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Gender-specific medicine is the study of how diseases differ between men and women in terms of prevention, clinical signs, therapeutic approach, prognosis, psychological and social impact. It is a neglected dimension of medicine. In this review we like to point out some major issues in five enormous fields of medicine: cardiovascular diseases (CVDs), pharmacology, oncology, liver diseases and osteoporosis. CVDs have been studied in the last decades mainly in men, but they are the first cause of mortality and disability in women. Risk factors for CVD have different impacts in men and women; clinical manifestations of CVD and the influence of drugs on CVD have lot of gender differences. Sex-related differences in pharmacokinetics and pharmacodynamics are also emerging. These differences have obvious relevance to the efficacy and side effect profiles of various medications in the two sexes. This evidence should be considered for drug development as well as before starting any therapy. Gender disparity in cancer incidence, aggressiveness and prognosis has been observed for a variety of cancers and, even if partially known, is underestimated in clinical practice for the treatment of the major types of cancer. It is necessary to systematize and encode all the known data for each type of tumor on gender differences, to identify where this variable has to be considered for the purposes of the prognosis, the choice of treatment and possible toxicity. Clinical data suggest that men and women exhibit differences regarding the epidemiology and the progression of certain liver diseases , i.e., autoimmune conditions, genetic hemochromatosis, non-alcoholic steatohepatitis and chronic hepatitis C. Numerous hypotheses have been formulated to justify this sex imbalance including sex hormones, reproductive and genetic factors. Nevertheless, none of these hypothesis has thus far gathered enough convincing evidence and in most cases the evidence is conflicting. Osteoporosis is an important public health problem both in women and men. On the whole, far more epidemiologic, diagnostic and therapeutic studies have been carried out in women than in men. In clinical practice, if this disease remains underestimated in women, patients’ and physicians’ awareness is even lower for male osteoporosis, for which diagnostic and therapeutic strategies are at present less defined. In conclusion this review emphasizes the urgency of basic science and clinical research to increase our understanding of the gender differences of diseases.

The usefulness of %[−2] proPSA and Prostate Health Index (phi) in the detection of prostate cancer are currently unknown. It has been suggested that these tests can distinguish prostate cancer from benign prostatic diseases better than PSA or %fPSA. We performed a systematic review and meta-analysis of the available scientific evidence to evaluate the clinical usefulness of %[−2] proPSA and phi. Relevant published papers were identified by searching computerized bibliographic systems. Data on sensitivity and specificity were extracted from 12 studies: 10 studies about %[−2] proPSA (3928 patients in total, including 1762 with confirmed prostate cancer) and eight studies about phi (2919 patients in total, including 1515 with confirmed prostate cancer). The sensitivity for the detection of prostate cancer was 90% for %[−2] proPSA and phi, while the pooled specificity was 32.5% (95% CI 30.6–34.5) and 31.6% (95% CI 29.2–34.0) for %[−2] proPSA and phi, respectively. The measurement of %[−2] proPSA improves the accuracy of prostate cancer detection in comparison with PSA or %fPSA, particularly in the group of patients with PSA between 2 μg/L and 10 μg/L. Similar results were obtained measuring phi. Using these tests, it is possible to reduce the number of unnecessary biopsies, maintaining a high cancer detection rate. Published results also showed that %[−2] proPSA and phi are related to the aggressiveness of the tumor.

Evidence of the acute lack of interchangeable laboratory results and consensus in current practice among clinical laboratories has underpinned greater attention to standardization and harmonization projects. Although the focus is mainly on the standardization of measurement procedures, the scope of harmonization goes beyond method and analytical results: it includes all other aspects of laboratory testing, including terminology and units, report formats, reference intervals and decision limits, as well as test profiles and criteria for the interpretation of results. This review provides further insight on the issue of harmonization in laboratory medicine in view of the urgent need for a complete picture now that old and new drivers are calling for more effective efforts in this field. The main drivers for standardization and harmonization projects are first and foremost patient safety, but also the increasing trends towards consolidation and networking of clinical laboratories, accreditation programs, clinical governance, and advances in Information Technology (IT), including the electronic patient record. The harmonization process, which should be considered a three-tier approach involving local, national and international fronts, must go beyond the harmonization of methods and analytical results to include all other aspects of laboratory testing. A pertinent example of the importance of a complete picture in harmonization programs is given by the National Bone Health Alliance working in the field of bone turnover markers in cooperation with scientific societies including the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).

