Performance evaluation of the high sensitive troponin I assay on the Atellica IM analyser

IntroductionThe Fourth Universal Definition of Myocardial Infarction Global Taskforce recommends the use of high sensitive troponin (hs-Tn) assays in the diagnosis of acute myocardial infarction. We evaluated the analytical performance of the Atellica IM High-sensitivity Troponin I Assay (hs-TnI) (Siemens Healthcare Diagnostics Inc., Tarrytown, USA) and compared its performance to other hs-TnI assays (Siemens Advia Centaur, Dimension Vista, Dimension EXL, and Abbott Architect (Wiesbaden, Germany)) at one or more sites across Europe.Materials and methodsPrecision, detection limit, linearity, method comparison, and interference studies were performed according to Clinical and Laboratory Standards Institute protocols. Values in 40 healthy individuals were compared to the manufacturer’s cut-offs. Sample turnaround time (TAT) was examined.ResultsImprecision repeatability CVs were 1.1–4.7% and within-lab imprecision were 1.8–7.6% (10.0–25,000 ng/L). The limit of blank (LoB), detection (LoD), and quantitation (LoQ) aligned with the manufacturer’s values of 0.5 ng/L, 1.6 ng/L, and 2.5 ng/L, respectively. Passing-Bablok regression demonstrated good correlations between Atellica IM analyser with other systems; some minor deviations were observed. All results in healthy volunteers fell below the 99th percentile URL, and greater than 50% of each sex demonstrated values above the LoD. No interference was observed for biotin (≤ 1500 µg/L), but a slight bias at 5.0 g/L haemoglobin and 50 ng/L Tn was observed. TAT from was fast (mean time = 10.9 minutes) and reproducible (6%CV).ConclusionsReal-world analytical and TAT performance of the hs-TnI assay on the Atellica IM analyser make this assay fit for routine use in clinical laboratories.     

Evaluation of clinical utility of serum enzymes and troponin—T in the early stages of acute myocardial infarction

Laboratory infarction diagnostics are based on the detection of elevated serum activities of total Creatine Kinase (CK), Creatine Kinase isoensyme MB, (CKMB), Lactate dehydrogenase (LDH), isoenzyme forms of LDH and transaminases. Determination of these cardiac marker enzymes permits a highly sensitive diagnosis of transmural myocardial infarction. In such patients the diagnosis of acute myocardial infarction can be confirmed by the clinical, symptoms, and changes in the ECG in addition to the enzyme assays. The 50 AMI patients selected in the present study were those admitted to the ICCU of Shri Krishna Hospital, Karamsad. The blood samples were taken at the time of admission (ie. within four hours of the start of chest pain). The samples were analyzed for CK, CKMB, SGOT, (Serum glutamate oxaloactate transaminase) αHBDH α-hydroxybutyrate dehydrogenase and troponin T. The serum CKMB activity in AMI showed an increase only 5–6 hours after the commencement of chest pain. The elevation in SGOT and αHBDH was still delayed. At the same time we could observe that the cardiac Troponin T (cTnT) was elevated at the time of admission of the patient itself. This increase of cTnT in AMI patients was 20 times higher than the normal blood donors. The controls included 25 normal blood donors and 25 patients with polytraumatic injuries with no chest contusion. The study shows that cTnT estimation could serve in the early diagnosis of AMI. The increase of cardiac troponin T in AMI patients was 20 times higher than the normal blood donors in AMI patients at the time of admission. Cardiac troponin T in serum appears to be a more sensitive indicator of myocardial cell injury than CKMB activity and its detection in the circulation may be a useful prognostic indicator in patients with unstable angina as well. When the blood of normal blood donors or that of patients with polytraumatic injury was analysed the troponin T values were well within the normal range in both the above categories showing that cardiac troponin T is highly specific for heart tissue. Although CKMB and cardiac troponin T are released soon after the myocardial injury, the release of cardiac troponin T is much earlier than CKMB thereby invalidating the important role of cardiac troponin T in diagnosing AMI. Cardiac troponin T has been shown to be highly sensitive for cardiac injury and not elevated in any other trauma, heavy exercise or skeletal muscle injury. Cardiac troponin T is ordinarily undetectable in healthy individuals, and so its measurement can serve as a powerful tool in the diagnosis of AMI.     

