[Correlation between the head shaking test, the test for the detection of nystagmus of cervical origin and caloric test (author's transl)].
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It was our purpose to determine the characteristics of practitioners in the United States who were among the first to inquire about and use the BRCA1 and BRCA2 (BRCA1/2) genetic tests outside of a research protocol. Questionnaires were mailed to all practitioners who requested information on or ordered a BRCA1/2 test from the University of Pennsylvania (UPenn) Genetic Diagnostics Laboratory (GDL) between October 1, 1995 and January 1, 1997 (the first 15 months the test was available for clinical use). The response rate was 67% of practitioners; 54% (121/225) were genetic counselors, 39% (87/225) were physicians or lab directors. Most physicians were oncologists, pathologists, or obstetrician/gynecologists, but 20% practiced surgery or internal or general medicine. Fifty-six percent (125/225) had ordered a BRCA1/2 test for a patient; most of the rest had offered or were willing to offer testing. Of those who had offered testing, 70% had a patient decline BRCA1/2 testing when offered. Practitioners perceived that patients' fear of loss of confidentiality was a major reason for declining. Nearly 60% of practitioners reported that their patients had access to a genetic counselor, but 28% of physicians who ordered a BRCA1/2 test reported having no such access, despite the GDL's counseling requirement. The proportion of physicians reporting no access to genetic counselors for their patients increased from 22.4% in the first half of the study to 50% in the last half. Many practitioners have an interest in BRCA1/2 testing, despite policy statements that discourage its use outside of research protocols. Practitioner responses suggest that patient interest in testing seems to be tempered by knowledge of potential risks. An apparent increase in patient concern about confidentiality and inability to pay for testing could indicate growing barriers to testing. Although most practitioners reported having access to counseling facilities, perceived lack of such access among an increasing proportion of practitioners indicates that lab requirements for counseling are difficult to enforce and suggests that an increasing proportion of patients may not be getting access to counseling.
Altogether, 69 out of 98 fibromyalgia (FMS) patients who attended a 2-week multidisciplinary inpatient course and a 1-week control period 3 months later completed 2-km walking tests and stepwise-increased cycling tests at entry and after 3 months. The purpose was to compare the feasibility of the two fitness tests for assessment of FMS patients. The results showed a substantially lower fitness level in the results of the 2-km walking test than in the cycling test in the same patients: mean maximum VO2 was 28.5 ml/kg per min vs 34.6 ml/kg per min, respectively. At entry and after the 3-month training period, the correlations between the two tests were very poor, i.e., with Spearman's r coefficients of 0.37 and 0.34, respectively (P < 0.01), intraclass correlation coefficients (ICC) 0.20 (95% CI -0.29 to 0.50) and 0.47 (95% CI 0.15 to 0.67), reliability coefficients (alpha) 0.54 and 0.47, and Kendal-T coefficients 0.32 and 0.41 for ordinal correlation of the test results. The results did not correlate with pain, which remained at initial levels for the 3 months of follow-up. Principally, these tests should both measure the same property, i.e., the fitness of fibromyalgia syndrome (FMS) patients, but the results differed substantially. The 2-km walking test showed a markedly lower fitness level than the cycling test in the same patients. The primary explanation for this difference might be difficulties in controlling test performance. especially in walking. The 2-km walking test would not appear recommendable for subjects with chronic pain syndrome, e.g., fibromyalgia.
A method for the screening of human sera for tetanus antibodies has been developed and evaluated. The toxin binding inhibition test (ToBI-test) is based on inhibition of the binding of tetanus toxin to an antitoxin-coated immunoassay microtitre plate by tetanus antibodies. Serum samples from 191 healthy adults with different vaccination histories have been titrated for tetanus antibodies by the toxin neutralization (TN) test in mice, by toxoid-ELISA and by the ToBI-test. In every respect, the ToBI-test proved to be the best in vitro alternative to the TN-test in mice. Comparisons showed a higher degree of correlation between the ToBI-test and the TN-test than between the toxoid-ELISA and the TN-test. Furthermore, no overestimation of antibody content was seen in titrating low titre sera by the ToBI-test. In contrast, several false positive results were seen when using the toxoid-ELISA. It is concluded that the ToBI-test is a reliable and precise alternative to the TN-test and can be performed under simple laboratory conditions in a short time.
