Multi-Sample Slippage Test for Ordered Observations

A multi-sample slippage test based on ordered observations has been given. The test statistic is based on the sum of ranks of the sample. The probability distribution of the test statistic has been worked out for small sample and it turns out to be chi-square distribution for large sample. The analytical procedure has been explained by a numerical example.     

Fractionation in Triad Comparisons

A statistical procedure for comparing the performance of a new product with the existing products on the basis of sensory characters has been developed. A test statistic was evolved for testing the null hypothesis of equality of treatment effects in the case of fractional triad comparisons. The null distribution of the test statistic has been obtained and it is found that it has a χ²-distribution for large number of observations. The procedure is quite simple and is based on a distribution-free test requiring only ordinal scale measurement. The method of analysis has been explained by a numerical example.     

Applications of the Poly-K Statistical Test to Life-Time Cancer Bioassay Studies

The statistical analysis of cancer bioassay data has historically depended on the pathological determination of the experimental animal's cause of death. The poly-k statistical test has provided a method of statistical analysis of animal bioassay data without the need for cause of death information. The test has been shown to have good statistical properties in the typical 2-year cancer bioassay. However, while the poly-k test has been applied to chronic lifetime animal studies, it has not been formally evaluated with respect to the operating characteristics of this statistical test when applied to such studies. Thus, our objective is to assess the performance of the poly-k test for lifetime studies and to make comparisons with other tests. We observed in one recent lifetime study of the gasoline additive methyl tertiary butyl ether (MTBE) that the application of the poly-k test was not statistically robust. Simulation studies were subsequently conducted for a limited number of scenarios of lifetime cancer bioassays. These simulations showed that the poly-k test is not statistically robust for testing effect of increasing dose in some lifetime cancer studies.     

Quality control test for immunoreactivity of radiolabeled antibody

A rapid method for the measurement of the immunoreactive fraction of a radiolabeled monoclonal antibody or antibody fragment has been developed. This may be used as a quality control test prior to patient administration of the radiolabeled antibody preparation. The test employs solid phase antigens and the assay is conducted under conditions of antigen excess. Assay parameters have been evaluated and a standardized procedure has been developed. The assay has been compared to a standard extrapolation method and found to give approximately the same result. The test has been used on four different radiolabeled antibodies currently in clinical trials in patients with colorectal cancer. Mean immunoreactive fractions for these radiolabeled antibodies ranged from 35 to 65% and the variability of the immunoreactive fraction ranged from 140 to 240% for different antibodies. We conclude that the quality, defined as the immunoreactive fraction, of radiolabeled antibodies is both low and highly variable, indicating the need for a quality control test of these radiopharmaceuticals in the clinic prior to patient administration.     

Efficiency of the prediction of carcinogenic activities of chemical substances based on scoring somatic mutations in the soybean Glycine max (L.) Merrill

The efficiency of scoring somatic mutations in soybean (Glycine max (L.) Merrill) leaves as a test for carcinogenic activity of chemical substances in rodents has been evaluated. The efficiency of the test used alone or as part of a battery of tests has been estimated. The mutagenic activities of some chemical substances estimated using the soybean test are presented. Selective information on the carcinogenic activities of substances obtained in special carcinogenicity tests has been used as a quantitative measure of the efficiency of the tests with soybean leaves. To estimate the weight of evidence for the presence of this activity in the tested substances, a special function has been used whose values are uniquely related to the complete information, which is the sum of a priori information and the information obtained after testing. In general, the results have shown that the somatic mutation score test using soybean leaves is at least as efficient as the well-known tests that are generally used now, such as the Ames test and the chromosome aberration score test using mammalian cells in vitro. This test may be promising for the formation of efficient short-term test batteries.     

The standardization of the in-vitro tetanus toxin neutralization test on Chinese hamster ovary cells

A test for the titration of B. pertussis toxin with antisera on Chinese hamster ovary (CHO) cells has been worked out. B. pertussis protective antigenic cell-free complex containing 48-54% of B. pertussis toxin has been used as antigen. The specificity of the effect of this complex on CHO cells has been confirmed in the toxicity neutralization test with antisera. CHO cells have been adapted to reagents and culture media made in the USSR. The titration of B. pertussis toxin and antisera on CHO cells did not require the use of highly purified antigen.     

Bacteriosorption reaction on a smooth surface for detecting antibodies and antigens

The solid-phase technique for the detection of antibodies and antigens has been developed and named the bacteriosorption test. The test is based on binding staphylococci containing protein A with the Fc-regions of IgG-antibodies attached to antigens immobilized on polystyrene. The possibilities of this technique have been analyzed with the use of diphtheria toxoid, house-dust allergen and homologous rabbit antisera. In the detection of antibodies the proposed test is not inferior to the passive hemagglutination test, and its sensitivity in the detection of antigens by the sandwich technique reaches 0.05-0.1 micrograms/ml. The specificity of the technique has been experimentally confirmed by the inhibition of the reaction with soluble antigen and staphylococcal protein A. The variability factor of the technique does not exceed 10%.     

