Reliability of Laboratory Tests for the Control of Oral Anticoagulation

1974 ◽  
Vol 32 (02/03) ◽  
pp. 483-491
Author(s):  
E. A Loeliger ◽  
M. J Boekhout-Mussert ◽  
L. P van Halem-Visser ◽  
J. D. E Habbema ◽  
H de Jonge
Keyword(s):  
Human Brain ◽  
Laboratory Tests ◽  
Test Procedure ◽  
Rabbit Brain ◽  
Normal Range ◽  
Test Procedures ◽  
Discrimination Power ◽  
Power Of The Test ◽  
Assay Procedure ◽  
Low Sensitivity

SummaryThe present study concerned the reproducibility of the so-called prothrombin time as assessed with a series of more commonly used modifications of the Quick’s onestage assay procedure, i.e. the British comparative reagent, homemade human brain thromboplastin, Simplastin, Simplastin A, and Thrombotest. All five procedures were tested manually on pooled lyophilized normal and patients’ plasmas. In addition, Simplastin A and Thrombotest were investigated semiautomatically on individual freshly prepared patients’ plasmas. From the results obtained, the following conclusions may be drawn :The reproducibility of results obtained with manual reading on lyophilized plasmas is satisfactory for all five test procedures. For Simplastin, the reproducibility of values in the range of insufficient anticoagulation is relatively low due to the low discrimination power of the test procedure in the near-normal range (so-called low sensitivity of rabbit brain thromboplastins). The reproducibility of Thrombotest excels as a consequence of its particularly easily discerned coagulation endpoint.The reproducibility of Thrombotest, when tested on freshly prepared plasmas using Schnitger’s semiautomatic coagulometer (a fibrinometer-liJce apparatus), is no longer superior to that of Simplastin A.The constant of proportionality between the coagulation times formed with Simplastin A and Thrombotest was estimated at 0.64.Reconstituted Thrombotest is stable for 24 hours when stored at 4° C, whereas reconstituted Simplastin A is not.The Simplastin A method and Thrombotest seem to be equally sensitive to “activation” of blood coagulation upon storage.

Profil Penyakit Malaria Di Rumah Sakit Islam Siti Rahmah Padang Tahun 2018

2020 ◽  
Vol 2 (2) ◽  
pp. 08-15
Author(s):  
Rahma Triyana ◽  
Salmi Salmi
Keyword(s):  
Observational Study ◽  
Frequency Distribution ◽  
Cross Section ◽  
Laboratory Tests ◽  
Age Group ◽  
Normal Range ◽  
Cross Sectional ◽  
West Sumatra ◽  
Severity Of The Disease

Malaria is one of the health problems in Indonesia, especially West Sumatra. Determination of the description of Malaria disease in an area is needed to determine the spread and severity of the disease. This study aims to determine the frequency distribution according to age, sex and place of residence, description of the types of Plasmodium causes of Malaria and hematological features in Malaria patients at Siti Rahmah Padang Hospital in 2018. This type of research is a descriptive observational study with an approach or design cross section (cross sectional). The frequency distribution of Malaria sufferers in Siti Rahmah Padang Hospital in 2018 according to the highest age was in the age group 21-30 years as many as 28 cases (36.8%), the highest sex among men was 46 (60.5%) and the highest number of residences was found in Koto Tangah sub-district there were 31 cases (40.8%). The type of Plasmodium found in Malaria cases in Siti Rahmah Padang Hospital in 2018 was P. vivax (73 cases (96.05%)) and P. falciparum (3 cases (3.95%)). The results of laboratory tests on Hb, hematocrit, platelet and leukocyte levels in Malaria positive patients in Siti Rahmah Padang Hospital in 2018 were in the normal range.

Profil Penyakit Malaria di Rumah Sakit Islam Siti Rahmah Padang Tahun 2018

2020 ◽  
Vol 2 (2) ◽  
pp. 08-15
Author(s):  
Rahma Triyana Y ◽  
Salmi Salmi
Keyword(s):  
Observational Study ◽  
Frequency Distribution ◽  
Cross Section ◽  
Laboratory Tests ◽  
Age Group ◽  
Normal Range ◽  
Cross Sectional ◽  
West Sumatra ◽  
Severity Of The Disease