The linear trend test in proportions is frequently used to analyze the results of animal carcinogenicity experiments. This test has two major advantages over other frequently used tests; it is easily understood and it is simple to calculate. This test, however, fails to correct for treatment-related differences in survival across the experimental groups. A test which is a simple modification of the linear trend test in proportions and which has the same advantages is proposed to correct for differences in survival. The results of this modified test are compared to those of the linear trend test in proportions, the incidental tumor test, the logistic regression score test, the life table test, and the truncated trend test using information on the incidence of combined alveolar/bronchiolar adenomas or carcinomas in female B6C3F1 mice exposed to vinylcyclohexene diepoxide.
The lupus ratio (LR) test is a normalized ratio of the clotting times obtained with low and high phospholipid (PL) concentrations, where the test plasma is mixed 1:1 with normal pooled plasma (NP). As an integrated, automated, and computer-assisted assay, this principle has been applied to the dilute activated partial thromboplastin time (dAPTT) and dilute Russell viper venom time (dRVVT) test systems. In this study, we used recombinant thromboplastin to develop an automated LR test based on the dilute prothrombin time (dPT). Using plasma samples from a selected group of patients (N=92) with a well-defined lupus anticoagulant (LA) status, the dPT-based LR test showed fair agreement with the dAPTT-based LR test (kappa=.60, P<.001) and good agreement with the dRVVT-based LR test (kappa=.78, P<.001) regarding the classification of plasmas as LA-negative or -positive. Most discordant plasmas were low positive. Correlation between dPT- and dRVVT-positive LRs was only moderate (r(s)=.51, P=.002), and correlation between dPT- and dAPTT-positive LRs was nonsignificant (r(s)=.23, P=.18). Using dilutions of pooled LA-positive plasma, the dAPTT-based LR test appeared to be the most sensitive of the three tests. This study confirms the general validity of the LR principle and shows that the dPT-based LR test yields reproducible results. The low coefficients of variation (CV) of the LR assays, combined with a fairly low correlation among the three tests, support the assumption of antibody heterogeneity of LA-positive plasmas and the desirability of performing more than one test.
The fully automated BACTEC MGIT 960 PZA medium for susceptibility testing of Mycobacterium tuberculosis to pyrazinamide (PZA) was evaluated using 101 Mycobacterium tuberculosis clinical isolates. The results obtained with the system were compared with those of the pyrazinamidase (PZase) assay and the Kyokuto PZA test based on a broth culture, which is commercially available in Japan. The overall concordance rate was 90.1% (91/101) among the three methods in the initial test. The concordance rates between the BACTEC MGIT 960 PZA medium vs the PZase assay, the BACTEC MGIT 960 PZA medium vs the Kyokuto PZA test, and the PZase assay vs the Kyokuto PZA test were 93.1, 91.1, and 96.0%, respectively. On the repeat test of the 10 strains with discrepant results among the three methods, the concordance rates reached over 97% between each of the two systems. The results of the repeat test were confirmed by MIC testing and sequencing analysis of the pncA gene encoding PZase of M. tuberculosis. The mean turnaround times from incubation for PZA susceptibility testing were almost similar for the two methods based on liquid media, the BACTEC MGIT 960 PZA medium and the Kyokuto PZA test (7.7 and 7.4 days, respectively). These results indicate that both methods based on liquid media, the fully automated BACTEC MGIT 960 PZA medium and the Kyokuto PZA test for susceptibility testing to PZA, are useful for rapid diagnosis of PZA resistant tuberculosis.
