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Laboratory medicine in sport and exercise has significantly developed during the last decades with the awareness that physical activity contributes to improved health status, and is present in monitoring both professional and recreational athletes. Training and competitions can modify concentrations of a variety of laboratory parameters, so the accurate laboratory data interpretation includes controlled and known preanalytical and analytical variables to prevent misleading interpretations. The paper represents a comprehensive summary of the lectures presented during the 35th Annual Symposium of the Croatian Society of Medical Biochemistry and Laboratory Medicine. It describes management of frequent sport injuries and sums up current knowledge of selected areas in laboratory medicine and sports including biological variation, changes in biochemical parameters and glycemic status. Additionally, the paper polemicizes sex hormone disorders in sports, encourages and comments research in recreational sports and laboratory medicine. In order to give the wider view, the connection of legal training protocols as well as monitoring prohibited substances in training is also considered through the eyes of laboratory medicine. [ABSTRACT FROM AUTHOR]

Introduction: The aim of this study was to perform a comprehensive verification of a 6-part differential haematology analyser Siemens Advia 2120i (Erlangen, Germany), prior to its routine implementation. Materials and methods: Our verification protocol included: precision (within- and between-run), estimated bias (%) as measure of trueness, which was calculated from observed and manufacturers' declared value, analytical measuring interval (AMI), carryover, confirmation of a limit of blank (LoB), determination of a limit of detection (LoD) and limit of quantitation (LoQ). The K2 ethylenediaminetetraacetic acid (EDTA) patients' leftover samples were used for verification of analyser Advia 2021i. Acceptance criteria were based on manufacturer technical specifications (Siemens), 2016 state-of-the-art criteria (Vis and Huisman), and EFLM Biological Variation Database. Results: The within- and between-run precision were acceptable for all parameters and the lowest coefficients of variation were observed for mean corpuscular volume (MCV) (0.3% and 0.6%, respectively). Estimated bias was within the acceptance criteria for all parameters except for MCV (the estimated bias was 2.2% (acceptance criteria 2.0%). AMI was confirmed for all tested parameters (r > 0.99). The carryover estimates ranged from 0.1% for platelet count (Plt) to 0.6% for red blood cell count and were within the manufacturers' specifications (= 1%). Manufacturers' claims for LoB were confirmed for leukocytes, erythrocytes, haemoglobin, and platelets. The estimated LoD and LoQ were 0.05 x109/L and 0.1 x109/L for white blood cell count, while for Plt values were 2 x109/L and 3 x109/L, respectively. Conclusions: Analytical performance of the Siemens Advia 2120i meets predefined quality goals and is suitable for routine use in a clinical laboratory. [ABSTRACT FROM AUTHOR]

In 2019 The Croatian Working Group for Laboratory Hematology, on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine, wanted to explore the background in field of laboratory hematology routine practice among Croatian laboratories in order to develop future strategies for producing national recommendations, if needed. During April and May 2019, a comprehensive survey covering all main parts of the total testing process within the field of laboratory hematology among Croatian medical laboratories was conducted. The survey comprised 49 inquiries. Data was collected using Survey Monkey (Palo Alto, CA, USA). All collected data was anonymized. The response rate was 72%. There is still a substantial number of laboratories that have only three-part differential hematology analyzers (9%). Furthermore, a very high number of laboratories did not perform analyzer verification prior to implementation into routine work (31%). Out of those who have verified their analyzers, a diversity of guidelines and recommendations were used. Nearly 10% of the laboratories do not have a defined policy regarding specimen rejection. The majority of the participants perform internal quality control daily (83%), however, only 51% of respondents evaluate the agreement between different hematology analyzers on daily basis. Although more than 90% of Croatian laboratories have a defined policy regarding specimen rejection, only 61% of respondents continuously monitor quality indicators in routine practice. The survey revealed substantial differences in all aspects of laboratory hematology practices among Croatian medical laboratories, indicating the need for universal recommendations at the national level. [ABSTRACT FROM AUTHOR]

