Primena »six sigma« u kontroli kvaliteta zdravstvenih laboratorija

The goal of every operation or production system is to generate a useful product. Most quality-control methods were initially developed to aid manufacturing. This is not surprising because high volume production typically requires many repetitions involving a controlled sequence of operations. Not all of the many approaches to quality control are equally effective. Nonconformities in laboratory testing are caused basically by excessive process variation and mistakes. A critical limitation of the statistical quality control - based methods is that they are ineffective in detecting and controlling mistakes, the dominant source of nonconformities in most organizations today. Statistical quality control can effectively control process variation, but it cannot detect or prevent most mistakes. Six Sigma belongs to statistical quality control and provides a new methodology for measuring process performance and refines earlier methodologies for making process improvements. Six Sigma Quality Management is slowly making inroads in healthcare organizations and offers a real hope for improving quality management thinking and processes. The reason is that Six Sigma focuses on defects, which in turn requires that goals for good quality be defined. Six Sigma provides a universal methodology for measuring quality by counting the defects, determining the defect rate as »defects per million« or »DPM«, and then converting DPM to a sigma-metric (by use of standard tables available in any Six Sigma text). To reduce (and oversimplify) Six Sigma, there now are »Sigma metrics« that provide a universal benchmark for process performance. The performance of all processes can be characterized on the »Sigma scale.« Values typically range from 2 to 6, where the goal for »world class quality« is 6. Based on the data from real-world health laboratory is an obvious statement that current instrumentation performs well. The new generation of clinical analyzers have achieved some high Sigma metrics. Customers in healthcare are going to enjoy a new era empowerment with instruments and methods that perform at 6 Sigma or higher

Biomarkeri oboljenja - pristup zasnovan na dokazima

Evidence-based medicine (EBM) combines individual clinical expertise with the best available clinical evidence from systematic research in making decisions about the care of individual patients. Clinical expertise is the proficiency and judgment that individual clinicians acquire through knowledge, clinical experience, and practice. Clinical evidence comes from patient-centered clinical research which investigates the accuracy and precision of diagnostic tests and biomarkers, the efficacy and safety of therapeutic regimes, and the reliability of prognostic indicators. The powerful combination of clinical expertise and documented evidence results in safer, more efficacious and accurate care of the patient. Evidence-based guidelines are commonly used tools for supporting medical decisions. Formulating evidence-based recommendations has become a leading principle in guideline development. In laboratory medicine, guidelines provide recommendations on the use of a wide range of tests in detecting or predicting a target condition, for staging and monitoring a disease, and for decisions to initiate, modify, or terminate treatments. Systematic, standardized, and explicit methodology, adapted to laboratory medicine, should be followed when developing recommendations involving the use of laboratory tests and biomarkers. There are many opportunities for the application and evaluation of laboratory tests in good clinical trials. There are even greater opportunities for correlating various laboratory procedures with the clinical findings, outcomes and diagnoses, and using the stored samples collected for those studies. In this era of evidence-based medicine, clinicians and other decision-makers turn to the scientific literature for high-quality evidence about the usefulness, precision, and accuracy of diagnostic tests. Such evidence is needed more than ever because the list of diagnostic tests is growing exponentially, and even more biomarkers, proteomics, and applications of gene expression profiling will be added in the years to come.Medicina zasnovana na dokazima (EBM) pri donošenju odluka o nezi pacijenata kombinuje individualnu kliničku veštinu sa najboljim raspoloživim kliničkim dokazima iz sistematičnih istraživanja. Klinička veština odlikuje se tačnošću u proceni i stiče se učenjem, kliničkim iskustvom i praksom. Klinički dokazi dobijaju se iz kliničkih istraživanja koja su usmerena na pacijenta, a koja ispituju tačnost i preciznost dijagnostičkih testova i biomarkera, efikasnost i sigurnost terapeutskih postupaka i pouzdanost prognostičkih indikatora. Kombinacija kliničke veštine i dokumentovanih dokaza omogućava sigurniju, efikasniju i pouzdaniju negu pacijenta. Vodiči zasnovani na dokazima najčešće se koriste kao dodatne alatke pri donošenju medicinskih odluka. Formulisanje preporuka zasnovanih na dokazima predstavlja vodeći princip u pripremi vodiči. U razvoju preporuka koje uključuju laboratorijske testove i biomarkere treba primeniti sistematsku i standardizovanu metodologiju koja je prilagođena laboratorijskoj medicini. Postoji veliki broj mogućnosti za primenu i evaluaciju laboratorijskih testova u dobrim kliničkim ispitivanjima. Još su veće mogućnosti za uspostavljanje korelacija između različitih laboratorijskih postupaka i kliničkih nalaza, ishoda i dijagnoza, kao i za korišćenje uzoraka koji su skladišteni za ova ispitivanja. Era medicine zasnovane na dokazima zahteva od eksperata koji donose medicinske odluke proučavanje naučne literature kako bi se obezbedio visok kvalitet dokaza o korisnosti i tačnosti dijagnostičkih testova. Ovakva vrsta dokaza potrebnija je više nego ikad zato što lista dijagnostičkih testova raste eksponencijalno i u godinama koje dolaze na nju će biti dodato još više biomarkera, proteomike aplikacija profiliranja ekspresije gena

