Bayer Diagnostics Research Articles

The Heidelberg registry of atrial fibrillation. a summary in the era of transition of oral anticoagulation regimes over an 11-year period

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): The study was supported by a research grant from Daiichi Sankyo and Bayer diagnostics. The sponsor had no influence on the study concept, data collection, or interpretation. Background Management of patients with atrial fibrillation (AF) has improved in recent years. Particularly, the shift from vitamin-k containing (VKA) oral anticoagulation (OAC) regimes to factor Xa or thrombin inhibitor containing non-vitamin K regimes (NOAC) regimes has revolutionized stroke prevention in AF patients. Purpose This study aimed to illustrate the shift from VKA to NOAC regimes over an 11-year period in an emergency department (ED) setting. Methods The Heidelberg Registry of Atrial Fibrillation (HERA-FIB) is a retrospective, observational single-center study and collected data from patients with AF presenting to the ED of our hospital between 2009 and 2020. Inclusion criteria were (a) diagnosis of AF and (b) age >18 years. Exclusion criteria were (a) non-availability of at least one high sensitive troponin T value and (b) lost to follow-up for all-cause mortality. Repeated visits to the ED were also excluded. Clinical data was accessed retrospectively from available medical records. A sequential follow-up was performed for all-cause mortality, stroke, major bleeding and myocardial infarction. This study was conducted according to ethical principles stated in the Declaration of Helsinki (2008). Results Within the inclusion period of HERA-FIB a total of 76,528 visits to CPU were screened over an 11-year time period. 24.4% were excluded for other diagnosis than AF, resulting in a total of 12,279 visits to ED within the inclusion period. Here, a total of 5.4% of the patients were excluded after re-adjustment of AF diagnosis, 1,5% for non-sufficient laboratory values and 10% for lost-to follow-up. The total study population of HERA-FIB included 10,222 patients with the diagnosis of AF. Within the inclusion period of HERA-FIB, a significant change form VKA containing to NOAC containing anticoagulation regimes could be detected among patients presenting to the ED. Additionally, the number of patients on OAC compared to the number of patients without any OAC regime increased over time. Within the inclusion period, a total of 69.7% received an OAC regime. Here 59.5% of the AF patients received a NOAC and 40.5% VKA at discharge. Hazard ratio for patients on VKA for all-cause mortality was 1.25 (95%CI: 1.11-1.41), p=0.0003. Conclusions HERA-FIB is one of the largest real-world retrospective single-center databases for patients with AF, reflecting the shift from NOAC to VKA containing anticoagulation regimes in AF patients presenting to an ED over an 11-year period.

Anti-Hypertensive Activity of Hydro Alcoholic Extract of Cìraka Cūraṇam on High Salt Loaded Wistar Albino Rats

Background: Hypertension is called as Silent killer. The most important risk factor for heart diseases and stroke and it may leads to premature death. Several medicinal plants have high effective in anti-hypertensive and anti-thrombotic activity without any side effects. Aim: To evaluate the anti-hypertensive activity of hydro alcoholic extract of Cìraka cūraṇam on deoxycorticosterone acetate (DOCA) salt induced wistar albino rats. Study design: Observational in-vivo study Place and duration of study: Animal house, Dept. of Pharmacology, Arulmigu Kalasalingam College of Pharmacy, Krishnankoil, Srivilliputtur,Tamilnadu. Materials and methods: Antihypertensive activity was conducted on wistar albino rats by determining serum Sodium and Potassium levels by using semi auto analyzer (RA-50, Bayer Diagnostics), using specific kits (Auto span, India) at 500 and 550 nm respectively and left carotid artery (for recording BP) was cannulated under aseptic conditions with polyethylene cannula filled with 1% heparin in normal saline. Rest procedure, which was stated under the 2K1C-model was followed and BP was observed in terms of mm of Hg. Results: The Cìraka cūraṇam possesses strong antihypertensive effect against DOCA-salt hypertensive rats, which is evidenced by a considerable decrease in blood pressures. Keywords: Anti-hypertensive activity, Cìraka cūraṇam, Wistar albino rats, Deoxycorticosterone acetate.

Cardio-oncology services during the COVID-19 pandemic: practical considerations and challenges.

Cardio-oncology services during the COVID-19 pandemic: practical considerations and challenges.

Discordance in the diagnosis of diabetes: Comparison between HbA1c and fasting plasma glucose.

