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A test material for tissue characterisation and system calibration in MRI.

A tissue-equivalent test material for MRI has been produced from a polysaccharide gel, agarose, containing gadolinium chloride chelated to EDTA. By varying the amounts of each constituent, the T1 and T2 of the material can be varied independently. As a result, the entire range of in vivo tissue relaxation times can be covered. Through the mathematical modelling of the 1H relaxation theories for both the gel and chelated paramagnetic ion, it has been possible to create a material with relaxation properties and behaviour predictable as functions of both the Larmor frequency and temperature. The similarity of the material to in vivo tissues, in terms of its biological and physical NMR characteristics, makes it an excellent tissue-equivalent substance, in addition to being an accurate calibration standard for routine MRI.

Edetic Acid↗

The chicken enucleated eye test (CEET): a practical (pre)screen for the assessment of eye irritation/corrosion potential of test materials.

The enucleated eye test with chicken eyes (CEET) obtained from an abattoir proved to be a valuable and practical alternative for the 'traditional' enucleated eye test with eyes of laboratory rabbits. Since 1992, the CEET has been incorporated in standard contract toxicity testing at the Toxicology Division of the TNO Nutrition and Food Research Institute as a (pre)screen for the Draize eye test with rabbits. The results of the first 44 compounds tested showed excellent correlation with the in vivo results. The CEET identified non-irritating or severely irritating compounds, and predicted (slightly to moderately) irritating compounds. Statistical analysis of the CEET and the rabbit in vivo scores showed high linear correlations between the critical values of both tests and confirmed the relevance of this assay with respect to ocular effects. In general, tiered in vitro/in vivo testing was considered a meaningful approach for further validation of alternative methods and for reducing the use of suffering of laboratory animals to a minimum. Tiered testing of compounds in cases of eye irritation hazard assessment should be incorporated in the legislation of the European Community.

Animal Testing Alternatives↗

Advances of unilateral mobile NMR in nondestructive materials testing.

Unilateral mobile NMR employs portable instrumentation with sensors, which are applied to the object from one side. Based on the principles of well-logging NMR, a hand-held sensor, the NMR-MOUSE (MObile Universal Surface Explorer) has been developed for nondestructive materials testing. In the following, a number of new applications of unilateral NMR in materials science are reviewed. They are the state assessment of polyethylene pipes, the characterization of wood, the in situ evaluation of stone conservation treatment, high-resolution profiling of rubber tubes and 2-D imaging for defect analysis in rubber products.

Construction Materials↗

The "edge effect" with patch test materials.

A positive "edge effect", i.e., the accumulation on the skin of a chemical solution (such as fluorescein 0.01% in a 50/50 water-ethanol solution) at the periphery of the patch test sites has been demonstrated. It occurs with different test materials (Finn Chamber; Silver Patch Test; Patch Test Chamber). Practical implications are discussed: this observation could be important when discussing results of laboratory investigations. In clinical practice, it could explain the occurrence of "ring-shaped" positive allergic patch test reactions to chemicals used in solution, i.e., Kathon CG or hydrocortisone.

Humans↗

External contamination of hair with cocaine: evaluation of external cocaine contamination and development of performance-testing materials.

The National Laboratory Certification Program undertook an evaluation of the dynamics of external contamination of hair with cocaine (COC) while developing performance testing materials for Federal Drug-Free Workplace Programs. This characterization was necessary to develop performance materials that could evaluate the efficacy of hair testing industry's decontamination procedures. Hair locks (blonde to dark brown/black) from five different individuals were contaminated with cocaine HCl. Hair locks were then treated with a synthetic sweat solution and hygienic treatments to model real-life conditions. Hair locks were shampooed daily (Monday through Friday) for 10 weeks, and samples of the hair locks were analyzed for COC, benzoylecgonine (BE), cocaethylene (CE), and norcocaine (NCOC). Three commercial analytical laboratories analyzed samples under three protocols: no decontamination procedure, individual laboratory decontamination, or decontamination by an extended buffer procedure at RTI International. Results indicated substantial and persistent association of all four compounds with all hair types. Hair that was not decontaminated had significantly greater quantities of COC and BE than did hair that was decontaminated. The only hair samples below detection limits for all four compounds were those decontaminated 1 h after contamination. Additionally, BE/COC ratios increased significantly over the 10-week study (regardless of decontamination treatment). From 21 days postcontamination until the end of the study, the mean BE/COC ratio for all hair types exceeded 0.05, the proposed Federal Mandatory Guidelines requirement. The largest variability in results was observed for samples decontaminated by participant laboratories. This suggests that current laboratory decontamination strategies will increase variability of performance testing sample results. None of the decontamination strategies used in the study were effective at removing all contamination, and some of the contaminated hair in this study would have been reported as positive for cocaine use based on the proposed Federal Mandatory Guidelines.