Medical Biochemistry as Subdiscipline of Laboratory Medicine in Serbia

Medical biochemistry is the usual name for clinical biochemistry or clinical chemistry in Serbia, and medical biochemist is the official name for the clinical chemist (or clinical biochemist). This is the largest sub-discipline of the laboratory medicine in Serbia. It includes all aspects of clinical chemistry, and also laboratory hematology with coagulation, immunology, etc. Medical biochemistry laboratories in Serbia and medical biochemists as a profession are part of Health Care System and their activities are regulated through: the Health Care Law and rules issued by the Chamber of Medical Biochemists of Serbia. The first continuous and organized education for Medical Biochemists (Clinical Chemists) in Serbia dates from 1945, when the Department of Medical Biochemistry was established at the Pharmaceutical Faculty in Belgrade. In 1987 at the same Faculty a five years undergraduate study program was established, educating Medical Biochemists under a special program. Since the academic year 2006/2007 the new five year undergraduate (according to Bologna Declaration) and four-year postgraduate program according to EC4 European Syllabus for Postgraduate Training in Clinical Chemistry and Laboratory Medicine has been established. The Ministry of Education and Ministry of Public Health accredited these programs. There are four requirements for practicing medical biochemistry in the Health Care System: University Diploma of the Faculty of Pharmacy (Study of Medical Biochemistry), successful completion of the professional exam at the Ministry of Health after completion of one additional year of obligatory practical training in the medical biochemistry laboratories, membership in the Serbian Chamber of Medical Biochemists and licence for skilled work issued by the Serbian Chamber of Medical Biochemists. In order to present laboratory medical biochemistry practice in Serbia this paper will be focused on the following: Serbian national legislation, healthcare services organization, sub-disciplines of laboratory medicine and medical biochemistry as the most significant, education in medical biochemistry, conditions for professional practice in medical biochemistry, continuous quality improvement, and accreditation. Serbian healthcare is based on fundamental principles of universal health coverage and solidarity between all citizens

