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PubMed2004

Comparison of helicobacter pylori stool antigen test with CLO test in the diagnosis of helicobacter pylori associated dyspepsia in a Saudi population.

OBJECTIVE: To compare the diagnostic usefulness of Helicobacter pylori (H.pylori) stool antigen test (HpSA) enzyme immunoassay (EIA) with the Campylobacter-like organism (CLO) test in Saudi patients with H.pylori associated dyspepsia. METHODS: Sixty consecutive adult Saudi patients suspected of H.pylori infection with dyspepsia attending the Gastroenterology Unit of the King Khalid National Guard Hospital, Jeddah, were recruited into the study. The study was carried out between 1st January and 30th June 2003. There were 25 males and 35 females. Their ages ranged from 19-72 years. Mean age was 39.6 years. At endoscopy diagnosis was made by taking gastric antrum mucosal biopsy for histology (Giemsa stain) and the CLO test was performed on a biopsy sample. A stool sample from each patient was sent to the Microbiology Department for HpSA EIA test. Helicobacter pylori status was determined by the positivity of the CLO test, the histology, or both. RESULTS: Both tests were positive in 26 specimens and negative in 21 patients. Discordant results were obtained in 13 specimens. Discordant results were resolved using the histology biopsy results. The sensitivity of the HpSA test was 88.6% and specificity 93.5%. The positive predictive value (PPV) of the HpSA test was 93.9%, while the negative predictive value (NPV) was 87.8%. The sensitivity of the CLO test was 87.8%, and specificity 92.5%, while PPV of the CLO test was 93.5% and NPV was 86.2%. CONCLUSION: The HpSA test is a useful and reliable test for the diagnosis of H.pylori infection. It is non-invasive, relatively cheap and convenient for the patient. It can be performed in any laboratory performing the enzyme-linked immunoabsorbent assay test. It is particularly suitable for developing countries where facilities for endoscopy are not readily available.

Adult↗
PubMed2005

HIV testing practices of TB patients after introduction of a new testing policy in Kiev City, Ukraine.

SETTING: The Kiev City Health Administration published a new policy for human immunodeficiency virus (HIV) testing of tuberculosis (TB) patients. According to this policy, all TB patients should be offered voluntary HIV testing after counselling. OBJECTIVE: To evaluate the implementation of the new HIV testing policy and to determine the HIV prevalence in TB patients in Kiev City. DESIGN: TB patient medical records were retrieved from eight TB facilities in Kiev City. They were reviewed for information about offering an HIV test, accepting to be HIV tested and outcome of the HIV test. Information was collected about patient characteristics and TB risk groups. RESULTS: Of 914 patients, 75% were offered HIV testing. Females were less frequently and alcohol abusers more frequently offered HIV testing. Of the patients who were offered HIV testing, 84% accepted. Of the 574 who were HIV tested, 36 (6.3%) had a positive test result. CONCLUSION: Not all TB facilities adhere strictly to the new policy. HIV testing seemed to be targeted to individuals with a high risk for HIV infection. To improve adherence to the new policy we recommend training of TB physicians in voluntary counselling and testing. The HIV prevalence among TB patients in Kiev City was 6.3%.

Comorbidity↗
PubMed1988

The dexamethasone suppression test and depression. Approaches to the use of a laboratory test in psychiatry.

The dexamethasone suppression test has undergone unprecedented study among the biologic tests proposed for clinical use in psychiatry. Since the 1970s, its study has involved hundreds of reports and thousands of patients. Although important technical aspects of the test appear to be well accepted and validated, additional information is needed regarding the pharmacokinetics of dexamethasone. Marked interindividual differences in plasma dexamethasone suggest that performance of the test might be improved by factoring dexamethasone levels into test interpretations. There also may be advantages to the development of a modified test involving other exogenous and index steroids, such as monitoring corticosterone levels. Although it is too early to determine how ROC analysis will alter the clinical application of the test, some implications for methodology and data presentation are already clear. First, because the test is a diagnostic system with nonbinary outcomes, ROC analysis can augment traditional performance indices such as sensitivity, specificity, and positive predictive power. Second, ROC analysis will improve comparisons between the studies of different research groups and will help assess innovations in the application of the test. Third, ROC analytic techniques permit appropriate planning of sample size given estimates of the expected values of AUC that would be obtained from the studies. ROC theory thus promises to play an increasingly important role in the evaluation and future improvement of the dexamethasone suppression test and other biologic markers in clinical psychiatry. In conclusion, neither uncritical enthusiasm nor excessive skepticism is warranted about the use of the dexamethasone suppression test in clinical psychiatry. Evidence to date should encourage investigators to pursue refinement of the test or other tests of hypothalemic-pituitary-adrenal functioning to increase their accuracy and clinical utility.

