Ethical Checklists for Clinical Research Projects and laboratory medicine: two tools to evaluate compliance with bioethical principles in different settings.

OBJECTIVES: To develop two ethical checklists to evaluate (i) management of ethical concerns in research projects and (ii) awareness of ethical conduct of healthcare laboratory professionals. METHODS: Comprehensive discussion among the members of IFCC Task Force on Ethics based on pertinent literature. RESULTS: This Checklist for Clinical Research Projects should be useful to evaluate research proposals from an ethical perspective before submitting it to an IRB or its equivalent, thereby diminishing rejection rates and resulting in more time-effective projects. The checklist designed to evaluate the ethical conduct in laboratory medicine could be useful for self evaluation (internal audits) and for certification/accreditation processes performed by third parties. CONCLUSIONS: These checklists are simple but powerful tools useful to guide professionals to adhere to ethical principles in their practice, especially in developing countries where accredited ethics committees may be difficult to find.

Serum biomarkers in normal pressure hydrocephalus.

Aim To investigate the serum value of brain derived neurotrophic factor (BDNF), proteins S-100, NSE, IL-6 in normal pressure patients (NPH) compared to control (healthy) group and also a possible correlation with radiological findings in NPH patients. Methods Study patients were included during the period of 2020- 2022. All NPH patients met the diagnostic criteria for probability of NPH. Control patients group included patients without known brain disorder, without clinical symptoms of NPH. Blood samples were taken before planned surgery for NPH. BDNF serum concentrations were assessed by a sensitive ELISA kit, and serum concentrations of S-100, NSE and IL-6 were assessed by using ECLIA technology for immunoassay detection. Results Among 15 patients who were included, seven NPH patients were compared to eight control patients. Non-significant decrease in BDNF serum concentrations, an increase of protein S-100 serum concentrations, a decrease of NSE serum concentrations, as well as an increase of IL-6 serum concentrations in NPH patients compared to healthy controls was found. Strong positive correlation between BNDF and Evans index was observed (p=0.0295). Conclusion We did not find a significant difference of BDNF, protein S-100, IL-6 and NSE between serum concentration in NPH and healthy patients. More future research is needed to find the role of BDNF in NPH patients.

Systematic Differences Between Total and Free Prostate-Specific Antigen Immunoassays: Comparison Using Passing and Bablok Regression.

Recent studies have shown that there are systematic differences among total and free prostate-specificantigen (PSA) immunoassays. In this study we analyzedintermethod differences in total PSA (tPSA) and free PSA(fPSA) measurement using ARCHITECT i2000SR (Abbott Diagnostics) and COBAS E601 (Roche Diagnostics). A number of 160 blood samples were tested for tPSA and 50 samples for fPSA (selecting only sampleswith tPSA: 4.1-10.0 µg/L). Passing-Bablok regression analysis was used to compare the two analytical methods fortPSA, fPSA and percentage of fPSA (%fPSA). A strong correlation was noticed between ARCHITECT i2000SR and COBAS E601 for tPSA, fPSA and %fPSA (r between 0.94 and 0.99). Concentrations of tPSA and fPSA measured by COBAS E601 were higher thanthose measured by ARCHITECT i2000SR with a bias of 0.8 µg/L for tPSA and 0.14 µg/L for fPSA. Analyzing therelative difference between methods for fPSA and %fPSA, COBAS E601 exceed a 10% relative difference limit. Our study confirms that there are differences in measured concentrations of tPSA and fPSA byvarious commercial methods. Because clinical judgment on subsequent diagnostic procedures, such as prostatebiopsy, is based on tPSA and fPSA results, tests harmonization should be a priority.

Peritoneal Transport Characteristics at the Beginning and in Long Term Peritoneal Dialysis: a Single Center Experience.