Diagnostic accuracy of heart fatty acid binding protein (H-FABP) and glycogen phosphorylase isoenzyme BB (GPBB) in diagnosis of acute myocardial infarction in patients with acute coronary syndrome

Introduction:

This study aimed to assess whether heart fatty acid-binding protein (H-FABP) and glycogen phosphorylase isoenzyme BB (GPBB) could be used for the accurate diagnosis of acute myocardial infarction (AMI) in acute coronary syndrome (ACS) patients.

Materials and methods:

The study included 108 ACS patients admitted to a coronary unit within 3 h after chest pain onset. AMI was distinguished from unstable angina (UA) using a classical cardiac troponin I (cTnI) assay. H-FABP and GPBB were measured by ELISA on admission (0 h) and at 3, 6, 12, and 24 h after admission; their accuracy to diagnose AMI was assessed using statistical methods.

Results:

From 92 patients with ACS; 71 had AMI. H-FABP and GPBB had higher peak value after 3 h from admission than cTnI (P = 0.001). Both markers normalized at 24 h. The area under the receiver operating characteristic curves was significantly greater for both markers in AMI patients than in UA patients at all time points tested, including admission (P < 0.001). At admission, the H-FABP (37%) and GPBB (40%) sensitivities were relatively low. They increased at 3 and 6 h after admission for both markers and decreased again after 24 h. It was 40% for H-FABP and approximately 2-times lower for GPBB (P < 0.01). In AMI patients, both biomarkers had similar specificities, positive- and negative-predictive values, positive and negative likelihood ratios, and risk ratios for AIM.

Conclusion:

H-FABP and GPBB can contribute to early AMI diagnosis and can distinguish AMI from UA.     

Homocysteine status and acute myocardial infarction among Tamilians

Myocardial infarction is a major consequence of coronary artery disease. Apart from the traditional risk factors of myocardial infarction, recently many reports have suggested that hyperhomocysteinemia plays important role in myocardial infarction. Plasma homocysteine level was determined in 60 myocardial infarction patients and in 35 age matched healthy individuals. Statistically significant differences (p<0.01) were observed in the mean of plasma homocysteine concentrations between the acute myocardial infarction patients (24.59±6.14 mM/L) and in normal healthy individuals (13.73 ±3.54 mM/L). The level of homocysteine in myocardial infarction patients is significantly high (p <0.01) among myocardial infarction patients when compared to that of the controls. The the present study indicates a strong association between plasma homocysteine and acute myocardial infarction among Tamilians, thus implying plasma homocysteine as a possible risk factor for myocardial infarction.     

音乐在PCI术后早期急性心肌梗死患者中的应用

目的:探讨音乐应用于PCI术后早期急性心肌梗死患者的作用,促进患者康复.方法:便利抽样100名PCI术后AMI患者,分对照组和音乐组各50例,采用《HAD》和《AIS》调查并记录患者实验前后血压、心率、呼吸.结果:音乐组患者焦虑、睡眠质量、血压、心率、呼吸得分差值下降多于对照组,但抑郁得分较对照组高(P＜0.05).结论:音乐可缓解患者的焦虑,提高睡眠质量,维持血压、心率、呼吸处于相对较低水平.但音乐可释放抑郁情绪,应注意心理护理.     