Cocaine↗

In vivo validation of the historical in vitro thermocycling temperature range for dental materials testing.

In dental research, restorative materials have been regularly subjected to alternating in vitro thermal stress in investigations since the 1950s, in order to simulate in vivo alternating temperature stress and to artificially stress them in vitro. The provocation temperature is mostly 5 degrees C for cold provocation, and 55 degrees C for hot provocation. These temperatures are determined quite arbitrarily based on very few examinations in vivo. Extensive temperature data for the approximal space of teeth, which is decisive for the success of fillings adhesively attached to dentin, has so far not been addressed. The objective of this study was to examine the interproximal temperature characteristics created in the space of all teeth in vivo with thermal alternating stress, and therefore to validate the in vitro standardized thermal alternating stress of 5-55 degrees C. Fifteen study participants with healthy teeth were used to determine the temperature in each inter-dental space, resulting from hot/cold provocation in the upper and lower jaw, from the central incisor to the second molars. This was performed by a thermal element (cable sensor GTF 300, Greisinger Electronic GmbH, Regenstauf, Germany). The temperature sensor was attached with dental floss into the interproximal space and the temperature was recorded by the computer. The participants in the pilot test had to state when they were able to sip an 85 degrees C hot drink. That particular temperature value was taken for hot provocation as maximum temperature reference. Cold ice water (0 degrees C) was used for cold provocation as minimum temperature reference. The respective recordings with a total of 14 measurements for each individual were performed simultaneously in the upper and lower jaw. The study participants were to start with hot provocation, followed by cold provocation. This cycle was repeated at least once with an individual dwell time. The highest recorded approximal space temperature was 52.8 degrees C in the lower jaw, between the first and the second premolar. The lowest temperature of 13.7 degrees C was recorded in two participants in the upper jaw, between the 1st and 2nd incisor, and between the two central incisors. The mean of the maximum temperatures was 43.8+/-3.7 degrees C, and the mean of the minimum temperatures 24.2+/-4.6 degrees C. The mean initial temperature was 35.2+/-1.3 degrees C. None of the recordings reached either the upper threshold (55 degrees C) or the lower threshold (5 degrees C). This study showed that the actual thermal stress in the interproximal space of teeth is slightly lower than the one used in in vitro examinations. For class II cavities, most of the alternating temperature stress limits selected at 5-55 degrees C cover the actually occurring temperature interval quite well.

Adolescent↗

Patch test materials for mercury allergic contact dermatitis.

The objective of this study was to define adequate patch test materials to evaluate mercury allergic contact dermatitis. We applied 0.1% and 0.05% mercuric chloride, and 0.5% and 0.2% mercury in petrolatum to systemic eczematous contact-type dermatitis (baboon syndrome), and gold-dermatitis patients. All baboon-syndrome patients reacted not only to mercuric chloride but also to metallic mercury. In gold-dermatitis patients, significantly more patients reacted to mercuric chloride than to metallic mercury (21 of 35, 60%, versus 2 of 19, 10.5%, p < 0.0005). We speculated that sensitization to mercury may be of 2 types: one a reaction to ionized mercury only, the other to both ionized mercury and non-ionized mercury. The possibility that the phenomenon is caused by differences in bioavailability or percutaneous penetration between ionized and non-ionized mercury cannot be ruled out, but could be explored by penetration measurement. For the evaluation of mercury hypersensitivity, it may be more reliable to apply both ionized and non-ionized mercury, rather than only mercuric chloride or ammoniated mercury.

