Volume 42, Issue 1

Clinical laboratory automation is very important to obtain reliable test results and to provide patient safety. There are some difficulties in implementing total automation to the clinical laboratories because they need a continuous, high quality customer service to keep their high quality serving, a questionable cost-affecting situation. It may be very difficult to keep the balance between the cost and the quality goals, patient safety, and demands. However, clinical laboratory automation may solve the dilemma and be implemented in clinical laboratories provided that it does not result in new bottlenecks in laboratory workflow. It is beyond the dispute that the minimal operator intervention benefited by total lab automation results in increased productivity, intra laboratory traceability of specimens, the decreased turnaround times, improvements in specimen handling, improved laboratory safety, and minimized errors. It has become very difficult, time-consuming, challenging task for the laboratories to decide to automate and which tests must be included in the analytical automation, to decide which one is more appropriate. First of all, a workflow and a workload analysis must be made for the present semi-automated laboratory. It would be focused in the present review that some strategies can be developed for this purpose.

Aim The aim of the present study is to establish a moAb combination and a study procedure for the accurate determination of circulating EPC using multicolor flow cytometry, as well as to find out whether there is a relation between disease severity and EPC count by comparing the circulating EPC count between the subgroups of patients presented with acute coronary syndrome. Materials and methods Absolute circulating EPC count was identified in 40 healthy subjects and acute coronary syndrome patients using multicolor flow cytometry with a single-tube panel consisting of CD45, CD31, CD34, CD309 and syto 16 monoclonal antibodies. Results Circulating EPC count was 11.33 (7.89–15.25) cells/μL in healthy control group and 4.80 (0.70–10.85) cells/μL in acute coronary syndrome patients. Conclusion In the present study, which investigated whether there is a difference between EPC counts of STEMI and USAP patients that have presented with ACS, EPC count was lower in both disease groups as compared to healthy controls. First the method must be standardized and then harmonization studies are required in order to use this method as a prognostic factor in cardiovascular diseases.

Background In this study, we planned to evaluate the comparison of serum prolidase activity with other biochemical markers. Methods The patient group was consisted of totally 73 patients with 21 male and 18 female who were diagnosed as chronic renal failure (CRF) and were undergoing peritoneal dialysis while 21 male and 13 female who were undergoing hemodialysis. The control group was composed of 54 healthy volunteers, including 25 men and 29 women. Serum and erythrocyte prolidase activities were measured in both patient and control groups and the relationship between serum prolidase activities and metabolic markers of bone (osteocalcin, bone-specific alkaline phosphatase, calcitonin, vitamin D and parathormone) were compared in both groups. Results There was a significant difference between the serum prolidase activity of peritoneal dialysis and pre-hemodialysis groups as compared with the control group (p<0.05). Serum prolidase activity of the pre-hemodialysis group was lower than that of post-hemodialysis group and there was a statistically significant difference (p<0.05). There was a significant difference between prolidase activities in erythrocytes of prehemodialysis and control groups (p<0.05). Conclusion Kidney is the most prolidase-rich tissue in the human body. According to our results, the prolidase activity decreased in CRF; and the level of decrement was independent from the hemodialysis procedure.

Introduction Determining the factors affecting hemoglobin A 1c (HbA 1c ) levels may help better interpretation of HbA 1c values. In this study, we investigated if insulin resistance is a significant parameter contributing to the variability of HbA 1c values. Methods We retrospectively analyzed serum fasting glucose, fasting insulin, 2 h glucose and HbA 1c records of 18–85 years aged outpatients who underwent a 75 g oral glucose tolerance test (OGTT) in our hospital during the period January 2010–May 2014. Homeostasis model assessment of insulin resistance (HOMA-IR) ≥2.5 was defined as insulin resistant. Results Insulin resistant subjects with normal glucose tolerance had significantly higher HbA 1c and fasting glucose levels compared to insulin sensitive subjects with normal glucose tolerance (p=0.002, p<0.001, respectively). Similarly, insulin resistant subjects with pre-diabetes had significantly higher HbA 1c and 2-h glucose levels compared to insulin sensitive subjects with pre-diabetes (p=0.016, p=0.013, respectively). Regression analysis showed that HOMA-IR(log) is associated with HbA 1c levels independent of fasting and 2h glucose concentrations (p<0.001). Age was the variable with highest standardized β coefficient in regression model. Conclusion Our data showed that HOMA-IR is associated with glycated hemoglobin values independent of glycemic status and the effect of age on HbA 1c values should not be ignored in non-diabetic subjects.

