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PubMed1992

Readability and sensitivity of a new faecal occult blood test in a hospital ward environment. Comparison with an established test.

OBJECTIVE: To compare the readability and sensitivity of a new guaiac faecal occult blood test, HemoccultSENSA, with those of a standard guaiac-based test, Hemoccult, in a normal working environment. DESIGN: The two tests were performed in parallel on routine clinical and contrived faecal specimens; those developing the tests were blinded as to the test type. SETTING: All tests were carried out in the hospital ward environment under normal conditions by nurses working in the ward. SAMPLES: Fifty faecal samples from healthy volunteer subjects (low concentrations of haemoglobin were added to 40 of these samples) and 145 faecal samples from 65 inpatients likely to have gastrointestinal bleeding. MAIN OUTCOME MEASURES: Test positivity rate, and graded measures of colour intensity, colour stability and colour pattern. RESULTS: With patients' samples, the new test gave a greater number of positive results than the standard test (73.1% v. 65.5%; 95% confidence interval of the difference, 3.3%-11.9%). With contrived samples, the blue colour produced during development was more intense (P less than 0.0003), more stable (P less than 0.0025) and covered a larger area (P less than 0.01) with the new test compared with the standard test. CONCLUSIONS: These results demonstrate the better readability and slightly higher sensitivity of the new test. They justify its use in the ward environment or doctor's office. Patients being tested should consume a low peroxidase diet until the specificity of the new test has been fully evaluated.

Color↗

PubMed2000

National Inventory of Clinical Laboratory Testing Services (NICLTS). Development and test distribution for 1996.

CONTEXT: A statistically valid inventory of the distribution, both geographic and by laboratory type, of clinical and anatomical laboratory testing in the United States is needed to assess the impact of the Clinical Laboratory Improvements Amendments of 1988 and to provide information for other health care and public health policy decisions. OBJECTIVE: To present initial US laboratory testing volume data compiled by the National Inventory of Clinical Laboratory Testing Services. DESIGN: Stratified random sample of laboratories performing testing in 1996 with data on the number of laboratory tests performed, identified by method and analyte. Data were collected by field tabulators (moderate- or high-complexity laboratories) or through a mail/telephone survey (waived or provider-performed microscopy laboratories) for each site. PARTICIPANTS: Laboratories that were enrolled in the 1996 Online Certification Survey and Reporting System, maintained by the US Health Care Finance Administration, and that performed laboratory testing during 1996. MAIN OUTCOME MEASURE: Laboratory testing distribution for 1996 in the United States by analyte, method, and specimen type. RESULTS: An overall response rate of 79% provided data from 757 moderate- or high-complexity laboratories and 1322 waived or provider-performed microscopy laboratories. The estimated total US testing volume for 1996 was 7.25 +/- 1.09 billion tests. Laboratories performing complex testing, defined as greater than 16 method/analyte/specimen type combinations, comprised 16% of the US laboratories by survey site, but performed 80% (95% confidence limits, 43% to 100%) of the testing volume. Glucose analysis was the most frequently performed test. Automated hematology and chemistry analyzers were the most frequently used methods. CONCLUSIONS: A statistically valid, consistent survey of the distribution of US laboratory testing was obtained. Simple analysis of these data by laboratory type and geographic region can provide insights into where laboratory testing is performed. The study design allows extensions that will facilitate collection of additional data of importance to public health and medical care delivery.

Clinical Laboratory Techniques↗

PubMed1987

Computerized display of past test results. Effect on outpatient testing.