Introduction: It has already been reported that subinhibitory concentrations of β-lactam antibiotics can cause abnormal changes of bacterial forms, such as spheroplasts. Herein we report a case of Croatian male patient with Escherichia coli spheroplasts present in urine after treatment with tazobactam, on the tenth day of hospitalization. The aim of this report is to emphasize the inability of imaging based automated urine analysers to recognize some relatively uncommon forms of bacterial presentation in urine sediment. Materials and methods: During routine urine analysis, unusual particles were observed in patient urine. Urine sediment was examined by two urine analysers: Atellica 1500 (Siemens, Germany) and Iris iQ200 (Beckman Coulter, USA). Additionally, urine was sent for culture testing to Microbiology department. Results: Both urine analysers didn't indicate presence of bacteria in urine sediment. Unusual particles observed on the tenth day were classified as erythrocytes by both instruments. Dipstick test showed blood trace and microscopic analysis revealed bacteria in urine. Urine culture was positive for Escherichia coli. Careful examination of urine sediment has confirmed that shapes present in urine were abnormal bacterial forms called spheroplasts. Conclusions: Imaging based automated urine analysers are not able to recognize bacterial spheroplasts in urine sediment misclassifying it as erythrocytes. Microscopic examination remains the gold standard for urines with blood trace or negative blood, in which erythrocytes are reported by urine analyser in urine sediment. Failure to identify and follow up such cases may lead to inaccurate treatment decisions and puts patient safety at risk. [ABSTRACT FROM AUTHOR]

Chronic kidney disease (CKD), International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), guidelines, action plan, questionnaire. [Extracted from the article]

Objective. Diagnosing acute appendicitis (AA) is challenging and this has stimulated surgeons to develop scoring systems that could potentially decrease the rate of misdiagnosis in patients with suspected appendicitis. One of the most widely used today is the Modified Alvarado scoring system (MASS), however its sensitivity and specificity varies a great deal between studies. As a result, we wanted to assess the diagnostic accuracy of MASS retrospectively at our institution to achieve the highest possible value of sensitivity and decrease the number of false negative patients. Material and Methods. We retrospectively calculated MASS for all subsequent patients who had undergone an appendectomy at our institution between July 2015 and March 2017. Results. In 118 out of 146 operated patients, AA was confirmed intraoperatively. There was a statistically significant difference between the average MASS score in the positive and negative appendectomy groups (6 v. 4, respectively, P<0.001), with a significantly higher number of females among the negative appendectomies (P<0.001). When lowering the cut-off to a value as low as =3, the sensitivity of the MASS score increased to 97.45% (95% CI: 92.7 - 99.5), thus obtaining a very low false negative rate of merely 2.55%. Conclusion. This retrospective diagnostic accuracy study confirmed the higher average MASS score in the group of patients with confirmed AA diagnosis. A MASS score above the proposed low cut-off value (=3) can be a useful tool to help surgeons ruling in patients with AA in order to reduce the risk of missing diagnosis. [ABSTRACT FROM AUTHOR]

Chronic kidney disease (CKD) is a common clinical condition with significant adverse consequences for the patient and it is recognized as a significant public health problem. The role of laboratory medicine in diagnosis and management of CKD is of great importance: the diagnosis and staging are based on estimation of glomerular filtration rate (eGFR) and assessment of albuminuria (or proteinuria). Therefore, the joint working group of the Croatian society of medical biochemistry and laboratory medicine and Croatian chamber of medical biochemists for laboratory diagnostics in CKD issued this national recommendation regarding laboratory diagnostics of CKD. Key factors for laboratories implementing the national guidelines for the diagnosis and management of CKD are: 1. Ensure good communication between laboratory professionals and clinicians, such as nephrologists or specialists in general/family medicine, 2. Ensure all patients are provided with the same availability of laboratory diagnostics, 3. Ensure creatinine assays are traceable to isotope dilution mass spectrometry (IDMS) method and have minimal bias and acceptable imprecision, 4. Select the appropriate GFR estimating formula. Recommended equation is the 2009 Chronic Kidney Disease Epidemiology Collaboration (CKD - EPI) equation, 5. In reporting the key laboratory tests (creatinine, eGFR, urine albumin-to-creatinine ratio, urine protein-to-creatinine ratio) use the appropriate reporting units, 6. Provide adequate information on limitations of creatinine measurement. The manuscript has been organized to identify critical points in laboratory tests used in basic laboratory diagnostics of CKD and is based on the Kidney Disease: Improving Global Outcomes (KDIGO) 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. [ABSTRACT FROM AUTHOR]

The article discusses a study which evaluates the impact of under-filled blood collection tubes containing K2EDTA and 3EDTA as anticoagulants on automated complete blood count (CBC) testing. Blood samples were collected from 30 patients which were analyzed for CBC on a Siemens Advia 120 hematology analyzer. Also discussed is the limitations of the study.