Funkcija bubrega - Procena brzine glomerularne filtracije

The glomerular filtration rate (GFR) is widely accepted as the best overall measure of kidney function. American National Kidney Foundation guidelines define chronic kidney disease (CKD) by either a GFR of less than 60 mL/min/1.73 m2 or the presence of kidney damage, regardless of the cause, for 3 or more months, and classify stages of CKD severity according to GFR. GFR can be measured as the urinary or plasma clearance of exogenous filtration markers such as inulin. However, because of difficulty in use, expenses and radiation exposure, these methods have limited use in the routine laboratories. Creatinine clearance may be a useful alternative when exogenous markers are not available, but timed urinary collection is not convenient for patients and is susceptible to error during collection. GFR is often estimated clinically from serum concentrations of endogenous creatinine or cystatin C. Serum cystatin C has not yet been adequately evaluated as an index of GFR, and serum creatinine is affected by the GFR and by factors independent of GFR, including age, sex, race, body size, diet, certain drugs and laboratory analytical methods. According to National Kidney Foundation clinical guidelines, clinical laboratories should report an estimated GFR calculated from prediction equations, in addition to reporting the serum marker value. The currently recommended estimating equation was developed from the Modification of Diet in Renal Disease (MDRD) study. This equation uses age, sex, race (African-American vs. non-African-American), and serum creatinine concentration, and does not require a body weight variable because it normalizes GFR for a standard body surface area of 1.73 m 2. To achieve improved accuracy of calculated GFR with this equation, it is recommended that commercial creatinine methods should be calibrated against certified reference material and should be traceable to IDMS (isotope dilution mass spectrometry) methodology. MDRD equation has been shown to be useful for CKD patients, but its use is still unclear for people with low values for serum creatinine and high values for GFR, including healthy individuals, children and pregnant women. Validation studies are in progress to evaluate the MDRD equation for other ethnic groups and various disease conditions.Brzina glomerularne filtracije (GFR) je široko prihvaćena kao najbolja opšta mera funkcije bubrega. Vodiči američke Nacionalne fondacije za bubreg definiš u hroničnu bubrežnu bolest (HBB) bilo sa vrednošću GFR koja je manja od 60 mL/min/1,73 m2 ili sa prisustvom oštećenja bubrega, bez obzira na uzrok, u toku 3 ili više meseci i klasifikuju stadijume težine HBB prema GFR. GFR se može meriti kao urinarni ili plazma klirens egzogenih filtracionih markera kao što je inulin. Međutim, zbog teškoća u primeni, troškova i radijacionog izlaganja, ove metode imaju ograničenu upotrebu u rutinskim laboratorijama. Klirens kreatinina može biti korisna alternativa kada egzogeni markeri nisu dostupni, ali sakupljanje urina u vremenskim intervalima nije pogodno za pacijente i osetljivo je na grešku pri sakupljanju. GFR se često procenjuje klinički iz serumskih koncentracija egzogenog kreatinina ili cistatina C. Cistatin C u serumu još uvek nije adekvatno procenjen kao indeks GFR, a na kreatinin u serumu utiču GFR i faktori nezavisni od GFR, uključujući godine pol, rasu, telesnu veličinu, ishranu, izvesne lekove i laboratorijske analitičke metode. Prema kliničkim vodičima Nacionalne fondacije za bubreg kliničke laboratorije bi trebalo da izdaju "procenjenu " GFR (estimated GFR) izračunatu iz prediktivnih jednačina, kao dodatak izveštavanja vrednosti markera u serumu. Trenutno preporučena jednačina za procenu je razvijena iz MDRD (Modification of Diet in Renal Disease) studije. Ova jednačina koristi godine, pol, rasu (afro-američka prema ne-afro-američkoj) i koncentraciju kreatinina u serumu, a ne zahteva varijablu za telesnu težinu zato što normalizuje GFR za standardnu telesnu površinu od 1,73 m2. Da bi se postigla poboljšana tačnost preračunate GFR sa ovom jednačinom, preporučuje se da komercijalne metode za kreatinin budu kalibrisane prema sertifikovanim referentnim materijalima i sledljive sa IDMS (isotope dilution mass spectrometry) metodologijom. Za MDRD jednačinu je pokazano da je korisna za pacijente sa HBB, ali njena upotreba je još uvek nejasna za ljude sa niskim vrednostima kreatinina u serumu i visokim vrednostima za GFR, uključujući zdrave pojedince, decu i trudnice. Validacione studije su u razvoju kako bi se procenila MDRD jednačina za druge etničke grupe i različita bolesna stanja