Malaria is one of the health problems in Indonesia, especially West Sumatra. Determination of the description of Malaria disease in an area is needed to determine the spread and severity of the disease. This study aims to determine the frequency distribution according to age, sex and place of residence, description of the types of Plasmodium causes of Malaria and hematological features in Malaria patients at Siti Rahmah Padang Hospital in 2018. This type of research is a descriptive observational study with an approach or design cross section (cross sectional). The frequency distribution of Malaria sufferers in Siti Rahmah Padang Hospital in 2018 according to the highest age was in the age group 21-30 years as many as 28 cases (36.8%), the highest sex among men was 46 (60.5%) and the highest number of residences was found in Koto Tangah sub-district there were 31 cases (40.8%). The type of Plasmodium found in Malaria cases in Siti Rahmah Padang Hospital in 2018 was P. vivax (73 cases (96.05%)) and P. falciparum (3 cases (3.95%)). The results of laboratory tests on Hb, hematocrit, platelet and leukocyte levels in Malaria positive patients in Siti Rahmah Padang Hospital in 2018 were in the normal range.

scholarly journals Experimental Testing of a Size-Exclusion Chromatography Method Used for Evaluation of Molecular Parameters of Equine Anti-Ebola Immunoglobulin

2019 ◽  
Vol 19 (4) ◽  
pp. 261-267
Author(s):  
Е. Yu. Mishalova ◽  
E. V. Gordeev ◽  
V. N. Lebedev ◽  
S. A. Melnikov ◽  
S. A. Nimirskaya ◽  
...  
Keyword(s):  
Specific Activity ◽  
Experimental Testing ◽  
Horse Serum ◽  
Test Procedure ◽  
Size Exclusion ◽  
Array Detector ◽  
Test Procedures ◽  
Molecular Parameters ◽  
Hplc System

Haemorrhagic fever caused by the Ebola virus is a highly hazardous infectious disease with a mortality rate of 50– 90 %. Heterologous immunoglobulins with a high virus-neutralizing titer are an important element of the WHO-endorsed set of measures for emergency prevention and treatment of the disease. Specific activity of these products is largely determined by their fractional composition, and, in particular, by molecular mass distribution (MMD). The size-exclusion-high-performance liquid chromatography (SEC-HPLC) has traditionally been used for determination of the MMD of the target protein in human immunoglobulin-based products. The use of this method for evaluation of molecular parameters of heterologous immunoglobulin requires confirmation of its specificity, accuracy and precision, and establishment of the chromatographic system suitability criteria in the context of a new test object.The aim of the study was to test the applicability of the SEC-HPLC method to the assessment of molecular parameters of anti-Ebola immunoglobulin derived from horse serum.Materials and methods: three batches of purified equine anti-Ebola immunoglobulin were used in the study. Normal equine and human immunoglobulins of the IgG isotype were used as reference standards. The HPLC test procedures described in the European Pharmacopoeia 9.6 and State Pharmacopoeia of the Russian Federation, 14th ed., were used for determination of monomers and other immunoglobulin fractions. An Agilent 1260 Infinity (Agilent, USA) HPLC system with a diode array detector and an Agilent Bio SEC-3 HPLC column were used for quality evaluation of the tested products.Results: the resolution factor between IgG monomer and dimer peaks (1.69 and 2.10), and the chromatographic column efficiency (>2000) make it possible to use the SEC-HPLC system for evaluation of molecular parameters of heterologous immunoglobulin. The study demonstrated reproducibility of the test procedure.Conclusions: the study confirmed the applicability of the SEC-HPLC procedure for evaluation of molecular parameters of anti-Ebola immunoglobulin derived from horse serum. It demonstrated the compliance of the purified immunoglobulin to the national and international quality requirements in terms of «Molecular parameters».

scholarly journals Pengaruh Kemampuan Analisis terhadap Prestasi Belajar Matematika Ditinjau dari Intellegent Quotion (IQ)

2017 ◽  
pp. 57
Author(s):  
Agus Setiawan
Keyword(s):  
Comparative Research ◽  
Homogeneity Test ◽  
Discrimination Power ◽  
Learning Achievement ◽  
Normality Test ◽  
Power Of The Test ◽  
Mathematics Test ◽  
Bartlett Test ◽  
Lilliefors Test ◽  
Achievement In Mathematics