Objective To determine the association of missense substitution of alanine 49 threonine (A49T) and valine 89 leucine (V89L) in the steroid-5-alpha-reductase type II (SRD5A2) gene with prostate cancer in Turkish patients. Methods Eighty patients with prostate cancer and 76 healthy control subjects were evaluated for A49T and V89L polymorphisms in the SRD5A2 gene mutations via real time fluorescence PCR and melting curve analysis. Results Patients and controls were similar in terms of allele frequencies for polymorphic markers A49T and V89L in the SRD5A2 gene. Most patients had T2b (51.3%), N0 (96.3%) stage tumors with Gleason Score of ≥6 (82.7%) and surgical margin in 28.8%. While 81.3% had no seminal vesicle invasion, 36.3% had capsular invasion. Carrying the 49T allele was associated with higher likelihood of positive surgical margin status (27.5% in 49A vs. 75.0% in 49T, p=0.038) and Gleason Scores of ≥7 (47.5% in 49A vs. 100.0% in 49T, p=0.032) than 49A allele. Conclusion Our findings revealed no significant difference between patient and control groups in terms of allele frequencies of polymorphic markers in the SRD5A2 gene. T allele was only shown in the patient group. Carrying the 49T allele was associated with higher tumor aggressiveness in A49T polymorphism.

Objective We aimed to investigate the frequency of delayed notifications and probable causes of delays for critical value notification in clinical laboratory of university hospital. Materials and methods All data was obtained from critical value reporting forms and laboratory information system. The frequency and location of critical and delayed results, latencies throughout a working day and the professional status who received the critical callbacks were shown as percentages. Results A total of 2018 (1.02%) critical values were reported and 13.1% of them were delayed notifications. Most of them were observed in laboratory tests ordered from patients of service and polyclinics compared to ICU and emergency department (26.7%, 26%, 6.2% and 4.9%, respectively, p<0.01). Delayed notifications were significantly higher for biochemical parameters (19.7%, p<0.001) and observed particularly in morning hours (06:00 a.m.–10:00 a.m.), lunch break time (12:00–14:00) and end of the working day (16:00–18:00). Latencies of mild-delayed reporting were 18.5±4.4 min for 62.8% and advanced-delayed reporting were 47.1±11.3 min for 37.2% of total delayed notifications. Most of the critical results were reported to the health care staff other than physician (55.6%). Conclusion Laboratory professionals should work in collaboration with responsible clinician and healthcare staff in critical value reporting process.

Objective This study aimed to determine significant liver fibrosis and cirrhosis with different FIB-4 cut-off points, and the need for liver biopsy (LB) by optimizing the initially established cut-off points of 1.45 and 3.25. Materials and methods The study included 201 patients monoinfected with chronic HBV. METAVIR classification was used to determine the stage of fibrosis. ROC analysis and the Youden index were performed to define the optimum cut-off points. Results A FIB-4 cut-off point of 1.45 and 1.62 generated Youden indexes of 0.51 and 0.55, the accuracy of 78.6% and 81.1% for significant liver fibrosis, respectively. The FIB-4 cut-off was set at 2.40 and 3.25 Youden indexes were 0.46 and 0.16, accuracies were 79.6% and 69.7% for significant liver fibrosis, respectively. A cut-off point of 1.45 and 1.62 for FIB-4 generated Youden indexes of 0.62 and 0.66, the accuracies of 81.6% and 84.1% for cirrhosis, while the FIB-4 cut-off point of 2.40 and 3.25 generated Youden indexes of 0.59 and 0.22, with the accuracies of 90% and 84.1% for cirrhosis, respectively. Conclusions The FIB-4 cut-off points of 1.62 and 2.40 have higher accuracy and may decrease the need for LB 12% more than the initially established ones in HBV monoinfected patients.