INTRODUCTION: Peritoneal dialysis (PD) is an established treatment for patients with end-srage kidney disease. The method was developed as an alternative to hemodialysis (HD) presenting a patient survival rate equivalent to HD and better preservation of residual renal function. Peritoneal dialysis (PD) patients have different peritoneal membrane permeability (transport) characteristics. High peritoneal membrane permeability is associated with increased mortality risk in the patient population. AIM: The aim of this study was to analyze the importance of the peritoneal membrane transport status in patients treated with continuous ambulatory peritoneal dialysis (CAPD). METHODS: The study included 60 adult continuous ambulatory peritoneal dialysis (CAPD) patients, 29 male and 31 female, mean age 56.63±15.06 years. All patients treated with conventional glucose- based PD fluids. For the short term (within 3 month after start of PD) and long term (more than 12 months) peritoneal dialysis analysis of peritoneal transport characteristics has been used peritoneal functional test (PFT). With the test, categorisation of patients was possible into high (H), high-average (HA), low average (LA), and low (L) transporters. RESULTS: Dialysate-to plasma ratio (D/P) of creatinine showed significantly increased over time (0.654±0.141 vs... 0.705±0.13, p<0.001). In multivariate analysis age, gender, time on dialysis, comorbid diseases, diabetes mellitus (DM), serum albumin, were considered as independent factors influencing the PFT. The high transporter group had higher D/Pcreat (H 0.84±0.03 vs... LA 0.57±0.05, p<0.001), higher proportion of man (H 100% vs... LA 39.5%, p<0.05), higher proportion of patients with comorbid diseases (H 60% vs... LA 20.9%, p<0.05), lower serum albumin concentration (H 29±6.0 vs... LA 37±5.2, p<0.001), lower D4/D0 glucose ( H 0.23±0.07 vs... LA 0.42±0.14, p<0.001), and lower drained volume (H 600±173 vs... LA 1016±355, p<0.001). CONCLUSION: The PFT was en easy, inexpensive, reliable test to assess peritoneal transport type and it also provided information about peritoneal clearance of solutes and ultrafiltration. Peritoneal transport type classification was recognized not only as aid for prescription, but also as a prognostic index.

Idiopathic Membranous Nephropathy and Treatment Related Complications.

INTRODUCTION: Idiopathic Idiopathic membranous nephropathy (iMN) is an immune-complex mediated renal disease which is usually associated with the nephrotic syndrome (NS). The course of the disease is variable. Some patients maintain normal kidney function with or without a spontaneous remission of proteinuria, while others progress to end-stage renal failure or die from complications related to the nephrotic syndrome. Whether or not to treat a patient with idiopathic membranous nephropathy is still controversial. The controversy is mainly related to the toxicity of the therapy and the variable natural course of the disease-spontaneous remission occurs in 40-50% of patients. AIM: The aim of this study was to describe our experience of treatment of an idiopathic membranous nephropathy (iMN), efficacy and complications rate. CASE REPORT: Our patient was older, mail gender, in high-risk group with persistent proteinuria 10,68 g/day and stable renal function. We have taken these factors into consideration, along with age and other comorbidities, that may significantly elevate the risk of treatment. We chose to start with early treatment, following the Ponticelli's group protocol based on high dose corticosteroids (odd months) alternating with clorambucil (even months) for six months. This treatment was accompanied by the steroid side effects, including hyperglycaemia dependance on insulin therapy and pulmonary thromboembolism despite administered prophylactically low molecular weight heparin. The six-month treatment was successfully completed with the reduction of proteinuria to nephritic values 2,86 g/day, despite many complications. Complete remission of the disease with non-significant proteinuria and with stable renal function was achieved in 14 months which has been maintained for 2 years. CONCLUSION: We suggest that decisions on the timing of start of therapy, whom to treat, best sequence of the use of the various immunosuppressive drugs must be based on an individualized assessment of risks and benefits.

Serum Uric Acid Concentration in Patients with Cerebrovascular Disease (Ischemic Stroke and Vascular Dementia).