Poređenje dve metode procene kardiovaskularnog rizika - 'Framingham' rizik skor i 'Score' sistem

Numerous studies have shown that the major risk factors for coronary heart disease (cigarette smoking, hypertension, elevated serum total cholesterol and low-density lipoprotein cholesterol - LDL, low serum high-density lipoprotein cholesterol - HDL, diabetes mellitus and advancing age), are additive in predictive power. Accordingly, the total risk of a person can be estimated by summing up the risk imparted by each of the major risk factors. Using data obtained from population studies, various risk assessment algorithms have been developed. The aim of this study was to compare the two most common risk scores. Risk assessment for determining 10-year risk in 185 healthy, asymptomatic individuals of both sexes, 30-85 years old, was carried out according to both Framingham (FRS) and SCORE risk scoring. The risk factors included in the calculation of 10-year risk are gender, age, total cholesterol, HDL-cholesterol, systolic blood pressure, treatment for hypertension and cigarette smoking. The determinations of total cholesterol and HDL-cholesterol were made in sera collected after a 12h fasting period using an Olympus AU2700 automated analyzer. The Framingham risk score was determined using an electronic calculator - ATP III Risk Estimator, and the risk status according to SCORE was obtained using charts for the 10-year risk in populations at high risk. Among 185 participants, in 152 (82%) 10-year risk for Coronary Heart Disease (CHD) death was lt 10%, 24 (13%) had intermediate and 9 (5%) had high risk (>20%) according to FRS. According to SCORE, 110 (60%) participants had lt 1%, 56 (30%) had 1-5% and 19 (10%) had >5% of 10-year risk for cardiovascular death. Different categories of risk were assigned to ∼30% of individuals according to different risk assessment models. Differences in risk classification when using two different risk assessment algorithms can be explained with several important issues including different endpoints, consideration of interactions and incorporation of antihypertensive use. It is important to note that neither FRS nor SCORE have been appropriately adjusted for our population, according to the national cardiovascular mortality rate.Brojne studije su pokazale aditivnu prediktivnu vrednost glavnih faktora rizika za pojavu koronarne srčane bolesti (pušenje, hipertenzija, povišena koncentracija ukupnog i LDL-holesterola i niska koncentracija HDL-holesterola u serumu, dijabetes i starost). Na osnovu toga, ukupan rizik za jednu osobu može se proceniti sumiranjem rizika koji nosi svaki glavni faktor rizika pojedinačno. Veliki broj algoritama za procenu rizika razvijen je na osnovu podataka dobijenih iz populacionih studija. Cilj ovog rada bio je poređenje dva najčešće korišćena rizik skora. Za 185 zdravih, asimptomatskih osoba oba pola, 30-85 godina starosti, procenjen je rizik od pojave kardiovaskularnih bolesti (KVB) u narednih 10 godina prema "Framingham" (FRS) i SCORE sistemu. Faktori rizika koji su uključeni u izračunavanje 10-godišnjeg rizika su pol starost, ukupan i HDLholesterol, sistolni krvni pritisak, terapija antihipertenzivima i pušenje. Ukupan i HDL-holesterol određivani su u uzorcima seruma, dobijenim posle 12 sati gladovanja, na biohemijskom analizatoru Olympus AU2700. FRS je izračunavan pomoću programa "ATP III Risk Estimator", a SCORE rizik je dobijen pomoću tablica za 10-godišnji rizik za populacije sa visokim rizikom. Od 185 učesnika, kod 152 (82%) 10- godišnji rizik za srčanu smrt bio je lt 10%, 24 (13%) je imalo srednji, a 9 (5%) je imalo visoki rizik (≥20%) na osnovu FRS. Prema SCORE-u, 110 učesnika (60%) imalo je 10- godišnji rizik od kardiovaskularne smrti lt 1%, 56 (30%) je imalo 1-5% rizika, dok je kod 19 osoba (10%) identifikovan visok rizik (≥5%). Oko 30% ispitanika svrstano je u različite kategorije rizika na osnovu različitih modela za procenu rizika. Razlike u klasifikaciji na osnovu kardiovaskularnog rizika, koje se dobijaju korišćenjem dva različita algoritma za procenu rizika, mogu se objasniti time što ovi sistemi koriste različite krajnje ishode bolesti i što se razlikuju po uticaju interakcija i uzimanju u obzir upotrebe antihipertenzivnih lekova. Važno je naglasiti da ni FRS ni SCORE nisu prilagođeni našoj populaciji, na osnovu nacionalne stope mortaliteta od KVB

