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PubMed2001

Absence of risk factors for false-positive test results in blood donors with a reactive test result in an automated treponemal test (PK-TP) for syphilis.

BACKGROUND: Screening and confirmatory serologic tests for syphilis are known to generate false-positive results in low-risk populations, which include blood donors. This study assessed whether conditions previously reported to cause biological false-positive (BFP) test results for syphilis are relevant to contemporary syphilis testing of blood donors and the extent to which seropositive donors report a history of syphilis. STUDY DESIGN AND METHODS: A history of conditions reported to be associated with BFP syphilis tests or a history of syphilis infection was assessed by a case-control study of donors with reactive and nonreactive automated treponemal test results, using an anonymous mail survey. Analysis of cases was stratified by fluorescent treponemal antibody absorption (FTA-ABS) result. RESULTS: Adjusted ORs (95% CIs) for reported BFP-associated conditions were 1.3 (0.8-2.1) for FTA-ABS-positive cases and 0.8 (0.3-1.9) for FTA-ABS-negative cases. Among responding blood donors, syphilis history was reported in 78 (51%) of 153 FTA-ABS-positive cases, 0 of 142 FTA-ABS-negative cases, and 3 (0.4%) of 716 automated treponemal test (PK-TP)-negative controls. CONCLUSION: Approximately half of donors with FTA-ABS-positive test results reported a syphilis history. There was no difference between reported BFP conditions for FTA-ABS-positive or FTA-ABS-negative cases and controls. This information may be useful when providing donors with better predonation or post-test counseling information about syphilis testing.

Adolescent↗

PubMed2002

Age- and gender-related test performance in community-dwelling elderly people: Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and gait speeds.

BACKGROUND AND PURPOSE: The interpretation of patient scores on clinical tests of physical mobility is limited by a lack of data describing the range of performance among people without disabilities. The purpose of this study was to provide data for 4 common clinical tests in a sample of community-dwelling older adults. SUBJECTS: Ninety-six community-dwelling elderly people (61-89 years of age) with independent functioning performed 4 clinical tests. METHODS: Data were collected on the Six-Minute Walk Test (6MW), Berg Balance Scale (BBS), and Timed Up & Go Test (TUG) and during comfortable- and fast-speed walking (CGS and FGS). Intraclass correlation coefficients (ICCs) were used to determine the test-retest reliability for the 6MW, TUG, CGS, and FGS measurements. Data were analyzed by gender and age (60-69, 70-79, and 80-89 years) cohorts, similar to previous studies. Means, standard deviations, and 95% confidence intervals for each measurement were calculated for each cohort. RESULTS: The 6MW, TUG, CGS, and FGS measurements showed high test-retest reliability (ICC [2,1]=.95-.97). Mean test scores showed a trend of age-related declines for the 6MW, BBS, TUG, CGS, and FGS for both male and female subjects. DISCUSSION AND CONCLUSION: Preliminary descriptive data suggest that physical therapists should use age-related data when interpreting patient data obtained for the 6MW, BBS, TUG, CGS and FGS. Further data on these clinical tests with larger sample sizes are needed to serve as a reference for patient comparisons.

Activities of Daily Living↗

PubMed1977

Comparison between the automated reagin test and reagin screen test methods of VDRL screening tests for syphilis in use in a routine laboratory.

A comparison is made between the automated reagin test (ART) using Technicon AutoAnalyzer equipment and the reagin screen test (RST) introduced by Lederle using a new antigen formulation. Treponemal haemagglutination tests (TPHA) were done simultaneously as second screen tests. The absorbed fluorescent treponemal antibody test (FTA-ABS) was used in all seropositive cases. Altogether 1154 sera were tested; 1028 were negative with all tests, 66 were positive with all tests, 42 were positive with TPHA and negative with ART and RST, and 16 were positive with TPHA and RST and negative with ART. It was concluded that the use of the RST and TPHA together would be the more sensitive screen test.

Antibodies, Bacterial↗

PubMed1992

The use of the D-dimer test in combination with non-invasive testing versus serial non-invasive testing alone for the diagnosis of deep-vein thrombosis.