The significance of troponin T and CK-MB release in coronary artery bypass surgery

Measurement of cardiac markers is an index of care standard in the assessment and diagnosis of cardiovascualr disease. Two of the major cardiac markers are Creatine Kinase isoenzyme CK-MB and Troponin T, which are extensively used in the diagnosis of heart disease. The release of Troponin T and creatine kinase isoenzyme (CK-MB) was investigated in 50 coronary artery bypass surgery patients. Measurement of plasma samples was carried out at five different time points, namely before surgery, 1,6,12,24 hours after surgery. The results indicated that CK-MB level were increased by a factor more than four times compared with the upper limit of baseline (befor surgery). Troponin T concentration showed more than six fold over the upper limit of baseline (before surgert) at 1,6,12,24 hours after surgery. In order to assess the significance of the length of the surgical procedure on the release of Troponin T and CK-MB, the surgery patient were divided into two groups according to the length of the surgical procedure: group I was selected on the basis that the surgical procedure they underwent lasted above 90 minutes and group II with a surgical procedure below 90 minutes. Both Troponin T and CK-MB showed a significant increase in-group I compared to group II. To investigate the likelihood that this effect is party due to myocardial infarction during surgery, the patients were divided into two groups: Group A with some sings of myocardial infarction on Q wave of ECG and group B without any change. The results showed approximately a two-fold increase of these markers in-group A compared to group B. Since these markers reach into blood following damage to myocardial their increase in patients with time course surgery of more than 90 minutes and those with a probability of MI during operation, indicating that these patient fall into a high risk group of repeat (MI) after surgery.     

Development of a highly sensitive direct microtiter plate ELISA for human serum testosterone

A simple, highly sensitive, direct, competitive ELISA for human serum testosterone has been indigenously developed. Specific antisera against testosterone were raised in rabbits using testosterone—3carboxymethyl oxime (CMO)—bovine serum albumin (BSA) as the antigen. For the enzyme conjugate, testoterone—3CMO was coupled with horse raddish peroxidase by the active ester method. The standard curve covered a wide range from 3.9 pg/ml to 500 pg/ml. The inter and intra-assay variation were found to be low and within the acceptable limits. Specificity and accuracy for the assay was established by having negligible crossreactivity with the related steroids and an excellent parallelism between the sample and standard dilution curve. Samples measured by RIA and ELISA showed very high degree of correlation (r=0.991).     

Combinatorial Determination of Ischemia Modified Albumin and Protein Carbonyl in the Diagnosis of NonST-Elevation Myocardial Infarction

Ischemia modified albumin (IMA) and Protein Carbonyl (PC) have known as proteins that are modified on the similar basis of oxidative stress induced protein modification and may have diagnostic potential in acute myocardial infarction. This study aims to evaluate the ability of using IMA and PC content to diagnose Non-ST elevation myocardial infarction (NSTEMI) and efficiency of combining these two markers. Serum from NSTEMI and healthy control were determined for serum IMA and PC content. The results showed that both of serum IMA level and PC content in NSTEMI was significantly higher than that of healthy controls. However, the PC content showed greater diagnostic performance than IMA. Combinatorial determination of serum IMA level with PC content level was enhanced test efficiency. In conclusion, our finding demonstrated that IMA and PC content can be used as a diagnostic marker for NSTEMI.     

The neutrophil-lymphocyte ratio to predict poor prognosis of critical acute myocardial infarction patients: a retrospective cohort study