INTRODUCTION: Significance of serum uric acid (UA) in cerebrovascular disease still remains controversial. UA is most abundant natural antioxidant in human plasma. Its antioxidant properties might protect against free radical damage, thereby reducing the risk of oxidative stress-related cognitive impairment and dementia. AIM: In our investigation, we determine the level of UA in 100 male patients diagnosed with the first ischemic brain stroke (blood samples were collected during the acute phase and post-acute phase), 100 male patients diagnosed with vascular dementia and 100 male healthy volunteers (control group). METHODS: UA was determined using DIMENSION LxR automatic analyzer. Measurement of UA concentration was based on an enzymatic method (range 208-428 µmol/L). RESULTS: The prevalence of hyperuricemia among ischemic stroke and vascular dementia patients was 30% and 8%, respectively. Serum UA concentration was higher 7 and 14 days after the stroke compared to the acute phase (24-48 hours after hospitalization) and these concentrations were significantly higher than those measured in the control group. UA levels measured at 24-48 hours after the first symptoms of ischemic stroke were strongly correlated with those measured after 7 days of treatment (r = 0.79, p = 0.001) or after 14 days (r = 0.839, p = 0.0049). No significant differences were found between ischemic stroke and vascular dementia groups. CONCLUSION: UA concentrations were higher in ischemic stroke and vascular dementia groups than in controls. UA increase may reflect vascular atherosclerosis and tissue hypoxia. UA monitoring in patients with cerebrovascular disease is essential, because UA is more harmful than protective.

The Cigarette Smoking, Coffee and Supplements Intake at Students of Sarajevo University.

INTRODUCTION: The dietary supplements are defined as vitamins and minerals or herbal products and are typically given in the form of a capsule or tablet. The nonsmokers are more attempted to use dietary supplements than individuals who smoke. AIM: In our investigation, we examined associations between vitamin B, folic acid, multivitamin or mineral intake among the student population and their correlation with smoking prevalence and drinking coffee. MATERIALS AND METHODS: We used a questionnaire to examine the general characteristics of the subjects, age, sex, their lifestyle, cigarette smoking, coffee intake and their use of dietary supplements. Data were collected from participants of the University of Sarajevo and a longitudinal study of 960 men and women aged 18-24 years from 2017 to 2018 was conducted. RESULTS: The results showed that 32% of students took vitamin B supplements and 10% folic acid. In opposite, more than half of students took multivitamins (59.5%) and minerals (60.4%) less than one year. About a quarter or less took multivitamins (23.9%) and minerals (24.3%) for years. Less than 20% of students took multivitamins and minerals within a period of one year. In student population smoking prevalence was estimated at 21.2% and coffee intake in 71.2%. The smoking and use of vitamin B supplements were independent of each other, p = 0.201. The use of folic acid did not depend on smoking p = 0.501. There were no observed correlations between multivitamin and mineral supplement consumption compared to smoking status or drinking coffee. CONCLUSION: Deficient dietary intake of folic acid and B vitamins from food and supplemental sources appear to be one of the atherosclerosis incidences. Further studies should examine associations between dietary supplements intake and lifestyle of students, as well as smoking status and coffee intake.

The Vitamine Source, Usual Food Intake at Students.

INTRODUCTION: Inadequate vitamin B 12, folate status and B6 are associated with an increased risk for chronic diseases that may have a negative impact on the health. AIM: The aim of our study was to investigate dietary intake of vitamin B12, B6 and folates from various foods among the university students. METHODS: Dietary intake of foods having vitamins B12, B6 and folate was assessed among the students of University of Sarajevo, 19-22 years old, from 2017 to 2018. The participants were interviewed to collect information regarding age, socioeconomic status, B12, folate, B6 vitamin, and usual food intake during one week. RESULTS: The main sources of vitamin B12 and B6 in the students' diet were chicken white meat (51.8-53.7 %), beef (45-63 %), cream (62.2 -72.1 %), sardines in oil (47.9-52.2 %), tuna (55.2 -60.4 %), cheese edamer (80.1%) and cheese feta (67.4%-73%). The foods with a high source of vitamin B12 and B6 but rarely consumed were fish, shellfish, salmon, roasted trout and mackerel. Sufficient folate intake was mainly achieved through dietary intake of beans (48.5-57.2%) and oatmeal (46.3-48.2%), while folate-insufficient diet resulted from intake of spinach (30.9-35 %), turkey (26.2-33.4 %), lentils (16.9-19.7 %) and soy (9.4-15.5%). CONCLUSION: Our results show that there is an important percentage of the students in Canton Sarajevo that do not meet the recommended intakes for vitamin B12 and B6 and folate. Additional research is needed to establish the best cost-effective public health approach to achieve sufficient intake of these vitamins.