We studied the usefulness of the determination of plasma D-dimer levels (using an ELISA) in combination with non-invasive testing with impedance plethysmography (IPG) or real-time ultrasonography (US) for the diagnosis of deep-vein thrombosis (DVT), in outpatients with clinically suspected DVT. This combined approach was compared to serial non-invasive testing alone in these patients. The sensitivity of a positive D-dimer test (greater than 300 micrograms/l) for the presence of DVT was 100% (70/70 patients; 95% C.I.: 95-100%), whereas the specificity was 29% (69/239 patients; 95% C.I.: 23-34%). The proportion of patients in which a definitive decision about the presence or absence of DVT could be made on the day of referral, was calculated for both approaches. When applying the combined approach, in 42% of all referred patients the diagnosis of DVT could either be established or refuted on entry, as opposed to only 19% of patients using serial non-invasive testing alone. Also, the costs per DVT diagnosed were calculated for the two diagnostic approaches. For the diagnosis of DVT the costs using serial IPG were comparable to the costs using the combination of IPG and the D-dimer test. The same conclusion holds for the comparison of serial US with the combination of US and D-dimer testing. We conclude that for the diagnosis of DVT in symptomatic outpatients the combination of non-invasive testing with the D-dimer test might be preferred over serial non-invasive testing alone, although the safety of such an approach remains to be established in future management studies.

Cost-Benefit Analysis↗

PubMedDate not supplied

[Comparison of rheumatoid test procedures--value and critical interpretation of sensitivity and specificity and their effect on pre-test and post-test probability].

In this prospective study, sera of 440 patients with rheumatic and degenerative joint diseases were tested for the presence of rheumatoid factor (RF). The Latex agglutination test (LFT), Waaler-Rose hemagglutination, laser nephelometry and IgM-Enzyme immunoassay (IgM-EIA) were used for detecting IgM-rheumatoid factors. In addition, rheumatoid factor of IgA isotype was measured by an IgA-Enzyme immunoassay. Sensitivity, specificity, pre-test- and post-test-probability were evaluated based on the data obtained to compare the test systems used. Under prospective patient selection, none of the test systems used reached a sensitivity of 100% concerning its cut off level. Despite this limitation, latex agglutination and IgM-EIA reached the highest sensitivity. Waaler-Rose test (90,8%) showed the best result for specificity. The IgA-EIA held the third position in sensitivity, specificity and efficiency. By comparing sensitivity with specificity, no test system can be recognized as the absolutely best one, since the receiver operating characteristic curves (ROC) overlapped. Practically rheumatoid factor measurement should initially use a highly sensitive assay, such as LFT and IgM-EIA to screen for RF. In the case of a positive result a more specific assay should be used, for example laser nephelometry, to confirm the result.

Adolescent↗

PubMed1996

[Androgen test: comparison of a low test and a high test in the development of the penis in male pseudohermaphroditism].

BACKGROUND: The androgen sensitivity test used in male pseudohermaphroditism for clinical assessment of the androgen sensitivity and prediction of penile development is an important element in choice of gender. However, there is a wide range of testosterone dosage and no standardized test. METHODS AND PATIENTS: Two doses (2.5 mg and 100 mg) of testosterone heptylate were used in six cases of male pseudohermaphrodism with sexual ambiguity and small penis (ages 6 to 18 months). The clinical results were compared with those of the study of androgen receptors. RESULTS: In two cases, both low-dose and high-dose tests resulted in only minimal changes in the penis. In two cases, the low-dose test gave a good result which was confirmed by the high-dose test; on the other hand, in two cases, the low-dose test was considered to be negative whereas the high-dose test led to the development of a normal-sized penis. In all cases except one, there was good concordance between the results of study of androgen receptors and those of the clinical test. CONCLUSION: The high-dose androgen test is thus useful in both diagnosis and treatment and facilitates the gender assignment.

Antineoplastic Agents, Hormonal↗

PubMed1988

Comparison of acidified glycerol lysis test, Pink test and osmotic fragility test in hereditary spherocytosis: effect of incubation.

In this study we compared the results of the acidified glycerol lysis test, the Pink test and the osmotic fragility test in 38 patients with hereditary spherocytosis and in healthy controls. The sensitivity of the acidified glycerol lysis test was 81.6% when performed within 3 h after blood collection. After incubating for 24 h, the sensitivity increased to 100% whereas the specificity remained maximal. Similar incubation did not improve the diagnostic utility of the Pink test. All patients, but none of the controls, showed a positive osmotic fragility test. It is concluded, because of sensitivity and specificity in this study, that the acidified glycerol lysis test after incubation and the osmotic fragility test are superior to the Pink test in detecting spherocytosis.