STUDY OBJECTIVE: To determine the effect of displaying previous results of diagnostic tests on the ordering of selected outpatient tests. DESIGN: Sixteen-week controlled trial with a 13-week pre-intervention and 8-week post-intervention observation periods. Patients were randomly assigned to intervention or control groups so that each physician was his or her own control. Only scheduled visits were included. Randomization occurred before the pre-intervention observation period. SETTING: Academic primary care general medicine clinic affiliated with an urban general hospital. SUBJECTS: Pre-intervention period: 111 physicians (97 internal medicine residents, 14 faculty internists), 4683 patients, 5942 scheduled visits. INTERVENTION period: same 111 physicians, 5946 patients, 8148 visits. Post-intervention period: 76 physicians (62 residents, 14 faculty), 2571 patients, 2858 scheduled visits. INTERVENTION: With an order for one of eight selected diagnostic tests through microcomputer workstations, a window was opened on the screen and previous test results were displayed along with the time interval between the first and last result. Tests were ordered for control patients into the same workstations without previous results displayed. MEASUREMENTS AND MAIN RESULTS: Previous results of one or more study tests were available for display for 96% of scheduled patients. Significantly lower results (p less than 0.05 by paired t-test) for the selected tests were found for intervention patient visits than for control visits: charges per visit (mean +/- SE) for intervention patients $12.17 +/- 0.62, compared with $13.99 +/- 0.77 for controls, a 13.0% difference; tests per visit were 0.51 +/- 0.03, compared with 0.56 +/- 0.03, an 8.5% difference. The number of study tests ordered decreased significantly for intervention patients (16.8%) and for controls (10.9%). During the post-intervention period, ordering of study tests increased for both groups, but the increase from the intervention period was not significant. CONCLUSIONS: Presenting physicians with previous test results reduced the ordering of those tests. The actual effect may have been greater than 13%, because there were reductions in study tests ordered for both intervention and control patients during the intervention period when compared with the pre-intervention period, and both tended to rise after the intervention, or display, was turned off.

Data Display↗

PubMed2006

Laboratory errors as judged by test request slips and test reports.

OBJECTIVE: To evaluate common laboratory transcription errors made in requisition forms and rate of report failure in test result reports. DESIGN: Descriptive study. PLACE AND DURATION OF STUDY: Jinnah Postgraduate Medical Center (JPMC) from February 01, till February 28, 2002. PATIENTS AND METHODS: One hundred and eight patient s records were collected randomly from 24 different departments of the hospital, during the month of February 2002. Each record was scrutinized for requisition slips and test reports. Tabulation of the content matter of all requisition slips and the test reports was done on the spread sheet, for the transcription errors; and compared with the minimum standards of requisition forms, as laid down by clinical laboratory improvement amendments; 1988 (CLIA 88). Request forms on which urgent test/any comment was given, were tabulated separately. Differences in the number of tests ordered and actually performed were also tabulated. Percentage of error was calculated. RESULTS: Four hundred and sixty-nine test request forms, requesting 1112 tests, were analyzed. None of them had pre-formatted laboratory forms. They were written on torn file papers, Out-patient department (OPD) slips and plain papers. The transcription errors included physician s identification errors (469/469 or 100%), patient s name, age, sex and unique identifier errors (0, 94, 95 and 81%) respectively, error in patients data aiding diagnosis (100%) and report failure error (37%). The requesting pattern of the laboratory tests ordered by clinicians revealed inclination towards panel-test ordering. The results of requested tests were available in 63% requested tests, and not available in 37% tests. No reason for rejection of the specimen was found on feed-back/report. Further analysis of un-reported results revealed that the emergency tests of electrolytes and sugar were the most affected ones, followed by PT/APTT, ESR and urine analysis. Tests for serum electrolytes done in elective and emergency setup, showed that out of 152 test requests for electrolytes, 124 requests were sent in elective and 28 in emergency setup. There was report failure in 84 cases (67.7%) in former and 13 cases (46.4%) in the latter. CONCLUSION: A good insight on error-prone steps in the laboratory process is essential to achieve error reduction; hence, in addition to maintaining quality standards within laboratory, it is imperative to go outside the laboratory to identify the common errors made in laboratory process and to reorganize the activity of the wards.

Clinical Laboratory Information Systems↗

PubMedDate not supplied

HIV counseling and testing: women's experiences and the perceived role of testing as a prevention strategy.

