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[Paracoagulation tests in laboratory verification of intravascular coagulation. Comparative clinical evaluation of the SDPS test and of the ethanol test with serial dilution (SD ethanol test)].

The AA. remark that laboratory diagnosis of intravascular coagulation is a still alive methodological problem. The presence in the flowing blood of certain molecules (fdp) that derive from that alteration of fibrinogen metabolism, that is at the basis of any intravascular coagulation syndrome, can be detected by immunological methods. Paracoagulation tests allow on the contrary to detect fibrin monomers and fibrin degradation products (fdp) that are still clottable (nonenzymatic coagulation). The positivity of these ones constitutes therefore an indirect evidence of the effects of thrombin on fibrinogen and keeps us nearer to the pathogenetic moment which is the real basis of any I.C. syndrome. The AA. make here a parallel between the two principal paracoagulation tests that are S.D.P.S. test according to GUREWICH (1971 [7]) and Ethanol Gelation test according to GODAL (1966 [6]) whose details are given. These two tests were performed in parallel in 589 cases which showed clinical evidence or suspicion of I.C. mostly supported by the further clinical courses of the patients. The two tests are both positive only in 164 cases (27,8%); both non-positive in 109 cases (18,6%); S.D.P.S. test is positive alone in 306 cases (51,9%); Godal's test is positive alone in 10 cases (1,7%). These data, supported by clinical course, allow the AA. to think that S.D.P.S. test is more sensitive than Godal's test. Although the AA. make the hypothesis that S.D.P.S. test may be more sensitive owing to its serial diluitions method that allows it to achieve an optimal ratio between the paracoagulant agent and the molecules which are capable to be clotted (paracoagulated). So they modify Godal's test applying to it too the principle of serial diluitions. The details are given. This new Serial Diluition Ethanol Gelation test is therefore performed in parallel with S.D.P.S. test in 314 cases which showed clinical evidence or suspicion of I.C. mostly supported by further clinical courses of the patients. In this second series of 314 patients the two tests are both positive in 138 cases (43,9%); both non-positive in 33 cases (10,5%); S.D.P.S. test was positive alone in 108 cases (34,3%); S.D.E.G. test was positive alone in 35 cases (11,3%). As we can see in this second series S.D.P.S. test remains more sensitive showing positivities in 246 cases (78,2%) whereas S.D.E.G. test is positive in 173 cases (55,2%). In conclusion the application of serial diluitions also to Ethanol Gelation test increase its sensitivity (from 29,5% to 55,2%), but it does not reach S.D.P.S. test's one. S.D.E.G. test may be really useful in clinics because it gives informations within 10 min but its non-positivity must be supported by the results of S.D.P.S. test which on the contrary gives sure informations only after 24 hours.

Blood Coagulation Tests↗

Quantitative determination of beta-lactamase production in Staphylococcus aureus strains compared to qualitative testing by a microbiological clover leaf test, a chromogenic cephalosporin test and a iodometric test.

One hundred and twelve beta-lactamase producing strains of Staphylococcus aureus with known quantitative production were investigated together with 45 non-beta-lactamase producing derivatives by three qualitative beta-lactamase tests: the microbiological clover leaf test, the iodometric tube test and a chromogenic cephalosporin disc test. For the beta-lactamase producing strains strong positive reactions in the qualitative tests were not correlated with high beta-lactamase production, large degree of extracellularity or high induction ratio in any of the tests. Low beta-lactamase production was not correlated to weak reactions. Best results in identifying beta-lactamase production were obtained using the iodometric test in which 109 of 112 beta-lactamase producing strains were positive and no false positive reactions were observed. Some strains had only weak positive reactions but they were easily read. The clover leaf test and the chromogenic cephalosporin test detected 105 and 107 of 112 strains, respectively. The chromogenic cephalosporin disc test had more weakly reacting strains, which were difficult to read, especially among strains of phage type 95. Three non-beta-lactamase producing strains of phage type 95 were positive in the clover leaf test. It is concluded that the iodometric tube test is the most useful one for qualitative determination of beta-lactamase production in S. aureus. It is recommended as control when normal susceptibility testing for penicillin has shown susceptibility or doubtful susceptibility. Furthermore, it is useful when no susceptibility testing has been carried out and a rapid result is needed.

Biological Assay↗

[A study of caries activity test. 1. Comparison of MSBB test, Cariostat test, RD test].