Predictive Role of Electroencephalography in Regard to Neurological and Cognitive Sequelae After Acute Central Nervous System Infection.

INTRODUCTION: Electroencephalography can also be used to monitor long-term recovery of the patient after acute phase of the disease. Impaired neurocognitive function after infection, similar to brain injury, may present a transient but also prolonged problem for the functioning of an individual. Some studies have shown that importance of EEG may not be significant in sequel monitoring, because the extensive changes in EEG seen with severe forms of CNS infection do not necessarily imply a longer-term poor outcome. AIM: To examine the predictive potential of electroencephalography (EEG) in regard to the emergence of neurological and cognitive sequelae of acute central nervous system (CNS) infection. METHODS: The study included 62 patients treated at the Clinic for Infectious Diseases, Clinical Center of Sarajevo University, who were diagnosed with acute CNS infection. The EEG record was characterized as: normal, non-specific changes of mild, moderate and severe degree and specific changes. The sequelae (headache, cognitive dysfunction, neurological and neurophysiological disorders, audiological and behavioral disorders) was evaluated by combining neurological, psychiatric, pediatric, otolaryngological, ophthalmic and infectological examination in the Neuroinfective Counseling Department for up to 6 months after discharge. RESULTS: After a treatment of an acute CNS infection 25 (40.3%) patients had no sequelae and 37 (59.7%) were with sequelae. The EEG in the initial stage of the disease (Wald's coefficient = 12.8), followed by the age of the patients (Wald = 6.4), had the greatest influence on the prediction of sequela (p=0.0001). For each additional degree of verified pathological changes in the EEG, the risk of sequelae was increased by 5 degrees (OR = 5.3), respectively. There was no statistically significant association between changes in cerebrospinal fluid (CSF) findings, meningeal symptoms, and signs with sequelae development. CONCLUSION: Younger age, as well as severe clinical status of a patient, which implies a disorder of consciousness and seizures on admission, are associated with irreversible consequences on a previously mentally healthy individual. Pathological changes (Delta and Theta waves, spike slow complex wave) on the EEG finding significantly predicted presence of sequelae. .

The role of pro-fibrotic biomarkers in paroxysmal and persistent atrial fibrillation.

PURPOSE: Signaling pathways involved in electrical, structural and contractile remodeling processes behind development and progression of atrial fibrillation (AF) have not been completely elucidated, but it seems to be related to complex interactions among neurohormonal and cellular mediators. We aimed to investigate interleukin-6 (IL-6), transforming growth factor-beta1 (TGF-ß1), matrix metalloproteinase-9 (MMP-9), tissue inhibitor of metalloproteinase-1 (TIMP-1), as biomarkers of atrial remodeling, in patients with paroxysmal and persistent AF, and their correlation with N-terminal prohormone of brain natriuretic peptide (NT-proBNP) and left atrial (LA) diameter. METHODS: Thirty-seven patients (22M/15F) with paroxysmal AF, 32 patients (22M/10F) with persistent AF and 30 healthy control subjects (18M/12F) were enrolled in the study. Serum levels of biomarkers were measured by ELISA. Cardiac function was assessed echocardiographically. RESULTS: IL-6 levels and MMP-9/TIMP-1 ratio were significantly higher in AF patients than in non-AF controls (P < .001), and in persistent than in paroxysmal AF (P < .001), in line with NT-proBNP and LA diameter. In contrast, TGF-ß1levels declined with increasing AF duration (from 51.2 pg/mL, IQR: 38.9-87.9 pg/mL in paroxysmal to 23.9 pg/mL, IQR: 16.9-43.6 pg/mL in persistent AF). TGF-ß1 was negatively correlated with NT-proBNP (r = -0.53, P = .001 in paroxysmal AF and r = -0.71, P < .001 in persistent AF) and LA diameter (r = -0.44, P = .006 in paroxysmal AF and r = -0.51, P = .003 in persistent AF). CONCLUSIONS: Our results demonstrate that AF development and progression (from paroxysmal to persistent) is associated with a gradual increase in serum levels of NT-proBNP, IL-6 and MMP-9/TIMP-1 ratio. Moreover, this study suggests that the relationship between TGF-ß1, NT-proBNP and LA diameter allows for the progression of atrial remodeling during AF, despite compensatory changes in the TGF-ß1 signaling pathway.

