods Eighty human serum samples were analyzed with Architect 25-OH D vitamin kit (Abbott Diagnostics, Lake Forest, IL, USA) and LC-MS/MS systems (Zivak Technology, Istanbul, Turkey). The results of the immunoassay method were compared with the LC-MS/MS using Passing-Bablok regression analysis, Bland-Altman plots and correlation coefficient analysis. We also evaluated results in four levels of D vitamin as a severe deficiency, deficiency, insufficiency, and sufficiency. Results Architect showed 9.59% bias from LC-MS/MS with smaller mean. Passing-Bablok regression analysis demonstrated the value of 0.95 slope and had a constant bias with an intercept value of -4.25. Concordance correlation coefficient showed moderate agreement with the value of 0.918 (95% CI 0.878-0.945). Two methods revealed good interrater agreement (kappa = 0.738). While the smallest bias determined in deficiency (9.95%) group, the biggest was in insufficiency (15.15%). Conclusions Architect 25-OH D vitamin immunoassay can be used in routine measurements but had potential misclassification of vitamin D status in insufficient and deficient groups. Although there are recent standardization attempts in 25-OH D measurements, clinical laboratories must be aware of this method.

BACKGROUND: A major objective of the IFCC Committee on Education and Use of Biomarkers in Diabetes is to generate awareness and improvement of HbA1c assays through evaluation of the performance by countries and manufacturers. METHODS: Fresh whole blood and lyophilized hemolysate specimens manufactured from the same pool were used by 17 external quality assessment organizers to evaluate analytical performance of 2166 laboratories. Results were evaluated per country, per manufacturer, and per manufacturer and country combined according to criteria of the IFCC model for quality targets. RESULTS: At the country level with fresh whole blood specimens, 6 countries met the IFCC criterion, 2 did not, and 2 were borderline. With lyophilized hemolysates, 5 countries met the criterion, 2 did not, and 3 were borderline. At the manufacturer level using fresh whole blood specimens, 13 manufacturers met the criterion, 8 did not, and 3 were borderline. Using lyophilized hemolysates, 7 manufacturers met the criterion, 6 did not, and 3 were borderline. In both country and manufacturer groups, the major contribution to total error derived from between- laboratory variation. There were no substantial differences in performance between groups using fresh whole blood or lyophilized hemolysate samples. CONCLUSIONS: The state of the art is that 1 of 20 laboratories does not meet the IFCC criterion, but there are substantial differences between country and between manufacturer groups. Efforts to further improve quality should focus on reducing between- laboratory variation. With some limitations, fresh whole blood and welldefined lyophilized specimens are suitable for purpose. (C) 2018 American Association for Clinical Chemistry

Clinical laboratories worldwide are accredited according to the "ISO standard, 15189:2012: Medical Laboratories-Requirements for Quality and Competence." Seeking accreditation has many challenges. Success requires the right competencies and knowledge and the right technical expert and trainer to lead the laboratory through the process. The right competencies and knowledge typcially are beyond the core knowledge, skills and attitudes gained during education of laboratory professionals. The main objective of this paper is to discuss what competencies, knowledge and expertise are essential for laboratories to meet accreditation challenges and gain ISO 15189:2012 accreditation.

Some laboratory tests or biomarkers are used as surrogate outcomes for health care effectiveness. HbA1c is defined as a surrogate biomarker since HbA1c values have been approved to be used in predictions of clinically important complications of diabetes mellitus. With the advance of information technology (IT) the real life data are aggregating as electronic health records (EHRs). About 70-85% of individuals admitted to hospitals have laboratory test results. As such, medical laboratories are the data centers in the hospitals. The test results can be used for assessment of health care delivered, especially for chronic diseases. This information provides insights of healthcare services, and can be used to enhance for individual and population well-being, research, and education. This article focuses on the importance of using laboratory tests results as outcome measures for specific population health status that are important in assessing the quality of health care services. The findings from our studies on the diabetic care quality is presented.