ObjectiveHbA1c has been introduced as a complementary diagnostic test for diabetes, but its impact on disease prevalence is unknown. This study evaluated the concordance between HbA1c and fasting plasma glucose (FPG) in the diagnosis of diabetes in the general population.Materials and methodsThe study was designed as a population based investigation, with participants being sampled from the Ho Chi Minh City, Vietnam. Blood samples were collected after overnight fasting and analyzed within 4 hours after collection. HbA1c was measured with high pressure liquid chromatography (Arkray Adams, Japan). FPG was measured by the hexokinase method (Advia Autoanalyzer; Bayer Diagnostics, Germany). Diabetes was defined as HbA1c ≥ 6.5% or FPG ≥ 7.0 mmol/L. Prediabetes was classified as HbA1c between 5.7% and 6.4%.ResultsThe study included 3523 individuals (2356 women) aged 30 years and above. Based on the HbA1c test, the prevalence of diabetes and prediabetes was 9.7% (95%CI, 8.7–10.7%; n = 342) and 34.6% (33.0–36.2; n = 1219), respectively. Based on the FPG test, the prevalence of diabetes and prediabetes was 6.3% (95%CI, 5.5–7.2%; n = 223) and 12.1% (11.1–13.2; n = 427). Among the 427 individuals identified by FPG as "pre-diabetes", 28.6% were classified as diabetes by HbA1c test. The weighted kappa statistic of concordance between HbA1c and FPG was 0.55, with most of the discordance being in the prediabetes group.ConclusionThese data indicate that there is a significant discordance in the diagnosis of diabetes between FPG and HbA1c measurements, and the discordance could have significant impact on clinical practice. FPG appears to underestimate the burden of undiagnosed diabetes.

Effect of the oral iron chelator deferiprone in diabetic nephropathy rats.

The aim of the present study was to investigate the effects of the iron chelator deferiprone in diabetic nephropathy (DN) rats and the mechanisms involved. Thirty-two male Wistar rats (180-220 g, 6 weeks old) were randomly divided into a control group, a DN group and two DN groups treated with either 50 or 100 mg/kg per day deferiprone. The DN group was established by feeding of a high-carbohydrate-fat diet and injection of 35 mg/kg streptozotocin into the vena caudalis. The duration of deferiprone treatment was 20 weeks. Histopathological changes were detected by hematoxylin-eosin and Masson staining, as well as transmission electron microscopy. Levels of nuclear factor (NF)-κB, monocyte chemotactic protein (MCP)-1, matrix metalloproteinase (MMP)-9, tissue-specific inhibitor of metalloproteinase (TIMP)-1, cyclo-oxygenase (COX)-2, and nitrotyrosine were determined in kidney tissues using reverse transcription-polymerase chain reaction (RT-PCR), western blotting, and immunohistochemistry. Histopathological observations showed that deferiprone treatment alleviated inflammation infiltrates and collagenous fibrosis in DN rats. Results from RT-PCR and western blotting indicated that deferiprone inhibited the expression of NF-κB, MCP-1, COX-2, and nitrotyrosine, which were overexpressed in DN rats. Immunohistochemistry showed that the mechanism of deferiprone action may involve regulation of MMP-9 and TIMP-1. Decreased MMP-9 expression and increased TIMP-1 expression in DN rats were significantly promoted and inhibited by deferiprone, respectively. Iron chelation by oral deferiprone has a renoprotective effect in DN rats by relieving oxidative stress, inflammation, and fibrosis, which is related to the cytokines NF-κB, MCP-1, MMP-9, TIMP-1, COX-2, and nitrotyrosine.

The Incidence of Electrolytes and Acid-Base Abnormalities in Diabetic Emergencies using the I-Stat Portable Analyser.