Adult↗

Dispensing glucose test materials in Dutch community pharmacies.

OBJECTIVE: To assess the proportion of diabetic patients who collect self-monitoring equipment for glucose testing in Dutch community pharmacies. METHODS: Data were used from the PHARMO-Record Linkage System, containing pharmacy dispensing records from 1991 to 1998. The study population consisted of patients who received at least two prescriptions of insulin and/or oral hypoglycemic agents. Information was collected on patient demographics, antidiabetic drug use and self-monitoring equipment (blood glucose meters and test strips). Type of diabetes was determined for all incident users of antidiabetic drugs. MAIN OUTCOME MEASURE: The proportion of patients per community pharmacy, who were dispensed self-monitoring equipment at least once. RESULTS: The study population consisted of 11,358 diabetic patients. The number of incident patients was 5,050, of whom 91.7% had type 2 diabetes. Twenty-nine pharmacies were included. The mean proportion of patients per pharmacy who received test strips at least once was 30.1% (SD = 6.7%), range 19-46%. The proportion of patients who were dispensed test strips was almost three times higher among type 1 than among type 2 patients (54% vs. 17%). CONCLUSION: In comparison to other countries' published data, Dutch community pharmacies dispense relatively few glucose test materials to diabetic patients. There are substantial differences between pharmacies in dispensing test strips. Further research is needed into the determinants governing the use of test strips at both patient and pharmacy level.

Aged↗

Frequency importance functions for a feature recognition test material.

The relative importance of different parts of the auditory spectrum to recognition of the Diagnostic Rhyme Test (DRT) and its six speech feature subtests was determined. Three normal hearing subjects were tested twice in each of 70 experimental conditions. The analytical procedures of French and Steinberg [J. Acoust. Soc. Am. 19, 90-119 (1947)] were applied to the data to derive frequency importance functions for each of the DRT subtests and the test as a whole over the frequency range 178-8912 Hz. For the DRT as a whole, the low frequencies were found to be more important than is the case for nonsense syllables. Importance functions for the feature subtests also differed from those for nonsense syllables and from each other as well. These results suggest that test materials loaded with different proportions of particular phonemes have different frequency importance functions. Comparison of the results with those from other studies suggests that importance functions depend to a degree on the available response options as well.

Acoustic Stimulation↗

Selection of reference or test materials for the validation of atomic absorption food analysis methods.

A strategy to select reference or other test materials on which method validation experiments should be performed is developed for the AAs analysis of foodstuffs. Representative materials are selected for each category of food (meat, cereals, vegetables, etc.) and for the complete food spectrum. A principal component analysis and two cluster analysis procedures are applied to accomplish this.

Cluster Analysis↗

A comparison of human chorionic gonadotropin- related components in fresh frozen serum with the proficiency testing material used by the College of American Pathologists.

CONTEXT: As part of a College of American Pathologists (CAP) proficiency testing survey, a comparison is made between human chorionic gonadotropin (hCG) results from an actual patient pool and a similarly targeted artificial sample. The goal is to gain insight into the possible source(s) of bias attributable to the proficiency testing material (PTM) with a view toward creating more appropriate survey materials. OBJECTIVE: To compare hCG and related variants in a pool of fresh frozen sera (FFS) with that found in PTM. DESIGN: The 2003 CAP K/KN-A Survey included a FFS specimen along with admixtures of PTM. The FFS (K-02) and 1 PTM admixture (K-01) had similar mean hCG values. Five hCG-related analytes were measured on these 2 samples by a reference laboratory. PARTICIPANTS: Approximately 1800 clinical laboratories and diagnostic test kit manufacturers participated in the K/ KN-A Survey. MAIN OUTCOME MEASURES: Method imprecision (coefficient of variation) and method bias (relative difference between peer group mean and all-method median) were computed for the 2 samples. Differences were evaluated with respect to hCG-related analytes levels. RESULTS: All-method hCG results were 12.9 mIU/mL (12.9 IU/L) for the PTM material and 21.6 mIU/mL (21.6 IU/L) for the FFS material. Method biases for 14 manufacturers were greater for PTM than for FFS (-40% to +35% and -16% to +23%). Twelve of 14 methods had higher coefficients of variation on PTM. Total hCG and free beta hCG measurements by the reference laboratory were 14.1 mIU/ mL (14.1 IU/L) for the PTM material and 18.5 mIU/mL (18.5 U/L) for the FFS material (FFS), and 2.4 (PTM) and 0.7 (FFS) mIU/mL (2.4 and 0.7 IU/L), respectively. On a molar basis, free beta represented 17% and 4% of the total hCG, respectively. Levels of hyperglycosylated hCG, nicked hCG, and beta core fragment were not measurable in either sample. CONCLUSIONS: It is unlikely that the hCG added to the PTM is the source of the increased bias and variability. The main difference is a 3-fold increase in free beta found in the PTM, but methods previously found to strongly react with free beta were not systematically elevated. The biases between manufacturers found for the FFS specimen are likely attributable to calibration differences.