In vitro diagnostic (IVD) medical laboratory devices, tests and equipment are closely related with public health, patient safety and the safety of all who utilize these tools in laboratories. The close monitoring of the process from the production line to the end-point user is crucial so that IVD devices and tests do not pose a risk to individuals and society. Based on this background, the "First Turkish in vitro Diagnostic Symposium: Medical Laboratory Tests" was held in February, 2016. The symposium was organized by the cooperation of Turkish Biochemical Society, Izmir Branch and Dokuz Eylul University Health Sciences Institute along with the contributions of TurkLab Calibration Association. It was intended that the meeting would shed light on questions such as, 'What is the place and importance of IVD in Turkey?', 'What are the responsibilities of educational institutions?', 'What is the role of Ministry of Health?', with the aim that the answers would help to determine the infrastructure needed for successful production of IVD medical devices in Turkey. At the end of the symposium, feedback from participants were collected via a questionnaire. This article presents the general evaluation of the symposium based on the results of this survey.

Abstract “The 1st Turkish in vitro Diagnostic Symposium” was organized in İzmir between the dates 18–20 February 2016 with cooperation of Turkish Biochemistry Society Izmir Branch and Dokuz Eylul University Institute of Health Sciences. This article presents a collection of the subjects, recommendations and results included in the final report of the symposium. Symposium subjects were analysed under separate titles and evaluated together with results obtained from various reports on medical devices (MD) in the last decade. According to the final report, the subjects to be considered on preferential basis include “configuration of the websites of legal authorities, standardization and accreditation institutions in a way to access work on in vitro Diagnostic (IVD)”, “activation of university-industry cooperation”, “determination of national standards parallel to international standards” and “carrying out the statistics about IVD-MD in Turkey as immediate as possible”. Drawing attention to the fact that there is a requirement for competent man power for every-stage of IVD-MD lifecycle, it is recommended that postgraduate education programmes are founded to serve these fields. Consequently, this symposium enabled to determine the basic problems about the sector by bringing together the stakeholders related to IVD-MD field and to come up with an action plan in accordance with the recommendations.

Biomarkers are essential decision-making tools in medicine as indicators of normal biological processes, pathogenic processes, or pharmacologic response to a therapeutic intervention. Advanced technologies give opportunities to researchers to examine thousands of molecules together from transcriptional processes to metabolic pathways, and understand the interrelations between cells, tissues and organs in both healthy and diseased states. Biomarkers have been extensively researched for diseases such as diabetes mellitus, which is a highly heterogeneous, chronic disorder and responsible for damage, dysfunction and failure of different organs both before and after its diagnosis. In this chapter, biomarkers of type 1 (T1D) and type 2 (T2D) diabetes mellitus that are mostly retrieved from genomics, transcriptomics, proteomics, proteoglycomics, and metabolomics studies are discussed and listed in the context of their types, and relations to physiological and pathological processes. It covers clinical biomarkers used as diagnostic tests and in validation of drugs and recommended by diabetes management practice guidelines, and also novel biomarkers associated with the transcriptional (gene biomarkers), post-transcriptional (microRNA biomarkers), post-translational (proteins), and metabolic (molecules other than DNA and RNA) regulations in the patients with diabetes mellitus and related complications.