This study was undertaken to compare the relative values of the low level predischarge exercise test and the postdischarge (6 weeks) symptom-limited test in 518 consecutive patients admitted with an acute myocardial infarction. Of the patients who did not develop significant ST segment depression or angina during the predischarge test, the symptom-limited test also remained negative in 91.5 and 91.9% of the patients, respectively. Similar results were obtained with ST segment elevation and the systolic blood pressure response during the two exercise tests with only 2.1 and 11.4% changing from normal to abnormal, respectively. Discriminant function analysis was done to predict the occurrence of coronary events (unstable angina, reinfarction, cardiac failure, cardiac death) with use of the data from the exercise tests together with other clinical and investigational data. The jackknife method correctly classified 71.9 and 71.4% of the patients with the data from the predischarge exercise test and symptom-limited test, respectively. Combining the data from the two tests improved the overall predictive accuracy to only 75.0%. It is concluded that the routine performance of a symptom-limited test 6 to 8 weeks after infarction does not reveal any significant additional information in those patients who have undergone a predischarge low level exercise test. Thus the 6 to 8 week test should be restricted to selected patients after myocardial infarction.
The value of the exercise-electrocardiography test in detecting coronary artery disease in women is limited. Recently, the high dose dipyridamole-echocardiography test (two-dimensional echocardiographic monitoring during intravenous dipyridamole infusion, up to 0.84 mg/kg body weight over 10 min) was proposed as an alternative to exercise testing for the diagnosis of coronary artery disease. To establish the diagnostic usefulness of the exercise-electrocardiography and dipyridamole-echocardiography tests in this disease, the two tests were performed--on different days and in random order--in 83 consecutive women evaluated for a chest pain syndrome. All 83 women had taken no medications for greater than 48 h, and 15 had had a previous myocardial infarction. Positivity of the dipyridamole-echocardiography test was based on detection of a transient asynergy of contraction that was absent or of lesser degree at rest; the exercise-electrocardiography test (by upright cycloergometer) was considered positive when the ST segment was shifted greater than 0.1 mV 0.08 s after the J point. Coronary angiography showed significant coronary artery disease (greater than 70% luminal reduction of at least one major coronary vessel) in 39 women. No significant complications occurred in any patient during either test. Sensitivity and predictive value of a negative test were similar for the dipyridamole-echocardiography and the exercise-electrocardiography test (79 versus 72% and 84 versus 68%, respectively, whereas the dipyridamole-echocardiography test had greater specificity (93 versus 52%, p less than 0.001), accuracy (87 versus 62%, p less than 0.001) and a higher predictive value of a positive test (91 versus 57%, p less than 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)
A new test to detect genotoxicity, that we refer to as the VITOTOX test, was developed. Four gene fusions that are based on the Escherichia coli recN promoter were constructed and evaluated for their SOS response-dependent induction. The wild-type recN promoter, a derivative mutated in the second LexA binding site, a derivative with a mutated -35 region, and a derivative from which both the second LexA binding site and the -35 region were mutated, were cloned upstream of the promoterless Vibrio fischeri luxCDABE operon of pMOL877, in such a way that lux became under transcriptional control of the recN promoter derivatives. The inducibility by the SOS response of the promoter constructs was tested in both E. coli and in the Ames test Salmonella typhimurium strains TA98, TA100 and TA104. In all strains, the highest sensitivity and induction was observed with the plasmids pMOL1067 and pMOL1068, that contain the lux operon under control of the recN promoter mutated in the second LexA binding site, or a recN promoter with a mutated -35 region, respectively. Therefore, strains containing pMOL1067 or pMOL1068 were further used for genotoxicity testing. With the VITOTOX test, genotoxicity was detected within 1-4 h. The VITOTOX test is very sensitive: for most products tested, the minimal detectable concentration (MDC) values were considerably lower (5 to > 100 times) than those described for the Ames test and the SOS chromotest. A good correlation was observed with the results from the Ames tests, but certain PAHs that are not mutagenic in the Ames test were genotoxic in the VITOTOX test. With the VITOTOX strains, the kinetics of SOS induction can be determined. This feature made it possible to distinguish between compounds in mixtures of genotoxic products so long as they had different induction kinetics.