The Comparison Between Different Immunoassays for Serum Carbohydrate Antigen (CA 19-9) Concentration Measurement.

INTRODUCTION: The carbohydrate antigen (CA 19-9) is a marker for pancreatic and colorectal carcinoma. In our study, we have investigated the level of CA 19-9 at 50 patients with benign and malign disease using three immunoassays. METHODS: The COBAS e 601 (Roche) uses an ECLIA, Architect i2000 analyzer (Abbott) uses CMIA and VITROS 5600 uses integrated System Intellicheck Technology with cut off 0.0-37.0 U/mL for determination of CA 19-9. Results were with a statistical significance of p < 0.05. RESULTS: Comparison of CA19-9 on COBAS with Architect show correlation coefficient R = 0.708. The results showed a regression line between immunoassay in patients with CA 19-9 treatment of y (Cobas) = 16.14 x (Architect) + 0.53. The comparison of CA19-9 on Architect and Cobas show correlation coefficient R = 0.709. The results showed regression line between immunoassay in patients with CA 19-9 treatment of y (Vitros) =-5.558 + 2.432 x (Architect) and correlation coefficient R = 0. 990. The mean concentration of CA 19-9 in the CMIA method was 41.49 U/mL, Intellicheck Technology was 103.45 U/mL and using ECLIA method was 47.25 U/mL at patients. CONCLUSIONS: Patients should be monitored on a single method to avoid differences in the results. The various immunoassay techniques for the detection of CA 19-9 tumor marker using different monoclonal antibodies, which leads to different results. Different antibodies recognize different parts of the molecule, and antigen heterogeneity may account in part for inter-method differences.

The Estimation of Glomerular Filtration Rate Based on the Serum Cystatin C and Creatinine Values.

BACKGROUND: Renal insufficiency is one of the most serious renal diseases. Early diagnosis plays an essential role. Serum creatinine as a marker has had priority so far. The use of cystatin C for estimation of glomerular filtration rate has been recommended recently. There is a set of formulae which consolidates serum values of both creatinine and cystatin C. The study focuses on different formulae and their estimation for the purpose of better, faster, and more accurate diagnosis of renal insufficiency. METHODS: The sample consists of 75 examinees which are divided into three groups. The first group is made of patients with the glomerular filtration rate (GFR) 90 - 120 mL/minute/1.73m². The second group consists of patients with GFR 60 - 89 mL/minute/1.73m² and the third with GFR 30 - 59 mL/minute/1.73m². The exclusion criteria are the following: children and adolescents under the age of 20, pregnant women, patients on corticosteroid therapy and blockers of the distal tubular creatinine secretion. The five equations (GFR1-5) used in this research are: a Cockcroft-Gault equation - GFR1; a MDRD equation - GFR2; CKD-EPI - an equation based on cystatin C - GFR3; CKD-EPI - an equation based on cystatin C, adjusted according to the gender and age - GFR4; and CKDEPI - a combined equation based on cystatin C and creatitine, adjusted according to the age, gender, and race - GFR5. Upon acquiring the results, it is followed up with the statistical data analysis followed by graphs and tables. RESULTS: After data analysis, it is established that data distribution does not show normal distribution in each case, which leads to the use of nonparametric statistics. Depending on the stage of kidney injury there are different results regarding the difference in statistics of the used formulae. The highest sensitivity is recorded with the formulae GFR4 and GFR5. Then the increase in cystatin C levels increases sensitivity with the formulae GFR3 and GFR4. CONCLUSIONS: As a result of this study, it is to be established that the formula of choice is the GFR3 - CKD-EPI formula based on serum cystatin C values, without adjustments. Its sensitivity, specificity, price, and feasibility are to be observed as parameters. Besides that, the increase in serum cystatin levels leads to the increase of sensitivity of the GFR3 formula, which could be an additional factor in the selection of formulae.