Adrenocorticotropic Hormone↗
PubMed1996

Harmonization of animal clinical pathology testing in toxicity and safety studies. The Joint Scientific Committee for International Harmonization of Clinical Pathology Testing.

Ten scientific organizations formed a joint international committee to provide expert recommendations for clinical pathology testing of laboratory animal species used in regulated toxicity and safety studies. For repeated-dose studies in rodent species, clinical pathology testing is necessary at study termination. Interim study testing may not be necessary in long-duration studies provided that it has been done in short-duration studies using dose levels not substantially lower than those used in the long-duration studies. For repeated-dose studies in nonrodent species, clinical pathology testing is recommended at study termination and at least once at an earlier interval. For studies of 2 to 6 weeks in duration in nonrodent species, testing is also recommended within 7 days of initiation of dosing, unless it compromises the health of the animals. If a study contains recovery groups, clinical pathology testing at study termination is recommended. The core hematology tests recommended are total leukocyte (white blood cell) count, absolute differential leukocyte count, erythrocyte (red blood cell) count, evaluation of red blood cell morphology, platelet (thrombocyte) count, hemoglobin concentration, hematocrit (or packed cell volume), mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration. In the absence of automated reticulocyte counting capabilities, blood smears from each animal should be prepared for reticulocyte counts. Bone marrow cytology slides should be prepared from each animal at termination. Prothrombin time and activated partial thromboplastin time (or appropriate alternatives) and platelet count are the minimum recommended laboratory tests of hemostasis. The core clinical chemistry tests recommended are glucose, urea nitrogen, creatinine, total protein, albumin, calculated globulin, calcium, sodium, potassium, total cholesterol, and appropriate hepatocellular and hepatobiliary tests. For hepatocellular evaluation, measurement of a minimum of two scientifically appropriate blood tests is recommended, e.g., alanine aminotransferase, aspartate aminotransferase, sorbitol dehydrogenase, glutamate dehydrogenase, or total bile acids. For hepatobiliary evaluation, measurement of a minimum of two scientifically appropriate blood tests is recommended, e.g., alkaline phosphatase, gamma glutamyltransferase, 5' -nucleotidase, total bilirubin, or total bile acids. Urinalysis should be conducted at least once during a study. For routine urinalysis, an overnight collection (approximately 16 hr) is recommended. It is recommended that the core tests should include an assessment of urine appearance (color and turbidity), volume, specific gravity or osmolality, pH, and either the quantitative or semiquantitative determination of total protein and glucose. For carcinogenicity studies, only blood smears should be made from unscheduled sacrifices (decedents) and at study termination to aid in the identification and differentiation of hematopoietic neoplasia.

Animal Welfare↗
PubMed1996

Pap test coverage in São Paulo municipality and characteristics of the women tested.

Interview data collected in March-September 1987 as part of an international multi-center study were used to assess Pap test coverage in the municipality of São Paulo and determine characteristics that made study subjects more likely or less likely to have been tested. The data analyzed came from interviews with 967 women. Information gathered during the interviews included demographic and socioeconomic data as well as information about use of health service facilities, use of oral contraceptives, breast self-examination, smoking, alcoholism, and prior Pap testing. The results showed that 666 (69%) of the women said they had received a Pap test in the past; 588 (61%) said they had one within three years of the interview; and 399 (41%) said they had one during the past year. Statistically significant relationships were found between Pap testing sometime in the past (and also Pap testing within the preceding three years) and age, education, marital status, use of oral contraceptives, breast self-examination, and consulting with a physician during the year preceding the interview. Adjustment for all the other statistically significant variables through multivariate analysis influenced but did not undo the statistical significance of each of these relationships. Overall, the results of this study point to levels of Pap test coverage exceeding those found by other São Paulo studies. One reason could have been this study's inclusion of Pap tests obtained at medical clinics that were not specifically accredited to give the test; another, which does not exclude the first, could have been a real increase in coverage resulting from increasing dissemination of messages in the 1980s stressing the importance of Pap testing. It is also noteworthy that 40% of the women interviewed said they had not had the test within the preceding three years. Characteristics associated with those not having had the test were youth (being 15-24 years old), being single, having low socioeconomic status, not having consulted a physician for a year, not having used oral contraceptives, and not having performed breast self-examination for a year. Knowing these characteristics could help implement measures to increase Pap test coverage of specific subgroups.