CONTEXT: It is unclear why women decide to undergo testing for HIV, and how positive and negative testresults impact their sexual behavior. METHODS: A sample of 360 family planning clinic clients in New York City were randomly assigned to receive a four- or eight-week intervention aimed at reducing sexual risk or to serve as controls. Information on their HIV testing experiences was gathered through interviews at baseline and one month, six months and one year after the intervention. RESULTS: At baseline, 67% of women had been tested for HIV. The predominant reason for not being tested was anxiety about the result. Regardless of their testing status at baseline, more than 40% of the women believed that getting tested is a good way to prevent acquiring HIV. Women in the intervention who had been tested multiple times or had last been tested more than six months ago were more likely than women in the control group to initiate HIV testing by the one-month follow-up (relative risk, 2.9 and 6.1, respectively). Rates of mutual testing (being tested at the same time as one's partner) were significantly greater among women who participated in an intervention than among controls at the one-month and six-month interviews. CONCLUSIONS: HIV test counseling must emphasize that testing is not a prevention strategy in and of itself. Mutual testing, although not without risks, offers the safest possible alternative for monogamous couples who choose to forgo condoms.

AIDS Serodiagnosis↗

PubMed2005

The L test of functional mobility: measurement properties of a modified version of the timed "up & go" test designed for people with lower-limb amputations.

BACKGROUND AND PURPOSE: Walk tests provide essential outcome information when assessing ambulation of individuals with lower-limb amputation and a prosthetic device. Existing tests have limitations such as ceiling effects or insufficient challenge. The objective of this study was to assess the reliability and validity of data for a clinical measure of basic mobility, the L Test of Functional Mobility (L Test). SUBJECTS: For this methodological study, 93 people with unilateral amputations (74% transtibial, 26% transfemoral; 78% male, 22% female; mean age=55.9 years) were consecutively recruited from an outpatient clinic. Twenty-seven subjects returned for retesting. METHODS: To assess concurrent validity, subjects completed the L Test, Timed "Up & Go" Test (TUG), 10-Meter Walk Test, and 2-Minute Walk Test, followed by the Activities-specific Balance Confidence scale, Frenchay Activities Index (FAI), and mobility subscale of the Prosthetic Evaluation Questionnaire (PEQ-MS). Amputation cause and level, walking aid use, automatic stepping, and age variables were used to assess discriminant validity. RESULTS: Intraclass correlation coefficients were .96 for interrater reliability and .97 for intrarater reliability, and minimal bias existed upon retesting. The magnitude of concurrent validity correlations (r) was very high between the L Test data and data for other walk tests and fair to moderate between the L Test data and data for self-report measures. The L Test discriminated between all groups as hypothesized. DISCUSSION AND CONCLUSION: The L Test is a 20-m test of basic mobility skills that includes 2 transfers and 4 turns. It demonstrated excellent measurement properties in this study.

Adult↗

PubMed2006

A scientific and animal welfare assessment of the OECD Health Effects Test Guidelines for the safety testing of chemicals under the European Union REACH system.

We have assessed each of the OECD Health Effects Test Guidelines (TGs) that were included in an annex to the Internet consultation issued by the European Commission relating to the Registration, Evaluation and Authorisation of Chemicals (REACH) legislation for the testing of new and existing chemical substances. Each guideline has been analysed with respect to its design and its scientific and animal welfare implications, the extent to which it makes use of modern techniques, and its suitability to be used in the REACH system for the testing of large numbers of chemicals. The scientific basis of the test and its justification are considered, as well as the numbers of animals required, and the potential adverse effects on them. The prospects and possibilities for applying the Three Rs (reduction, refinement and replacement) to each of the TGs are also discussed. We have proposed an overall testing strategy for how these TGs and other methods could best be deployed for chemicals testing, should it be necessary to fill data gaps. Certain TGs have been omitted from the strategy, when we have considered them to be unnecessary for chemicals testing. A series of recommendations has been made for improving the TGs with regard to both their scientific content and ways in which they could be better designed in relation to optimising the use of the animals concerned, and minimising adverse welfare consequences to them. Our investigations show that there is an urgent need to update the TGs to reflect modern techniques and methods, and to use current approaches for applying refinement strategies to improve the scientific and animal welfare aspects of the procedures used. Improvements can and should be made in all aspects of toxicity testing, from sample preparation, and animal housing, care and feeding, to dose formulation, test material administration, and the histopathological and clinical analysis of tissue samples. Opportunities for streamlining individual assays are very limited, but testing could be made more efficient by: a) only undertaking studies that provide relevant data; b) making greater use of screens and preliminary testing; c) applying some tests simultaneously to the same animals; d) using one sex; and e) eliminating redundant tests. In conclusion, it is clear that, as they stand, the OECD Health Effects TGs are unsuitable for use in the European Union REACH system, for which potentially very large numbers of laboratory animals will be needed for the testing of a very large number of chemicals.