In the present study, experiments were performed using three variations of the caries activity test: the modified MSBB test (MSBB test), Cariostat test and Resazurin Disk test (RD test). The subjects of experiment I consisted of 147 patients treated in Nippon Dental University Hospital and first- and second-year students of Affiliated School of Dental Hygiene. Those of experiment II consisted of 25 men and women, aged 14 to 28 years. Experiment I was performed to determine the influence of the subject's concept of dental hygiene, DMF rate, presence or absence of regular brushing and skill in brushing, on the scores of MSBB and Cariostat test, and to determine whether or not there was a correlation between these two test. In experiment II, the correlation between the MSBB and Cariostat tests was studied, using the RD test as a standard. In experiment I, a comparison of MSBB scores before and after practice in dental hygiene revealed significantly decreased caries activity in the first-year students. Similar results were obtained by the Cariostat test. There was a positive correlation between the scores of the MSBB and Cariostat tests. The second-year students, who were considered to have a relatively good sense of oral hygiene, had the lowest scores. Experiment II revealed a correlation between the scores of the RD and MSBB tests.

Adolescent↗

Mutagenicity testing of ST-film with the Ames test, chromosome test in vitro and micronucleus test in female mice.

The mutagenicity of ST-film and its components polyoxyethylenenonylether (NP-10) and polyvinylalcohol (PVAL) were studied by a reverse mutation test in S. typhimurium (Ames test), a chromosome test in cultured Chinese hamster V 79 cells and a micronucleus test in female mice. The results obtained from these test systems were all negative. Thus, it may be concluded that ST-film is not mutagenic either in vitro or in vivo mutagenicity testing systems.

Animals↗

Comparative study of three tests (dye test, indirect haemagglutination test, latex agglutination test) for the detection of antibodies to Toxoplasma gondii in human sera.

An evaluation has been made of a commercial latex agglutination test, Toxotest-MT (TMT) (Eiken, Japan), for the detection of antibodies to Toxoplasma gondii in human sera. In qualitative studies, 878 sera were examined in both the TMT and dye test (DT) and 96.6% agreement was found, In quantitative studies 339 sera were titrated in the TMT and DT, with 337 of these sera also titrated in the indirect haemagglutination test (IHAT). Agreement between the DT and TMT was best, 78% of the sera showing titres within +/- 1 dilution in the two tests. The IHAT and TMT gave 66% agreement, while the DT and IHAT showed least agreement, 40.9%. The results suggest that the pattern of antigenic determinants to which antibody levels are measured are different in the three test systems. The TMT is a better substitute for the DT than the IHAT.

Antibodies↗

Mutagenicity and dominant lethal test of kojic acid--Ames test, forward mutation test in cultured Chinese hamster cells and dominant lethal test in mice.

The mutagenicity of kojic acid was studied by means of reversion mutation test in bacteria (Ames test), forward mutation test in cultured Chinese hamster cells and dominant lethal test in mice. A positive result was obtained only in Ames test (TA 98, 1535 and 100) which was not modified by the presence of S-9 fraction. Thus, it is concluded that although kojic acid is a weak mutagen in bacteria, it is nonmutagenic in eukaryotic systems either in vivo or in vitro.

Animals↗

A direct immunofluorescence test for the detection of sperm surface bound antibodies. Comparison with sperm agglutination test, indirect IF test and MAR test.

A direct immunofluorescence (DIF) test using sperm suspensions and F (ab')2 antisera was carried out on 30 patients with sperm-agglutinating (SA) activity and on 25 negative controls. Its results were related with the occurrence of SA activity in serum and seminal plasma, with the results of the indirect IF test and those of the direct IgG-MAR test. DIF test gave positive results in all patients with significant serum SA activity, even when it was undetectable in seminal plasma, except in 2 cases with serum IF-reactivity for IgM, and negative results in all controls. IgG were involved in IF-reactivity in 88.4% of positive cases and IgA in 42.3%. IgA were always found in association with sustained SA activity in seminal plasma. In these cases the IgG-MAR test might not result strongly positive, in spite of the high titre of SA activity in semen.

Antibodies↗

[Exceptional Application of Content Uniformity Test and Weight Variation Test in the Japanese Pharmacopoeia 13 revision and usage of these tests for in-process tests].

The criteria of Content Uniformity test and Weight Variation test in JP 13 were greatly changed to reduce consumer's risk. The new criteria were set to keep the rate of defectives in lots passing the tests less than the acceptable rate. However, in some cases, the new criteria can not directly be applied to some formulations and several modifications are needed in the criteria. In this report, the several resolution of this problem are represented. The applicability of these tests for in-process tests is also discussed.