Effects of post-sampling analysis time, type of blood samples and collection tubes on values of blood gas testing.

AIM: To investigate effects of post-sampling analysis time, a type of blood samples and collection tubes on blood gas testing. METHODS: This study included 100 patients at the Clinic for Pulmonary Diseases, Clinical Centre Sarajevo. The partial pressure of oxygen (pO2) and carbon dioxide (pCO2), and the oxygen saturation level of hemoglobin (sO2) were analyzed in the arterial blood samples (ABS) and capillary blood samples (CBS) by a potentiometric method using a blood gas analyzer ABL 555 (Radiometer, Copenhagen, Denmark). Paired measurements of ABS were performed within 15 minutes and after 60 minutes from sampling and compared. The results of CBS obtained within 15 minutes were compared with matching ABS results, as well as the results obtained from CBS within 15 minutes taken into glass and plastic tubes. RESULTS: pO2 and sO2 values were significantly lower after 60 minutes compared to those within 15 minutes in ABS (9.20±1.89 vs. 9.51±1.95 and 91.25±5.03 vs. 92.40±4.5; p<0.01, respectively). Values of pO2 and sO2 in CBS were significantly lower than values obtained in ABS (8.92±2.07 vs. 9.51±1.95 and 91.25±4.86 vs. 92.40±4.50; p<0.01, respectively). Obtained pO2 and sO2 values in CBS in the plastic tubes were higher than those in the glass tubes (8.50±1.98 vs. 7.89±2.0 and 89.66±11.04 vs. 88.23±11.22, p<0.01 respectively). pCO2 blood values were not influenced significantly (p>0.05). CONCLUSION: The length of post-sampling analysis time, a type of blood samples and collection tubes have significant impact on blood oxygen parameters. Analysis within 15 minutes after blood sampling is considered as appropriate.

IL-4, IL-10 and high sensitivity-CRP as potential serum biomarkers of persistent/recurrent disease in papillary thyroid carcinoma with/without Hashimoto's thyroiditis.

OBJECTIVE: To investigate the potential role of interleukin 4 (IL-4), interleukin 10 (IL-10) and high-sensitivity C-reactive protein (hs-CRP) as serum biomarkers of persistent/recurrent disease in papillary thyroid carcinoma (PTC) with/without Hashimoto's thyroiditis (HT). METHODS: Eighty consecutive patients (64 F/16 M, 43.2 ± 12.7 years) with PTC and 40 (37 F/3 M, 40.6 ± 12.3 years) with papillary thyroid carcinoma associated with Hashimoto's thyroiditis (PTC + HT) were evaluated before radioiodine therapy. A control group of 20 patients with HT without thyroid cancer (18 F/2 M, 47.3 ± 2.8 years) was included in the study for the comparison of cytokine levels. RESULTS: No meaningful differences were found in clinical outcomes between PTC and PTC + HT groups (47.5% vs. 45% persistent/recurrent disease). Serum IL-4, IL-10 and hs-CRP levels were higher in patients with persistent/recurrent disease compared to those without recurrence (p < 0.001). IL-4, IL-10 and hs-CRP were also found in substantially higher concentrations in PTC + HT patients with persistent/recurrent disease than in patients with HT or PTC (with or without recurrence) (p < 0.01). Positive correlations were observed between IL-4, IL-10, hs-CRP and thyroglobulin (Tg) (r between 0.48 and 0.56, p < 0.005) or antithyroglobulin antibodies (TgAb) (r between 0.63 and 0.80, p < 0.002) in PTC and PTC + HT patients with persistent/recurrent disease. CONCLUSIONS: Increased levels of serum IL-4, IL-10 and hs-CRP are associated with persistent/recurrent disease in PTC and PTC + HT patients. Our results suggest that these biomarkers might be used to improve patient stratification according to the risk of recurrence, especially in patients with PTC + HT, where Tg levels are not reliable due to presence of TgAb.