Adolescent↗

PubMed2005

Reliability and validity of arm function assessment with standardized guidelines for the Fugl-Meyer Test, Action Research Arm Test and Box and Block Test: a multicentre study.

OBJECTIVES: To establish: (1) inter-rater and test-retest reliability of standardized guidelines for the Fugl-Meyer upper limb section, Action Research Arm Test and Box and Block Test in patients with paresis secondary to stroke, multiple sclerosis or traumatic brain injury and (2) correlation between these arm motor scales and more general measures of impairment and activity limitation. DESIGN: Multicentre cohort study. SETTING: Three European referral centres for neurorehabilitation. SUBJECTS: Thirty-seven stroke, 14 multiple sclerosis and five traumatic brain injury patients. MAIN MEASURES: Scores of the Fugl-Meyer Test (arm section), Action Research Arm Test, and Box and Block Test derived from video information. RESULTS: All three motor tests showed very high inter-rater and test-retest reliability (ICC and rho for main variables > 0.95). Correlation between the motor scales was very high (rho > 0.92). Motor scales correlated moderately highly with the Hemispheric Stroke Scale, a measure of impairment (rho = 0.660-0.689), but not with the Modified Barthel Index, a measure of the ability to cope with basic activities of daily living (rho = 0.044-0.086). CONCLUSIONS: The standardized guidelines assured comparability of test administration and scoring across clinical facilities. The arm motor scales provided information that was not identical to information from the Hemispheric Stroke Scale or the Modified Barthel Index.

Adolescent↗

PubMed1997

Multicenter evaluation of the Micral-Test II test strip, an immunologic rapid test for the detection of microalbuminuria.

OBJECTIVE: To assess the performance of the Micral-Test II immunologic test strip for the detection of microalbuminuria, a multicenter evaluation in eight European study sites was performed. RESEARCH DESIGN AND METHODS: Using both the Micral-Test II test strip and the routine method for the determination of albumin concentration, we investigated 2,228 urine samples from diabetic patients. Additionally, interperson variability, color stability, and possible interfering factors (temperature, pH, leucocyturia, erythrocyturia, and drugs) were tested. RESULTS: For a cutoff concentration of 20 mg/l with respect to the routine methods, a sensitivity of 96.7% and a specificity of 71% were calculated for the Micral-Test II test strip. The negative predictive value was 0.95, and the positive predictive value was 0.78, with a prevalence of positive samples (laboratory method) of 52%. The interperson variability of color interpretation showed 93% concordant readings. The interference study showed an influence of oxytetracycline, leading to higher readings. There was no interference from pH. A sample temperature of < 10 degrees C led to lower readings. In the case of samples with massive leucocyturia and erythrocyturia that may delete the chromatographic process, waiting an additional 1-2 min is needed before reading. CONCLUSIONS: The results of the multicenter evaluation show that the Micral-Test II test strip permits an immediate and reliable semiquantitative determination of low albumin concentrations in urine samples with an almost user-independent color interpretation.

Albuminuria↗

PubMed2000

Use tests: ROAT (repeated open application test)/PUT (provocative use test): an overview.

As one step in defining the clinical relevance of exposure to an allergen identified with patch testing, use tests (provocative use test (PUT), and repeated open application test (ROAT)) have been used. In 1/2 of the cases of seemingly reliable patch tests, use tests are negative, suggesting that the patient's biologic threshold of response had not been reached with open application dosing. Dramatic differences exist in regional skin reactivity and percutaneous penetration. Negative results of use tests on normal skin may become positive on diseased skin. To refine this assay further, more controlled observations and analysis of reaction differences between normal and damaged skin, and among regional anatomic sites might be performed. In addition, we require a standardized measurement for the results. Use testing has significant potential in refinement of the evidence-based diagnosis of clinical relevance. However, for general validation, we should fill the deficiencies described above.

Animals↗

PubMedDate not supplied

Mayo's Older Americans Normative Studies: Age- and IQ-Adjusted Norms for the Boston Naming Test, the MAE Token Test, and the Judgment of Line Orientation Test.