Journal Article↗

PubMed2006

Rapid fecal cytokeratin-19 test and fecal occult blood test in screening for gastrointestinal diseases.

To evaluate the screening power of the fecal cytokeratin-19 test (CK-19) and the fecal occult blood test (FOBT), we performed rapid fecal CK-19 and FOBT tests on 515 stool samples from patients with various GI diseases and 814 stool samples from control patients. The rapid fecal CK-19 test (developed by DiNonA Research Institute, Seoul, Korea) is based on gold immunochromatography and has a sensitivity of 1 ng/ml. The positive rate of the FOBT was 2.1% in controls, 14.0% in GI cancer patients, 3.5% in GI inflammation patients, 11.7% in bone marrow transplant (BMT) patients, and 6.0% in childhood diarrhea patients. Except for the GI inflammation patients, the patients' positive rates for FOBT were all higher than the controls (p <0.05). The positive rate of the fecal CK-19 test was 8.2% in controls, 42.1% in GI cancer patients, 66.0% in GI inflammation patients, 84.8% in BMT patients, and 19.9% in childhood diarrhea patients. In all of the patient groups, positive rates for the CK-19 test were higher than in the controls (p <0.05). The fecal CK-19 test was more frequently positive (42.1%) in GI cancer patients than the FOBT; if both tests were used, the sensitivity was 49.1%. The fecal CK-19 test (but not the FOBT) gave a higher positive rate in GI inflammation patients than the controls, suggesting that the CK-19 test could serve as a screening test for GI inflammation. The highest positive rate of the fecal CK-19 test was found in the BMT group, indicating that significant GI epithelial desquamation had occurred. Although the positive rate of the fecal CK-19 test in childhood diarrhea patients was higher than in the controls, it was much lower than in adults with GI inflammatory disease. Evidently, children with GI inflammation do not desquamate as much intestinal epithelium as adult patients with GI inflammation. This study shows that the rapid fecal GK-19 test, used in conjunction with the FOBT, may be a valuable screening technique for GI diseases and can assist physicians in the differential diagnosis of GI diseases.

Adult↗

PubMedDate not supplied

Who plans to be tested for HIV or would get tested if no one could find out the results?

We analyzed the characteristics of individuals at risk for HIV who have not been tested but who (1) planned to be tested, or (2) would get tested "if no one other than you (the respondent) could find out your results." Data were from the 1991 National AIDS Behavioral Surveys, a probability sample of the U.S. population. Logistic regression was used to analyze the correlates of testing behavior among the 41% of individuals in high-prevalence cities who had HIV risk factors (n = 3,175). Of this group, 7% planned to be tested and 30% would get tested "if no one other than you could find out the results." Minorities and individuals with less education and without insurance were more likely to plan to be tested (versus previously tested), and individuals with less education and lower incomes were more likely to be willing to be tested "if no one other than you could find out the results" (versus previously tested). We conclude that a variety of options to increase testing rates should be explored, including accessible testing services, policies and procedures to increase perceptions of testing privacy, and home testing.

AIDS Serodiagnosis↗

PubMed1993

Comparison of Shams' test for rectal mucus to an immunological test for fecal occult blood in large intestinal carcinoma screening. Analysis of a check-up of 6480 asymptomatic subjects.