Biohemija i metabolizam vitamina D

Vitamin D is not technically a vitamin, since it is not an essential dietary factor. It is rather a prohormone produced photochemically in the skin from 7-dehydrocholesterol. Vitamin D and its metabolites may be categorized as either cholecalciferols or ergocalciferols. Cholecalciferol (vitamin D3) is the parent compound of the naturally occurring family and is produced in the skin from 7-dehydrocholesterol on exposure to the ultraviolet B portion of sunlight. Vitamin D2 (ergocalciferol), the parent compound of the other family, is manufactured by irradiation of ergosterol produced by yeasts and its potency is less than one-third of vitamin D3's potency. The steps in the vitamin D endocrine system include the following: 1) the photoconversion of 7-dehydrocholesterol to vitamin D3 in the skin or dietary intake of vitamin D3; 2) metabolism of vitamin D3 by the liver to 25-hydroxyvitamin-D3 [25(OH)D3], the major form of vitamin D circulating in the blood compartment; 3) conversion of 25(OH)D3 by the kidney (functioning as an endocrine gland) to the hormone 1,25-dihydroxyvitamin D3 [1,25(OH)2D3 ]; 4) systemic transport of the dihydroxylated metabolite 1,25(OH)2D3 to distal target organs; and 5) binding of 1,25(OH)2D3 to a nuclear receptor (VDR) at target organs, followed by generation of appropriate biological responses. The activation of vitamin D to its hormonal form is mediated by cytochrome P450 enzymes. Six cytochrome P450 (CYP) isoforms have been shown to hydroxylate vitamin D. Four of these, CYP27A1, CYP2R1, CYP3A4 and CYP2J3, are candidates for the enzyme vitamin D 25-hydroxylase that is involved in the first step of activation. The highly regulated, renal enzyme 25-hydroxyvitamin D-1a-hydro xylase contains the component CYP27B1, which completes the activation pathway to the hormonal form 1,25(OH)2D3. A five-step inactivation pathway from 1,25(OH)2D3 to calcitroic acid is attributed to a single multifunctional CYP, CYP24A1, which is transcriptionally induced in vitamin D target cells by the action of 1,25(OH)2D3. An additional key component in the operation of the vitamin D endocrine system is the plasma vitamin D binding protein (DBP), which carries vitamin D3 and its metabolites to their metabolism and target organs. DBP is a specific, high-affinity transport protein. It is synthesized by the liver and circulates in great excess, with fewer than 5% of the binding sites normally occupied. 1,25(OH)2D3, acts as a ligand for a nuclear transcription factor, vitamin D receptor - VDR, which like all other nuclear receptors, regulates gene transcription and cell function. The widespread presence of VDR, and the key activating (1a-hydroxylase, CYP27B1) and inactivating (24-hydroxylase, CYP24A1) enzymes in most mammalian cells means that the cells in these tissues have the potential to produce biological responses, depending on the availability of appropriate amounts of vitamin D3. Thanks to this widespread presence of elements of vitamin D endocrine system, its biological