According to regulations in the European Union, new chemical substances must be notified before they can be introduced onto the market. One of the prerequisites for notification is that toxicological properties, including mutagenicity, are examined. In this paper, a report on routine in vitro mutagenicity testing is given for 776 new substances notified in Germany between 1982 and 1997. In general, the methodological quality of testing was in line with internationally accepted guidelines. Bacterial gene mutation tests (Bact) were conducted for nearly all of the substances, 13.4% were positive. Of the Bact-positive substances, 36 were also tested in the in vitro chromosomal aberration test (CAbvit) and the mammalian cell gene mutation test (MCGM). Twenty-six of these (72. 2%) were negative in both mammalian cell tests indicating that the genotoxic potentials of the substances are not relevant for man. Of all new substances, 333 were tested in CAbvit, here the percentage of positive findings was 25.2%. More than 80% of the in vitro clastogens were negative in the Bact. With respect to a sensitive detection of genotoxic potentials of substances, the combination 'Bact+CAbvit' is appropriate for basic testing. In our database CHL cells were more sensitive to clastogenic effects than other cell types. Only very few clastogens were identified as 'high toxicity clastogens'. MCGM tests were performed for 118 substances, quite often as follow-up in case of positive Bact tests. In total, 12.7% of the substances were positive in the MCGM. However, there was a clear difference in the frequencies of positive findings in HPRT tests (5.5%) and mouse lymphoma assays (MLA; 37.0%). None of the MCGM-positive substances was a 'unique positive', i.e., negative in Bact and CAbvit.
BACKGROUND: Conventional (13)C-urea breath testing ((13)C-UBT) includes a test meal to delay gastric emptying, which, theoretically, improves the accuracy of the test. Citric acid has been proposed as the best test meal. However, recent studies have suggested that a test meal may not be necessary. AIM: To investigate a new (13)C-UBT protocol without a test meal in a Chinese population. METHODS: Consecutive dyspeptic patients referred for upper endoscopy were recruited. (13)C-UBT was performed on two separate days with or without a test meal (2.4 Gm citric acid) and compared with the 'gold standard' (CLO test and histology). RESULTS: Two hundred and two patients were tested. Using receiver operating characteristics (ROC) analysis, the optimal delta-value and optimal measurement interval for UBT were 5% and 30 min, respectively, both with or without a test meal. The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of (13)C-UBT with citric acid (96.5%, 97.7%, 98.2%, 95.6%, 97.0%) were similar to (13)C-UBT without a test meal (94.7%, 97.7%, 98.2%, 93.5%, 96.0%). CONCLUSION: This simplified (13)C-UBT protocol without a test meal produced highly accurate and reliable results in the Chinese population.
PURPOSE: Random dot stereoacuity can be quantified to between 40 and 800 seconds of arc in preschool children by using the Randot Preschool Stereoacuity test (Stereo Optical Co, Inc, Chicago, Ill). To incorporate this test into clinic and research settings, the reliability of its stereoacuity scores obtained by separate examiners needs to be evaluated. The purpose of this study was to evaluate its interobserver test-retest reliability. METHODS: Participants included 102 consecutive children with binocular sensory function ranging from fine to no measurable stereopsis. Clinical research participants included children with anomalous binocular vision caused by strabismus, cataracts, anisometropia, and ptosis. In a prospective study, random dot stereoacuity was measured twice under masked testing conditions by 2 examiners within a 1-hour period. RESULTS: Interobserver test-retest reliability of the Randot Preschool Stereoacuity test is high among a population of children with diverse binocular sensory function. The correlation coefficient between individual test scores was highly significant (r = 0.97, P<.001). Mean differences between the 2 scores (0.021 log seconds of arc) were not significantly different from zero (t(99) = 1.33, P>.1). The upper and lower limits of agreement were narrow, reflecting both the large sample size and the small variation between the 2 test scores. Interobserver test-retest reliability of the Randot Preschool Stereoacuity test was nearly constant across levels of functional stereoacuity, patient categorization, and age at the time of the test. CONCLUSIONS: The high agreement between the Randot Preschool Stereoacuity test scores by 2 independent observers supports its use in clinical management and research settings for the quantitative assessment of binocular sensory vision, as well as in multicentered research studies.