Use of the indirect immunofluorescence test in the diagnosis of an infection, caused by Mycoplasma pneumoniae

The indirect immunofluorescence test has been used for the serodiagnosis of M. pneumoniae infections in two paired blood sera of patients with acute respiratory diseases and acute pneumonia. The optimum methods for obtaining M. pneumonia antigen, its fixation and storage have been determined. The data on the study of the sensitivity, specificity and diagnostic value of the test are presented. The indirect immunofluorescence test has been shown to be capable of the simultaneous detection of complete (complement-binding) and incomplete (not binding the complement) antibodies to M. pneumoniae. This test may be used in the diagnostic practice as a highly sensitive, specific and sufficiently simple serological method.     

Selection of Judges for Sensory Evaluation

A test based on ordered observations for selection of consistent judges for sensory evaluation has been given. The test–statistic depends on the sum of ranks of different products under consideration. The probability distribution of the test-statistic has been worked out for small sample and it turns out to be chi-square distribution for large sample. The analytical procedure has been explained by a numerical example of a taste-testing experiment.     

Efficiency of the prediction of carcinogenic activities of chemical substances based on scoring somatic mutations in the soybean <Emphasis Type="Italic">Glycine max</Emphasis> (L.) Merrill

The efficiency of scoring somatic mutations in soybean (Glycine max (L.) Merrill) leaves as a test for carcinogenic activity of chemical substances in rodents has been evaluated. The efficiency of the test used alone or as part of a battery of tests has been estimated. The mutagenic activities of some chemical substances estimated using the soybean test are presented. Selective information on the carcinogenic activities of substances obtained in special carcinogenicity tests has been used as a quantitative measure of the efficiency of the tests with soybean leaves. To estimate the weight of evidence for the presence of this activity in the tested substances, a special function has been used whose values are uniquely related to the complete information, which is the sum of a priori information and the information obtained after testing. In general, the results have shown that the somatic mutation score test using soybean leaves is at least as efficient as the well-known tests that are generally used now, such as the Ames test and the chromosome aberration score test using mammalian cells in vitro. This test may be promising for the formation of efficient short-term test batteries.     

The preparation of an IgG diagnostic agent based on stained polyacrolein latexes for use in the latex agglutination reaction

IgG diagnosticum for measuring the concentration of 131I-labeled IgG antibodies to enteric antigen beta 1MA by the latex agglutination inhibition (LAI) test has been prepared on the basis of polyacrolein latexes. A method for the titration of anti-IgG antibodies with the use of the above diagnosticum has been developed, based on the late, agglutination (LA) test. The optimum conditions for the microtitration variant of the LA and LAI tests have been defined. High sensitivity, specificity and simplicity of analysis with the use of latex IgG diagnosticum have been demonstrated. The newly developed methods have been successfully used in laboratory trials of a new diagnostic radiopharmaceuticals for the assay of 131I-labeled antibodies in this preparation and for the detection of side effects of immunization on the recipients.     

Use of solid-phase immunoenzyme analysis for the serodiagnosis of pseudotuberculosis

The diagnostic test system based on the solid-phase enzyme immunoassay (EIA) for the detection of antibodies to Yersinia pseudotuberculosis in the sera of patients with the use of Soviet-made preparations and reagents has been developed. The test has been performed in microchambers for immunological reactions, thus making it possible to decrease the consumption of reagents 10-20 times in comparison with the traditional technique with the use of plates. The results of the titration of 42 sera in EIA and in the passive hemagglutination test (PHAT) are indicative of the presence of positive correlation (r = 0.78; p less than 0.05) between antibody titers in EIA and PHAT. A fourfold or greater increase in antibody titers has been determined by means of EIA in 80% of cases and with the use of PHAT in 55% of cases. The minimum diagnostic titer yielded by EIA has been determined: 1:256.     

Rank Analysis of Block Designs Having Different Cell Frequencies

A distribution–free test is considered for testing the treatment effects in block designs with different cell frequencies. A test statistic which is a function of treatment ranks has been proposed which is distributed as chi-square for large samples. The null distribution of the test statistic has been obtained. The entire procedure has been explained by a numerical example.     

Methods for detecting interactions between imprinted genes and environmental exposures using birth cohort designs with mother-offspring pairs

Genomic imprinting is a form of epigenetic regulation in mammals in which the same allele of a gene is expressed differently depending on the parental origin of the allele. Traditionally, the detection of imprinted genes that affect complex diseases has been focused on linkage designs with pedigrees or case-parent designs with case-parent trios. In the past two decades, the birth cohort design with mother-offspring pairs has been applied to understand better the effect of environmental influences during pregnancy and beginning of life on the growth and development of children. No work has been done on the detection of imprinted genes using birth cohort designs. Moreover, although the importance of imprinting has been well recognized, no study has looked at how environmental exposures modify the effects of imprinted genes. In this study, we show that the proposed imprinting test using the birth cohort design with mother-offspring pairs is an efficient test for testing the interactions between imprinted genes and environmental exposures. Through extensive simulation studies and a real data application, the proposed imprinting test has demonstrated much improved power in detecting gene-environment interactions than that of a test assuming the Mendelian dominant model when the true underlying genetic model is imprinting.     