In clinical practice, glycemic control is generally assessed by measuring and interpreting glycated hemoglobin levels, however, this test should be run under standardized conditions. We focus here on the crucial steps to ensure IFCC standardized HbA 1c results, pointing out several residual weak points, mostly relating to the laboratory end-user (calibration, quality control materials, and EQAS). We also review the use of HbA 1c for diagnosing diabetes and the various indicators useful for assessing glucose variability because in some cases they seem to represent a patient’s glucose profile more accurately than one-off HbA 1c assays. Finally, the potential utility of glycated albumin and the glycation gap, the costs involved and the laboratory management issues are briefly discussed.

Internal quality control (IQC) is essential to good laboratory practice. IQC for certain tests are, however, limited due to inherent problems in providing stabilized IQC material, as applicable to many whole-blood and cell-based systems. Paradigmatic in the hemostasis field is platelet function testing, where IQC processes remain at their infancy, despite such tests being undertaken for decades. One example is the PFA-100, a popular primary hemostasis screening system used to evaluate pre-surgical bleeding risk, screen for possible von Willebrand disease and/or platelet function disorders, and assess desmopressin and anti-platelet therapy; whatever application, laboratories are required to ensure instruments are in optimal working condition, but currently available IQC is limited. Accordingly, a novel test process for IQC of the PFA-100 is explored as an example of potential development. In brief, IQC test systems were prepared to yield prolonged PFA closure times (CTs) (‘pathological QC’) after the addition of normal whole blood (which provided ‘normal QC’). Inter-run test systems coefficients of variation (CVs; range 3.1%–26.2%) were typically similar or better than normal baseline CTs (16.1%–19.2%). There was no evidence of deterioration in CTs over time, indicating at least several years test system stability, and Levey-Jennings plots, typically applied to IQC monitoring, could also be devised. This provides the first evidence of feasibility, or proof of concept, for IQC testing for the PFA-100 incorporating pathological test findings and Levey-Jennings plots. Such a concept is also potentially more broadly applicable to other platelet function, or whole blood or cell-based test systems.

The progress of information and communication technologies has strongly influenced changes in healthcare and laboratory medicine. E-learning, the learning or teaching through electronic means, contributes to the effective knowledge translation in medicine and healthcare, which is an essential element of a modern healthcare system and for the improvement of patient care. E-learning also represents a great vector for the transfer knowledge into laboratory practice, stimulate multidisciplinary interactions, enhance continuing professional development and promote laboratory medicine. The European Federation of Laboratory Medicine (EFLM) has initiated a distance learning program and the development of a collaborative network for e-learning. The EFLM dedicated working group encourages the organization of distance education programs and e-learning courses as well as critically evaluate information from courses, lectures and documents including electronic learning tools. The objectives of the present paper are to provide some specifications for distance learning and be compatible with laboratory medicine practices.

Background: We sought to detect specimen mix-up by developing a new cumulative delta-check method applicable to a mixture of test items with heterogeneous units and distribution patterns. Methods: The distributions of all test results were successfully made Gaussian using power transformation. Values were then standardized into z-score (zx) based on reference interval (RI) so that limits of RI take zx=±1.96. To find a weight for summing absolute value of delta between current and previous zx (Dz), we evaluated the distribution of Dz. Its central portion was always regarded as Gaussian despite the presence of symmetrical long tails. Thus, an adjusted SD (aSD) representing the center was estimated with an iterative method. By setting 1/aSD 2 as a weight factor, we computed a weighted mean of Dz as an index for specimen mix-up (wCDI). Results: The performance of wCDI was evaluated, using a model laboratory database consisting of 32 basic test items, by a simulation study generating artificial cases of mix-up. When wCDI was computed from three commonly ordered test sets consisting of 6–9 items each, its diagnostic efficiency in detecting the artificial cases was 0.937–0.967 expressed as area under ROC curves (AUC). When the performance of wCDI was evaluated simply by the number of test items (p) included in the computation, AUC gradually increased from 0.944 (p=5) to 0.976 (p=8). However, when p≥10, AUC stayed at approximately 0.98. Conclusions: wCDI was proven to be highly effective in uncovering cases of specimen mix-up. The diagnostic efficiency of wCDI depends only on the number of test items included in the computation.

