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PubMed1993

In vitro tests for teratogens: desirable endpoints, test batteries and current status of the micromass teratogen test.

Information from in vitro tests can be usefully used as a component of the risk/hazard assessment process. In vivo studies will be required to confirm the in vitro data. If the in vitro test system is designed around endpoints that reflect changes following in vivo toxic insult then it may be possible to modify the in vitro system to account for some of the discrepancies observed between in vivo and in vitro outcomes. When the discrepancy can be accounted for by low bioavailability in vivo, pharmacokinetic studies may be required to determine the relevance of the in vitro toxic concentrations. Reproductive hazard, especially teratogenicity, has been the subject of intensive in vitro test development. The observation of teratogenicity may affect the development of new products more significantly than any other type or category of reproductive toxicity. The micromass test, involving culture of differentiating rat embryo limb and midbrain cells exposed to test agents, may be useful as part of a battery of in vitro tests for teratogens. The most recent protocol for the micromass test is described, followed by a summary of validation and mechanistic studies confirming its usefulness. The test is robust in its transfer to new laboratories. Interlaboratory variability is small.

Abnormalities, Drug-Induced↗

PubMed2002

Computer-adaptive testing: the impact of test characteristics on perceived performance and test takers' reactions.

This study examined how specific features of adaptive tests are related to test takers' reactions. Participants took a computer-adaptive test in which 2 features, difficulty of the initial item and difficulty of subsequent items, were manipulated, then responded to questionnaires assessing their reactions to the test. The data show that the relationship between a test's objective difficulty, which was determined by the 2 manipulated test characteristics, and reactions was fully mediated by perceived performance. Additional analyses evaluated the impact of feedback on reactions to the adaptive test. In general, feedback that was consistent with perceptions of performance was positively related to reactions. The results suggest that minor changes to the design of an adaptive test may potentially enhance examinees' reactions.

Adult↗

PubMed1998

Experimental study for the development of an in vitro test for contact allergens. 2. Comparison of the in vitro sensitization test with the guinea pig maximization test for contact allergens.

We have previously reported an in vitro hapten-specific sensitization method using Pam-212 cells (in vitro sensitization test) to identify the potential effectiveness of contact allergens. In the present study, we conducted comparison studies of 11 allergens and 2 irritants in order to evaluate the method as an alternative predictive test. The guinea pig maximization test (GPMT) was developed based on the test described by Magnusson and Kligman. Our assay was carried out as follows: we treated Pam-212 cells with 13 test chemical solutions, while T cells and macrophages of BALB/c mice were cultured with hapten-conjugated Pam-212 cells for 5 days. After incubation, 10(5) T cells were stimulated with mitomycin-C-treated spleen cells conjugated with chemicals. Three days later, the [3H]methyl thymidine incorporation was counted. The results of the GPMT were in agreement with those reported in previous studies except for benzocaine. In our GPMT experiments, benzocaine was negative, but it had been classified as a moderate sensitizer in previous studies. Our assay detected extreme, strong and moderate sensitizers as previously classified by the GPMT They could be summarized as follows: three of five chemicals classified as moderate sensitizers, and 100% of strong or extreme sensitizers were detected by both the GPMT and the in vitro sensitization test. No irritants showed a positive reaction in our assay. These results support the view that the sensitivity of our in vitro test may be equivalent to that of the GPMT and may be useful as a rapid and objective allergen screening test.

Allergens↗

PubMed1979

[Comparative studies on the stability of aqueous drug solutions in the isothermal and the non-isothermal short-time test as well as in the long-time test. Part 2: The stability of aqueous tetracaine solutions in the non-isothermal short-time test (author's transl)].

A study of the hydrolytic degradation of tetracaine solutions at various pH values demonstrates that the results from non-isothermal stability testing with logarithmic rise in temperature are in good agreement with the activation energies determined, under analogous conditions, by means of the isothermal short-time test and long-time test. The range of the maximum of stability is more clearly evinced by the non-isothermal short-time test than by the isothermal stability test. The comparison of the two methods reveals that the deviation of the reaction rate constants is greater in the non-isothermal test, which is due to the calculation required for the logarithmic rise in temperature. The results obtained with tetracaine evidence that the non-isothermal stability test is an appropriate method for the rapid determination of stability parameters (e.g. stability maximum, hydrolysis velocities) in the frame-work of testing potential drugs for stability and in the optimization of prescriptions.