Importance of determination of urine neutrophile gelatinase associated lipocalin in early detection of acute kidney injury.

Acute kidney injury (AKI) is a complex, frequent and serious clinical problem with high rate of mortality. Therefore there is a serious need for early detection of AKI, with a tendency to detect early stage--RISK dut to start with therapy as soon as possible and prevent irreversible changes in renal function. Study's purposes were to explore the rhythm of urine neutrophile gelatinase associated lipocalin (urine NGAL) concentration changes before and after cardiovascular surgery and compare results of urine NGAL values with results of serum creatinine and creatinine clearance as main diagnostic indicators of renal function in order to define role of urine NGAL biomarker in early diagnosis of acute kidney injure. In the prospective clinical study 150 cardiovascular surgery patients were included. Basal value and concentration of urine NGAL were tested 3, 6 and 12 hours after cardiovascular surgery, and concentration of serum creatinine was tested once per day first three days after surgery. Also creatinine clearance value was calculated according to Cockrof-Goult formula. After above mentioned, rate of acute kidney injure was estimated according to RIFLE criteria. The study results showed that the value of urine NGAL was elevated above cutt-off after cardiac operation in a group of patients who developed AKI (defined according to RIFLE criteria). There were statisticaly significant difference between all four measerments (p < 0.05). There were also moderate positive correlation (0.500 and 0.502) between urine NGAL values and percentage difference of serum creatinine and creatinine clearence. All that indicate that higer values of urine NGAL are followed by higher percentage difference of serume creatinine and creatinine clearence. By using of automated urine NGAL test detection of acute kidney injure is posible 24-48 hours earlier comparing with actual results acquired by determination of serum creatinine concentration. The results of this study will indicate urine NGAL as a reliable biomarker of early acute kidney injure. A combination of early and late markers of kidney damage (urine NGAL, serum creatinine) can greatly contribute to better control the outcome of all those who are a risk group for the development of AKI.

Comparison of Architect i2000 for determination of Scc with IMX determination of SCC with different methods.

BACKGROUND: SCC (squamous cell carcinoma) antigen (SSCA), a tumor marker, is already used for the diagnosis and follow-up of carcinoma of the cervix and lungs. The aim of our study was the determination of SCCA concentration in 96 serum samples using CMIA (chemiluminesecent microparticle immnoassay) on an Architect i2000 (Abbott Diagnostics) and MEIA (microparticle enzyme immnoassay) on an IMx Chemistry Analyzer (Abbott Diagnostics). METHODS: In our investigation we used a CMIA (chemiluminesecent microparticle immnoassay) Architect i2000 and MEIA (microparticle enzyme immnoassay) Imx Chemistry Analyzer for SCCA determination. RESULTS: All patients were hospitalized at the Department of Gynecologic Oncology and Department for Oncology at the University Clinics Center of Sarajevo. The normal serum range of SCCA should be < 0.1 microg/L. The quality control, precision and accuracy of the Architect i2000 were assessed. The quality control was done using quality control serums for low (X = 2.17 microg/L), medium (X = 10.23 microg/L), and high (X = 48.99 microg/L) range. The precision for the Architect i2000 has a CV of 3.44% to 4.44%. We established that the main difference between Architect i2000 and IMx was statistically significant at p < 0.05 according to Student's t-test. The correlation coefficient was r = 0.990. The some samples have higher concentrations on the Architect than on the IMx because the sensitivity of the Architect assay is high (< 0.1 microg/L). CONCLUSIONS: The CMIA Architect technology is an applicable method significant in diagnostic of SCCA.