Background: The present study was conducted to evaluate the analytical performance and the organizational aspects of Capillarys 2 Flex Piercing system (CFP) respect to agarose electrophoresis and HPLC methods in hemoglobinopathies screening. Methods: The measurement of imprecision in HbA 2 and HbF quantification was verified on HbA 2 CFP control and on three samples; 74 whole blood samples were used to evaluate migration time imprecision of hemoglobin variants S, C and E (HbS, HbC, and HbE); to compare methods, 451 samples were tested on CFP and HPLC; reference values were verified as value distribution in 160 blood donors and at ROC curve analysis on 449 samples from routine analysis. Results: Imprecision: the analytical CV%s ranged from 1.25 to 3.9 at HbA 2 quantification, the CV% was 3.78 at HbF quantification; the running time imprecision for HbS and HbC and HbE ranged from 0.20 to 0.69%. Method comparison: at regression analysis findings were HbA 2 : CFP=1.21×HPLC–0.64, HbF: CFP=1.31×HPLC-0.75, HbS: CFP=1.10×HPLC-3.24. Reference values: the HbA 2 95th percentile range was 2.5–2.8; HbF was undetectable in 154 out 160 samples tested; at ROC curve analysis the best combination of sensitivity and diagnostic efficiency was obtained using 2.2 and 3.0, as reference values, for HbA 2 and 1.1 as the upper reference limit for HbF. Organizational aspects: with respect to the procedures currently implemented in our laboratory CFP requires 2 h less time and obviates the need for some manual steps. Conclusions: The quantification, reproducibility and diagnostic efficiency provided by CFP in identification and quantification of hemoglobins appear accurate. In addition, the use of primary tubes allows improved safety, and the avoidance of some manual steps, that prolong working time and are a source of possible errors.

Background: Knowledge of the fatty acid composition of lipid classes in human plasma is an important factor in the investigation of human metabolism. Therefore, a method for the analysis of neutral lipid (NL), phospholipid (PL) and free fatty acids (FFA) in human plasma has been developed and validated. Methods: Separation of lipid classes was carried out by solid phase extraction of the lipid extract. The fractions were transesterified and the resulting fatty acid methyl esters were determined by GC/FID. For the method to be validated, precision, detection and quantification limits, as well as recovery, were determined for combined lipid extraction, solid phase extraction and GC analysis. Results: The lipid extraction was miniaturized and simplified by application of an ultrasound ‘Sonotrode’. The resolution of lipid classes was optimized with appropriate standards added to a representative plasma sample. In addition, a rapid derivatization procedure using trimethylsulfoniumhydroxide was established. Low determination limits (1.5, 0.2 and 1.3 μg/g plasma for NL, PL and FFA, respectively) indicate that the method’s sensitivity is sufficient to quantify even minor components. Furthermore, recovery for NL and PL fatty acids was found to range from 80% to 110%. The results were similar for FFA apart from more polar free fatty acids due to their higher solubility in water. Repetitive measurements showed very good precision apart from the long chain PUFA for which the coefficients of variation were significantly higher. Conclusions: The present method is applicable to the quantitation of fatty acids in lipid classes of human plasma including several minor components.