The sugar moiety detected from rectal mucus by the Galactose oxidase-schiff (Shams' test) is considered a substitutive test for immunological fecal occult blood test (FOBT) in screening colorectal carcinoma. Two strategies of screening were applied in 6480 subjects over 40 years of age, and 130 cm flexible colonoscope used for sigmoidoscopy or pancolonoscopy. Of them, 3820 were taken for immune FOBT (SPA test) and Shams' test. Only those who showed positive tests were chosen for 60 cm flexible sigmoidoscopy, while another 2660 subjects for both sigmoidoscopy and tests at the same time. Additionally, 130 cm flexible pancolonoscopy was carried out in 103 individuals with positive Shams' test for evaluating the false positive rate. Shams' test showed a sensitivity of 85.7% for colorectal cancer, 47.1% for adenomas in preselected patients, while the positive rate of SPA test were 90.5% and 41.2% respectively. In 3820 asymptomatic subjects undergoing sequential screening (aged 45 years and higher), Shams' test showed 9.1% positive, SPA showed 11.2% and 620 (16.2%) subjects were selected for sigmoidoscopy based on their positive galactose oxidase result or positive FOBT result. Two early stage carcinomas and 33 adenomas (0.32% and 4.2% respectively in sigmoidoscopy) were found. Another 2 660 subjects were taken for sigmoidoscopy screening. Four carcinomas and 78 adenomas were found. Of them, only two carcinoma (50%) and 17 (21.8%) or 22 (28.2%) adenomas were positive in Shams' or SPA test. But both tests combined in screening showed a rate of 61.3% in adenomas and 75.0% in cancers. 103 subjects with positive Shams' test were taken for pancolonoscopy. 82.5% showed no lesions.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1994

Assessing the risk of heritable gene mutation in mammals: drosophila sex-linked recessive lethal test and tests measuring DNA damage and repair in mammalian germ cells.

The former U.S. EPA OPPT tiered test scheme for heritable gene mutations included the Drosophila sex-linked recessive lethal (SLRL) test in which positive results triggered the mouse specific locus (MSL) test. However, review of available literature indicated that the evaluation of mutations in the germ cells of this insect is not a good predictor of the risk of heritable gene mutations in mammals. The database contained 29 compounds for which there were conclusive MSL test results in either spermatogonial and/or postspermatogonial cells. Results in the SLRL test were available for 27 of those compounds. Of the 24 SLRL-positive chemicals, only 13 (54%) induced heritable mutations in mice; the three SLRL-negative compounds were nonmutagenic in mouse germ cells. The overall concordance between the two tests was 59%. In contrast, results of unscheduled DNA synthesis (UDS: 18 chemicals) and alkaline elution (AE: 14 chemicals) assays in rodent testicular cells following in vivo exposure correlated well with results in the MSL test (83% and 86%, respectively). MSL test results in spermatogonia and postspermatogonia were also compared separately to the SLRL, UDS, and AE assays. The concordances for the two cell types in the SLRL relative to the MSL test were 36% and 79%, respectively, indicating that the SLRL test is extremely poor in predicting heritable gene mutations in mammalian spermatogonia. Concordances for UDS and AE assays relative to MSL test results in spermatogonia (53% and 54%, respectively) and postspermatogonia (91% and 100%, respectively) were greater. Based on these analyses, the U.S. EPA OPPT has revised its tiered test scheme using assays for interaction with gonadal DNA (e.g., UDS and AE) in place of the SLRL test.

Animals↗

PubMed2000

Comparison of diagnostic accuracy of sublingual nitroglycerin test and low-dose isoproterenol test in patients with unexplained syncope.