BACKGROUND: Untreated bacterial vaginosis (BV) is a risk factor for postabortion pelvic inflammatory disease (PID). METHODS: Eight hundred and eight women who requested therapeutic abortion were consecutively examined for the presence of BV, using either pH/whiff test or QuickVue Advanced pH and Amines test. All patients who tested positive to BV were treated with clindamycin or metronidazole prior to abortion. RESULTS: Based on the wet smear examination, the incidence of BV was 21.6%. Positive pH and whiff test had a sensitivity of 53%, specificity of 98% and Kappa index 0.59 (n=239). Values for QuickVue Advanced pH and Amines test were 53%, 97%, and 0.58 respectively (n=508). The incidence of PID among all patients was 2.4% after pharmacological abortion and 4.9% after surgical abortion. Among the patients with microscopic presence of BV diagnosed positive by the pH/whiff test or QuickVue Advanced pH and Amines test and treated with antibiotics, no PID occurred. Patients with negative pH/whiff test or QuickVue pH and amines test who consequently did not receive preoperative antibiotics, but who later demonstrated microscopic presence of BV, had an incidence of 14.3% (5/35) postoperative PID compared to women with normal lactobacilli flora 4.3% (10/234) (OR 3.73; 95% CI 1.21-9.21). CONCLUSIONS: Although the pH/whiff test and QuickVue pH and Amines test failed to ascertain BV in almost half of the participants later found to have BV, we found that preabortal screening and subsequent treatment of those who test clinically positive does lower the incidence of postabortion PID.
In an attempt to reduce clinical laboratory testing, a strategy was designed for a clinician-oriented restriction policy imposed on the laboratory test-ordering mechanism. The program examined the requirement of a written justification to accompany test requests. Directed justification, where specified conditions were required for test performance, was applied to the prothrombin and partial thromboplastin times and resulted in a mean reduction of 44% (P less than 0.001) in these tests; a nonspecific justification directive for leukocyte differentials, where any clinical condition listed generated the test, reduced differentials 35% (P less than 0.001). The justification policy then was extended more broadly and applied on a trial basis to general medical wards. Although no review was made on validity of listed test rationalizations, the justification process alone significantly reduced four common laboratory tests from 28% (BUN/creatinine) to 45% (electrolytes); significant reductions were not seen in less frequently ordered tests. The authors concluded that the most common clinical laboratory tests may be reduced by demanding that the clinician perform a clerical justification when requesting these tests. This mild restrictive policy in the ordering process allows the clinician to maintain responsibility over laboratory testing, while effectively reducing laboratory volume.
The purposes of this descriptive cross-sectional study were to describe (1). women's affective (emotional) responses before, during, and after a Papanicolaou smear test and after receiving the test result and (2.) the difference in affective response between women who did or did not intend to repeat the Papanicolaou smear test in the future. The theory of reasoned action was used as the theoretical basis for this study. Participants were selected by convenience sampling and included 515 women aged 24 to 69 years who had a previous Papanicolaou smear test, did not have cervical cancer, and who agreed to participate. Affective response was measured with an instrument developed by Park. Intention to repeat the Papanicolaou smear test was measured with a single question on intention of repeating the Papanicolaou smear test. Women with intention to repeat the Papanicolaou smear test showed higher apprehension after the test ( = 2.695, =.04) and higher positive affective responses such as feeling relieved, great, and comfortable after receiving the test result ( = 3.014, =.003). This result suggests that women with the intention to repeat the test are more concerned with the test result and that emotional relief after confirming normal findings is an important motivator for repeating the Papanicolaou smear test.
Most studies of modifying test ordering have focused on costs. Questions not addressed are whether programs to reduce testing lead to a higher proportion of clinically indicated tests and is underutilization an adverse outcome of such programs? To investigate this, we studied the house staff's ordering of three common laboratory tests at baseline and after educational and administrative interventions. Over a 2-year period, 3,603 urine cultures, sputum cultures, and admission urinalyses were reviewed. A lecture emphasizing the indications for these tests followed by chart audit and weekly feedback increased the proportion of clinically indicated tests. Subsequently, an administrative intervention requiring the intern to list the reason for ordering the test on the laboratory request form further improved test ordering. Underutilization, defined as a failure to order a potentially indicated test, was assessed during two representative periods. The "underutilization rate" (omitted tests per 100 patients) was no worse during maximal intervention than it was 9 months after the last intervention (7.7 vs. 11.1, NS). No immediate adverse consequences resulted from tests not ordered. Our findings indicate that it may be possible to selectively reduce the ordering of unnecessary tests without sacrificing quality of care.