Diabetic patients with prolonged insulin insufficiency can present in the emergency department with life threatening ketoacidosis,el ectrolyte abnormalities,an d morbid arrhythmias. A quick and accurate determination of the metabolic abnormalities with rapid intervention is paramount in their management. The aim of this study was to determine the incidence of electrolyte and acid-base abnormalities in diabetic emergencies using the I-STAT point of care testing technique. The study involved thirty diabetic patients admitted into the accident and emergency department of the Lagos University Teaching Hospital. Informed consent was obtained from all participants. Blood samples were obtained for estimation of electrolytes and acid-base using point of care testing (I-Stat portable analyser). A Multistix urine strip (Bayer Diagnostics Reagent Strips) was used for urine analysis to detect the presence of ketones. The mean age was 60.37 ±10.45 (40-79) years, made up of 21(70%) females and 9(30%) males, with a mean duration of diabetes mellitus of 6.5 ±3.56 years. Hyperglycaemia was observed in 70%, and hypoglycaemia in 20%.T he commonest electrolyte abnormality was hypokalaemia (56.67%)followed by hyponatremia (50%).Other abnormalities included hyperkalaemia (10%) and hypernatremia (3.3%). Abnormalities of acid base balance included low pH (20%), low TCO 2 (16.67%), high TCO 2 (16.67%), high PCO 2 (46.67%),and low PCO 2 (23.33%). The results indicated that in diabetic emergencies the commonest electrolyte abnormality was hypokalaemia followed by hyponatremia, and the least was hypernatremia. Key words: Diabetes mellitus, I-stat portable analysers, electrolyte and acid-base abnormalities

Predictors and prognostic value of biomarkers in patients and an intermediate or low risk grace score

Purpose: To assess the prevalence, predictors and prognostic value of biomarkers underlying the pathological process of atherothrombosis in patients with known or suspected coronary artery disease having an intermediate or low risk Grace Score. Methods: Eight biomarkers [myeloperoxidase (MPO), von Willebrand factor (vWf), high-sensitivity C-reactive protein (hsCRP), homocysteine, cardiac troponin T (cTnT), B-type natriuretic peptide (BNP), antithrombin III (AT III), D-dimers] and mean platelet volume (MPV) were measured in 150 patients presenting on admission with symptoms of unstable angina (M/F=120/60, 61±12.2 years) and having an intermediate or low risk according to Grace Score. MPV measurements were obtained from the admission blood work. All samples were obtained in standardized dipotassium ethylenedinitrotetraacetic acid (EDTA) tubes. The measurements were performed using automated hemograms (Bayer Advia 2120, Bayer Diagnostics, NY). End points were all-cause mortality and major cardiac events (MACE, i.e., cardiac death or myocardial infarction). Results: Over a mean follow-up of 18±3.4 months 30 MACE occurred. MPO >283,7pmol/ml (OR 1.01, 95% CI 1.00-1.02, p <0.001), MPV> 8,8 fl (OR 5.84, 95% CI 3.41-7.20, p <0.002), D-dimers > 250mcmol/l (OR 1,3, 95% CI 1.00-1.57, p <0.05) were predictors of MACE. Even after log transformation, these biomarkers remained independent predictors. In multivariate analysis Conclusions: MPV, MPO and D-dimers can be used as a risk biomarker in prognosticating the 12 months outcomes for unstable angina and help in decision making in intermediate and low risk patients.

Religious fasting: an alternative approach to improve hyperlipidaemia

PurposeThe purpose of this paper is to evaluate the effect of fasting on blood lipid profile in fasting obese and non‐obese subjects.Design/methodology/approachMale and female subjects from the International Islamic University, Malaysia (IIUM), Kuantan Campus were assessed for body compositional changes during Ramadan fasting. In total, 25 males and females volunteered to participate in this study in the holy month of Ramadan. The mean age of the volunteers was 26.5±5.86 years and the age range was 21‐45 years. The age, weight and height of the volunteers were recorded on day 1 of Ramadan and weight was also recorded on day 21. The volunteers were asked for donation of blood samples on days 1, 7, 14 and 21 of the Ramadan. The blood serum was separated and stored at −20°C immediately after each collection. The serum samples stored at −20°C were analyzed for serum glucose and lipid profile. The analysis of serum lipid profile was performed with the help of clinical kits from Bayer Health Care using Bayer Express Plus Clinical analyzer. The serum was used for the estimation of total cholesterol (TC), HDL‐cholesterol (HDL‐c) and triglycerides (TG) concentrations using kit reagents from M/s Bayer Diagnostics, whereas low density lipoprotein cholesterol (LDL‐c) was determined by calculation. The statistics were performed using MINITAB statistical software (release 8.2).FindingsThe serum triglyceride concentration was significantly reduced and the reduction was 17.48 percent from day 1‐21. The serum TC concentration also reduced from day 1‐21 and the reduction was 15.93 percent. The serum LDL‐c concentration also significantly reduced from day 1‐21 and the reduction was 21.67 percent. The serum HDL‐c concentration decreased in the first weak and second week but an improving trend was observed on day 21 of the Ramadan.Research limitations/implicationsThis study was not a controlled one and was conducted on free‐living individuals and therefore there is need to have controlled or adjusted physical activities studies in fasting individuals. It is always difficult to conduct experiment on human beings in the metabolic area. Furthermore, in this study it was not possible since it was a religious fasting. Another limitation is that the size of the sample was smaller than is advisable for this kind of study. However, the results were confirmed in the following month of Ramadan, as described in the paper.Originality/valueThe paper takes into consideration the effect of Ramadan fasting on blood lipid profile, which has ever been studied in obese individuals.