Background: Iodine requirements increase during pregnancy and previous studies have reported the inadequate iodine status of pregnant women in areas that have achieved iodine sufficiency in the general population. We examined the urinary iodine (UI) concentrations of pregnant women in Ukraine, where the iodine status is showing improvement among the general population. Methods: We enrolled 148 pregnant women <16 weeks pregnant and 80 healthy women as a control group living in Zhitomir, Ukraine. UI concentration, thyroid-stimulating hormone (TSH), antithyroglobulin antibodies (TGAb), and antithyroid peroxidase antibodies (TPOAb) were measured. Results: The median UI concentrations were significantly lower in pregnant women than in control women [13.0 (ND–51.0) μg/L vs. 62.0 (35.3–108.5) μg/L, p<0.001]. TSH concentrations were significantly lower in pregnant women than in control women [1.7 (1.2–2.7) IU/L vs. 2.2 (1.4–3.1) IU/L, p=0.011], but this difference disappeared when adjusted for age (2.1±0.1 IU/L vs. 2.4±0.2 IU/L, p=0.097). The frequency of TSH over 6.2 IU/L and the frequency of positive TGAb and/or TPOAb were not statistically different between groups (p=0.70 and p=0.48, respectively). The UI concentrations of 142 pregnant women (95.9%) were <150 μg/L indicating insufficient iodine intake. Conclusions: The UI concentration of pregnant women in Ukraine revealed severe iodine deficiency. Regular monitoring and appropriate nutrition education are essential because iodine deficiency can be easily prevented by adequate iodine intake. The risk of iodine deprivation during pregnancy needs to be assessed locally over time because it may occur in areas that are not globally recognized as being iodine-deficient.

Background: The eosin-5′-maleimide (EMA) binding test is a flow cytometric test widely used to detect hereditary spherocytosis (HS). EMA binds to plasma membrane proteins of red blood cells (RBCs), mainly to band 3 protein. The mean fluorescence of EMA-stained RBCs in HS patients is lower when compared with control RBCs due to the decreased amount of target proteins. EMA dye in aqueous solution is sensitive to light and high temperature. Its fluorescence can decrease when exposed to light or ambient temperatures higher than 4°C. The aim of the study was to evaluate the stability of fluorescence readings of EMA-labeled RBCs over a period of 24 h. Methods: The EMA test was performed in peripheral blood from 35 patients with microcytic anemia (five with HS, and 30 without HS). Peripheral blood samples were stained immediately after blood collection and analyzed using a flow cytometer at three time points: 0, after 1 and 24 h of storage at 4°C in the darkness. The results are presented as the percentage of normal control RBCs fluorescence. Flow cytometric studies were performed with Cytomics FC500 (Beckman Coulter, USA). Results: In HS patients the mean result of the test reached 66.72%±9.26% of normal controls, and in non-HS patients the EMA result was 99.48%±5.03% of normal control cells. The results of patients with HS were 66.72%±9.26%, 66.90%±10.24% and 67.86%±11.31% at 0 h, and after 1 and 24 h of storage, respectively. The results obtained from non-HS patients at time 0, after 1 and 24 h of storage reached 99.48%±5.03%, 99.49%±5.34% and 99.78%±6.13%, respectively. There was no difference between the results from each time point in samples from patients with or without HS. Conclusions: Results of the EMA binding test do not depend on storage time of stained samples when stored at 4°C up to 24 h after staining.

Background: Faecal calprotectin is a non-invasive marker for neutrophilic intestinal inflammation. It can be used in the differential diagnosis between functional and organic bowel disease. Moreover, it correlates with endoscopic organic bowel disease activity. The objective of this study is to evaluate a recently launched quantitative immunochromatographic point-of-care test: Quantum Blue Calprotectin (Bühlmann Laboratories AG, Schönenbuch, Switzerland) in comparison to an established ELISA method (Bühlmann Laboratories AG). Methods: We included 142 samples, either archived (–80°C) faecal extracts or fresh routine samples. Both the normal range cartridges as well as the high range cartridge from the point-of-care test were used. The ELISA was compared with the point-of-care test and the optimal the point-of-care test cut-off values were searched for using Microsoft ® Excel 2002 and MedCalc Software version 10.0.0.0 (Mariakerke, Belgium). Results: In the method comparison a determination coefficient (R 2 ) of 0.89 was found. The Passing Bablok regression analysis showed a significant deviation from linearity (y=–40.8+1.0x). The use of a cut-off value of 30 μg/g faeces and a grey zone of 30–110 μg/g faeces resulted in the best agreement between the ELISA interpretation and the point-of-care test interpretation, with 89.4% (127/142) agreement and 10.6% (15/142) mismatches. Conclusions: We may conclude that the point-of-care test can serve as a reliable alternative to the time consuming ELISA in the differential diagnosis between functional and organic bowel disease. Furthermore, it seems to be reliable in the follow-up of inflammatory bowel disease patients.