Background and objective We aimed to investigate the effect of “training about the pre-analytical phase” and “technological arrangements in laboratory information systems (LISs) and tube barcoding system”, on decreasing PEs. Materials and methods PEs in 2013 and 2014 were obtained from the LIS retrospectively in order to evaluate the effect of improvements. Ten quality indicators (QIs) described for pre-analytical phase were calculated. We compared QIs of the “improved year” with the past year. Four quality specification criteria were defined as “unacceptable”, “minimum”, “desirable” and “optimum” for each quality indicator. Results There was a reduction in all types of PEs related to the improvement strategies. When QIs were considered as quality specifications (QSs), QI-14 (number of samples damaged in transport) and QI-16 (samples improperly stored) were “unacceptable”, QI-8 (samples lost-not received) and QI-12 (samples with insufficient sample volume) were “minimum” and QI-9 (samples collected in inappropriate container) was “desirable” in 2013; QI-10a, 10b (samples hemolyzed), 11a (samples clotted) and 13 (samples with inadequate sample-anticoagulant) were all “optimum” in 2 years. Conclusion It was shown that continuous education on pre-analytical phase and improvements of the technological infrastructures are the main factors that will enable the control of this phase.

Introduction Prostate specific antigen (PSA) has a lower sensitivity and specifity range of 4–10 ng/mL. We aimed to investigate the effectiveness of pPSA in reducing number of prostate biopsies. Methods This study enrolled 80 patients aged 50 years or older whom had serum total PSA levels between 4 ng/dL and 10 ng/dL. Age, prostate volume, tPSA, fPSA, pPSA, PSA%, pPSA%, t/pPSA, f/pPSA, p/fPSA, p/tPSA, f/p/tPSA, p/f/tPSA, PSAD, fPSA/PSAD, pPSA/PSAD, (Prostate Health Index) PHI, (t/f/pPSA)/tPSA, and PHI2 (New Prostate Health Index) biopsy results were compared between subjects BPH and PCa. Results Out of 80 subjects, 23 (29%) had PCa and 57 (71%) had BPH. Prostate volume was 51.65 mL in PCa and 64.85 mL in non-PCa group (p>0.05). The rate of PCa increased as prostate volume was reduced and age increased. fPSA, PSA%, p/f/tPSA, fPSA/PSAD values were significant in favor of respectively; BPH, BPH, PCa and BPH (p<0.05). Discussion Using prostate health index (PHI) was beneficial for predicting PCa. In addition, using pPSA in formulas such as (PHI2) pPSA/(fPSA*√tPSA), p/f/tPSA, (t/f/pPSA)/tPSA may also be useful. This study suggests that the use of pPSA may have a role in reducing the number of prostate biopsies in differentiating PCa and BPH.

Introduction Heart failure due to hemosiderosis is frequent in beta-thalassemia major (β-TM) patients. Magnetic resonance imaging (MRI) is used in the early detection of heart failure. Amino-terminal pro-brain natriuretic peptide (NT-proBNP) is a very sensitive marker in the diagnosis of heart failure. In this study, we aimed to investigate the efficacy of NT-proBNP levels in thalassemia patients, who are thought to have no cardiac iron deposition according to T2* scoring system (CMRT2*>20 msn), in early identification of cardiac failure. Methods NT-proBNP levels of 31 patients, who have T2*>20 ms, and of 25 healthy population were measured by chemoluminescence method. Results NT-proBNP levels were not different in thalassemic patients [median: 33 (IQR: 28–94) pg/mL] compared to control group [median: 41 (IQR: 28–59) pg/mL]. We found that NT-proBNP level was above cut-off value in six patients. Conclusion NT-proBNP is a cheaper, reachable, and noninvasive method compared to MRI technique, it can be easily used in monthly controls. Detection of high NT-proBNP levels above cut-off values in patients whose T2* values are normal indicates that measurement of NT-pro-BNP is a more sensitive marker in early detection of cardiac failure.