Despite the widespread use of head-up tilt testing as a means for diagnosing vasovagal syncope, standardization of test methodology remains a controversial issue. The aim of this study was to compare the diagnostic value of head-up tilt testing potentiated with sublingual nitroglycerin with that of head-up tilt testing potentiated with low-dose isoproterenol. For this purpose, 71 patients with unexplained syncope (mean age 43 years) and 30 asymptomatic controls were studied. All underwent the sublingual nitroglycerin and low-dose isoproterenol tests on separate days in a randomized fashion. The protocol of the 2 tests was similar and consisted of 2 phases. Initially, subjects were tilted at 60 degrees for 20 minutes without medication; then, if syncope did not occur, patients and controls received sublingual nitroglycerin (300 microg) or low-dose intravenous isoproterenol (mean infusion rate 1.3 +/- 0.5 microg/min) and continued to be tilted at 60 degrees for a further 20 minutes. During the sublingual nitroglycerin test, a positive response (syncope associated with sudden hypotension and bradycardia) occurred in 35 patients (49%), a negative response in 36 (51%), and drug intolerance in none (0%). During the low-dose isoproterenol test, these percentages were 41%, 59%, and 6%, respectively. A concordant response was observed in 53 cases (75%). Among controls, 3 subjects (10%) had a positive response to the sublingual nitroglycerin test and 4 (13%) to the low-dose isoproterenol test. It is concluded that sublingual nitroglycerin and low-dose isoproterenol are equivalent tests for evaluating patients with unexplained syncope. The sublingual nitroglycerin test, however, is simpler, better tolerated, and safer than the low-dose isoproterenol test and, thus, more suitable for routine clinical use.

Administration, Sublingual↗

PubMed2002

Loss of stereopsis with optic chiasmal lesions and stereoscopic tests as a differential test.

OBJECTIVE: To identify and characterize the loss of stereopsis observed in patients with lesions of the optic chiasm. STUDY DESIGN: Cross-sectional study. PARTICIPANTS: Forty-three patients who had good visual acuity with orthophoria and without strabismologic histories were divided into two groups. Group 1 consisted of 13 patients with lesions involving the optic chiasm (regardless of their visual field loss) diagnosed by magnetic resonance imaging findings. Group 2 (control group) consisted of 30 patients who had large absolute visual field defects as a result of other causes, including 11 intracranial disorders other than optic chiasmal lesions, 11 cases of open-angle glaucoma, and 8 patients with lesions of the retina. METHODS: The stereoacuity and visual field in each case in group 1 (before and after surgery) and group 2 were assessed, and the results were compared. MAIN OUTCOME MEASURES: Stereoacuity was assessed by the Titmus stereo test (normal value for circle, 6/9; 80 seconds of arc) and by Lang-stereotest (normal value for circle, 3/3; 350 seconds of arc). Visual field was evaluated by Goldmann and Humphrey perimetry (conventional perimetry), the starlight test (binocular visual field test), and scanning laser ophthalmoscopic microperimetry (microperimetry). RESULTS: Before surgery, 11 of 13 cases (85%) in group 1 failed stereo tests, and after surgery, 5 of 13 cases (38%) in group 1 failed stereo tests. Before surgery, four patients who failed stereo tests showed no absolute scotoma by Humphrey or Goldmann analysis; after surgery, one patient who failed stereo tests showed no absolute scotoma by Humphrey or Goldmann analysis. However, starlight testing showed complete bitemporal hemianopsia only under binocular conditions, and microperimetry demonstrated a relative bitemporal hemianopsia at the fixating point. No patient failed in the Titmus circle test, but one patient in group 2 failed the Lang test (3%). The patients with chiasmal lesions significantly lost the ability of stereopsis compared with other diseases (group 1 [before or after surgery] vs. group 2, P < 0.001, Fisher's exact test). Conventional perimetry was unable to measure scotomas within 3 degrees of the fixation point, which is the key area for acute foveal stereopsis, because of an attached observational mirror. CONCLUSIONS: The difficulty with stereopsis in patients with lesions of the optic chiasm is most likely caused by the compression of the decussating optic nerve fibers resulting in the loss of an overlapping visual field at the fixation point. Stereo tests were demonstrated to be simple and effective adjunctive tests for suspected chiasmal compression.

Adolescent↗

PubMed1997

Immunological testing for occult blood in patients with acute infectious diarrhea. Can it improve the specificity of the guaiac test?