IntroductionInflammation is closely related to adverse outcomes of acute myocardial infarction (AMI). This study aimed to evaluate whether neutrophil-lymphocyte ratio (NLR) can predict poor prognosis of critical AMI patients.Materials and methodsWe designed a retrospective cohort study and extracted AMI patients from the “Medical Information Mart for Intensive Care-III” database. The primary outcome was 1-year all-cause mortality. The secondary outcomes were 90-day and in-hospital all-cause mortalities, and acute kidney injury (AKI) incidence. The optimal cut-offs of NLR were picked by X-tile software according to the 1-year mortality and patient groups were created: low-NLR (< 4.8), high-NLR (4.8 - 21.1), and very high-NLR (> 21.1). Cox and modified Poisson regression models were used to evaluate the effect of NLR on outcomes in critically AMI patients.ResultsFinally, 782 critical AMI patients were enrolled in this study, and the 1-year mortality was 32% (249/782). The high- and very high-NLR groups had a higher incidence of outcomes than the low-NLR group (P < 0.05). The multivariate regression analyses found that the high- and very high-NLR groups had a higher risk of 1-year mortality (Hazard ratio (HR) = 1.59, 95% CI: 1.12 to 2.24, P = 0.009 and HR = 1.73, 95% CI: 1.09 to 2.73, P = 0.020), 90-day mortality (HR = 1.69, 95% CI: 1.13 to 2.54, P = 0.011 and HR = 1.90, 95% CI: 1.13 to 3.20, P = 0.016), in-hospital mortality (Relative risk (RR) = 1.77, 95% CI: 1.14 to 2.74, P = 0.010 and RR = 2.10, 95% CI: 1.23 to 3.58, P = 0.007), and AKI incidence (RR = 1.44, 95% CI: 1.06 to 1.95, P = 0.018 and RR = 1.34, 95% CI: 0.87 to 2.07, P = 0.180) compared with low-NLR group. NLR retained stable predictive ability in sensitivity analyses.ConclusionBaseline NLR is an independent risk factor for 1-year mortality, 90-day mortality, in-hospital mortality, and AKI incidence in AMI patients.     

Glycogen phosphorylase isoenzyme BB in the diagnosis of acute myocardial infarction: a meta-analysis

Background

Early diagnosis is crucial for management of patients with suspected acute myocardial infarction (AMI). Among innovative and promising biomarkers, the recent interest raised on glycogen phosphorylase isoenzyme BB (GPBB) has prompted us to perform a meta-analysis of published studies.

Materials and methods:

A systematic electronic search was carried out on PubMed, Web of Science and Google Scholar, with no date restriction, to retrieve all articles that have investigated the early diagnostic performance of GPBB in patients with suspected AMI, and directly reported or allowed calculation of sensitivity and specificity. A meta-analysis of the reported sensitivity and specificity of each study and pooled area under the curve (AUC) was then performed by random effect approach. Heterogeneity was assessed by I-square statistics.

Results:

Eight studies were finally selected for analysis (941 subjects; 506 cases and 435 controls), with a high heterogeneity (I-squared, 86.3%). The resulting pooled estimates and 95% confidence interval were 0.854 (0.801–0.891) for sensitivity, 0.767 (0.713–0.815) for specificity, 0.826 (0.774–0.870) for negative predictive value, 0.802 (0.754–0.844) for positive predictive value, and 0.754 (0.602–0.907) for AUC. In those studies that have simultaneously assessed GPBB and a troponin immunoassay, the combination of these biomarkers did not significantly improve the performance of troponin alone.

Conclusion:

GPBB does not meet the current requirements for an efficient diagnosis of AMI when used as a stand-alone test, whereas its combination with troponin merits further investigation in larger trials.     

Effect of vitamin E on platelet enzymatic anti-oxidants in the patients of myocardial infarction

Effect of administration of 600 mg. vitamin E each day, for six days, was observed on activity of some of the anti-oxidant enzymes and levels of malondialdehyde (as an index of free radical mediated damage) in the platelets of patients reperfused after myocardial infarction. It has been found that vitamin E administration significantly lowers the level of malondialdehyde in the patients. Vitamin E administration increases the activities of anti oxidant enzymes (viz. superoxide dismutase, glutathione reductase and catalase) tested both in the patients and healthy controls. Vitamin E administration causes general stimulation of anti-oxidant enzyme activities both in healthy persons and the patients, however, lowering of lipid per-oxidation upon administration of vitamin E is specific for patients. These findings exhibit beneficial role of vitamin E administration in the management of the patients reperfused after myocardial infarction.     