Introduction: Early identification and management of chronic kidney disease (CKD) is highly cost-effective and can reduce the risk of kidney failure progression and cardiovascular disease. In 2014, the Joint Croatian Working Group (JCWG) for laboratory diagnostic of CKD on the behalf of Croatian society of medical biochemistry and laboratory medicine (CSMBLM) and Croatian chamber of medical biochemists (CCMB) conducted a survey across Croatian medical-biochemistry laboratories to assess the current practice in this area of laboratory medicine. The aim of this study was to present the data collected through the survey and to give insight about laboratory diagnostics of chronic kidney disease in Croatia. Materials and methods: An invitation to participate in the survey was sent to all Croatian medical-biochemistry laboratories (N = 196). The questionnaire was designed in a form of questions and statements, with possible multiple answers, comprising 24 questions. Results: The response rate was 80/196 (40.8%). 39 answers were from primary medical-biochemistry laboratories. 31/78 (0.40) laboratories measure creatinine with non-standardized method (uncompensated Jaffe method). 58/78 (0.74) of laboratories that measure creatinine do not report eGFR values. Similar number of laboratories (58/80, 0.73) do not measure urine albumin or protein. Conclusions: There is a large heterogeneity among Croatian laboratories regarding measuring methods, reporting units and reference intervals (cut-off values), both for creatinine and urine albumin or protein. The two key prerequisites for CKD screening, automatic reporting of eGFR and albuminuria or proteinuria assessment, are not implemented nationwide. There is a need for harmonization in laboratory diagnostics of CKD in Croatia. [ABSTRACT FROM AUTHOR]

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Point-of-care (POC) glucose technology is currently considered to be insufficiently accurate for the diagnosis of diabetes. The objective of this study was to investigate the diagnostic accuracy of an innovative, interference-resistant POC glucose meter (StatStrip glucose hospital meter, Nova Biomedical, USA) in subjects with a previous history of dysglycaemia, undergoing a 75 g diagnostic oral glucose tolerance test (oGTT). Venous and capillary blood sampling for the reference laboratory procedure (RLP) and POC-glucose measurement was carried out at fasting and 2 h oGTT, and categories of glucose tolerance were classified according to 2006 WHO diagnostic criteria for the respective sample type. We found an excellent between-method correlation at fasting (r = 0.9681, P < 0.0001) and 2h oGTT (r = 0.9768, P < 0.0001) and an almost perfect diagnostic agreement (weighted Kappa=0.858).Within a total of 237 study subjects, 137 were diagnosed with diabetes with RLP, and only 6 of them were reclassified as having glucose intolerance with POC. The diagnostic performance of POC-fasting glucose in discriminating between the normal and any category of disturbed glucose tolerance did not differ from the RLP (P = 0.081). Results of this study indicate that StatStrip POC glucose meter could serve as a reliable tool for the diabetes diagnosis, particularly in primary healthcare facilities with dispersed blood sampling services. [ABSTRACT FROM AUTHOR]

Background: The aim of the study was to determine the values of hematological markers of anemia and of C-reactive protein (CRP) in patients with stable chronic obstructive pulmonary disease (COPD) in order to define the presence of anemia, degree of systemic inflammation and correlations between the analytes. Material and methods: The study included 150 COPD patients (FEV1 = 48 ± 21%) and 51 control subjects (FEV1 = 106 ± 15%). Pursuant to GOLD guidelines, the patients were divided into four subgroups and according to WHO criteria for anemia into two subgroups: subjects with and those without anemia. Serum CRP concentration was determined by immunoturbidimetric method and hematological markers were determined by flow cytometry. Results: No significant differences were found in the values of erythrocytes, hemoglobin and hematocrit either between the group of all COPD patients and control subjects or between GOLD subgroups and control subjects. Anemia was present in 24% of COPD patients. CRP concentration was significantly higher in the group of all COPD patients, in all GOLD subgroups (I, lIA, IIB and Ill) and in subgroups with and without anemia as compared to control subjects (P < 0.001 all). CRP specificity and sensitivity were determined by ROC analysis and showed good diagnostic accuracy for CRP in COPD patients. Correlation coefficient between CRP and hemoglobin and hematocrit values revealed a good negative correlation (r = -0.60 and r = -0.59, respectively; P <0.001 both) only in GOLD subgroup Ill. Conclusion: CRP concentration, a marker of systemic inflammation, was significantly higher in COPD patients and in all GOLD subgroups as compared to the control group. Good negative correlation was recorded between hematocrit and hemoglobin values and advanced inflammation (CRP concentration) in GOLD subgroup Ill. The rate of anemia was in agreement with literature data. [ABSTRACT FROM AUTHOR]