Diagnosis of Hypoglycemia due to Over-Dosage of Insulin Analog, Insulin Lispro

Serum insulin assay is used for the diagnosis of diabetes and hypoglycemia and is also used to quantify insulin for insulin pharmacokinetic evaluations. Serum C-peptide is usually measured in subjects who use insulin for evaluation of intrinsic insulin secretion. We experienced a hypoglycemic diabetic patient treated by premixed insulin lispro 75/25 (75% insulin lispro protamine suspension and 25% insulin lispro) who showed undetected serum levels of both insulin and Cpeptide. A 74-year-old type 2 diabetic man has been treated by injection of 26 units of premixed insulin lispro 75/25 before breakfast. In December 2010, his food intake decreased due to appetite loss, however, he injected 26 units of premixed insulin lispro 75/25, and subsequently developed disturbance of consciousness. He was admitted to our department, and his blood glucose level was 37 mg/dL. His consciousness promptly recovered after intravenous injection of glucose, and then he has been diagnosed as having hypoglycemia. We expected that his serum insulin level is high. However, serum insulin and also C-peptide were not detected. HbA1c is 5.5%, and anti-glutamic acid decarboxylase antibody was negative, and 125I-insulin binding rate was not too high (2.6%). His urinary C-peptide level was very low (4.0 μg/ day; normal range, 29.2 167.0 μg/day), suggesting the presence of severely decreased insulin secretion capacity. What is the cause of his hypoglycemia? Insulin analogs that are prepared with recombinant DNA technology are available for clinical use. One obvious question with insulin analogs is whether they are detectable by immunoassay. Serum insulin could not be detected by the chemiluminescent enzyme immunoassay (CLEIA) using Lumipulse Presto Insulin (Fuji Rebio, Tokyo, Japan) in our patient (Table 1). However, serum insulin could be measured by radioimmunoassay (RIA) using Insulin Eiken (Eiken Chemical Company, Tokyo, Japan). Lumipulse Presto Insulin could detect NPH human insulin, but, could not detect insulin lispro, and showed very low cross-reactivity with premixed insulin lispro 75/25 (Table 1). Insulin Eiken showed a high cross-reactivity with NPH human insulin, insulin lispro and premixed insulin lispro 75/25 (Table 1). Insulin lispro is a human insulin analog created by reversing the amino acids at positions 28 (Pro to Lys) and 29 (Lys to Pro) of the B chain of human insulin [1]. A sensitive RIA that is specific for insulin lispro has been developed [2]. Further, the combination of insulin assays that detect human insulin only or both human insulin and insulin analogs provides a new tool for studying pharmacokinetics of insulin lispro [3]. However, all of these assays are used mainly for research and are not usually used in clinical laboratories. Owen WE, et al studied cross-reactivity of insulin analogs with commercial insulin immunoassays [4]. Insulin lispro had a high cross-reactivity of 80% and 90% with the Access analyzer (Beckman Coulter) and the Advia Centaur analyzer (Bayer Diagnostics), respectively, whereas insulin lispro had a low cross-reactivity of 43% and 28% with the Coat-ACount (Diagnostic Products Corporation) and the IMMULITE 2000 analyzer (Diagnostics Products Corporation), respectively. The E170 method did not detect insulin lispro, indicating that the antibody used in this assay could not recognize an epitope that includes B28 and/or B29 of the B chain. The antibody in the assay of Lumipulse Presto InsuManuscript accepted for publication April 6, 2012

Hypoglycaemic effect of Berberis vulgaris L. in normal and streptozotocin-induced diabetic rats