Japan↗

A quantitative comparison of induction and challenge concentrations inducing a 50% positive response in three skin sensitization tests; the guinea pig maximization test, adjuvant and patch test and Buehler test.

The sensitivities of three skin sensitization tests such as the Guinea pig maximization test (GPMT), Adjuvant and patch test (APT) and Buehler test (BT), were quantitatively compared with reference to induction and challenge concentrations. Four chemical which had different physico-chemical properties (octanol-water partition coefficient (logP) and reactivity with NH2-group) were used in order to clarify the effect of the physico-chemical properties of chemicals on the sensitivity of the different methods. The induction concentrations inducing a 50% positive response (IC50) demonstrated extreme variation with the three methods. For example, the BT/GPMT ratio of IC50 values for 2,4-dinitrochlorobenzene was 33, whereas that for maleic anhydride was 300,000. The results were thought to be caused by difference properties such as the logP and reactivity of chemicals. This correlation was confirmed by using 2-dodecen-1-yl succinic anhydride, which had the same reactivity but higher logP than that of maleic anhydride. On the other hand, the challenge concentrations inducing 50% positive responses (CC50) were less affected by the methods and the BT/GPMT ratios for CC50 values were all within a 10-fold range. These results suggest that the sensitivity might be strongly different with reference to induction concentration, but not challenge concentration among the three methods.

Adjuvants, Immunologic↗

Genotoxicity testing of the herbicide Roundup and its active ingredient glyphosate isopropylamine using the mouse bone marrow micronucleus test, Salmonella mutagenicity test, and Allium anaphase-telophase test.

The genotoxic potential of the herbicide Roundup and its active agent, glyphosate isopropylamine salt, was studied in three different assays. No clastogenic effects were found in the mouse bone marrow micronucleus test for either of the two agents. In the Salmonella assay only Roundup was tested. It showed a weak mutagenic effect for the concentrations 360 micrograms/plate in TA98 (without S9) and 720 micrograms/plate in TA100 (with S9). These concentrations are close to the toxic level. The anaphase-telophase Allium test showed no effect for the glyphosate isopropylamine salt, but a significant increase in chromosome aberrations appeared after treatment with Roundup at concentrations of 1.44 and 2.88 mg/l when calculated as glyphosate isopropylamine. The most frequent aberrations observed could be characterized as disturbances of the spindle.

Allium↗

Standardized ability tests and testing. Major issues and the validity of current criticisms of tests are discussed.

At the outset a distinction was made between criticisms directed at the validity of tests and criticisms not affected by the validity of the tests. It was noted further that all criticisms of tests must take into consideration the type of test and the use to which the test is put. Criticisms of the validity of tests involved the following issues: (i) tests may be unfair to certain groups and individuals, including the extremely gifted, the culturally disadvantaged, and those who lack experience in taking tests; (ii) tests are not perfect predictors of subsequent performance; (iii) tests may be used in overly rigid ways; (iv) tests may not measure inherent qualities of individuals; and (v) tests may contribute to their own predictive validity by serving as self-fulfilling prophecies. Criticisms that are more or less independent of test validity included the effects of tests on (i) thinking patterns of those tested frequently; (ii) school curricula; (iii) self-image, motivation, and aspirations; (iv) groups using tests as a criterion for selection or allocation, or both; and (v) privacy. Several concluding remarks are in order: 1) This paper has focused almost entirely on criticisms of tests. However, the positive value of standardized tests should not be ignored. Here we must keep in mind what possible alternative measures would be used if standardized tests were abandoned. 2) We must begin thinking about tests in a much broader perspective- one that includes consideration of the social effects of tests as well as their validity and reliability. 3) Finally, an effort should be made to develop rational and systematic policies on the use of tests with the culturally disadvantaged, the dissemination of test results, and the problem of invasion of privacy. Such policies can be formulated only if we are willing to take a long hard look at the role we want testing to play in the society. Standardized tests currently are a cornerstone in the edifice of stratification in American society. It is up to the social scientist to conduct research that will enable policy makers in education, business and industry, and government to determine in a consistent and rational way the ultimate shape of this edifice.

Achievement↗

[Potency testing of inactivated rabies vaccines with the antibody binding test in comparison with the NIH and habel test(author's transl)].