Pseudothrombocytopenia (PTCP) is defined by the occurence of spouriously low platelet count as a consequence of in vitro platelet aggregation. It is a rare and benign artifact, not associated with any specific disorder or therapy, that becomes clinically relevant when it is not timely and reliably recognized. Thus, it may result in inappropriate clinical decisions (i.e. unnecessary further testing, misdiagnoses and potential patients' mismanagement) unavoidably compromising patient safety. The most common form of PTCP is caused by ethylenediaminetetraacetic acid (EDTA). Several approaches for the management of samples with EDTA-induced PTCP have been described in the literature. However, expert recommendations are scarce. The scope of these recommendations is to assist in achieving national harmonisation in laboratory management (i.e. detecting and reporting platelet counts) of samples with EDTA-induced PTCP. These minimal recommendations were prepared by the members of the joint working group of the Croatian Chamber of Medical Biochemists and Working group for Laboratory Hematology of the Croatian Society of Medical Biochemistry and Laboratory Medicine, and might be customized according to specific conditions (i.e. personnel and equipment) of each individual laboratory. These recommendations are primarily intended to all laboratory professionals involved in the management of samples with EDTA-induced PTCP, but also to other healthcare professionals involved in collecting samples and interpreting complete blood count results. [ABSTRACT FROM AUTHOR]

Introduction: Information about analyte stability is of crucial importance. The aims of this study were to determine the short- and long-term stability of synovial fluid calprotectin at various temperature conditions (4-8 °C for 7 days, - 20 °C and - 80 °C for 6 weeks). Materials and methods: Eleven samples from patients were included in this study. The samples were promptly transported at room temperature (RT) to the laboratory immediately after arthrocentesis. Upon arrival, the samples were transferred into plastic tubes without additives and pretreated with hyaluronidase solution. After centrifugation at 1500xg for 10 minutes at RT, the baseline calprotectin concentrations were determined. Seven aliquots were stored in LoBind tubes (Eppendorf) at 4-8 °C and the calprotectin was measured every day. Six additional aliquots were stored at temperatures - 20 °C and - 80 °C and the concentration of calprotectin was measured weekly. Analysis was done using Buhlmann fCAL turbo reagent on analyzer Siemens Atellica Solution (Siemens Healthcare, Erlangen, Germany). Data were analyzed by Microsoft Excel and MedCalc statistical software. The percentage difference (PD%) was calculated. The maximum permissible difference (MPD) was 9.1% for PD%. Results: The PD% with the corresponding 95% confidence intervals were inside the predefined MPD. The instability equations and correlation coefficient for storage temperatures were PD% = 0.1644 x time (day), r = 0.06, P = 0.614 for 4-8°C, PD% = 0.5190 x time (week), r = - 0.22, P = 0.080 for - 20°C, and PD% = 0.1316 x time (week), r = 0.08, P = 0.545 for - 80°C. Conclusions: The calprotectin in the synovial fluid is stable when stored long-term for 6 weeks at - 20 °C or at - 80 °C or short-term (7 days) at 4-8 °C. [ABSTRACT FROM AUTHOR]