The objective of this research was to investigate the effect of analytical on learning achievement viewed from IQ. This research used the causal comparative research with the factorial design of 3 x 3. Its population was all of the students of mathematics education in Islamic Institute Of Ma’arif NU Metro Lampung. The samples of the research were taken by using the random sampling. The instruments used to gather the data of the research were test of learning achievement in Mathematics, test of analytical individu and test of IQ of the students. Prior to their use, both the test were tried out. Their contents were validated by the related experts. The reliability of the instruments was tested by using the Cronbach Alpha formula. The discrimination power of the test and the internal consistency of the questionnaire used Karl Pearson’s product moment correlation formula. The pre-requisite tests of the research included the normality test by using Lilliefors test and homogeneity test by using Bartlett test. The proposed hypotheses of the research were tested by using the two-way analysis of variance with unbalanced cells. The results of the research are as follows. 1) The students with high IQ have a better learning achievement in Mathematics than students with moderate IQ. 2) The students with the high analytical individu have a better learning achievement in Mathematics than those with the moderate and low analytical individu, and the students with the moderate analytical individu have a better learning achievement in Mathematics than those with the low analytical individu. 3) There was interaction among analytical and IQ on learning achievement mathematics.

Test procedure and sample size determination for a proportion study using a double-sampling scheme with two fallible classifiers

2017 ◽  
Vol 28 (4) ◽  
pp. 1019-1043 ◽  
Author(s):  
Shi-Fang Qiu ◽  
Xiao-Song Zeng ◽  
Man-Lai Tang ◽  
Wai-Yin Poon
Keyword(s):  
Sample Size ◽  
Null Hypothesis ◽  
Test Procedure ◽  
Sample Size Determination ◽  
Double Sampling ◽  
Score Statistic ◽  
Wald Statistic ◽  
Test Procedures ◽  
Practical Applications ◽  
Logit Transformation

Double sampling is usually applied to collect necessary information for situations in which an infallible classifier is available for validating a subset of the sample that has already been classified by a fallible classifier. Inference procedures have previously been developed based on the partially validated data obtained by the double-sampling process. However, it could happen in practice that such infallible classifier or gold standard does not exist. In this article, we consider the case in which both classifiers are fallible and propose asymptotic and approximate unconditional test procedures based on six test statistics for a population proportion and five approximate sample size formulas based on the recommended test procedures under two models. Our results suggest that both asymptotic and approximate unconditional procedures based on the score statistic perform satisfactorily for small to large sample sizes and are highly recommended. When sample size is moderate or large, asymptotic procedures based on the Wald statistic with the variance being estimated under the null hypothesis, likelihood rate statistic, log- and logit-transformation statistics based on both models generally perform well and are hence recommended. The approximate unconditional procedures based on the log-transformation statistic under Model I, Wald statistic with the variance being estimated under the null hypothesis, log- and logit-transformation statistics under Model II are recommended when sample size is small. In general, sample size formulae based on the Wald statistic with the variance being estimated under the null hypothesis, likelihood rate statistic and score statistic are recommended in practical applications. The applicability of the proposed methods is illustrated by a real-data example.

scholarly journals Effects of a Synthetic Factor Xa Inhibitor (JTV-803) on Various Laboratory Tests

2002 ◽  
Vol 8 (4) ◽  
pp. 325-336 ◽  
Author(s):  
Mahmut Tobu ◽  
Omer Iqbal ◽  
Debra A. Hoppensteadt ◽  
Christopher Shultz ◽  
Walter Jeske ◽  
...  
Keyword(s):  
Oral Anticoagulant ◽  
Laboratory Tests ◽  
Factor Xa ◽  
International Normalized Ratio ◽  
Factor Xa Inhibitors ◽  
Rabbit Brain ◽  
Factor Xa Inhibitor ◽  
Thrombin Time ◽  
Clotting Time ◽  
Direct Inhibitors