features are being recognized outside bone tissue, i.e. calcium and phosphate metabolism.Vitamin D nije pravi vitamin, odnosno nije esencijalni dijetetski faktor, već je pre prohormon koji nastaje fotohemijskom reakcijom u koži iz 7-dehidroholesterola. Vita min D i njegovi metaboliti mogu da se kategorizuju kao holekalciferoli ili ergokalciferoli. Holekalciferol (vitamin D3) je polazno jedinjenje za familiju koja se nalazi u prirodi i produkuje se u koži iz 7-dehidroholesterola pri izlaganju ultraljubičastom B delu spektra sunčeve svetlosti. Vitamin D2 (ergokalciferol), polazno jedinjenje druge familije, nastaje radijacijom ergosterola koga produkuju kvasci i ima samo jednu trećinu aktivnosti vitamina D3. Faze u endokrinom sistemu vitamina D su: 1) fotokonverzija 7-dehidroholesterola u vitamin D3 u koži ili unos vitamina D3-hranom; 2) metabolizam vitamina D3 u jetri do 25-hidroksivitamina D3 [25(OH)D3], glavnog oblika vitamina D u cirkulaciji; 3) konverzija 25(OH)D3 u bubregu (koji ovde funkcioniše kao endokrina žlezda) do hormona 1,25-dihidroksivitamin D3 [1,25(OH)2D3]; 4) sistemski transport dihidroksi-metabolita do distalnih ciljnih organa; i 5) vezivanje 1,25(OH)2D3 za nuklearni receptor (VDR) u ciljnim organima, što prati odgovarajući biološki odgovor. Aktivacija vitamina D do hormonskog oblika je posredovana citohrom P450 enzimima. Pokazano je da šest izoformi citohroma P450 (CYP) učestvuje u hidroksilaciji vitamina D. Za četiri od njih, CYP27A1, CYP2R1, CYP3A4 i CYP2J3, se pretpostavlja da imaju aktivnost 25-hidroksilaze koja uče s tvuje u prvom koraku aktivacije. Renalni enzim, 25-hidroksivitamin D-1a-hidroksilaza sa strogo regulisanom aktivnošću, predstavlja CYP27B1, koji završava aktivaciju do hormonskog oblika 1,25(OH)2D3. Proces inaktivacije, koji se sastoji iz pet stupnjeva od 1,25(OH)2D3 do kalcitroične kiseline, obavlja jedan multifunkcionalni CYP, CYP24A1, čija je transkripcija indukovana u ciljnim ćelija carbonma dejstva vitamina D posredstvom 1,25(OH)2D3. Dodatna ključna komponenta u dejstvu vitamin D endokrinog sistema je vitamin D vezujući protein u plazmi (DBP), koji transportuje vitamin D3 i njegove metabolite do ciljnih i organa gde se odvija njihov metabolizam. DBP je specifičan transportni protein velikog afiniteta. Sintetiše se u jetri i cirkuliše u velikom višku, sa zasićenjem vezujućih mesta manjim od 5%. 1,25(OH)2D3 deluje kao ligand nuklearnog transkripcionog faktora, VDR, koji reguliše transkripciju gena i funkciju ćelija. široka rasprostranjenost VDR i ključnih enizma aktivacije (1a-hidroksilaza, CYP27B1) i inaktivacije (24-hidroksilaza, CYP24A1) u većini ćelija sisara znači da ćelije u ovim tkivima imaju potencijal za produkovanje bioloških odgovora, zavisno od raspoloživosti dovoljnih ko li čina vitamina D3. Zahvaljujući rasprostranjenosti elemenata endokrinog sistema vitamina D, njegove biološke oso bi ne se prepoznaju i izvan koštanog sistema, odnosno metabolizma kalcijuma i fosfora

Apoptosis, annexin a5 and anti-Annexin a5 antibodies in the antiphospholipid syndrome