Although many extant normative data sets for standardized neuropsychometric instruments feature adjustments for subject variables, there are reasons to believe that improvements in interpretive accuracy that result from such adjustments are less than optimal. In particular, several theoretical considerations suggest that years of formal education may be less closely related to test performances than is general intellectual functioning. In this first of four reanalyses of results from the Mayo Clinic's Older Americans Normative Studies (MOANS) databases, age-adjusted scores on the Boston Naming Test, the MAE Token Test, and the Judgment of Line Orientation Test were indeed found to be more strongly associated with Mayo Age-adjusted WAIS-R Full Scale IQ scores (rs=.608, .473, and .502, respectively) than with education (rs=.310, .306, and .236, respectively) for healthy older examinees (56-99 years). Consistent with the remarks of Dodrill (19971999), these correlations generally decreased at higher levels of intelligence. The magnitude and pattern of such declines varied across the three tests, however, suggesting that IQ-test score associations must be empirically determined rather than assumed to be linear. Tables of Age- and IQ-Adjusted percentile equivalents of MOANS Age-adjusted BNT, Token Test, and JLO scaled scores are presented for eleven age ranges and seven IQ ranges. The article concludes with a discussion of factors that may underlie observed relations among age, intelligence, and neuropsychometric test performances.

Age Factors↗

PubMed1989

Comparison of a new type of skin test (Phazet) with existing skin test methods and the radioallergosorbent test (RAST).

A new skin test method (Phazet) for diagnosis of immediate-type allergic disease was tested in 232 patients attending the Guy's Hospital Allergy Clinic, and compared with conventional skin test methods, using Bencard and Pharmalgen allergen solutions, and with serum IgE antibody tests (RAST). Six allergens (cat, dust mite, Cladosporium, grass pollen birch pollen and plantain pollen) were used, as well as histamine and a negative control. Phazet proved easy to use and was popular with inexperienced operators (medical and dental students). For the majority of allergens there was reasonably good agreement with the different tests, but overall Phazet and RAST produced fewer positive results than the other skin tests methods. In particular, the frequency of positive histamine tests was lower with Phazet (82%) than with Bencard or Pharmalgen (99%), but this discrepancy was lower in the second part of the study when the minimum time for the insertion of the needle (1 sec) was more scrupulously observed. Phazet offers a convenient and practical alternative to conventional 'wet' skin test methods.

Allergens↗

PubMed1958

Reiter protein complement fixation test; a preliminary comparison of the TPI test with the complement fixation test employing a soluble protein antigen derived from the Reiter strain.

A comparative study of the specificity of the Reiter protein complement fixation (RPCF) test and the Treponema pallidum immobilization (TPI) test on 180 sera showed that the results in 178 instances or 98.9 per cent were in agreement. The sensitivity of the RPCF test, when compared to the TPI test, on 189 sera from patients known to have syphilis was in agreement in 182 or 96.3 per cent, assuming a correlation exists between positive TPI and both the "reactive" or "weakly reactive" RPCF test results. As to reproducibility of results, the RPCF test results agreed in 84 of the 87 sera tested (95.4 per cent). The sera were tested at least three times on different days. Anticomplementary reactions were observed in three of 91 normal sera.

Complement Fixation Tests↗

PubMed1986

[Comparative study of 2 latex tests (rubalex and rubascan) with an immunoenzyme test (enzygnost-rubella) and a hemagglutination inhibition test for the study of anti-rubella antibodies].

Four different assays for detection of rubella IgG antibodies, two latex agglutination (Rubalex and Rubascan), one hemagglutination inhibition (HAI) and one enzyme-linked immunosorbent assay (ELISA IgG), were used to test 372 human serum samples. All samples were also tested with a rubella ELISA IgM test and all of them were found negative. The results obtained in 358 (96.2%) out of 372 samples tested were identical with all procedures. Inconclusive results were obtained in 14 (3.8%) specimens, in that there were positive and negative results for the different assays. These 14 specimens were sent to the Institute of Virology in Turku (Finland) and tested by using a hemolysis in gel and a non commercially-available ELISA IgG test. Results obtained with the two last tests were considered definitive. The two latex tests were found equal or better than HAI and ELISA IgG for sensitivity and specificity. Furthermore they were also cost effective and more simple to perform.

Antibodies↗

PubMed1987

A new glass microfibre-based histamine analysis for allergy testing in children. Results compared with conventional leukocyte histamine release assay, skin prick test, bronchial provocation test and RAST.