Chorionic Gonadotropin↗

Frozen raw foods as skin-testing materials; further studies of use in cases of allergic disorders.

In further studies on the use of frozen raw food as skin-testing material in patients with allergic disorders, the results of previous work were confirmed in a greater number of subjects using a larger number of foods:Tests with frozen raw foods by the scratch method induce true positive reactions of a larger size and in greater frequency than the corresponding commercial extracts by either the scratch or the intracutaneous method. Storage in the frozen state for several years does not affect the antigenic potency of the materials. The frozen preparations have caused no harmful effects in the subjects, are free from irritant properties, and are not urticariogenic.

Female↗

Masticatory efficiency. A new method for determination of the breakdown of masticated test material.

One of the purposes of mastication is to break down the food and enlarge the area of food particles. A method is described by which the masticatory efficiency is estimated by calculating the area of a chewed test material, gelatin-hardened by formalin. When test pieces, after being chewed, are placed in a water-soluble dye, the dye will diffuse into the particles, and consequently the dye concentration in the surrounding solution will decrease. The concentration of the dye solution is read from a photometer. A close correlation was found between the gelatin particle area and the reduction of the dye solution concentration. The method will be applied in clinical studies.

Coloring Agents↗

Evaluation of orthogonal mechanical properties and density of human trabecular bone from the major metaphyseal regions with materials testing and computed tomography.

We evaluated the orthogonal mechanical properties of human trabecular bone from the major metaphyseal regions with materials testing and quantitative computed tomography (CT). The proximal tibia, distal femur, proximal femur, distal radius, and proximal humerus from fresh cadaver specimens between the ages of 55 and 70 years were excised and prepared for experimentation. The bones were embedded and scanned at 1 or 1.5 mm intervals on a Technicare HPS 1440 and GE 9800 CT scanner. After scanning, the bones were sectioned, producing 8-mm cubes of trabecular bone which were mechanically tested in uniaxial compression at a strain rate of 1%. The testing sequence consisted of preyield tests in two of the three orthogonal directions and failure in the third. After testing, the cubes were evaluated for apparent density and ash weight. The results of the study show that the strength and stiffness of trabecular bone varies significantly within metaphyseal regions and from metaphysis to metaphysis. The power and significance of relationships between density and modulus varied as a function of metaphyseal location. Both linear and nonlinear models were significant, suggesting that trabecular deformation occurs in response to both axial and bending loads. Finally, the need for architectural measures of trabecular bone to predict mechanical properties is emphasized.

Aged↗

[Dependence of microbiologic test results of formaldehyde gas sterilization methods on the nature of the test material].