The Antibody Binding Test, a new technique for the evaluation of inactivated Rabies vaccines, developed by Arko, Wiktor and Sikes, was compared with the NIH- and Habel Test. Various vaccines were tested with these methods with the following results and conclusions. 1. The Habel Test was useful for testing of Hempt vaccines. With highly potent vaccines however it was not possible to get exact protection values, for all vaccinated mice were protected against all virus dilutions. 2. The NIH Test seemed to have an advantage over the Habel Test, since animals are vaccinated only twice, instead of 6 times, within two weeks. But this test was less suitable for the evaluation of Hempt vaccines. The requested Antigenic Value was reached only rarely with these vaccines. Repeated, NIH Tests gave widely differing results with Hempt vaccines. Vaccines which passed the NIH Test also passed the Habel Test, but not always vice versa. Antigenic Values of highly potent vaccines could be determined exactly with the NIH Test. This method is much better standardized by using a Standard vaccine in the test. The NIH Test is preferable for inactivated Rabies vaccines, with the exception of vaccines containing brain tissue, like the Hempt vaccine. 3. The Antibody Binding Test is a useful technique for the examination of inactivated cell culture vaccines. Consistent results can be achieved by skilled and experienced laboratory personnel. To avoid irregularities in the mortality rates, at least 10 mice should be used for each dilution of vaccine. With this method only Rabies virus antigen is measured which is bound by serum antibody during an incubation period of 60 min. Other factors supporting immunization like adjuvant- or booster-effects are not evaluated. Compared with the Habel and NIH Test the Antibody Binding Test is the best method for the evaluation of the amount of antigen in a Rabies vaccine. Hempt vaccines reached - as they did in the NIH Test - only Antigenic Values in this test. Vaccines with an Antigenic Value of larger than or equal to 0,3 in the Antibody Binding Test gave positive results also in the Habel and NIH Test, Vaccines with a Protection Value of 10-3 in the Habel Test and an Antigenic Value of 0,3 in the NIH Test did not always reach an Antigenic Value of 0.3 in the Antibody Binding Test.

Animals↗

Accuracy of four commercially available serologic tests, including two office-based tests and a commercially available 13C urea breath test, for diagnosis of Helicobacter pylori.

BACKGROUND: Diagnosis of H. pylori infection may be made by endoscopic (invasive) tests, or by nonendoscopic (noninvasive) tests. Our aim was to evaluate recently available nonendoscopic tests, including two office-based serologic tests and a commercially available 13C urea breath test. METHODS: Gastric biopsy specimens (for culture and stain) from 178 patients (mean age 46 +/- 13.3 years, 79 men and 99 women), none of whom had received anti-H. pylori therapy, were tested for H. pylori infection. These tests were compared against two commercial serum IgG antibody immunoassays (Biowhittaker's Pyloristat, and Quidel), 2 office-based serum qualitative IgG antibody tests (FlexSure HP, and QuickVue One-Step), the Meretek 13C urea breath test, and the CLOtest (a biopsy urease test). RESULTS: The breath test (n = 147) had the best accuracy (96%) of the noninvasive tests studied. The serologic tests had similar accuracy to one another (84%-90%). The major drawback of the serologic tests was suboptimal specificity (75%-87%). Diagnosis of H. pylori based on the two office-based tests were not significantly different compared to the quantitative IgG antibody tests. The CLOtest had an accuracy of 97%. CONCLUSIONS: The Meretek 13C urea breath test is an excellent test, but is considerably more expensive than serologic tests. The FlexSure HP and the QuickVue One-Step office-based qualitative IgG serologic antibody tests gave similar results to laboratory based quantitative antibody tests, and are acceptable for initial diagnosis of H. pylori infection. The advantages of the office-based tests are low cost, simplicity, and immediacy of results.

Adult↗

Modification of the Rappaport rapid test in large-scale testing for syphilis. Evaluation of the rapid plate and rapid card tests.

The Rappaport rapid (RR) plate and card tests were developed as modifications of the RR tube test to permit rapid and inexpensive screening of large numbers of subjects for the diagnosis of syphilis. More than 2,000 sera were examined in parallel by the Venereal Disease Research Laboratory (VDRL) slide test, the rapid plasma reagin (RPR) card test and the RR plate and card tests. There was complete agreement between the RR plate and card tests and the VDRL slide and RPR card tests in 96.6% of sera. In a selected group of 1,530 sera examined, in addition, by the fluorescent treponemal antibody absorption (FTA-ABS) test, there was agreement between the RR plate and card tests and the FTA-ABS test in 74.3% of sera and between the VDRL and RPR tests and the FTA-ABS test in 73.7% of sera. The RR plate test was found to be sufficiently sensitive and specific for the diagnosis of syphilis, although the VDRL slide test is perhaps more sensitive in primary and late latent syphilis. Since the antigen used in the RR tests is colored and stable and the sera do not require inactivation before the test, the tests are easier to perform than the VDRL slide test: the RR plate and card tests could therefore replace the VDRL test as a screening test, with hardly any loss of accuracy.