Adolescent↗
PubMed2005

Use of the dog as non-rodent test species in the safety testing schedule associated with the registration of crop and plant protection products (pesticides): present status.

The results from a survey of the expert information that is publicly accessible on the use of the dog as test species during the regulatory evaluation of agricultural chemicals and pesticides are reported. Methods that are being used or considered in order to reduce the number of dogs used for this purpose are described. Regulatory evaluation aims at establishing threshold values for safe human exposure; it is based on no-observed-adverse-effect levels (NOELs) determined in animal studies. Current regulations require testing in two species, a rodent species (usually rat or mouse), and a non-rodent species (usually the dog). Subchronic (90-day) and chronic (12-month) repeated-dose feeding studies must be routinely conducted in dogs. This report first focuses on the results from a retrospective study analysing data on 216 pesticides kept on record by the Bundesinstitut für Risikobewertung, BfR (German Federal Institute for Risk Assessment), the competent regulatory authority in Germany. The study was sponsored and coordinated by SET, the German Foundation for the Promotion of Research on Replacement and Complementary Methods to Reduce Animal Testing (Stiftung zur Förderung der Erforschung von Ersatz-und Ergänzungsmethoden zur Einschränkung von Tierversuchen, Mainz) and conducted by the BfR. Since the data submitted for registration of a product is the property of the manufacturer, the study could only proceed with the collaboration of the German Association of Manufacturers of Agricultural Chemicals (Industrieverband Agrar, IVA). To ensure confidentiality, designated codes were used instead of the compounds' proper names when the study was published. The results support two major conclusions. The use of the dog for the testing of pesticides is indeed necessary because the dog has proved to be the most sensitive species for about 15% of the compounds examined. However, chronic studies are only of limited value since they only provide essential information that cannot be obtained in sub-chronic studies in about 5% of cases. These conclusions are supported by several retrospective analyses using data on pharmaceutical drugs carried out in the context of the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH). Over 90% of drugs elicited no toxic symptoms in 12-month studies in dogs in addition to those that had been recorded previously in studies conducted for 90 or 180 days in dogs and rats. Another approach comparing the results from pre-clinical animal studies with clinical studies noted that animal studies predicted about 70% of the effects observed in volunteers, and in about 94% of cases the effects occurred in animal studies lasting not more than one month. Furthermore, the report summarises the current methods under consideration that could refine or reduce the use of dogs in toxicity testing: industrial data sharing and harmonisation of guidelines, in vitro methods, human studies, computational prediction models, and integrated testing approaches. The integrated Agricultural Chemicals Safety Assessment (ACSA) testing scheme, which is currently being developed in an international project initiated by the International Life Sciences Institute (ILSI, USA), is of particular relevance, since an ambitious attempt is being made to design a new comprehensive test framework incorporating modern scientific approaches and covering most aspects of current regulatory testing requirements. The ACSA project has access to the pesticide database of the US EPA's Office of Pesticide Programs (OPP). Preliminary results have confirmed the two major conclusions from the joint SET/BfR study conducted in Germany. Taking these results into account, it is recommended that the regulatory requirement for 12-month studies to be routinely carried out in dogs should be abandoned. While 90-day studies should be conducted in both rats and dogs, chronic studies should only take place in rats. If the dog is more sensitive than the rat in the 90-day study, an additional safety factor to the NOEL value obtained in the chronic rat study should be applied in order to set the threshold for safe human exposure, instead of conducting a 12-month study in dogs. This safety factor may be calculated from chronic NOEL data available in several pesticide databases. Chronic tests using dogs would then only be required if the test compound belongs to a new class of chemicals that has never been tested before. Thus, the report concludes that, according to current scientific knowledge, the routine 12-month studies in dogs are no longer required for agricultural chemicals and pesticides, and international regulations should be changed accordingly. Active international support of such measures is welcomed, from both an economical and an animal welfare perspective.