Background: Isotope dilution LC-MS/MS methods used in the clinical laboratory typically involve multi-point external calibration in each analytical series. Our aim was to test the hypothesis that determination of target analyte concentrations directly derived from the relation of the target analyte peak area to the peak area of a corresponding stable isotope labelled internal standard compound [direct isotope dilution analysis (DIDA)] may be not inferior to conventional external calibration with respect to accuracy and reproducibility. Methods: Quality control samples and human serum pools were analysed in a comparative validation protocol for cortisol as an exemplary analyte by LC-MS/MS. Accuracy and reproducibility were compared between quantification either involving a six-point external calibration function, or a result calculation merely based on peak area ratios of unlabelled and labelled analyte. Results: Both quantification approaches resulted in similar accuracy and reproducibility. Conclusions: For specified analytes, reliable analyte quantification directly derived from the ratio of peak areas of labelled and unlabelled analyte without the need for a time consuming multi-point calibration series is possible. This DIDA approach is of considerable practical importance for the application of LC-MS/MS in the clinical laboratory where short turnaround times often have high priority.

Background: Trace elements (TEs) are ubiquitous and their potential interest for human health has been constantly expanding. Biological monitoring is generally considered to be a useful tool to assess human exposure to chemical agents in risk assessment both at occupational and environmental levels. However, the knowledge of accurate reference values, which may vary across countries or regions, is a prerequisite for correct interpretation of biomonitoring data. This study aimed at determining the reference distribution and the upper reference limit for 26 TEs (Al, As, Sb, Ba, Be, Bi, Cd, Cr, Co, Cu, In, Li, Mn, Hg, Mo, Ni, Pd, Pt, Pb, Se, Te, Tl, Sn, U, V, Zn) in the urine of the general adult population residing in Belgium. Methods: In total, 1022 adults not occupationally or extra-occupationally (mainly via hobbies, drugs) exposed to these TEs were recruited by occupational physicians and toxicologists according to an a priori selection procedure. Non-fasting spot urine samples were analyzed for 460 males and 541 females by inductively coupled plasma mass spectrometry (ICP-MS). Careful control was applied during collection, handling and analyses of the samples to avoid any contamination. Results: Globally, the results indicate that the exposure levels of the Belgian population to these TEs are low and grossly similar to those recently published by other national surveys. Conclusions: These new reference values and upper reference limits will be useful for future occupational and/or environmental surveys.

Background: Biological variation (BV) and reference change values (RCVs) have been widely described for the general population, but the use of these data derived from adults in the elderly population is a controversial issue. We determined the within- and between-subject BV and RCV in both elderly and young people and compared them with previously published analyses. Methods: Samples were collected from 135 volunteers over 80 years of age at weekly intervals over 4 weeks. Eighteen biochemical and eight haematological analytes were measured. The Fraser and Harris methods were used to calculate the components of BV and RCV. To perform a comparative analysis, a reference group of 118 young subjects was studied under the same conditions. Results: The obtained coefficients of BV showed statistical differences in many cases, but in general, both the elderly and young patient data fall within the ranges previously described for the general population. The indexes of individuality for the analytes investigated did not exceed 1.4 in any case and were <0.6 for some analytes. The RCVs derived from elderly subjects were similar to those published in the young population, both in healthy and diseased individuals. Conclusions: The strong individuality observed supports the preferential use of RCVs rather than population-based reference intervals in elderly people. For most of the analytes studied, data from the young population can be applied to elderly people, but the specific elderly coefficients of BV and RCVs are a recommended option.