Role of l-Arginine on Dyslipidemic Conditions of Acute Myocardial Infarction Patients

Oxidative stress conditions associated with atherosclerosis leads to oxidative modification of low-density lipoprotein (LDL). The body’s capabilities to inhibit LDL oxidation and to remove or neutralize the atherogenic oxidized LDL (ox-LDL) are limited. When the LDL cholesterol level increases in the blood, it leads to dangerous consequences like atherosclerosis, leading to myocardial infarction. The major effect of an antioxidant in the LDL environment is to prevent the formation of ox-LDL (during atherogenesis. Strategies to reduce LDL oxidation and prevent atherogenesis can involve the enrichment of arterial cells with potent antioxidants that can prevent oxidative damage to the arterial wall. The objective of this study is to evaluate the effect of l-arginine on serum lipid and cholesterol levels in the patients of acute myocardial infarction (AMI). The study consisted of 70 AMI patients and 60 healthy individuals (serving as control) age 55–65 years. Serum levels of total cholesterol, high density lipoprotein (HDL), LDL and Triglycerides were determined on day 1 and day 15 of l-arginine administration (oral dose 3 g/day). The total cholesterol/HDL and the LDL/HDL ratio were calculated and compared. As per the observations, l-arginine administration was found to improve the lipid profile of the subjects. Hence it could be used as an adjuvant therapy for AMI and as a preventive measure for the onset of the disease in the healthy elderly also.     

Utilization of biological variation data in the interpretation of laboratory test results – survey about clinicians’ opinion and knowledge

IntroductionTo interpret test results correctly, understanding of the variations that affect test results is essential. The aim of this study is: 1) to evaluate the clinicians’ knowledge and opinion concerning biological variation (BV), and 2) to investigate if clinicians use BV in the interpretation of test results.Materials and methodsThis study uses a questionnaire comprising open-ended and close-ended questions. Questions were selected from the real-life numerical examples of interpretation of test results, the knowledge about main sources of variations in laboratories and the opinion of clinicians on BV. A total of 399 clinicians were interviewed, and the answers were evaluated using a scoring system ranked from A (clinician has the highest level of knowledge and the ability of using BV data) to D (clinician has no knowledge about variations in laboratory). The results were presented as number (N) and percentage (%).ResultsAltogether, 60.4% of clinicians have knowledge of pre-analytical and analytical variations; but only 3.5% of them have knowledge related to BV. The number of clinicians using BV data or reference change value (RCV) to interpret measurements results was zero, while 79.4% of clinicians accepted that the difference between two measurements results located within the reference interval may be significant.ConclusionsClinicians do not use BV data or tools derived from BV such as RCV to interpret test results. It is recommended that BV should be included in the medical school curriculum, and clinicians should be encouraged to use BV data for safe and valid interpretation of test results.     

Evaluation of sevafilachek immunoassays and rapid ICT-filariasis test for detection of bancroftian filariasis

A comparative analysis was made on the utility of SEVAFILACHEK-stick based immunoassays and commercially available ICT-filariasis test to detect active infection in different groups of bancroftian filariasis. The SEVAFILACHEK immunoassays were found to be useful to detect filarial infection in microfilaraemia and in a significant number of clinical filarial cases with acute, chronic and occult clinical manifestations. In the clinical cases, microfilariae are not usually detected in peripheral circulation. Employing SEVAFILACHEK assays 6 and 5 of the 7 samples of patients with chronic filarial disease, and 6 and 5 of 6 microfilaraemic cases gave positivity for filarial IgG antibodies and antigen respectively. Four of the 6 occult filarial samples were positive for antibodies and antigen. Filarial antigen was detected by ICT-filariasis test in blood samples of all the 6 microfilariaemic cases, 1 chronic filarial and 2 occult filarial samples. The main advantage of ICT assay is its rapid format and convenience for field use.     

生物样本：生物多样性研究与保护的重要支撑

生物标本是生物学研究领域的重要素材,是不可再生的战略生物资源。中国科学院生物标本馆是中国生物标本资源保藏、研究和科学教育的中心,在中国生物多样性研究与保护中具有不可替代的重要作用。生物标本能够提供物种、空间和时间3个维度的重要信息,有巨大潜力服务于生物多样性的研究与保护。通过对这些信息的挖掘、利用,可有效支撑生物多样性相关领域的研究,包括物种认知、生物多样性编目、濒危物种保护与管理、外来生物入侵防治、生物多样性监测,以及物种分布格局与生物多样性变化等。未来对标本资源的建设和管理需要致力于更加全面地收集和保藏,加强深层次信息的获取和数据整合平台的建设,才能更好地为我国生态文明建设和生物多样性保护贡献力量。     