Animal Testing Alternatives↗
PubMed1993

Lack of predictivity of bone marrow micronucleus test versus testis micronucleus test: comparison with four carcinogens.

In vivo somatic chromosome mutation tests are usually carried out using the bone marrow micronucleus test in the mouse. This test is also considered predictive for the study of clastogenic effects in germ cells. However, it has been reported that the sensitivity of the bone marrow micronucleus test is insufficient to detect unstable compounds or short-lived metabolites and the use of target cells with metabolic activity (hepatocytes) has been questioned. In order to analyze in vivo micronucleus induction in cells with metabolic enzyme activity, we compared the sensitivity of somatic and germ cells to four carcinogens in the bone marrow and spermatid micronucleus test in the mouse. Three procarcinogens with a complex metabolic pattern (dimethylnitrosamine, diethylnitrosamine and 1,1-dimethylhydrazine) and one direct unstable mutagen (beta-propiolactone) were tested. All four carcinogens were not detected by the bone marrow micronucleus test but were detected in the mouse spermatid micronucleus test in which they induced clear clastogenic effects, as was the case in a previous study in liver micronucleus test. In conclusion, this study demonstrates that the bone marrow micronucleus test is not sufficient for the prediction of a clastogenic hazard in germ cells. In addition to a second in vivo test in an organ with metabolic enzymes, i.e., the liver, the spermatid micronucleus test can be performed when a specific risk to the testis is likely.

Animals↗
PubMed1995

Head-shake vestibulo-ocular reflex testing: comparison of results with rotational chair testing.

The currently accepted "gold standard" for rotational testing of the vestibulo-ocular reflex uses a servo-controlled chair for sinusoidal whole-body rotation. Previous work in our laboratory has shown good concordance between conventional rotational chair testing and head-on-body (or "head-shake") testing for gain and phase values of the vestibulo-ocular reflex as recorded and analyzed on our rotational chair system's software. In this article we describe results obtained from 10 normal subjects and 20 patients with reduced caloric responses using a portable system being developed in our laboratory that allows an examiner to generate both whole-body and head-on-body rotational stimuli. Test frequencies within the range 0.25 to 1.0 Hz were chosen for comparison with results obtained by conventional rotational chair testing. Visual conditions for all tests included both visually enhanced vestibulo-ocular reflex (real earth-fixed target) and mentally enhanced vestibulo-ocular reflex (imagined earth-fixed target, in darkness or with vision obscured) paradigms. Our results show general agreement between head-shake and rotational chair testing and both manual whole-body rotation and head-shake testing on our portable system for vestibulo-ocular reflex gain and phase testing, with the largest differences noted at 1.0 Hz. Portable rotational testing was well tolerated by young and elderly subjects alike. We expect manual whole-body rotation and head-shake testing will be useful adjuncts for examining vestibulo-ocular reflex function when more formal rotational chair testing is not possible.

Adult↗
PubMed1996

Immunopathogenesis of fish allergy: identification of fish-allergic adults by skin test and radioallergosorbent test.