Background: Determination of pediatric reference intervals (RIs) for laboratory quantities, including hematological quantities, is complex. The measured quantities vary by age, and obtaining samples from healthy children is difficult. Many widely used RIs are derived from small sample numbers and are split into arbitrary discrete age intervals. Use of intra-laboratory RIs specific to the examined population and analytical device used is not yet fully established. Indirect methods address these issues by deriving RIs from clinical laboratory databases which contain large datasets of both healthy and pathological samples. Methods: A refined indirect approach was used to create continuous age-dependent RIs for blood count quantities and sodium from birth to adulthood. The dataset for each quantity consisted of 60,000 individual samples from our clinical laboratory. Patient samples were separated according to age, and a density function of the proportion of healthy samples was estimated for each age group. The resulting RIs were merged to obtain continuous RIs from birth to adulthood. Results: The obtained RIs were compared to RIs generated by identical laboratory instruments, and to population-specific RIs created using conventional methods. This comparison showed a high concordance of reference limits and their age-dependent dynamics. Conclusions: The indirect approach reported here is well-suited to create continuous, intra-laboratory RIs from clinical laboratory databases and showed that the RIs generated are comparable to those created using established methods. The procedure can be transferred to other laboratory quantities and can be used as an alternative method for RI determination where conventional approaches are limited.

Background: Quality control materials with minimal inter-assay differences and clinically relevant proportions of different molecular forms of the analyte are needed to optimize intra- and inter-laboratory accuracy and precision. Methods: We assessed if clinically relevant total prostate-specific antigen (tPSA) levels were present in seven commercially available Multi Constituent Tumor Marker Controls (MC-TMC). Further, we determined the concentration of free PSA (fPSA) and calculated the percentage of free PSA (%fPSA) in all materials. Finally, we determined variability of TMC materials across several commonly used PSA platforms. Results: All MC-TMC materials contained at least one concentration of tPSA in normal and pathologic range. Control materials varied in the amount of fPSA and %fPSA, with most controls consisting of fPSA only and only one MC-TMC containing medically relevant levels of around 35% fPSA. Only a minority of MC-TMC materials showed minimal variability across four PSA methods while the majority of PSA controls showed wide inter-method differences. Conclusions: Use of many commercially available controls for PSA could lead to biased PSA measurements because they contain medically irrelevant proportions of fPSA and show significant variation among different PSA assay platforms.

Background: The non-coding prostate cancer antigen 3 (PCA3) RNA is currently the most specific biomarker for prostate cancer (PCa) diagnosis. Although its clinical value has been validated in a urine assay after intensive prostatic massage, few studies have been conducted to establish its diagnostic value in the peripheral blood (PBL). The aim of the present study was to examine the PCA3 expression in blood as a diagnostic tool, and to provide an additional strategy to improve PCa diagnosis. Methods: PCA3 transcripts were detected by RT-PCR in PBL and prostatic tissues from patients. PBL sampling also included a group of young healthy volunteers. The relationship between the PCA3 RNA detection and clinical characteristics was analyzed. Results: PCA3 detection in blood presented 94% specificity and 32% sensitivity, and its combined detection in tissues significantly improved diagnostic parameters. However, PCA3 RNA detection in blood was also associated with PSA levels ≥10 ng/mL, and their combination provided a sensitivity of 60% and specificity of 93%. Conclusions: Detection of the PCA3 RNA in patients’ blood is an efficient tool for PCa diagnosis because it allows a routine collection procedure, which is also supported by the ongoing screening marker, prostate-specific antigen (PSA). We propose its combined use with PSA levels ≥10 ng/mL, which improves accuracy, and prevents overdiagnosis and overtreatment.