Troponin T and Heart Type Fatty Acid Binding Protein (h-Fabp) as Biomarkers in Patients Presenting with Chest Pain

Acute coronary syndrome (ACS) is a term for a range of clinical signs and symptoms suggestive of myocardial ischemia. It results in functional and structural changes and ultimately releasing protein from injured cardiomyocytes. These cardiac markers play a major role in diagnosis and prognosis of ACS. This study aims to assess the efficacy of heart type fatty acid binding protein (h-FABP) as a marker for ACS along with the routinely used hs-TropT. In our observational study, plasma h-FABP (cut-off 6.32 ng/ml) and routinely done hs-Trop T (cutoff 0.1 and 0.014 ng/ml) were estimated by immunometric laboratory assays in 88 patients with acute chest pain. Based on the clinical and laboratory test findings the patients were grouped into ACS (n = 41) and non-ACS (n = 47). The diagnostic sensitivity, specificity, NPV, PPV and ROC curve at 95 % CI were determined. Sensitivity of hs-TropT (0.1 ng/ml), hs-TropT (0.014 ng/ml) and h-FABP were 53, 86 and 78 % respectively and specificity for the same were 98, 73 and 70 % respectively. Sensitivity, specificity and NPV calculated for a cut-off combination of hs-TropT 0.014 ng/ml and h-FABP was 100, 51 and 100 % respectively. These results were substantiated by ROC analysis. Measurement of plasma h-FABP and hs-TropT together on admission appears to be more precise predictor of ACS rather than either hs-Trop T or h-FABP.     

生物多样性保护与生物资源永续利用

通过阐释生物多样性研究的概念,探讨生物资源与生物多样性对人类的重要影响,分析生物资源研究状况、生物多样性研究进展、现代高新生物技术在生物资源利用和生物多样性保护中的应用等,提出了在扩大内需满足我国不断增长的社会需求之时,应注重生物多样性的有效保护机制、长效保护策略研究,为重点物种保护工程提供理论基础和关键核心技术支撑;同时加强具有自主知识产权的生物资源永续利用研发,推动新兴生物产业升级,对现代化生态城市建设、构建资源节约型和环境友好型社会都有重要指导作用。寻求自身发展与自然界和谐相处的可持续发展方式,将是人类发展道路的必然选择。     

外来物种入侵的预警与立法管理

文章从我国外来物种入侵和管理现状的实际情况出发,借鉴世界其它国家对生物入侵预警与管理的经验,提出我国应加强外来物种管理与入侵物种防治方面的立法,成立国家外来入侵物种鉴定与预警信息服务中心和国家外来入侵物种应急控制联合办公室,组织专家指导委员会,并加强培养抵御外来物种入侵的公众意识等建议。     

Serum markers for early diagnosis of non-‘Q’ wave and ‘Q’ wave myocardial infarction

The present study conducted on twenty-five uncomplicated cases of acute myocardial infarction diagnosed by clinical and electrocardiographic findings indicated significantly increased level of cardiac Troponin-T and increased activities of the enzymes total creatine kinase, creatine kinase-MB, aspartate transaminase and lactate dehydrogenase as compared to the twenty-five healthy control subjects. The level of cardiac Troponin-T and the activities of the enzymes total creatine kinase, creatine kinase-MB, aspartate transaminase and lactate dehydrogenase was found to be higher in “Q” wave myocardial infarction patients as compared to the non-“Q” wave and the controls. Since cardiac Troponin-T has been shown to increase in unstable angina and renal failure without cardiac disease and creatine kinase-MB activity has been found to be normal in patients with unstable angina and increase very slightly in patients with renal failure, it was concluded that a combination of cardiac Troponin-T and creatine kinase-MB activity was sufficient for the early diagnosis of acute myocardial infarction.