BACKGROUND: As the consumption of fish increases in the United States, the importance of allergic reactions to fish has become clear. Since most previous studies on fish allergy have focused on children reacting mainly to codfish, there is a need to investigate allergic reactions to other fish in adults. OBJECTIVE: To identify fish-allergic adults, and to assess cross-reactivity among different species of fish by RAST inhibition. METHODS: Thirty-nine individuals who reported fish allergy were selected for study; 32 (82%) were atopic as defined by two or more positive skin tests to common inhalant allergens and a history of allergic reactions and 33 (85%) experienced allergic symptoms within 30 minutes after ingesting fish. The most frequently reported symptoms were hives (69%), itching (69%), and wheezing/chest tightness (54%). Study subjects were skin tested with fish extracts and their sera assayed for IgE antibodies to different fish species. RESULTS: Thirty-six (92%) of the subjects tested had a positive skin test to at least one of 17 fish extracts tested; 9/35 (26%) reacted to all 17 extracts. Of the atopic (two or more positive skin tests to common inhalant allergens plus a personal and/or family history of allergy) and nonatopic fish-tolerant controls, 20/26 (77%) reacted by skin test to one or more fish extracts tested; the most prevalent positive reaction was to anchovy (73%). A significant correlation (P < .01) was observed between skin test reactivity of fish-allergic subjects to most fish extracts and fish RAST reactions. Radioallergosorbent inhibition testing demonstrated significant cross-reactivity among pollack, salmon, trout, and tuna; and between mackerel and anchovy. CONCLUSION: These results suggest that fish-allergic subjects may be clinically sensitive to more than one species of fish. Skin test reactivity to fish by itself is not an adequate criterion for the confirmation of clinically relevant fish allergy; consequently, fish-allergic subjects with positive skin tests to several fish species should exercise caution when eating fish until tolerance can be demonstrated by double-blind, placebo-controlled food challenge, at the patient's earliest convenience.

Adult↗
PubMed2005

Comparison of the effectiveness of two versions of the Rey memory test in discriminating between actual and simulated memory impairment, with and without the addition of a standard memory test.

The superiority of the modified 16-item Rey memory test over the original 15-item test has yet to be established in relation to the detection of feigned memory deficits. This study compares the effectiveness of these two versions of the test in combination with a standard memory test. Sixty-four participants, equally divided into "controls" and "simulators", and 32 "memory-impaired" volunteers completed the WAIS-III Digit Span test and either the 15-item or 16-item Rey test. The median scores of the simulators were worse than those of both the controls and the memory-impaired subjects on two types of score on the 16-item test compared to just one on the 15-item test. However, combining the total score from the 16-item test with the digits forward span accurately detected 63% of simulators (with only 6% of nonsimulators wrongly classified as simulators). This performance was better than that obtained from any of the test scores taken singly or from any other combination of a digit span score with a Rey score. It is concluded that the addition of a standard memory test to the Rey memory test improves the detection of individuals feigning memory impairment.

Adolescent↗
PubMed2000

Aerobic fitness testing in patients with chronic low back pain: which test is best?

STUDY DESIGN: This is a randomized comparison of three exercise tests in a sample of 30 patients with chronic low back pain. OBJECTIVES: To determine, by comparing three exercise tests, which test yields the highest peak and predicted oxygen consumption in a sample of patients with chronic low back pain. SUMMARY OF BACKGROUND DATA: Little is known about the level of aerobic fitness in patients with chronic low back pain, although many rehabilitation programs emphasize aerobic exercise as an important part of their therapy. Measurement of aerobic fitness levels in these patients remains a problem. In healthy individuals, the highest oxygen consumption values come from exercise tests that use the largest muscle groups. For a number of reasons, this may not be true in patients with chronic low back pain. METHODS: In this study, 30 participants with chronic low back pain performed three symptom-limited maximal exercise tests: a treadmill, an upper extremity ergometer, and a bicycle ergometer. The tests were administered in randomized order. Heart rate was continuously monitored and oxygen consumption in terms of mL/kg/minute was measured by indirect calorimetry each 30 seconds. RESULTS: The statistical difference among the tests was highly significant (P < 0.0001). The treadmill test yielded the highest peak and predicted oxygen consumption followed by the bicycle and the upper extremity ergometer test, respectively. CONCLUSIONS: The treadmill test is the best test for measuring aerobic fitness levels in patients with chronic low back pain. It yielded the highest peak oxygen consumption compared with the other tests, coming closest to measuring maximal oxygen consumption.

Adolescent↗
PubMed1995

Comparative evaluation of microagglutination test and serum agglutination test as supplementary diagnostic methods for brucellosis.