Background: Cancer biomarkers (CBs) can be used in early detection of several cancers as well as in detection of recurrence and following response to treatment. We aimed to investigate the levels of CBs in proteinuric patients with primary glomerular disease (PGD) and diabetes mellitus, and compare them with healthy controls. Methods: One hundred and two patients with untreated PGD, 62 proteinuric patients with diabetic nephropathy, and 84 healthy controls were enrolled. Levels of cancer antigen 125 (CA 125), cancer antigen 15–3 (CA 15–3), carcinoembriogenic antigen (CEA), α-fetoprotein (AFP), total prostate specific antigen (TPSA), free prostate specific antigen (FPSA) and carbohydrate antigen 19–9 (CA 19–9) were measured. Results: Compared to healthy controls, levels of CA 125, CA 15–3 and CA 19–9 were higher in patients with PGD and diabetic patients (all p<0.05), while levels of TPSA, FPSA, AFP and CEA were lower (all p<0.05). There was no correlation between levels of cancer biomarkers and serum fibrinogen and serum amyloid A protein levels (all p>0.05). Both urinary protein excretion rate and serum albumin levels were correlated with all CBs (all p<0.05). Conclusions: CBs levels seem to be changed in different proteinuric patients. This condition should be kept in mind when evaluating CBs levels in proteinuric patients.

Background: Surface neutrophil CD64 expression is upregulated in patients with bacterial infection. As it was suggested that the CD64 index could be used to detect sepsis in hospitalized patients, we questioned whether the CD64 index could discriminate between septic patients and postoperative surgical patients, defined as systemic inflammatory response syndrome (SIRS), both admitted at the intensive care unit (ICU). Furthermore, we wondered whether the CD64 index was an improved diagnostic compared to standard assays used at the laboratory. For this, outclinic (OC) patients were included as controls. Methods: The Leuko64™ assay was used to determine the CD64 index in residual EDTA blood samples from selected septic patients (n=25), SIRS patients (n=19), and OC patients (n=24). Additionally, WBC count, neutrophilic and eosinophilic granulocyte count, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were measured simultaneously. Results: The CD64 index was higher in septic patients compared to both the SIRS and OC group (p<0.0001). In addition, the WBC count, neutrophil count, ESR and CRP were also higher in septic patients than the OC group (p<0.0001). However, only the WBC count, eosinopenia, and ESR were comparable between the SIRS and the sepsis group and proved to be discriminative to the OC group (p<0.05). The CD64 index demonstrated higher sensitivity and specificity than CRP, WBC count, neutrophilic and eosinophilic granulocyte count, and ESR. Conclusions: A high CD64 index was found in septic intensive care patients, while a low CD64 index was observed in OC and SIRS patients, demonstrating that the CD64 index can be used for routine diagnostics in the ICU setting.

Background: Long pentraxin 3 (PTX3) is an acute-phase protein secreted by various cells, including leukocytes and endothelial cells. Like C-reactive protein (CRP), it belongs to the pentraxin superfamily. The aim of this study was to investigate the differential changes in plasma levels of PTX3 between before and after antibiotic treatment in hospitalized adult patients with community-acquired pneumonia (CAP). Methods: Plasma PTX3 levels were measured in 61 adult patients with CAP and 60 healthy controls using a commercial enzyme-linked immunosorbent assay (ELISA). Upon initial hospitalization, APACHE II, CURB-65, and pneumonia severity index (PSI) scores were determined to assess CAP severity in patients. Results: The results showed a decline in the number of white blood cells (WBCs) and neutrophils, and decreases in the concentrations of CRP and PTX3 observed after antibiotic treatment. The plasma concentration of PTX3, but not CRP, was correlated with the severity of CAP based on the PSI (r=0.290, p=0.023), CURB-65 (r=0.312, p=0.015), and APACHE II scores (r=0.427, p=0.001). The PTX3 level also exhibited a significant correlation with the length of hospital stay (r=0.500, p<0.0001). Conclusions: PTX3 may be able to play a role in the diagnosis and clinical assessment of the severity of CAP, which could potentially guide the development of treatment strategies.