Synthetic direct inhibitors of factor Xa are capable of prolonging the global anticoagulant assay times in a concentration-dependent fashion. The relative degree of thrombin generation inhibition at an equivalent prolongation is not similar to the results observed with heparins and oral anticoagulant drugs. In addition, the direct factor Xa inhibitors prolong the Russell' viper venom test (RVVT) and Heptest clotting times. Ecarin clotting time (ECT) and thrombin time (TT) remain unaffected. The kinetics of factor Xa inhibition are markedly different than those observed with pentasac-charide and heparins. Therefore, the methods developed for heparins and pentasaccharides may not be applicable for the monitoring of factor Xa inhibitors. To test the feasibility of using the prothrombin time (PT), International Normalized Ratio (INR), activated partial thromboplastin time (aPTT), Heptest, thrombin time, RVVT, ECT, and a modified anti-Xa amidolytic assay, to monitor a synthetic factor Xa inhibitor, normal human pool plasma samples were spiked with a synthetic factor Xa inhibitor in the concentration range of 0 to 1 μg/mL and 0 to 25 μg/mL. Different laboratory tests were performed and INR and other ratios were calculated. The anticoagulant effects on whole blood were measured using the activated clotting time (ACT). Further studies on the effect of factor Xa inhibitor on platelet aggregation; factor II, VII, and X functional levels; and fibrinopeptide A (FPA) generation were carried out at equivalent INR levels in comparison to oral anticoagulant and antithrombin agents. FPA generation at equivalent anticoagulant level in comparison to heparin (twice the baseline) was also carried out. Factor Xa inhibitor produced a concentration-dependent prolongation of the ACT. ACT was doubled at a concentration of 4 to 5 μg/mL. There was a marked difference in the prolongation of the PT by a synthetic factor Xa inhibitor dependent on the ISI of the PT reagent used. When the results were calculated to determine INR, marked variations were noted between the recombinant thromboplastin and rabbit brain thromboplastin. The rabbit brain thromboplastin reagent gave markedly high INR values. Similar results were observed when different aPTT reagents were studied. In the anti-Xa assay, modification of the incubation time was employed to extend the proper sensitivity range. These studies warrant further investigation to understand the mechanism of action of factor Xa inhibitors.

Investigation of the CoreLok for Maximum, Aggregate, and Bulk Specific Gravity Tests

2005 ◽  
Vol 1907 (1) ◽  
pp. 135-144 ◽  
Author(s):  
Gregory A. Sholar ◽  
Gale C. Page ◽  
James A. Musselman ◽  
Patrick B. Upshaw ◽  
Howard L. Moseley
Keyword(s):  
Specific Gravity ◽  
Test Procedure ◽  
High Porosity ◽  
Test Results ◽  
Test Procedures ◽  
Coarse Aggregates ◽  
Fine Aggregates ◽  
Florida Department ◽  
Plastic Bag ◽  
Apparent Reason

The Florida Department of Transportation uses long-established test procedures to determine the maximum specific gravity (Gmm) and bulk specific gravity (Gmb) of asphalt mixtures and the bulk specific gravity (Gsb) of aggregates. The CoreLok, a vacuum-sealing device that can be used to determine these properties, was evaluated by the department for these test procedures. With respect to the Gmm test procedure, for mixtures containing nonabsorptive granites, the CoreLok determined results equivalent to those of the department's test procedure. However, for mixtures containing absorptive limestones, the CoreLok determined higher Gmm values than did the department's test procedure. The apparent reason for the discrepancy is that the CoreLok does not determine a saturated surface dry condition of the sample. With respect to the aggregate specific gravity test procedures, the CoreLok provided test results equivalent to the department's test procedure for the nonabsorptive fine aggregates only. For the absorptive fine aggregates and all of the coarse aggregates, the CoreLok determined Gsb test results significantly different from those of the department's test procedures. The CoreLok may be suitable for determining Gmb for coarse-graded compacted specimens with high porosity and air voids. There are concerns with the accuracy of the CoreLok results because of the bridging effect of the plastic bag over the large surface voids and because of the CoreLok's significant underestimation of the specific gravity of a solid aluminum cylinder.

Comparison of effects of dry versus wet swallowing on Eustachian tube function via a nine-step inflation/deflation test

2005 ◽  
Vol 119 (9) ◽  
pp. 704-708 ◽  
Author(s):  
M Kemal Adali ◽  
Cem Uzun
Keyword(s):  
Middle Ear ◽  
Test Procedure ◽  
Step Test ◽  
Eustachian Tube Function ◽  
Single Session ◽  
Test Procedures ◽  
Tube Function ◽  
The Difference ◽  
Test Result ◽  
First Session