Chemistry, Pharmaceutical↗

PubMed1995

[Evaluation of drug sensitivities to gastric cancers by SDI test--study of quality control of SDI test by simulation test].

For the purpose to evaluate the feasibility of SDI test, a drug sensitivity test, against resected gastric cancer, a multiinstitutional study consisted of multiple institute, the 16th specified study was planned by Japanese Foundation for Multidisciplinary Treatment of Cancer. SDI test was performed individually in 15 institutes in Japan using surgically resected specimens from the patients with gastric cancer. The strict quality control was necessary to unify the method and the technique of this test in 15 institutes. Tumor bearing nude mice were delivered to each institute and the test was performed simultaneously. The data of test were sent by personal computer to Department of Surgery II Nagoya University. These data were estimated by two factors. One is the deviation of data in one institute and the other is the deviation of data among 15 institutes. This simulation test was continued through this study, 4 institutes could not pass this simulation test but the data from other three institute indicated excellent uniformity.

Animals↗

PubMed1982

[Correlations between immunoenzymatic test, neutralization test and fluorescent focus reduction test in rabies antibody titration].

Three methods have been used and compared for the detection and titration of antibodies in the serum of humans receiving post-exposure treatment with tissue culture inactivated rabies vaccines: mouse seroneutralization test, fluorescent focus reduction test and immunoenzymatic test. Results have shown that the fluorescent focus reduction test has a sensitivity and specificity which are equivalent to the mouse seroneutralization test with the advantage of giving results in 30 hr instead of 21 days, and that the immunoenzymatic test which avoids the use of laboratory animals and/or cell cultures, and which gives results in 5 hr, may advantageously replace the neutralization methods, particularly for the testing of large numbers of sera.

Antibodies↗

PubMed2002

Psychological characteristics of eating disorders as evidenced by the combined administration of questionnaires and two projective methods: the Tree Drawing Test (Baum Test) and the Sentence Completion Test.

The objective of this study is to examine psychological/psychopathological characteristics of eating disorders and their subtypes through a combined administration of questionnaires and projective tests. Three questionnaires (Eating Disorder Inventory - 2, Social Adaptation Scale, Southern California University Eating Disorder Inventory - Revised) and two projective tests (the Tree Drawing Test [TDT, Baum Test], and the Sentence Completion Test [SCT]) were administered to 126 female patients between the ages of 15 and 30 years, with eating disorders according to DSM-IV criteria at our outpatient clinic, and to 54 sex- and age-matched control subjects. The purging subtypes of eating disorders (anorexia nervosa - binge-eating/purging type [ANBP] and bulimia nervosa - purging type [BNP]) were clearly differentiated from the controls, both by the questionnaires and the projective tests. Compared with the controls, ANBP/BNP showed more problematic profiles across the three questionnaires, drew smaller and poorer trees in TDT to a more left location on the drawing paper, and gave fewer positive, and more negative responses in SCT. In contrast, few significant differences were found between anorexia nervosa- restricting type (ANR) and the controls, and between ANBP and BNP. As a trend, however, ANR was consistently located between the controls and ANBP/BNP across the whole questionnaires and projective tests.

Adolescent↗

PubMed1993

[Evaluation of immediate hypersensitivity and environmental factors by intracutaneous skin tests and specific IgE antibodies in allergic children. Part 1. The annual change of immediate hypersensitivity measured by intracutaneous skin tests and radioallergosorbent test].