It has been proposed that apoptosis is one of the mechanisms involved in the generation of antiphospholipid antibodies. The presence of antiphospholipid antibodies is the main laboratory criterion for a definite diagnosis of the antiphospholipid syndrome. Annexinopathies are disorders characterized by deregulation of annexins expression levels and function. Annexin A5 has been used as an agent for molecular imaging techniques (visualization of phosphatidylserine-expressing apoptotic cells) in vitro and in vivo in animal models and in patients (injection of human recombinant anxA5 into the patient's circulation). Although the determination of titers of anti-annexin A5 antibodies is not mandatory for the diagnosis of the antiphospholipid syndrome, it was reported that patients with primary antiphospholipid syndrome with a history of recurrent abortions had elevated titers of anti-annexin A5 antibodies, while the presence of thromboses was not associated with elevated levels of these antibodies

Hyperhomocysteinemia and smoking in primary antiphospholipid syndrome

The thrombotic tendency in anti phospholipid syndrome (APS) shares several pathways with atherosclerosis. Atherothrombosis (atherosclerosis superimposed with thromboses) is influenced by nonmodifiable and some modifiable risk factors (smoking, obesity, physical inactivity, alcohol abuse, hyperhomocysteinemia). Therefore, we investigated the association among clinical and serological features of patients with primary APS and potentially modifiable risk factors for the development of atherothrombosis. Also, we compared the analyzed parameters with those in control subjects. Homo cysteine concentrations were detected by HPLC (high performance liquid chromatography), while antiphospholipid antibodies were detected by ELISA. Smokers had elevated levels of homocysteine (chi(2) = 6.22, p lt 0.05). Independently of patients' age, the association between increased levels of homocysteine and history of myocardial infarctions was found (chi(2) = 4.61, p lt 0.05). Hyperhomocysteinemia and smoking are the most important modifiable risk factors for atherothrombosis in primary APS

Adiponectin, non-esterified fatty acids and antiphospholipid antibodies in type II diabetes mellitus

The importance of the association of antiphospholipid antibodies (aPL Abs) with the features of type II diabetes mellitus has not yet been elucidated. The aim of this work was to investigate the association of aPL Abs with adiponectin and non-esterified fatty acids (NEFA) in type II diabetes mellitus patients without micro and/or macrovascular complications, and to analyze the differences between the male and female patients with regard to the abovementioned parameters. Male patients with type II diabetes mellitus showed a positive correlation between NEFA concentrations and anti-oxLDL antibodies (r = 0.334, p = 0.019). A weak, but statistically significant correlation between adiponectin concentrations and the IgM isotype of anti-annexin A5 antibodies was found in type II diabetes mellitus patients (r = 0.285, p = 0.011). The presence of a positive correlation between NEFA and anti-oxLDL antibodies might be useful in the detection of patients with premature atherosclerosis in type II diabetes mellitus patients without any micro and/or macrovascular complications among type II diabetes mellitus patients

Uncertainty of Measurement in Laboratory Medicine

An adequate assessment of the measurement uncertainty in a laboratory medicine is one of the most important factors for a reliable interpretation of the results. A large number of standards and guidelines indicate the need for a proper assessment of the uncertainty of measurement results in routine laboratory practice. The available documents gene rally recommend participation in the proficiency schemes/external quality control, as well as the internal quality control, in order to primarily verify the quality performance of the method. Although all documents meet the requirements of the International Standard, ISO 15189, the standard itself does not clearly define the method by which the measurement results need to be assessed and there is no harmonization in practice regarding to this. Also, the uncertainty of measurement results is the data relating to the measured result itself, but all factors that influence the interpretation of the measured value, which is ultimately used for diagnosis and monitoring of the patient's treatment, should be taken into account. So in laboratory medicine, an appropriate assessment of the uncertainty of the measurement results should have the ultimate goal of reducing diagnostic uncertainty. However, good professional laboratory practice and understanding analytical aspects of the test for each individual laboratory is necessary to adequately define the uncertainty of measurement results for specific laboratory tests, which helps to implement good clinical practice. Also, setting diagnoses in medicine is a decision with a certain degree of uncertainty, rather than statistically and mathematically calculated conclusion