Objective To achieve a primary pharmacological screening contained in the aqueous extract of Berberis vulgaris ( B. vulgaris) and to examine the hypoglycaemic effect and biochemical parameters of aqueous and saponins extract on groups of rats rendered diabetic by injection of streptozotocin. Methods The phytochemical tests to detect the presence of different compounds were based on the visual observation of color change or formation of precipitate after the addition of specific reagents. Diabetes was induced in rats by intraperitoneal ( i.p.) injection of streptozotocin (STZ) at a dose of 65 mg/kg bw. The fasting blood glucose levels were estimated by glucose oxidase-peroxidase reactive strips (Dextrostix, Bayer Diagnostics). Blood samples were taken by cutting the tip of the tail. Serum cholesterol and serum triglycerides were estimated by enzymatic DHBS colorimetric method. Results Administration of 62.5 and 25.0 mg/kg of saponins and aqueous extract respectively in normal rats group shows a significant hypoglycemic activity (32.33% and 40.17% respectively) during the first week. However, diabetic group treated with saponin extract produced a maximum fall of 73.1% and 76.03% at day 1 and day 21 compared to the diabetics control. Also, blood glucose levels of the diabetic rats treated with aqueous extract showed decrease of 78.79% on the first day and the effect remains roughly constant during 3 week. Both extracts also declined significantly biochemical parameters (20.77%–49.00%). The control in the loss of body weight was observed in treated diabetic rats as compared to diabetic controls. Conclusions These results demonstrated significant antidiabetic effects and showed that serum cholesterol and serum triglycerides levels were decreased, significantly, consequently this plant might be of value in diabetes treatment.

Latent class evaluation of a milk test, a urine test, and the fat-to-protein percentage ratio in milk to diagnose ketosis in dairy cows

In this study, 3 commonly used tests to diagnose ketosis were evaluated with a latent class model to avoid the assumption of an available perfect test. The 3 tests were the KetoLac BHB (Sanwa Kagaku Kenkyusho Co. Ltd., Nagoya, Japan) test strip that tests milk for β-hydroxybutyrate, the KetoStix (Bayer Diagnostics Europe Ltd., Dublin, Ireland) test strip that tests urine for acetoacetate, and the fat-to-protein percentage ratio (FPR) in milk. A total of 8,902 cows were included in the analysis. The cows were considered to be a random sample from the population of Danish dairy cattle under intensive management, thus representing a natural spectrum of ketosis as a disease. All cows had a recorded FPR between 7 and 21 d postpartum. The KetoLac BHB recordings were available from 2,257 cows and 6,645 cows had a KetoStix recording. The recordings were analyzed with a modified Hui-Walter model, in a Bayesian framework. The specificity of the KetoLac BHB test and the KetoStix test were both high [0.99 (0.97–0.99)], whereas the specificity of FPR was somewhat lower [0.79 (0.77–0.81)]. The best sensitivity was for the KetoStix test [0.78 (0.55–0.98)], followed by the FPR [0.63 (0.58–0.71)] and KetoLac BHB test [0.58 (0.35–0.93)].

Usefulness of Mean Platelet Volume as a Biomarker for Long-Term Outcomes After Percutaneous Coronary Intervention

Larger size platelets have enhanced reactivity. The mean platelet volume (MPV) is a marker of platelet activation and is usually measured as part of blood testing. The aim of the present study was to investigate the utility of the MPV as a biomarker in prognosticating the long-term outcomes after percutaneous coronary intervention (PCI). The baseline MPV values from consecutive patients undergoing PCI were screened. Of the 1,432 patients, the composite primary end point of mortality or myocardial infarction at 1 year occurred in 80 (5.6%). The patients in the highest tertile (MPV >9.1 fL) had an increased frequency of the primary end point compared to those in the mid (8.1 to 9.1 fL) and lowest (<8.1 fL) tertiles (9.0%, 4.5%, and 3.5%, respectively; p <0.01). Logistic regression analysis demonstrated diabetes (odds ratio 2.44, 95% confidence interval 1.48 to 4.00) and highest tertile of MPV (odds ratio 2.42, 95% confidence interval 1.47 to 3.99) as the best predictors of adverse outcomes. In patients with acute coronary syndrome, the preprocedural MPV and troponin levels demonstrated a comparable predictive relation to the primary end point (receiver operator characteristics curve analysis, area under the curve 0.64, p = 0.01; and 0.63, p = 0.01, respectively). In conclusion, an elevated MPV was a strong independent predictor of long-term outcomes after PCI. The preprocedural MPV had prognostic value similar to that of troponin in patients with acute coronary syndrome. These findings could be of importance in the clinical evaluation of patients before PCI and the design of future studies assessing antiplatelet therapies.