The effect of bacterial and synthetic peptidoglycans on the toxicity of a cell-free pertussis preparation

The influence of bacterial and synthetic peptidoglycans on the toxicity of acellular pertussis preparations (APP) has been studied in the mouse weight gain test and in the endotoxic shock development test on mice treated with Actinomycin D. The data obtained in these tests indicate that the immunomodulators (IM) under study are capable of changing (increasing or decreasing, depending on the dose) the toxic properties of APP. The antitoxic action of IM, established in this study, depends on the combination of the doses of IM and APP and the time elapsed from the time of immunization. The possibility of using these IM in a dose of 0.0001 microgram for reducing the LD50 of APP has been established. The use of IM belonging to the group of bacterial synthetic peptidoglycans for the development of acellular pertussis vaccines with reduced reactogenicity has been shown to hold much promise.     

Use of Ranks in Comparisons of Variability in the Non-Normal Populations

A method of analysis for comparing the variability of two samples drawn from two populations has been developed. The method is also suitable for the nonnumeric form of data. A test based on ordered observations for testing the null hypothesis of equality of two variances has been given. The test statistic is a function of the sum of ranks assigned to smaller size sample. Ranking procedure has been modified to depict the variability in the data by the sum of ranks. The null distribution of the test-statistic has been worked out for small samples and it turns out to be chi-square distribution for large samples. The analytical procedure has been explained by a numerical example on the productivity and production of rice and wheat in India from 1950–51 to 1983–84.     

Preparation of diagnostic antitoxic serum to Clostridium difficile

The results of the studies on the preparation of diagnostic antitoxic sera to C. difficile, intended for use in biological assays with the aim of the laboratory diagnosis of clostridial enteric infections, are presented. The conditions for the detoxification of C. difficile native toxin have been established, the optimum schedules for the immunization of rabbits have been selected and specific antitoxic sera to C. difficile have been obtained. The neutralizing activity of these sera has been evaluated in the lethality test and in the cytotoxic test on human embryo dermo-muscular fibroblast cells M-19.     

An original clinical methodology for non-invasive assessment of pivot-shift test

Even if pivot-shift (PS) test has been clinically used to specifically detect anterior cruciate ligament (ACL) injury, the main problem in using this combined test has been yet associated with the difficulty of clearly quantifying its outcome. The goal of this study was to describe an original non-invasive methodology used to quantify PS test, highlighting its possible clinical reliability. The method was validated on 66 consecutive unilateral ACL-injured patients. A commercial triaxial accelerometer was non-invasively mounted on patient's tibia, the corresponding 3D acceleration was acquired during PS test execution and a set of specific parameters were automatically identified on the signal to quantify the test. PS test was repeated three times on both injured and controlateral limbs. Reliability of the method was found to be good (mean intra-rater intraclass correlation coefficient was 0.79); moreover, we found that ACL-deficient knees presented statistically higher values for the identified parameters – than the controlateral healthy limbs, averagely reporting also large effect size.     

A protocol for determination of anticardiolipin antibodies by ELISA

The anticardiolipin (aCL) test has been widely used by physicians since the mid-1980s for diagnosing patients with antiphospholipid syndrome (APS). Establishment of this diagnosis has enabled effective management of patients with recurrent thrombosis or recurrent pregnancy losses. The test was first established in 1983 as a radioimmunoassay and soon thereafter converted into ELISA. There have been numerous efforts to standardize the aCL test, but precise reproducible measurement of aCL levels is difficult and the use of semiquantitative measurements (high, medium and low) is recommended as this is probably sufficient for clinical diagnosis. Using validated ELISAs for measuring aCL Abs offers greater reproducibility, would reduce interlaboratory variations and limit discrepancies in results between different laboratories. This article details a procedure that takes approximately 2 h and summarizes the information available on the aCL ELISA test.     

An original clinical methodology for non-invasive assessment of pivot-shift test

Even if pivot-shift (PS) test has been clinically used to specifically detect anterior cruciate ligament (ACL) injury, the main problem in using this combined test has been yet associated with the difficulty of clearly quantifying its outcome. The goal of this study was to describe an original non-invasive methodology used to quantify PS test, highlighting its possible clinical reliability. The method was validated on 66 consecutive unilateral ACL-injured patients. A commercial triaxial accelerometer was non-invasively mounted on patient's tibia, the corresponding 3D acceleration was acquired during PS test execution and a set of specific parameters were automatically identified on the signal to quantify the test. PS test was repeated three times on both injured and controlateral limbs. Reliability of the method was found to be good (mean intra-rater intraclass correlation coefficient was 0.79); moreover, we found that ACL-deficient knees presented statistically higher values for the identified parameters - than the controlateral healthy limbs, averagely reporting also large effect size.