Introduction: Hemolysis can occur during sample collection, handling and transport. It is more frequent when the non-laboratory staff performs sampling. The aim of this study was to assess nurses' knowledge on the causes of hemolysis and consequential impact on the laboratory tests results. Additionally, the differences in knowledge, related to work experience, professional degree and previous education about hemolysis were explored. Materials and methods: An anonymus survey, containing 11 questions on demographics, causes of hemolysis, its impact on biochemical parameters and nurses' attitude towards additional education in preanalytics, was conducted in four Croatian hospitals. The answers were compared by Chi-squared and Fischer exact test. Results: In total, 562 survey results were collected. Majority of nurses declared familiarity with the term "hemolysis" (99.6%). There were 77% of correct answers regarding questions about the causes of hemolysis, but only 50% when it comes to questions about interference in biochemical tests. The percentage of correct answers about causes was significantly lower (P = 0.029) among more experienced nurses, and higher (P = 0.027) in those with higher professional degree, while influence of previous education was not significant. Also, higher percentage of correct answers about interferences was encountered in nurses with longer work experience (P = 0.039). More than 70% of nurses declared that additional education about preanalytical factors would be beneficial. Conclusion: Croatian nurses are familiar with the definition of hemolysis, but a lack of knowledge about causes and influence on laboratory test results is evident. Nurses are eager to improve their knowledge in this field of preanalytical phase. [ABSTRACT FROM AUTHOR]

Introduction: The aims of study were to assess: 1) performance specifications of Atellica 1500, 2) comparability of Atellica 1500 and Iris, 3) the accuracy of both analysers in their ability to detect bacteria. Materials and methods: Carryover, linearity, precision, reproducibility, and limit of blank (LoB) verification were evaluated for erythrocyte and leukocyte counts. ICSH 2014 protocol was used for estimation of carryover, CLSI EP15-A3 for precision, and CLSI EP17 for LoB verification. Comparison for quantitative parameters was evaluated by Bland-Altman plot and Passing-Bablok regression. Qualitative parameters were evaluated by Weighted kappa analysis. Sixty-five urine samples were randomly selected and sent for urine culture which was used as reference method to determine the accuracy of bacteria detection by analysers. Results: Analytical specifications of Atellica 1500 were successfully verified. Total of 393 samples were used for qualitative comparison, while 269 for sediment urinalysis. Bland-Altman analysis showed statistically significant proportional bias for erythrocytes and leukocytes. Passing-Bablok analysis for leukocytes pointed to significant constant and minor proportional difference, while it was not performed for erythrocytes due to significant data deviation from linearity. Kappa analysis resulted in the strongest agreements for pH, ketones, glucose concentrations and leukocytes, while the poorest agreement for bacteria. The sensitivity and specificity of bacteria detection were: 91 (59-100)% and 76 (66-87)% for Atellica 1500 and 46 (17-77)% and 96 (87-100)% for Iris. Conclusion: There are large differences between Atellica 1500 and Iris analysers, due to which they are not comparable and can not be used interchangeably. While there was no difference in specificity of bacteria detection, Iris analyser had greater sensitivity. [ABSTRACT FROM AUTHOR]

Introduction: Activated partial thromboplastin time (aPTT) is determined and reported as clotting time in seconds aPTT(s), but it is presumed that reporting results as patient-to-normal clotting time ratio, aPTT(r), could minimize within-laboratory variability. The aim of study was to investigate differences in reporting aPTT results that can affect comparability of the results among Croatian laboratories and suggest further steps for its harmonization. Materials and methods: The questionnaire on aPTT reporting practice was distributed to 83 laboratories through Survey Monkey application in March 2019 as the part of the first regular round of Croatian Centre for Quality Assessment in Laboratory Medicine proficiency testing. Results: The survey response rate was 0.49. Majority of laboratories report aPTT results as both, seconds and ratio. Participants reported use of 23 different aPTT(s) reference intervals along with 17 different combinations of reagent/coagulometer and 25 aPTT(s) denominators of different origin for aPTT(r) calculation. Despite the same aPTT(s) results, the use of different denominators caused a dispersion of aPTT(r) results that can lead to exceeding external quality assessment performance criteria of 7%, particularly when results were compared for the same reagent group only. By applying aPTT(s) reference interval mean as denominator for calculation of aPTT(r) reference interval better concordance to harmonized one was obtained (17 vs. 27; χ2 = 3.972; P = 0.046). Conclusion: In order to improve comparability of the results, laboratories are advised to use mean of aPTT(s) reference interval as denominator for aPTT(r) calculation. Type of coagulometer need to be considered when evaluating aPTT proficiency test results and its currently acceptable limit of performance evaluated accordingly. [ABSTRACT FROM AUTHOR]