The aim of the present study is to evaluate the effect of swallowing type (dry versus wet) on the outcome of a nine-step inflation/deflation tympanometric Eustachian tubefunction (ETF) test in healthy adults.Fourteen normal healthy volunteers, between 19 and 28 years of age, were included in the study. The nine-step test was performed in two different test procedures: (1) test with dry swallows (dry test procedure) and (2) test with liquid swallows (wet test procedure). If the equilibration of middle-ear (ME) pressure was successful in all the steps of the nine-step test, ETF was considered ‘Good’. Otherwise, the test was considered ‘Poor’, and the test was repeated at a second session.In the dry test procedure, ETF was ‘Good’ in 21 ears at the first session and in 24 ears after the second session (p > 0.05). However, in the wet test procedure, ETF was ‘Good’ in 13 ears at the first session and in 21 ears after the second session (p < 0.05).At the first session, ETF was ’Good’ in 21 and 13 ears in the dry and wet test procedures, respectively. The difference was statistically significant (p < 0.05). However, after the second session, the overall number of ears with ‘Good’ tubal function was almost the same in both test procedures (24 ears at dry test procedures versus 21 ears at wet test procedures;p > 0.05).Dry swallowing seems to be more effective for the equilibration of ME pressure. Thus, a single-session dependent evaluation of ETF may be efficient for the dry test procedure of the nine-step test. Swallowing with water may be easier for subjects, but a repetition of the test at a second session may be necessary when the test result is ‘Poor’.

Exact tests in binary data under an incomplete block crossover design

2016 ◽  
Vol 27 (2) ◽  
pp. 579-592 ◽  
Author(s):  
Kung-Jong Lui ◽  
Kuang-Chao Chang
Keyword(s):  
Binary Data ◽  
Logistic Regression Model ◽  
Crossover Trial ◽  
Test Procedure ◽  
Crossover Design ◽  
Incomplete Block ◽  
Primary Dysmenorrhea ◽  
Test Procedures ◽  
Exact Test ◽  
High Doses

To improve the power of a parallel groups design and reduce the time length of a crossover trial, we may consider an incomplete block crossover design. Under a distribution-free random effects logistic regression model, we derive an exact test and a Mantel-Haenszel Type of summary test procedure for testing non-equality in binary data when comparing three treatments. We employ Monte Carlo simulation to evaluate the performance of these test procedures. We find that both test procedures developed here can perform well in a variety of situations. We use the data taken as a part of the crossover trial comparing the low and high doses of an analgesic with a placebo for the relief of pain in primary dysmenorrhea to illustrate the use of the proposed test procedures.

scholarly journals Determination of Vancomycin B and Vancomycin Impurities by Liquid Chromatography

2021 ◽  
Vol 11 (4) ◽  
pp. 246-254
Author(s):  
S. I. Kuleshova ◽  
E. P. Simonova ◽  
O. N. Vysochanskaya
Keyword(s):  
Liquid Chromatography ◽  
Chromatographic Separation ◽  
Separation Efficiency ◽  
Test Procedure ◽  
Testing Time ◽  
Test Procedures ◽  
British Pharmacopoeia ◽  
Related Impurities ◽  
Vancomycin Hydrochloride

The preferred test methods for control of product-related impurities in medicinal products are high-performance liquid chromatography (HPLC) with a fine sorbent, and ultra-performance liquid chromatography (UPLC), which allow for better chromatographic separation of active substances and related impurities, reduction of time costs, and saving of material resources. The aim of the study was to develop HPLC and UPLC test procedures and assess the chromatographic separation capacity and efficiency in order to improve determination of the main vancomycin component and related impurities. Materials and methods: vancomycin hydrochloride lyophilisate for oral solution and solution for injection, and vancomycin hydrochloride reference standard (USP RS) were used as test objects. Agilent 1290 Infinity liquid chromatography system, and Chromolith® Performance RP-18e, Kinetex C18, Nucleodur C18 Isis, Zorbax RRHD Eclipse Plus C18, and LiChrospher® RP-18 columns were used for the testing. Results: HPLC analysis using a Chromolith® column (100×4.6 mm) reduces the testing time by 10 minutes compared to the USP test procedure, and by 15 minutes compared to the British Pharmacopoeia procedure. The proposed test procedure requires less eluent and increases chromatographic separation efficiency. UPLC analysis using a Kinetex C18 column (50×4.6 mm, 2.6 μm) made it possible to reduce the testing time by two thirds compared to the British Pharmacopoeia procedure. The use of isocratic elution greatly simplified the testing. The testing time under the proposed chromatographic conditions was 10 minutes. Conclusions: the selected HPLC and UPLC test conditions made it possible to significantly reduce the time of testing, minimise the use of expensive reagents, and increase efficiency of chromatographic separation in the determination of vancomycin impurities and the main component Vancomycin B.

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