The diagnosis of brucellosis in cattle and small ruminants requires the use of more than one serological test. The complement fixation test (CFT), the rose bengal test (RBT), and the serum agglutination test (SAT) are among the most useful tests for routine diagnosis. The microagglutination test (MAT) was developed as a simpler and more efficient test than the SAT. The relative efficacy of this test compared with that of the SAT was evaluated by using brucella-free sheep and goats prior to and after vaccination treatment. The specificities of the MAT and the SAT were 100%. Of the ewes and goats with a vaccination history, one ewe, expectedly a negative responder, had reactions in the MAT, the complement fixation test, and the rose bengal test but not in the SAT, suggesting a lower sensitivity of the SAT in this case. The calculated sensitivities of the MAT and the SAT were 93.9%. The agreement between MAT and SAT results from nonresponders was examined by using sera from unvaccinated lambs and kids (95.2% agreement), unvaccinated ewes and goats (84.4%), and ewes and goats with a vaccination history (43.9%). For the latter group higher levels of agglutination units were observed by the MAT than by the SAT in 51.5% of the samples. In testing sera from positive reactors after vaccination neither method was superior (MAT values were greater than SAT values for 23.5% of the samples, and MAT values were less than SAT values for 21.9% of the samples). Comparison of the methods on the individual sample level revealed a significant correlation between the MAT and the SAT (r = 0.96 +/- 0.005; P < 0.001). Since the MAT is simpler to perform than the SAT and can potentially be automated, the inclusion of the MAT as a supplementary test in brucellosis control programs is recommended.

Agglutination Tests↗
PubMed2002

Evaluation of a rapid-format antibody test and the tuberculin skin test for diagnosis of tuberculosis in two contrasting endemic settings.

OBJECTIVE AND SETTING: We evaluated a rapid-format antibody card test and the tuberculin skin test for diagnosis of active tuberculosis (TB) in high (Cairo, Egypt) and low (St. Louis, USA) prevalence areas. DESIGN: Prospective study of hospitalized TB patients and controls with other chest diseases. RESULTS: Test performance varied significantly in the two study sites. The antibody test detected 87% of 71 smear-positive pulmonary TB cases (86% of smear-negative pulmonary cases and 48% of TB meningitis cases) in Egypt; specificity was 82%. The tuberculin test was highly sensitive in Egypt in subjects with pulmonary TB (100%) but not in those with meningitis (23%); specificity was 70%. The sensitivity and specificity of the antibody test in St. Louis were 29% and 79%, respectively; 50% of St. Louis TB cases and 15% of controls had positive tuberculin tests. CONCLUSIONS: This convenient antibody card test may have value for diagnosis of patients suspected of having TB in high prevalence areas like Egypt. However, the specificity of the test is too low for it to be useful as a screening test. Our results suggest that neither the antibody test nor the tuberculin test have much diagnostic utility in low prevalence settings like St. Louis.

Adult↗
PubMed1990

Comparative assay of varicella skin test antigens by the ELISA and RPHA tests.

The antigenic potency of the varicella skin test antigens was assayed by reversed passive haemagglutination (RPHA) test using sheep red blood cells coated with zoster convalescent serum and by enzyme linked immunosorbent assay (ELISA) using anti-VZV sera or monoclonal antibody to gpI followed by an anti-IgG beta-galactosidase conjugate. Three kinds of varicella skin test antigens were compared: a soluble varicella skin test antigen, a modified soluble varicella skin test antigen, and a crude varicella skin test antigen. The RPHA test was suitable for the soluble and for modified soluble varicella skin test antigens but it was not suitable for the crude varicella skin test antigen. ELISA was applicable for all the three antigen types. It was possible to assess quantitatively the content of viral antigens in the same type of the skin test antigen, but not by comparing the different skin test antigen types. ELISA was more efficient in the quantitative assay of the amount of viral antigens than the RPHA test.

Animals↗
PubMed1996

Correlation of modified radioallergosorbent test scores and skin test results.

In addition to a significantly increased sensitivity as compared with the initial Phadebas radioallergosorbent test, a major advantage of the Fadal-Nalebuff modified RAST is its correlation with skin testing using skin end point titration. This correlation allows physicians to use both these modalities in the diagnosis and treatment of allergic disorders. However, it has been anecdotally believed that the correlation of radioallergosorbent test classes and skin test end points varied somewhat with different antigens. Fifty-three patients were tested by radioallergosorbent test for 12 inhalant antigens common to the North Texas region. These patients subsequently underwent confirmation of their radioallergosorbent test results by application of intradermal tests at a concentration of one fivefold step weaker than the corresponding radioallergosorbent test level (a "RAST minus one" dilution). The relationship between radioallergosorbent test and skin test results will be critically analyzed.

Administration, Inhalation↗