Introduction: This survey aimed to assess the state-of-the-art of current practices on critical results reporting among Portuguese Clinical Pathology Laboratories. The results of the survey will set basis for future standardization and national guideline development., Materials and Methods: The survey was transmitted to 49 Clinical Pathology Laboratories among public hospitals inserted in the Portuguese National Health System. In 27 questions, laboratories were asked about their critical results procedures, critical results list, reporting and further education. Data were analyzed using Microsoft Excel v.2016 and MedCalc Statistical Software version 12.5.0.0 (Ostend, Belgium). Where applicable, the comparison of proportions was used to estimate the level of significance (P<0.05)., Results: The response rate was 44/49 (90%), including 36 participants with a defined critical results reporting procedure. Among them, 31 laboratories defined a critical results list, mainly based on published literature (27/31). There was a statistically significant number of laboratories (P=0.019, 24/30) that report different critical results depending on the patient's age, but regardless of disease, ethnicity and location (P>0.05). The majority of laboratories (60%) report critical results via telephone within 15 minutes. Critical results are usually reported by clinical pathologists to physicians. Twenty-five laboratories periodically reevaluate their critical results list., Conclusion: Despite the fact that most of the Portuguese hospitals have a critical results policy, this survey showed high variability among the hospitals concerning critical results reporting practices and critical results list. This survey points out that nationally established procedures and guidelines are urgent step for critical results standardization., (Copyright © 2020 International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). All rights reserved.)

Chronic kidney disease (CKD) is a major public health issue worldwide and is associated with adverse health outcomes, especially in low- and middle-income countries. In a cash limited healthcare system, guidelines that improve the efficiency of health care free up resources needed for other healthcare services. This short review presents some examples from national acitivities in CKD testing, including countries throughout the globe: Mexico in North America, Uruguay in South America, Italy in Europe, Nigeria in Africa and India in Asia. Considering the fact that treatment of CKD is cost-effective and improves outcomes, this observation argue in favor of including CKD in national guidelines and noncommunicable chronic disease (NCD) programs. This diverse example of national activities fullfil the very first step in achieving this goal.

The principal benefit of guidelines is to improve the quality of care received by patients. In the 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (KDIGO) was released and it is designed to provide information and assist decision making. This review gives a brief overview of a various national CKD guidelines that rely on the newly released KDIGO guidelines. All of the included countries (France, Turkey, Norway and Croatia) are non-English speaking countries and they differ in population and socio economic aspects. Examples shown in this review may provide valuable experience for countries that are in process of creating their national CKD guidelines.

Objectives: Ion-exchange high-performance liquid chromatography (IE-HPLC) has long been used as a reproducible and versatile analytical tool for HbA 1c measurement. In this study, we performed analytical verification and quality assessment of the recently introduced small IE-HPLC Tosoh HLC-723GX HbA 1c analyzer, and a comparison of results to immunoassay (IA) and capillary electrophoresis (CE)., Design and Methods: The total imprecision of Tosoh HLC-723GX was verified according to CLSI EP15-A2 protocol using commercial control materials (C-QC) and pooled human whole blood samples (HWB). The Sigma metric was used for the evaluation of quality targets. HbA 1c results were compared to automated CE (MiniCap Flex Piercing, Sebia, France) and IA (Tina-quant HbA 1c Gen 2, Cobas Integra 400+, Roche Diagnostics, USA) procedures., Results: The total imprecision of Tosoh HLC-723GX-HbA 1c for IFCC(mmol/mol) and NGSP(%) units was: 1.91/1.25% (HbA 1c =31 mmol/mol/5.0%) and 0.51/0.63% (HbA 1c =84 mmol/mol/9.8%) for C-QC, and 0.39/0.2% (HbA 1c =47 mmol/mol/6.5%) and 0.77/0.46% (HbA 1c =94 mmol/mol/10.8%) in HWB samples, respectively. Bland-Altman analysis did not reveal any deviation of the results between Tosoh HLC-723GX and CE: mean difference 0.0% (95%CI: -0.02927 to 0.02653%), while the mean HbA 1c difference against IA was -0.07% (95%CI: -0.1039 to -0.02765). At the selected HbA 1c clinical decision level (48 mmol/mol/6,5%), six sigma analysis gave σ value of 3.91, within a desirable classification of performance., Conclusion: The analytical performance of the Tosoh HLC-723GX complies with the rigorous quality criteria for clinical use of HbA 1c , with the results comparable to the CE procedure. Tosoh HLC-723GX provides a plausible analytical choice for reliable HbA 1c measurement in low-volume laboratories.