The Performance of a Glucose-Ketone Meter in the Diagnosis of Diabetic Ketoacidosis in Patients with Type 2 Diabetes in the Emergency Room

Diabetic ketoacidosis (DKA) is a serious metabolic complication. One of its precipitating causes is insulin omission. DKA requires early diagnosis and strict glucose control, which increases the use of glucose meters in the Emergency Room (ER). We aimed to determine the performance of a glucose-ketone meter in the diagnosis of DKA. From 450 type 2 diabetes mellitus insulin-treated patients attending the ER with a capillary glucose level >13.9 mmol/L, 50 patients (26 men and 24 women, mean age 60.2 +/- 8.2 years) had DKA. Capillary glucose and beta-hydroxybutyrate (beta-OHB) were measured with the Precision-Xtra device (Abbott Laboratories, Abingdon, UK). Serum glucose and biochemical parameters were measured on an automatic analyzer; serum beta-OHB was determined using an enzymatic end-point spectrophotometric method. Urine ketones were determined using a semiquantitative assay (Ketodiastix, Bayer Diagnostics, Stoke Poges, Slough, UK). Serum and capillary beta-OHB values were highly correlated (r = 0.99, P < 0.001), and the mean difference between them was 0.49 mmol/L (95% confidence interval [CI], 0.35-0.95 mmol/L; P = 0.81). Similarly, serum and capillary glucose values were significantly correlated (r = 0.86, P < 0.001), and the mean difference between them was 0.43 mmol/L (95% CI, 0.82-0.93 mmol/L; P = 0.71). Patients with DKA were inadequately treated with insulin and missed clinic appointments: 80% of patients with DKA compared to 20% of patients without DKA. In all cases, DKA was attributed to insulin omission. Capillary ketonemia (beta-OHB >3.0 mmol/L) had the highest performance (sensitivity 99.87%, specificity 92.89%, positive predictive value 92.89%) for the diagnosis of DKA compared with serum ketonemia (sensitivity 90.45%, specificity 88.65%, positive predictive value 87.76%) or ketonuria (sensitivity 89.89%, specificity 52.73%, positive predictive value 41.87%). Implementation of measures such as home glucose and ketone monitoring can possibly decrease the number of hospital admissions due to DKA.

Evaluation of a Glucose Meter in Determining the Glycemic Index of Chinese Traditional Foods

The purpose of this study was to evaluate whether the Glucometer Elite((R)) meter (Bayer Diagnostics, Kyoto, Japan) (POG) could be used for determining the glycemic index (GI) values of Chinese traditional foods, compared with the YSI (Yellow Springs, OH) glucose analyzer (YSI). After consumption of either glucose or one of 11 test foods, the 2-h postprandial glucose responses were measured separately by POG and YSI. GI values and incremental area under the blood glucose response curve (IAUC) values were then calculated to make comparisons between POG and YSI. The mean glucose concentration measured by POG was higher than that measured by YSI (5.54 +/- 0.03 vs. 5.30 +/- 0.03 mmol/L, P < 0.01). The mean IAUC calculated by POG data was also higher than that calculated by YSI data (112.93 +/- 4.04 vs. 106.76 +/- 4.06 mmol.min/L, P < 0.01). However, there were no differences in the mean GI value determined by POG and YSI data for each test food. Although the glucose concentrations measured by POG were higher than that measured by YSI glucose analyzer, it seemed to be an appropriate instrument to determine the GI values of Chinese traditional foods. However, this conclusion should be cautiously applied to other kinds of glucose meters.

Evaluation of Platelet Indices for Differential Diagnosis of Thrombocytosis by ADVIA 120

For the diagnosis of essential thrombocythemia (ET), no single clinical or laboratory finding of diagnostic value is available and a differential diagnosis of other myeloproliferative neoplasms or reactive thrombocytosis (RT) is needed. Following recent developments in automated blood cell analyzers, various platelet indices can now be measured. In this study, we analyzed whether platelet counts and 6 platelet indices can be used for the differentiation of ET from RT in patients with a platelet count of 600x10(3)/microL or more. The subjects studied were 31 patients with ET and 224 patients with RT. The platelet counts, mean platelet volume (MPV), plateletcrit (PCT), platelet distribution width (PDW), mean platelet mass (MPM), mean platelet component concentration (MPC) and large platelets (LPLT) were measured by ADVIA 120 (Bayer Diagnostics, USA). The mean values of each item were compared between the two patient groups and the sensitivity and specificity of each item in the diagnosis of ET were determined by ROC curve analysis. In essential thrombocythemia, all parameters except MPC were significantly higher than in reactive thrombocytosis. For the diagnosis of ET, the sensitivity and specificity were: 74.2% and 84.4%, when the platelet count was > or = 820 x 10(3)/microL; 80.6% and 80.0%, when the plateletcrit was > or = 0.63%; and 64.5% and 99.1%, respectively, when LPLT was > or = 23 x 10(3)/microL. The platelet counts and platelet indices are useful for the differential diagnosis of thrombocytosis. The plateletcrit and LPLT are particularly useful for the diagnosis of ET when the platelet count is markedly increased.