To evaluate the relation between immediate hypersensitivity and environmental factors, a total of 2,187 allergic children were given the intracutaneous skin tests (IC test) and specific IgE antibodies (RAST) at Kudanzaka Hospital over a period of 21 years (1967-1987). The incidence of positive IC test to house dust (HD) and Japanese cedar pollen (sugi) increased, and that to molds increased transiently in the period 1965-1975. There was no sex difference in the incidence. Asthmatic children with allergic rhinitis scored higher both in IC test and RAST than those with asthma only. The more severely asthmatic children had a higher incidence of positive IC test to HD, molds, sugi, ragweed, cat dander, silk and buckwheat (sobagara). The recent rise of in the number of allergic diseases was partly proved by higher positive IC tests to HD and sugi. The number of positive test to HD mites also increased because twice as many non-wooden houses as wooden houses, have been built since 1969, and there were 3 times as many, high-rise building in 1975 as in 1965. Pollution and the increasing area of sugi forests were also responsible for increased allergic problems.

Animals↗

PubMed1993

[Evaluation of the relationship between immediate hypersensitivity and environmental factors by intracutaneous skin tests and specific IgE antibodies in allergic children. Part 2. The age distribution of immediate hypersensitivity by intracutaneous skin test and radioallergosorbent test].

To evaluate immediate hypersensitivity and environmental factors, 2,187 allergic children were given intradermal skin tests (ID test) and specific IgE antibodies (RAST) at Kudanzaka Hospital for 21 years (1967-1987). The incidence of positive ID test to house dust (HD) was 23% at 1 year, 50% at 2 years, 63% at 3 years and 84% at 8 years of age. The results of average positive test obtained at an earlier age in 1975 and 1985 than in 1965. Children born recently begin to have positive test scores earlier than those born between 1965 and 1969. This could be related to the recent increase in the number of HD mites. The incidence of positive ID test to Japanese cedar pollen (sugi) was 5% at 1 year, 10% at 4 years, 16% at 8 years and 30% at 15 years of age. The positive test scores were again obtained at an earlier age in 1975 and 1985 than in 1965, in the same way as for HD mites. Children born between 1965 and 1969 showed 30-60% positive rate after 13 years of age; this level was seen after 10 years of age in children born in 1975 and 1979, and after 6 years in those born between 1980-1984. This could be due to the recent increase in the amount of sugi pollen. Only Candida showed any significant rises in positive rate 27% at 1 year of age; slow increase was observed in the case of ragweed, molds, epidermals and others. No remarkable change was seen in ragweed and Alternaria at the years of examination and the years of birth.

Adolescent↗

PubMed1995

Metronidazole susceptibility testing of Helicobacter pylori with the PDM epsilometer test (E test).

The bacteriostatic activity of metronidazole against Helicobacter pylori was determined with the PDM epsilometer test (E test) and with an agar dilution test. Both methods correlated in the minimum inhibitory concentration (MIC) ranges (< or = 0.5- > 32 mg/l) and in the MIC 50 (E test: 1 mg/l; agar dilution test: 2 mg/l) and MIC 90 (> 32 mg/l) values. However, comparison of test results of single strains revealed that 14 out of 105 strains (13.3%) were classified as resistant by one method but classified susceptible by the other. The correlation coefficient of 0.71 also indicated a low congruence of test results. It is concluded that both methods should be used in order to ascertain all strains resistant to metronidazole.

Drug Resistance, Microbial↗

PubMed2000

Effect of dark test-substance pigmentation on skin perfusion assessments and effect of test technique on balsam of Peru patch-test results.

13 balsam of Peru (Myroxylon Pereirae) patch-test-positive subjects are re-tested with 25% balsam of Peru in petrolatum and with serial doses printed on polyester squares. All substances are applied with tape strips for 3, 6, 24 (1 day [D]), 48 (2D), 72 (3D) and 96 h (4D) on each subject and for 96 h (4D) with plastic foils. Tests are followed visually and with perfusion assessments from 3 h to 9 days. Results show that pigment remnants following detachment of patches affect perfusion assessments. Such effect due to pigment is supported by readings of patch tests through the petrolatum test substance while applied with transparent foils. For most reactions, good agreement is observed between the assessment techniques when peak assessment values of reactions are compared. There is inter-individual variation in perfusion with identical tests. With the petrolatum test substance, increased visible reactivity was observed when the application time was extended up to 24 h (1D), while extension of application time increased perfusion in most cases except for an extension from 24 (2D) to 48 h (4D) where decreased perfusion resulted in most cases. Dose and application time did not affect the timing of highest reactivity of reactions in most cases.