Microscopic stool examination can distinguish inflammatory from noninflammatory diarrheas. The modified guaiac test was shown to have good correlation to stool microscopy. In a prospective study we evaluated the diagnostic accuracy of a modified guaiac test (Colo-Rectal-Test, Roche) and of an immunological test for fecal haemoglobin (Colo-Immun-Test, Roche) in relation to the diarrheal pathogens identified and compared it with the stool microscopy. In 304 patients, clinical presentation, stool microscopy, stool culture, and modified guaiac test were recorded. Sensitivity of the guaiac test was 69% as compared to 63-67% for the stool microscopy. Specificity could be improved by 10-15% using an immunological test to exclude false-positive guaiac reactions. A modified guaiac test can replace microscopic stool examination to distinguish between inflammatory and non-inflammatory diarrhea. Immunological testing for occult blood can improve the specificity of the guaiac test, but is too elaborate to serve as a screening test. The modified guaiac test can easily be handled by community health workers and could be important in the diagnostic work-up for acute infectious diarrhea.

Acute Disease↗

PubMed2001

Laboratory diagnosis of heparin-induced thrombocytopenia: advantages of a functional flow cytometric test in comparison to the heparin-induced platelet-activation test.

Nearly one third of patients with heparin-induced thrombocytopenia (HIT) will progress to overt thrombosis. Owing to the severity of HIT, a reliable prompt diagnosis is mandatory. In this study 248 consecutive samples from patients referred to our laboratory for HIT diagnosis and 97 specimens from normal controls were prospectively evaluated in parallel using the heparin-induced platelet aggregation (HIPA) test and a flow cytometric (FC) test. The HIPA test resulted in 214 negative, 17 indeterminate and 17 positive samples of patients. The FC method detects activated platelets induced by heparin-immune complexes using the highly sensitive recombinant probe annexin V and pooled platelets from multiple donors. The criteria for positive FC test results included an increase in platelet activiation of at least 11% at 0.3 IU/mL heparin concentration in the tube, and a ratio of more than 1.5 between platelet activation at 0.3 and 200 IU/mL heparin. According to the cut-off level 17 patients who showed indeteminate HIPA test results had 14 negative and 3 indeterminate corresponding FC test results. Only one of these patients (HIPA test indeterminate, FC test indeterminate) had no other obvious medical cause for thrombocytopenia than HIT. Infections or inflammations did not show any association with the FC test results, whereas thromboembolic events displayed a significant patelet activation at pharmacological heparin concentration. Therefore the FC test is associated to the complications of HIT. In conclusion, the FC test, which is fast and practical, showed a good agreement with the HIPA test and may be an accurate and useful test for HIT.

Annexin A5↗

PubMed1998

Correlation between antigen-specific IL-2 response test and provocation test for egg allergy in atopic dermatitis.

BACKGROUND: The antigen-specific interleukin-2 response (AIR) test using lymphocytes is effective in searching for the antigen which causes allergic diseases and understanding their disease activity. OBJECTIVE AND METHODS: The correlation between the raw egg oral provocation test and egg white antigen-specific interleukin-2 (IL-2) response test was investigated in 123 children with infantile atopic dermatitis and 13 children with bronchial asthma. RESULTS: Among the 83 who showed positive reactions to provocation, 75 also reacted positively to the AIR test (sensitivity, 90.4%), while among the 53 children who showed negative responses to antigen provocation, 45 produced negative responses to the AIR test (specificity, 84.9%). The specificity of egg white IgE RAST score and skin-prick test are 88.7 and 81.3% which are comparable to that of the AIR test. However, their sensitivity was low (38.6 and 66.7%). In the patterns of symptom developed in the provocation AIR displayed late and delayed type allergic responses in addition to the immediate type which RAST reflected. The RAST-negative group composed of 98 patients included 51 (52.0%) who exhibited positive reactions to the provocation test. Among these 44 responded positively to the AIR test (86.3%). CONCLUSION: The AIR test is effective for screening egg white antigen as part of the tests for antigens responsible for allergic diseases and as a test to ascertain the relevant antigens, and that the conditions that could not be diagnosed by RAST can be detected by the AIR test.