Evaluation of Platelet Indices for Differential Diagnosis of Thrombocytosis by ADVIA 120.

Abstract 4472 BackgroundBecause there is no single clinical or laboratory finding for the diagnosis of essential thrombocythemia (ET), a differential diagnosis of other myeloproliferative neoplasms or reactive thrombocytosis (RT) is always necessary. Developments in automated blood cell analysers can now measure various platelet indices and were used in this study to differentiate between ET and RT in patients with a platelet count of 600×103/μL or more. MethodThe subjects studied were 31 patients with ET and 224 patients with RT. The platelet counts, mean platelet volume (MPV), plateletcrit (PCT), platelet distribution width (PDW), mean platelet mass (MPM), mean platelet component concentration (MPC) and large platelets (LPLT) were measured by ADVIA 120 (Bayer Diagnostics, USA) and the sensitivity and specificity of the two groups were determined. ResultsIn essential thrombocythemia, all parameters except MPC were higher than those of reactive thrombocytosis and were statistically significant. The sensitivity and specificity were 74.2% and 84.4% when the platelet count was more than 820×103/μL. The sensitivity and specificity were 80.6% and 80.0% when the plateletcrit was more than 0.63%. The sensitivity and specificity were 64.5% and 99.1%, respectively, when LPLT was more than 23×103/μL. ConclusionThe platelet counts and platelet indices are important for the differential diagnosis of thrombocytosis. The comparison of the plateletcrit and LPLT is particularly useful when the platelet count is markedly increased. Disclosures:No relevant conflicts of interest to declare.

Determination Of The Glycemic Index Of Selected Chinese Traditional Foods Using Different Glucose Analyzers

PURPOSE: To determine the glycemic index (GI) of 4 Chinese traditional foods and compare the agreement between portable glucose monitoring system (PoG) and the YSI glucose analyzer in determining the GI of the test foods. METHODS: Thirteen healthy adults (8 males and 5 females, age: 26.0 ± 1.3 y, BMI: 21.5 ± 0.6 kg·m-2) volunteered to participate the experiment. All subjects were required to refrain from alcohol consumption and vigorous physical activities 24h before test. After 10-14h overnight fast, the subjects consumed either reference (50g anhydrous glucose) or test foods containing 50g of available carbohydrate. The food included baked barbecued pork puff (BBPP), fried rice in Yangzhou-style (FRYS), fried fritter (FF), and "Mai-lai" cake (MLC). The finger-prick blood samples were collected immediately before, 15, 30, 45, 60, 90, and 120min after food consumption, and were analyzed with portable glucometer (Glucometer Elite, Bayer Diagnostics, Japan) and YSI glucose analyzer (YSI 1500, USA). The GI was calculated by expressing the incremental area under the blood glucose response curve (IAUC) for each test food as a percentage of each subject's average IAUC for the glucose. RESULTS: The mean glucose concentrations measured by PoG were higher than that measured by YSI (5.58 ± 0.05 vs. 5.39 ± 0.05 mmol·L-1, P<0.01). However, there were no differences in average IAUC (136.3 ± 8.3 vs. 135.8 ± 7.7 mmol·min·L-1) and GI (62.7 ± 4.6 vs. 68.8 ± 4.6) between PoG and YSI. There were no differences in the mean within-subject CV for the 13 subjects between IAUCYSI and IAUCPoG (47.3 ± 6.5 vs. 47.9 ± 3.2 %), GIYSI and GIPoG (47.9 ± 7.4 vs. 52.8 ± 3.1 %). Bland-Altman plots showed that the 95% limits of agreement for IAUC was -74.6 to 73.6 mmol·min·L-1, and for GI values was -45 to 57. No differences were observed in the mean GI values of the 4 food items determined by YSI and PoG (BBPP: 57 ± 7 vs. 54 ± 8; FRYS: 79 ± 7 vs. 73 ± 9; FF: 74 ± 9 vs. 69 ± 11; MLC: 66 ± 12 vs. 54 ± 9). CONCLUSIONS: The PoG and YSI glucose analyzer produced similar results in determining the GI of 4 Chinese traditional foods.