Flocculation↗

A comparative study of test methods for assessment of the biodegradability of chemicals in seawater--screening tests and simulation tests.

A comparative study has been performed on test methods for assessing the biodegradability of chemicals in seawater environments. A simple shake flask die-away test with natural seawater and 14C-labeled chemicals added in microgram/liter concentrations is proposed as a "simulation" test. The analytical parameter used in this test is residual dissolved 14C activity. The performance of the simulation test has been compared with the performance of similar screening tests with dissolved organic carbon analysis and test compounds added in mg/liter concentrations to nutrient-enriched seawater. All chemicals investigated that passed the screening tests were also degradable in the simulation test and some results with simulation tests were positive; even screening tests were negative, while some compounds, including maleinhydrazide, known to be degradable in soil, remained undegraded in either type of test. Disappearance times after the ended lag time were smaller in screening tests than in simulation tests, but the rates of biodegradation cannot be meaningfully compared, as zero-order kinetics in combination with an exponentially growing population of degraders prevail in screening tests, while first-order kinetics and frequently a constant activity of degraders (cooxidation) prevail in simulation tests where the test material is a secondary substrate only. In screening tests, lag times are sometimes excessively long and highly variable. Whether the lag times could be decreased and their variability narrowed by supplementation with a cosubstrate (yeast extract) or by inoculation with seawater that had been preadapted to the test material was investigated. In most experiments such test modifications had no significant effect but in one experiment with 4-nitrophenol, inoculation with 1% preadapted seawater decreased the lag phase from greater than 35 to 9 days.

Aniline Compounds↗

A comparison between the 1-microg adrenocorticotropin (ACTH) test, the short ACTH (250 microg) test, and the insulin tolerance test in the assessment of hypothalamo-pituitary-adrenal axis immediately after pituitary surgery.

The short ACTH stimulation test is an easy, reliable, and extensively used test in the assessment of the hypothalamo-pituitary-adrenal (HPA) axis. However, its use immediately after pituitary surgery is a matter of debate. The insulin tolerance test (ITT) is the gold standard in the evaluation of the HPA axis, but it is not always without side effects and may be unpleasant early after pituitary surgery. Our aim was to investigate the value of the 1-microg ACTH test in the assessment of the HPA axis early after pituitary surgery. We also aimed to determine the value of the 1-microg and 250-microg ACTH tests and the ITT in the estimation of HPA axis status after 3 months postoperatively. Nineteen patients subjected to pituitary tumor surgery were included in the study, and the ITT and the 1-microg and 250-microg ACTH tests were performed between the 4th and 11th days of surgery. The tests were repeated at the first month in 3 patients with subnormal peak cortisol responses (454, 125, and 301 nmol/L) and in 18 patients at the third month postoperatively. ACTH stimulation tests were performed by using 1 microg and 250 microg ACTH iv as a bolus injection, and blood samples were drawn at 0, 30, and 60 min for measurement of serum cortisol levels. The ITT was performed by using iv regular insulin, and serum glucose and cortisol levels were measured. The 1-microg and 250-microg ACTH stimulation tests and the ITT were performed consecutively. At least 48 h were allowed between each test. A peak serum cortisol level of 550 nmol/L or greater was considered as a normal response for both the ITT and the ACTH tests. The serum cortisol level was measured by RIA using commercial kits. Serum glucose was determined by glucose oxidase method. There were correlations between the peak cortisol response to the ITT and the 1-microg ACTH test (r = 0.39, P < 0.05) in the early postoperative period. No correlation was found between the ITT and the 250-microg ACTH test responses. In the early postoperative period, two patients showed normal cortisol responses (> or =550 nmol/L) to the 1-microg ACTH test and five patients showed normal cortisol responses to the 250-microg ACTH test among the six patients with subnormal cortisol responses to the ITT. Three patients with subnormal cortisol responses to ITT and baseline cortisol values less than 240 nmol/L showed normal HPA axis at the end of the first month. In the late postoperative period, at the third month, all the patients showed normal HPA axis. In the early postoperative period of pituitary surgery, the 1-microg ACTH test results are more concordant than the 250-microg ACTH test in comparison with the ITT. Our results also indicate that HPA axis dysfunction shown by ACTH stimulation tests and the ITT in early postoperative period may be normalized 1-3 months after surgery. For this reason, we think that dynamic tests including the ITT may not be useful early after pituitary surgery.

Adrenocorticotropic Hormone↗