Administration, Oral↗

PubMed2003

Breath testing to evaluate lactose intolerance in irritable bowel syndrome correlates with lactulose testing and may not reflect true lactose malabsorption.

OBJECTIVES: An increased prevalence of lactose intolerance is seen in irritable bowel syndrome (IBS). Recently, we demonstrated a high prevalence of abnormal lactulose breath test results in IBS suggesting bacterial overgrowth. Because symptoms of lactose intolerance result from bacterial fermentation, the purpose of this study was to determine whether an abnormal lactose breath test is reflective of malabsorption or early presentation to bacteria. METHODS: Subjects with diarrhea-predominant IBS were enrolled. On day 1, subjects underwent a lactulose breath test after an overnight fast. Within 1 wk, subjects returned after fasting for a lactose breath test with simultaneous blood glucose measurements every 15 min to complete a lactose tolerance test (LTT). Symptoms were evaluated 3 h after lactose administration. RESULTS: Twenty subjects completed the study. One subject inadvertently received dextrose through the intravenous and was excluded. Of the remaining 19 subjects, three (16%) had an abnormal LTT suggesting malabsorption. In all, 10 subjects (53%) had an abnormal lactose breath test, 14 (74%) had an abnormal lactulose breath test, and 11 (58%) had symptoms after lactose administration. The agreement with symptoms was moderate (kappa = 0.47) and fair (kappa = 0.24) when compared to the lactose breath test and LTT, respectively. There was a fair correlation between lactose breath test and LTT (kappa = 0.29). However, lactose breath test hydrogen levels >166 ppm were universally predictive of abnormal LTT. Finally, a significant correlation was seen between the hydrogen production on lactose and lactulose breath test (r = 0.56, p = 0.01). CONCLUSIONS: Lactose breath testing in IBS subjects does not seem to reflect malabsorption; it may be an indicator of abnormal lactulose breath test, suggesting bacterial overgrowth.

Adult↗

PubMed2003

Coagulase-negative staphylococci: comparison of phenotypic and genotypic oxacillin susceptibility tests and evaluation of the agar screening test by using different concentrations of oxacillin.

This study evaluated the oxacillin susceptibilities of 152 coagulase-negative staphylococcal (CoNS) strains of 12 species by disk diffusion; agar dilution; E-test; the slide latex agglutination test (Slidex MRSA Detection test; bioMérieux S/A, Paris, France); the agar screening test with 1, 2, 4, or 6 microg of oxacillin per ml and incubation for 24 or 48 h; and detection of the mecA gene by PCR. The results revealed that the agar screening test with 4 micro g of oxacillin per ml and incubation for 48 h was superior to any single phenotype-based susceptibility assay, presenting a sensitivity and a specificity of 100% each. For the different methods evaluated, the sensitivities and specificities were as follows: for disk diffusion, 94.2 and 91.8%, respectively; for the agar dilution test 100 and 73.5%, respectively; for E-test, 100 and 71.4%, respectively; and for the slide latex agglutination test, 97.1 and 98%, respectively. A good correlation was observed between oxacillin susceptibility testing results and PCR results for Staphylococcus epidermidis, S. haemolyticus, S. hominis subsp. hominis, and all mecA-positive strains. However, at least 60% of the mecA-negative isolates of the species S. saprophyticus, S. cohnii subsp. urealyticum, S. lugdunensis, and S. sciuri were erroneously classified as oxacillin resistant by the agar dilution test. Conversely, the slide latex agglutination test presented a high sensitivity (97.1%) and a high specificity (98%) for all CoNS species. Our results demonstrated the accuracy of the agar screening test with 4 micro g of oxacillin per ml and incubation for 48 h and the slide latex agglutination test for the appropriate detection of the oxacillin susceptibilities of CoNS isolates. Both assays are technically simple and can be easier to perform in routine laboratories than PCR.

Agar↗