Introduction We aimed to compare the positive predictive values (PPV) and negative predictive values (NPV) of four cardiac troponin assays in the diagnosis of AMI in Turkish population. Methods This study is an observational comparative study, which is performed between 2012 and 2013 (527 patients). Troponin levels were measured with chemiluminescence Cobas troponin T assay, immunofluorescence Triage troponin I assay and immunochromatographic Toyo troponin I assay. Results Sensitivity and specificity of immunofluorometric assay (Radiometer) are 56.82% and 71.34%; immunochromatographic assay (Toyo) are 29.4% and 88.62%, immunofluorescence assay (Triage) are 47.13% and 76.12%, chemiluminescence assay (Roche) are 60.49 and 67.42%, respectively. PPV, NPV and positive likelihood ratios (LR+) of immunofluorometric assay (Radiometer) are 45.5%, 79.7% and 1.98, immunochromatographic assay (Toyo) are 51.5%, 75.4% and 2.58, immunofluorescence assay (Triage) are 46.5%, 76.6% and 1.97, chemiluminescence assay (Roche) are 45.8%, 78.9% and 1.86, respectively. In four assays, troponin levels were statistically significant higher in AMI positive group in comparison to negative group (p<0.001 for all). Conclusion There was no statistically significant difference between these troponin methods in comparisons of PPV and NPV in the diagnosis of AMI, but low sensitivity of Triage and Toyo assays should be considered.

Objective Macroprolactinemia detection is important to avoid unneccessary tests and overtreatment. High prolactin levels require routine screening and clinicians must be aware of macroprolactinemia frequency encountered with the method in use. In this study we aimed to determine the macroprolactinemia rate in our laboratory. Methods Prolactin results of different patients analysed on two different immunoassay systems within two consecutive years were evaluated. Analyses were performed on Beckman Coulter UniCel ® DxI800 and Roche Cobas ® e601 immunoassay systems. Samples for macroprolactin analysis were precipitated using polyethylene glycol (PEG) 6000. Post-PEG recovery <40% was defined as positive, 40–60% as gray-zone and >60% as negative for macroprolactin. Results For the samples analysed on DxI800 (n=14,958) hyperprolactinemia frequency was 8.1% (n=1208). One of 138 samples submitted for macroprolactin analysis was positive, while three of them were in the gray-zone. For the samples analysed on Cobas ® e601 (n=14,040) hyperprolactinemia frequency was 13.9% (n=1954). Eighteen of 238 samples submitted for macroprolactin analysis were positive, while 21 of them were in the gray-zone. Conclusion A difference was found between two immunoassay systems used in our laboratory in terms of macroprolactinemia rate. However, inability of simultaneous analyses on both systems, lack of evaluation with gel filtration chromatography, and heterophile antibody blocking tube were the limitations.

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

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

Introduction The present study aims to investigate whether values of venous blood gas sampling can be used instead of arterial blood gas values in the evaluation of blood gas for the emergency service patients with acute exacerbation of chronic obstructive pulmonary disease (COPD). Methods Patients diagnosed COPD and identified to have acute exacerbation of COPD based on acute exacerbation of COPD criteria participated in the study. Data from arterial and venous samples were compared using Spearman and Pearson correlation and Bland-Altman analysis. Results Ninety patients were included in this study. The results indicated statistically significant correlations between venous blood gas pH, pO 2 , pCO 2 and HCO 3 values and arterial pH, pO 2 , pCO 2 and HCO 3 values of the patients. The correlation for pH, pCO 2 and HCO 3 values were found to be significantly important (p<0.0001). Discussion and conclusion The findings of the study suggest that some formulations can be used to estimate pH and pCO 2 values when evaluating the lung functions of the emergency service patients with acute exacerbation of COPD.