The efficiency of a formaldehyde gas sterilization procedure was evaluated with the aid of test pieces consisting of various materials. Both rigid and flexible tubes served as test pieces. The tubes were 75 cm long with an inner diameter of 1 mm and were sealed at one end. The bioindicators were placed inside the tubes close to the sealed end. Dried spores of Bacillus stearothermophilus adhering to linen threads served as test organisms. The test results varied according to the material of the test pieces and the thickness of their walls (see Table 1). In flexible tubes made of silicon rubber, all bioindicators became sterile, in tubes of stainless steel, all bioindicators exhibited test organisms that had survived. The findings for materials such as polyvinyl chloride, polyethylene, polyamide and polytetrafluorethylene ranged between these two extremes; the frequencies of bioindicators containing viable germs were 10, 55, 68 and 85%, respectively. Rigid and flexible tubes which had been sealed at both ends served to demonstrate that silicon rubber and polyvinyl chloride were highly permeable for formaldehyde and water vapour. Also the other plastic materials tested were permeable for formaldehyde and water vapour but longer exposure periods were needed to create conditions in the interior of the tubes that would result in a killing of the test organisms (see Fig 2). In this respect, polyamide exhibited a peculiar behaviour. The number of viable spores remained at the initial level for a long period before a decline took place. From the results of testing, it is concluded that test pieces must conform to the objects to be sterilized not only in their dimensions (length, inner diameter) but also in the characteristics of their material. The walls of the test pieces should not have a higher permeability for formaldehyde and water vapour than the material to be sterilized. The highest demands on the efficiency of formaldehyde gas sterilization procedures are those created by mental tubes and thick-walled flexible polytetrafluorethylene. Instruments and devices to be sterilized by a formaldehyde gas procedure should be preferentially made of materials which are sufficiently permeable for formaldehyde and water vapour as e.g. silicon rubber. Such gas-permeable components may considerably facilitate the sterilization of cavities which have a small lumen and are difficult to reach.

Chromium↗

Influence of context on speech understanding ability using German sentence test materials.

The use of contextual information for the recognition of subsequent words may be considered as a central auditory process. In the present study, preliminary test forms of a German version of the American SPIN test were evaluated. The test materials consisted of short sentences with a contextual part and a final word that was always a monosyllabic noun. The contribution of context to the recognition of "high predictable" (HP) and "low predictable" (LP) final words of these sentences was investigated. Testing was performed in noise. However, the masking noise was time-weighted such that the masking level was higher for the final word than for the preceding contextual portion of the sentence. At scores of 29.3%, 50% and 70.7% correct, the mean difference in S/N ratio between HP and LP items was approximately 5, 5 and 2.5 dB, respectively. Equal performance for HP and LP items would indicate central auditory dysfunction. Possible diagnostic applications are discussed.

Acoustic Stimulation↗

Comparison of fresh frozen serum to proficiency testing material in College of American Pathologists surveys: alpha-fetoprotein, carcinoembryonic antigen, human chorionic gonadotropin, and prostate-specific antigen.

CONTEXT: Most proficiency testing materials (PTM) contain an artificial matrix that may cause immunoassays to perform differently with this material than with clinical samples. We hypothesized that matrix effects would be reduced by using fresh frozen serum (FFS). OBJECTIVE: To compare the performance of an FFS pool to standard PTM for measurement of alpha-fetoprotein, carcinoembryonic antigen, human chorionic gonadotropin (hCG), and prostate-specific antigen (PSA). DESIGN: One FFS specimen and 4 different admixtures of PTM were distributed in the 2003 College of American Pathologists K/KN-A (for alpha-fetoprotein, carcinoembryonic antigen, hCG, and total and free PSA) and C-C (hCG only) Surveys. PARTICIPANTS: The number of laboratories that participated in the surveys varied from a low of 288 (free PSA, K/KN-A Survey) to a high of 2659 (hCG, C-C Survey). MAIN OUTCOME MEASURES: Method imprecision and method bias were compared between the FFS specimen and the standard PTM specimen with the closest value. Method imprecision was determined by calculating the coefficients of variation for each method and for all methods combined. Bias was defined as the proportional difference between peer-group mean and the median of all method means. RESULTS: The FFS specimen gave significantly higher imprecision than PTM for the analytes alpha-fetoprotein, carcinoembryonic antigen, total PSA, and free PSA. For hCG, no substantial imprecision differences were observed in both surveys. Bias was significantly greater for the alpha-fetoprotein, carcinoembryonic antigen, and total PSA assays and significantly lower for the hCG and free PSA assays when comparing the FFS with the PTM. CONCLUSIONS: Fresh frozen serum did not provide consistently lower imprecision or bias than standard PTM in a survey of commonly ordered tumor markers.

Carcinoembryonic Antigen↗