Interaction Between Genotypes for HFE and TFR2 Genes Mutations and Iron Status in Brazilian Blood Donors

Hereditary hemochromatosis (HH) is a disorder characterized by increased intestinal iron absorption, which leads to a progressive accumulation of iron in the body. This iron overload has been associated with mutations in HFE gene (C282Y, H63D and S65C) and other genes. The objectives of this study were to assess the frequencies of functional mutations in HFE and TFR2 genes and to investigate their relationship with the iron status in a sample of blood donors. Blood donors (n=542) were recruited at the Hemocenter of the Santa Casa Hospital, Sao Paulo, Brazil. The genotypes for HFE (C282Y, H63D and S65C) TFR2 (Y250X and Q690P) gene mutations were evaluated by PCR-RFLP. The concentrations of serum iron and total iron-binding capacity (TIBC) were measured by automation system Advia®(Bayer Diagnostics) and serum ferritin by Axsym System®(Abbott Laboratories). The frequencies of HFE 282Y, HFE 63D and HFE 65C alleles were 2.1, 13.6 and 0.6%, respectively. The frequency C282Y allele (2.1%) in Brazilian blood donors is lower than that observed in blood donors from Northern Europe (5.1 to 8.2%, P<0.05). The TFR2 250X and TFR2 690P alleles were not found in these subjects. The iron status was similar between HFE genotypes in women. However, men carrying HFE 282CY genotype had higher serum ferritin and lower TIBC concentrations when compared to the HFE 282CC genotype carriers. HFE 282CY genotype was also associated with higher transferrin saturation in men who donated blood at the first time. Moreover, male donors with HFE 63DD plus 63HD genotypes had higher serum iron and transferrin saturation when compared to those with HFE 63HH genotype. A relationship between HFE CY/HH/SS haplotype and lower TIBC concentrations was also found in men. The HFE 282Y and HFE 65C alleles were rare while the HFE 63D was frequent in blood donors. The mutations in TFR2 gene were not found in this study. The HFE 282Y and HFE 63D alleles were associated with alterations on iron status only in male blood donors.

Comparison of four hematology analyzers, CELL‐DYN Sapphire, ADVIA 120, Coulter LH 750, and Sysmex XE‐2100, in terms of clinical usefulness

We evaluated the clinical usefulness (leukocyte distribution classification, morphologic classification, and morphologic flags) of the following four hematology analyzers: CELL-DYN Sapphire (CD-Sapphire) (Abbott Diagnostics, Santa Clara, CA, USA), ADVIA 120 (Bayer Diagnostics, Tarrytown, NY, USA), Beckman Coulter LH 750 (Beckman Coulter, Miami, FL, USA), and Sysmex XE-2100 (TOA Medical Electronics Co., Kobe, Japan). Four hundred thirty samples from patients and 100 samples from healthy individuals were analyzed. For distributional classification, the sensitivity rates of CD-Sapphire, ADVIA 120, LH 750, and XE-2100 were 93.1, 95.9, 94.9, and 94.9%, respectively, and the efficiency rates were 80.7, 81.6, 84.1, and 84.2%, respectively. For morphologic classification, the sensitivity rates of CD-Sapphire, ADVIA 120, LH 750, and XE-2100 were 88.6, 93.2, 77.3, and 94.3%, respectively, and the efficiency rates were 80.9, 73.0, 79.5, and 74.2%, respectively. Comparing the findings in different morphologic flags, XE-2100 showed the highest sensitivity for Blasts flag (90.9%); CD-Sapphire showed the highest sensitivity for Immature granulocytes and/or Left-shift flag (85.5%); ADVIA 120 showed the highest sensitivity for Atypical lymphocytes flag (60.0%); and LH 750 showed the highest sensitivity for Nucleated RBC flag (75.0%). Our results demonstrate that the four analyzers are comparable in overall performance.

Uncommon Hepatitis B Virus and/or Hepatitis C Virus Occult Infection in HIV-Positive Patients With Abnormal Level of Hepatic Enzyme

Elevated liver enzyme levels, detected through liver function test (LFT), are markers of liveror biliary tract diseases. Alanine aminotransferase (ALT) is a more specific indicator of liverinflammation. These abnormal findings are very frequent in HIV infected patients and theirdiagnosis and management may be difficult because of intricacies of the pathogenic mechanisminvolved