Background: A nationwide multicenter study was organized to establish reference intervals (RIs) in the Turkish population for 25 commonly tested biochemical analytes and to explore sources of variation in reference values, including regionality.Methods: Blood samples were collected nationwide in 28 laboratories from the seven regions (>= 400 samples/region, 3066 in all). The sera were collectively analyzed in Uludag University in Bursa using Abbott reagents and analyzer. Reference materials were used for standardization of test results. After secondary exclusion using the latent abnormal values exclusion method, RIs were derived by a parametric method employing the modified Box-Cox formula and compared with the RIs by the non-parametric method. Three-level nested ANOVA was used to evaluate variations among sexes, ages and regions. Associations between test results and age, body mass index (BMI) and region were determined by multiple regression analysis (MRA).Results: By ANOVA, differences of reference values among seven regions were significant in none of the 25 analytes. Significant sex-related and age-related differences were observed for 10 and seven analytes, respectively. MRA revealed BMI-related changes in results for uric acid, glucose, triglycerides, high-density lipoprotein (HDL)-cholesterol, alanine aminotransferase, and.-glutamyltransferase. Their RIs were thus derived by applying stricter criteria excluding individuals with BMI >28 kg/m(2). Ranges of RIs by non-parametric method were wider than those by parametric method especially for those analytes affected by BMI.Conclusions: With the lack of regional differences and the well-standardized status of test results, the RIs derived from this nationwide study can be used for the entire Turkish population.

BACKGROUND:Efficient analytical and quality control solution is important for testing laboratories to ensure released results meet the required quality in regard to accuracy and precision.Technopath Manufacturing Ltd. recently introduced multi-constituent controls (MCC) for use with the Abbott ARCHITECT instruments.The performance of the urine and serum chemistry controls were evaluated in comparison to the laboratory's current QC. METHODS:3 European sites evaluated the Technopath MultiChem S Plus and Multichem U MCCs for a minimum of 30 days in parallel with routine QC controls.Testing was performed on the ARCHITECT c8000 and c16000 instruments.Data are from the following serum analytes:(A)ALT, (A)AST, total bilirubin, Cl, total cholesterol, glucose, K, total protein, Na, triglycerides, and urea; and the following urine analytes: Cl, creatinine, glucose, K, Na, and urea.The MultiChem S Plus is serum based with three control levels; the MultiChem U control is prepared from human urine with two control levels.All data were collected via AbbottLink for automated data retrieval.Means, standard deviation and range were calculated for all controls.Assay reagent lots and calibrator lots varied across the sites and within the sites. RESULTS:Results from 12 frequently performed clinical chemistry assays were analyzed.The %CV for the 12 assays with the MultiChem S Plus control ranged from 0.42 to 4.71%.The %CV for the 6 assays with the MultiChem U control ranged from 0.50 to 5.24%.For both controls, the majority of the CVs were less than 2%.The results from the Technopath controls compared favorably with the BioRad Liquichek and BioRad Multiqual serum controls and the BioRad Liquichek Urine control in terms of %CV.Little variation was seen instrument to instrument or even site to site.When all the data was consolidated by analyte across multiple reagent lots and instruments, the overall %CV ranged from 0.765 to 4.11% for S Plus and 1.01 to 3.171% for Urine. CONCLUSIONS:The Technopath MultiChem S Plus and U controls showed comparable performance to the routine QC solution at the 3 sites.The new MCCs allow the optimization of day-to-day analytical QC testing by having routine metabolites, specific proteins and TDMs consolidated into one control.