A new microfibre method for allergy testing measuring histamine release from human basophil leukocytes is described. Samples of 50 microliter washed blood are challenged with the suspected allergens. Released histamine is bound to microfibres and measured by a spectrofluorometrical method after removal of interfering substances by washing. The microfibre method (HR-MM) was compared to the conventional histamine release assay using the Ficoll-Hypaque gradient method (HR-FH) in 19 allergic children tested with one of three allergens. In addition, a comparison was made between the microfibre method and in vivo provocation tests, i.e. skin prick test (SPT), bronchial provocation test (BPT) and allergen specific serum IgE (RAST). It was found that the same individuals responded with histamine release to the same allergens in both histamine release assays, and the dose-response curves were almost identical. A positive correlation was found between the in vivo and in vitro tests. Thus it is concluded that the new method can provide reproducible, analytically precise (at the nanogram level) histamine release results in pediatric cases where: a positive SPT does not correlate with case history; BPT may be considered too hazardous or inconvenient; confirmation of negative or inconclusive SPT or RAST is needed. In contrast to other histamine release assays it is a convenient diagnostic tool in children since only small amounts of blood are needed and at least 96 tests can be carried out in 2 1/2 h.

Asthma↗

PubMed1987

Quantitative estimation of diphtheria and tetanus toxoids. 2. Single radial immuno-diffusion tests (Mancini) and rocket immuno-electrophoresis test in comparison with the flocculation test.

The concentration in Lf units, of an unknown diphtheria or tetanus toxoid preparation is estimated in the flocculation test relative to reference preparations of tetanus and diphtheria antitoxins, respectively. By replacing the antitoxin reference preparations with toxoid reference preparations it should be possible to use immunological methods other than the flocculation test for the quantitative estimation of toxoids in Lf units. A number of diphtheria and tetanus toxoids were tested by rocket immuno-electrophoresis and single radial immuno-diffusion (Mancini test). The concentrations of the unknown toxoids were expressed relative to a diphtheria toxoid calibrated in Lf units (DIFT) and a tetanus toxoid calibrated in Lf units (TEFT), respectively. These two toxoid preparations are regarded as candidates for establishment as international standard preparations. The results obtained in the two tests were compared with those obtained in the flocculation test. In most cases the differences between the results did not exceed 10%. It is concluded, therefore, that the rocket electrophoresis or the radial immuno-diffusion tests can be used as alternatives to the flocculation test.

Diphtheria Toxoid↗

PubMed1990

[Comparison of the Lithander (Kolt test) pediatric visual acuity test with the standardized Landolt ring test].

The visual acuity values obtained with the four test figures of Lithander's "Kolt-test" have been compared with Landolt ring acuity under standardized conditions which meet the requirements of DIN 58,220 and ISO/DIS 8596/7. For a given test figure size, the Kolt-test optotypes turned out to be somewhat easier legible than the Landolt ring. On average, visual acuity measured with the Kolt-test exceeded Landolt ring acuity by 0.08 log (angle of resolution) units. Thus, according to DIN and ISO criteria, the legibility of the Kolt-test is not equivalent to the standard Landolt ring. Equal acuity values could be obtained by increasing the observation distance proposed by the manufacturer of the Kolt-test by 19%. The legibility of the four optotypes differs on adult subjects: "circle" is more difficult, "cross" is easier legible than "square" and "triangle". Confusion of Kolt-test figures is basically restricted to two pairs of two optotypes ("cross" - "triangle", "square" - "circle").

Adult↗

PubMed1983

A comparison of the multi-test with the prick test and multi-test 2.

Allergy skin testing of infants and small children continues to be time-consuming and nerve-wracking. We hoped to have found the solution to these problems by using the multi-test (MT). The latter consists of an applicator with 8 heads, each head consisting of nine plastic needles on which the allergen solution rests. Thus eight allergens can be tested simultaneously. During routine control skin testing we compared MT with our usual method, the prick test (PT), amongst twenty patients. Twenty-seven per cent of the skin reactions differed by more than 1+. When we compared PT results with the previous PT, the correlation of 16% was better despite several years interval between tests, different persons carrying out the tests, and hyposensitization of patients. We adapted the MT system and produced a model, multi-test 2 (MT-2), which consists of eight sterile disposable needles on a stainless steel base. When we compared the MT-2 with PT, only 6% differed by more than 1+. Thus the MT-2 proves to be a useful alternative to the PT for those children, in whom the PT is too difficult to carry out.

Adolescent↗