Comparison of architect I 2000 for determination of cyclosporine with axsym.

BACKGROUND: Cyclosporine has been shown effective drug in suppressing acute rejection in recipients of allograft organ transplants. METHODS: The cyclosporine concentration of 96 blood samples was determined using CMIA (chemiluminesecent microparticle immnoassay) Architect i 2000 and FPIA (fluorescence polarization immunoassay) AxSYM Abbott diagnostic. All patients have transplantation of kidneys and were hospitalized at Department of Nephrology at the Clinical center of University of Sarajevo. The reference serum range of cyclosporine for kidney organ transplantation for maintenance lies between 50 and 150 ng/mL. The quality control, precision and accurancy of Architect i 2000 were assessed. RESULTS: The quality control was done using quality control serums for low (= 91 ng/mL), medium (= 328 ng/mL) and high (= 829 ng/mL). We have used commercial BIORAD controls and got reproducibility CV 5.83 % to 13 % for Architect i 2000. It was established that the main difference between Architect i 2000 and AxSYM and it was statistically significant for P < 0.05 according to Student t-test. Correlation coefficient was r = 0.903. CONCLUSION: The CMIA Architect assay has significant reduced cyclosporine metabolite interference relative to other immunoassay and is a convenient and sensitive automated method to measure cyclosporine in whole blood.

Saliva and serum lithium monitoring in hospitalized patients and possibility to replace serum to saliva.

The lithium ions concentration in human serum and saliva was determined using dry-slide technology Vitros 250 Analyser (Ortho Clinical Diagnostic) and atomic absorption spectrometry Perkin Elmer 403 (AAS). We analyzed lithium ions in 100 serum and saliva specimens of patients after oral administration of lithium carbonate (3 x 300 mg) Jadran, Galen Laboratory Rijeka. Saliva and blood were taken 2 and 12 hours after the last dose. At the same time lithium ions at samples of blood and saliva were determined with both methods which showed high level of correlation. The mean difference of lithium ions between saliva and serum was statistically significant for p<0.05 using t student test. At saliva we got constant of elimination Kel = 0.02(-1)h and elimination half life (t(1/2)) was t(1/2)=34.6 h. For serum was t(1/2)= 24 h what means that lithium ions elimination is slower from saliva then from serum. That is the reason why probably concentration at saliva is higher then at serum. Lithium elimination is two compartment pharmacokinetic model where important part of compartment are saliva and salivary glands. At a certain point in medical treatment it could be expected to use controlled determination of lithium ions in saliva with serum as control.

Comparison of vitros dry slide technology for determination of lithium ions with other methods.

The lithium ions concentration in human serum was determined using Dry-slide technology Vitros 250 Analyser (Ortho Clinical Diagnostic), atomic absorption spectrometry (AAS) method Perkin Elmer 403 and ion-selective electrode (ISE) potentiometry AVL 9181. We compared lithium ions results in sample sera between these methods. Our reference method was AAS. We analyzed lithium ions concentration in 23 sera samples of patients after oral administration of lithium carbonate (3x 300mg) Jadran, Galen Laboratory Rijeka, by dry-slide technology, AAS and ISE methods. The quality control, precision, reproducibility and accuracy for Vitros dry slide technology were assessed. We established that the main difference between AAS method and dry slide technology was not statistically significant at p< 0.05 according to Student t-test. Therefore, the dry slide technology may be a useful alternative or it may even replace other methods, such as AAS. The main difference between dry slide technology and ISE methods was statistically significant at p<0.05 using Student t-test. By ISE method, we obtained considerably higher results, which may be explained by the presence of electrolytes or medicaments interfering with lithium ions.