Adult↗

PubMed1993

Dose-response testing with nickel sulphate using the TRUE test in nickel-sensitive individuals. Multiple nickel sulphate patch-test reactions do not cause an 'angry back'.

The aim of this study was to employ the TRUE test assay to confirm the presence or absence of the 'angry back' phenomenon, i.e. that a strong positive patch-test reaction heightens adjacent patch-test response. In addition, we wished to establish the dose-response relationship for nickel sulphate patch tests among nickel-sensitive patients. Seventy-two nickel-sensitive patients, 36 in Odense and 36 in Stockholm, were tested with a 10-step nickel sulphate dilution series (TRUE test) and two placebo patches. The position of the patches was rotated, to provide a balanced spatial distribution of the different concentrations. Readings were performed blind. The results were analysed by means of polynomial multiple-regression methods and a logistic dose-response model. Half the patients (38/72) had a threshold patch-test concentration for nickel sulphate in the range of 3-0.3 microgram/cm2. The 'angry back' phenomenon was not apparent in this study, as the spill-over effect was not statistically significant. Strong reactions to high concentrations of nickel sulphate did not enhance the response to adjacent lower concentrations of nickel sulphate.

Dermatitis, Allergic Contact↗

PubMedDate not supplied

To test or not to test: interest in genetic testing for Alzheimer's disease among middle-aged adults.

Based on a hypothetical scenario positing 100 percent accuracy in test results, we examined interest in genetic testing for Alzheimer's disease (AD) among adult children, 40-60 years of age, who have a living parent with a diagnosis of probable AD (N = 108), and a matched comparison group of persons with no parental history of AD (N = 150). For both groups, planning for the future was the most important reason cited for being tested; lack of good treatment options and concerns about losing health insurance were the most important reasons for not being tested. Hierarchical regression was used to examine the effects of sociodemographic characteristics, subjective perceptions of memory functioning, concerns about having and developing AD, and mastery on interest in being tested. Personal concerns about developing AD and mastery emerged as significant predictors and subsample membership approached significance, although the full model explained just 18 percent of the variance. Because persons in the comparison group were more likely to report an interest in being tested, educational efforts about genetic testing should not be restricted only to family members of persons with a diagnosis of AD.

Adult↗

PubMedDate not supplied

Comparison of the metabolic response to a glucose tolerance test and a standardized test meal and the response to serial test meals in normal healthy subjects.

The plasma glucose and insulin response to a standardized meal test breakfast was compared with the time-honored glucose tolerance test in the same normal healthy subjects. The amplitude of glycemic excursion and between-subject variation was less with the more physiologic standardized test meal than with that seen with the glucose tolerance test. The glucose tolerance test's prime function is to amplify any glucose intolerance, thus aiding diagnosis, whereas a standardized meal gives a more clinically relevant metabolic status. The administration of serial test meals during the same day in a smaller group of normal subjects indicated, as seen previously with repeated glucose tolerance tests, a diminishing carbohydrate tolerance during the day.

Adult↗

PubMed2002

The tap test--an accurate first-line test for fetal lung maturity testing.

OBJECTIVE: To determine the accuracy of near-patient and laboratory-based fetal lung maturity tests in predicting the need for neonatal ventilation. DESIGN: A prospective descriptive study. SUBJECTS: One hundred high-risk obstetric patients where confirmation of fetal lung maturity would initiate delivery. METHODS: Fetal weight estimation, placental maturity grading, and amniocentesis were performed. The investigators examined the amniotic fluid visually, and performed the tap test and shake test. Laboratory technicians estimated the lecithin-sphingomyelin (L/S) ratio, determined the presence of a phosphatidyl glycerol (PG) band on gel electrophoresis, and the optical density at 650 nm. Neonates delivered within 1 week of amniocentesis were included in the analysis. The primary end-point was the ability of the lung maturity tests to predict the need for neonatal ventilation. RESULTS: Twelve of 100 neonates required ventilation. The tap test and optical density (OD) shift at 650 nm predicted the need for neonatal ventilation with the greatest accuracy. CONCLUSION: The tap test is a rapid, easy and accurate predictor of the need for neonatal ventilation. The OD shift at 650 nm is the laboratory-based test with the greatest accuracy in our setting.