Background: The preanalytical phase represents the major source of variability in laboratory diag-nostics. Our aim was to assess to what extent un-derfi lling of primary blood tubes may impact upon routine coagulation testing. Materials and methods: Blood was drawn by syringe from 21 healthy volunteers and 6 patients on warfarin therapy, and immediately transferred into 3.6 mL vacuum tubes containing 3.2% sodium cit-rate (Terumo Europe N.V., Leuven, Belgium). All tubes were fi lled using standardized volumes of whole blood to produce scalar amounts of fi lling: 3.6 mL (i.e., 100%), 3.2 mL (89%), 2.8 mL (78%) and 2.4 mL (67%). Samples were mixed and centrifuged at 1300 x g for 10 min. The plasma was tested for prothrombin time (PT), activated partial thrombo-plastin time (APTT) and fi brinogen (FBG) on ACL TOP (Instrumentation Laboratory-IL, Milan, Italy), using IL reagents. A polynomial plot was derived for each parameter from interpolation of clotting values obtained with diff erent percentages of fi ll-ing, and these plots were compared with quality specifi cations (± 2.0 for PT, ± 2.3 for APTT and ± 4.8 for FBG) to calculate the minimal fi lling volume required to produce clinically acceptable results. + 422.1 x PF + 147.07 (r = 0.994). According to these equations, the minimum allowed thresholds of blood tubes fi lling were > 61% for PT, > 87% for APTT and > 71% for FBG. Conclusions: Our results confi rm that routine co-agulation testing performed on underfi lled tubes may generate biased and clinically misleading test results. This is particularly critical for APTT, wherein tubes fi lled at less than ~90% generate unreliable data. The FBG and the PT seem more resistant to underfi lling, clinical signifi cant biases being observed only where blood tubes were fi lled at less than ~60 and ~70%, respectively. Background: Coagulation assays performed with photo-optical coagulometers may be aff ected by interfering substances, including lipids. According to the NCCLS guideline clotting parameters in li-pemic specimens should ideally be measured by mechanical or electromechanical methods, which are not always available. Elimination of interference by ultracentrifugation of lipemic plasma samples may aff ect accuracy due to concomitant sedi-mentation of fi brinogen. We aimed to determine the accuracy of fi brinogen measurement in lipemic plasma samples cleared by high-speed centrifuga-tion using an optical measurement procedure. Materials and methods: Twenty-two lipemic plasma samples with triglyceride concentration range of 6.01 to 40.18 mmol/L …

AMAC: Diyabet bakim kalitesinin degerlendirilebilmesi icin kalite indikatorleri belirlenmektedir. Bazi kalite indikatorleri hasta muayene verilerinden oldugu kadar HbA1c, LDL-Kolesterol, idrarda albumin, kreatinin klirens veya hesaplanmis glomeruler filtrasyon hizi (eGFR) gibi laboratuvar test sonuclarindan elde edilen sonuc olculerinden hesaplanir. Calismamizda bu testlerin klinik yararlanim ve diyabet bakim kalitesinin degerlendirilmesinde kullanilma durumunun degerlendirilmesi amaclandi.YONTEMLER: Diyabet ve komplikasyonlariyla iliskili klinik birimlerden ve laboratuvardan olusturulan ekip calisma protokolunu hazirladi. Davet edilen 199 kurulustan ucu calismayi yuruttu. Baslangicta hasta sayisi 243 idi. Klinik muayeneler calisma basinda yapildi. Hastalar protokole gore alti ay izlendi. Toplanan veriler diyabet bakim kalitesi acisindan degerlendirildi. BULGULAR: Baslangicta VKI, kan basinclari, aclik ve tokluk glukoz, HbA1c, HDL-K (kadinlarda), LDL-K duzeylerine gore hedef duzeyi karsilamayan hasta yuzdeleri %40 ile %81 arasindaydi. Altinci ayda HbA1c icin %25’e dustu. Ortalama degerler incelendiginde, hasta grubunda 6 aydaki HbA1c ortalamalarinda A, B ve C hastanelerindeki dususler ve %95 guven araliklari, sirasiyla, -0,46 (-0,64 ve 0,88); -1,71 (-2,17 ve -1,25) ve -1,20 (-1,64 ve -0,77) olarak saptandi. Risk grubundaki hasta yuzdesinde baslangica gore dusus gozlenemese de T.Kol, HDL-Kol, LDL-Kol, trigliserid ve idrarda Alb. ve kreatinin klirens ortalama duzeylerinde de olumlu yonde degisiklikler saptandi. SONUC: Calismamiz diyabet bakim kalitesinin degerlendirilmesinde laboratuvar test sonuclarindan yararlanilmasina ornek uygulamalar ve sonuclar icermektedir. Ancak ulkemizde henuz uygulanmayan bu tur calismalar icin coklu disiplinli ve sistematik bir yapilanma gerekmektedir.