Amniotic Fluid↗

PubMed1998

Presymptomatic testing for Huntington's disease by linkage and by direct mutation analysis: comparison of uptake of testing and characteristics of test applicants.

In Edinburgh, we have compared presymptomatic testing by linkage and by direct mutation analysis by investigating the demand for testing and characteristics of test applicants. Annual new requests for the direct test (DT) are now double the peak with the linkage test (LT) but only 6% individuals have requested re-testing. DT applicants were older with a smaller proportion having lived with an affected relative that LT applicants. This was because many were relatives of newly diagnosed first known cases in their family. This may also explain why DT applicants were less likely to expect a negative result and more likely to be uncertain about their risk. A greater proportion of DT applicants first heard about the test from relatives or their GP than LT applicants who were more likely to hear from Genetic Centre. The demand for follow-up by the Geneticist/Genetic Nurse was much less for DT than for LT applicants largely due to the support offered by the HD Advisors.

Adult↗

PubMed2003

Testing the test--why pursue a better test for Huntington disease?

In 1993, the gene mutation for Huntington disease (HD) was identified and testing became possible with a reliability of >99%, without the need for co-operation of relatives. In 1997, a systematic information program offered the mutation retest to individuals who had earlier received a linkage test result for HD, which has a residual uncertainty of 1-9%. The characteristics of 129 individuals tested by linkage analysis for HD are reported on, as well as the reasons for their reassessment by mutation testing. Three groups were compared: (1) people who were retested between 1993 and 1997, before this study had started, (2) people who were retested after we provided information, and (3) persons who refrained from retesting. Nearly half of the linkage-tested individuals were retested, with the exception of noncarriers with a residual risk of 1 or 2%. Of them, less than one out of five were retested. Carriers with a hopeful view on the future (BHS) and a better sense of well-being (GHQ) were more likely to have the retest. Female carriers were also more likely to have the retest before we contacted them. Noncarriers who were retested were more anxious (HADS) than noncarriers who refrained from the retest. Retestees were younger at the time of testing. No risk reversals were revealed by this study.

Adult↗

PubMed1995

[Evaluation of conventional and new generation tests for testing the humeral response to Mycoplasma pneumoniae antigens in natural infection in humans. III Use of ELISA, complement fixation and immunoelectroprecipitation tests in diagnosis of Mycoplasma pneumoniae infections--comparative analysis].

Agreement of the results of determining antibodies against M. pneumoniae was evaluated by the ELISA, complement fixation test (CFT) and immunoelectroprecipitation test (IEPT) in serum samples from 685 persons including 571 patients with respiratory tract infections and 114 clinically healthy subjects. Assuming the CF to be the reference test, a very high correlation exceeding 0.95 was found, on the basis of the calculated correlation coefficient, between the results of the CF and IEP tests and the CFT and ELISA in all immunoglobulin classes. The highest sensitivity (92.3%) was displayed by the ELISA in relation to the CF test when determining mycoplasmas antibodies of IgM and IgA + G + M classes and slightly lower sensitivity by the IEPT and ELISA when determining of IgG (83% and 82.1% respectively). The lowest sensitivity was displayed by the ELISA when determining mycoplasmal antibodies of IgA class (53.4%). Specificity of both the tests was high and exceeded 92%. Highest agreement of CFT and ELISA was obtained when detecting mycoplasmal antibodies in diagnostically significant titer in the M and A + G + M immunoglobulin classes (> 92%) while lowest agreement, although statistically significant, was obtained when detecting IgA antibodies (74.7%).

Adolescent↗