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Biomedical subjects

I Hinberg

Publications and source records attributed to I Hinberg.

At least 19 recordsLinked to original sources

Rapid detection of group A streptococci: comparative performance by nurses and laboratory technologists in pediatric satellite laboratories using three test kits.

Rapid tests for detecting group A streptococci in throat swabs are often performed outside hospitals or commercial laboratories by individuals with little or no technical training. We compared the abilities of nurses and technologists to perform and interpret three commercial kits (Directigen 1-2-3, ICON Strep A, and Culturette Brand 10-Minute Strep A ID) in three hospital satellite locations (the emergency department, a walk-in emergency clinic, and a general pediatric clinic). When the three tests were compared with culture, the sensitivities of the tests as performed by nurses and technologists, respectively, were 39 versus 44% for Directigen, 55 versus 51% for Culturette, and 72 versus 39% for ICON. A significant difference in sensitivity was found only with ICON tests. This result was largely explained by the tendency of technologists to test moist swabs, while nurses generally processed dry swabs; ICON test sensitivity was significantly greater with dry swabs. The specificities of Directigen and ICON tests performed by nurses and technologists were high (97 to 100%). The difference in the specificities of the Culturette test as determined from results obtained by nurses and technologists (80 versus 98%) was due to the tendency of one nurse to overinterpret the latex agglutination reaction. Analysis of the accuracies of the tests during practice periods compared with the accuracies of the tests during the study periods revealed statistically significant improvement in test performance. We conclude that these tests are specific but not sensitive when performed by nurses and technologists in satellite laboratories. With one exception, nurses and technologists performed the tests with comparable accuracy after brief training periods.

Emergency Service, Hospital

In vitro degradation of a poly(ether urethane) by trypsin.

In vitro enzymatic degradation of non-porous films of segmented poly(ether urethane) (Pellethane 2363-80AE) was investigated by incubating the biomaterial in concentrated trypsin solutions for 5 months at room temperature. Chemical degradation of films was monitored by surface analysis techniques such as Fourier transform infrared spectroscopy-attenuated total reflectance and electron spectroscopy for chemical analysis. This latter technique proved to be much superior in detecting chemical changes. Extraction of films with methanol and characterization of the extracts by gel permeation chromatography revealed the presence of low-molecular-weight polymers. Results have shown that trypsin has the ability to induce degradation in PEU, the soft segment being most affected, particularly the CH2-O bond of the ether linkages.

Biocompatible Materials

Effects of temperature and viscosity on prothrombin times of blood.

Accurate prothrombin time tests are important because they are frequently performed on presurgical patients to evaluate their blood-clotting status. We studied the effect of temperature (27-47 degrees C) on PTs obtained with eight different brands of thromboplastin. We also compared the sensitivities of two types of coagulation timers to changes in blood viscosities between 1 and 16 mPa/s. Viscosities were measured with the Brookfield Digital Viscometer. The MLA Eletra 800 and the BBL fibrometer were used to measure PTs. All eight thromboplastins gave convex curves of PT versus temperature, with optimum values lying between 38 and 39 degrees C. The curves were fitted to 4th-degree polynomials which showed that a mean temperature bias of 2 degrees C can increase PTs. Ortho Brain (7.8% change) was affected the most, while thromboplastin C (4.4% change) was affected the least. Plots of PT versus viscosity showed that the BBL fibrometer, which uses an electromechanical sensor, was more affected by viscosity than the MLA Electra 800, with an optical detector. However, above 8.2 mPa/s, all PTs were significantly elevated. Hence, patients with macroglobulinemia, whose plasma viscosities sometimes exceed 8.2 mPa/s, may have falsely elevated PTs. We conclude that temperature and viscosity are critical factors in the test and significantly contribute to within and between laboratory variations in PT measurements.

Blood Viscosity

Leaching of plasticizers from and surface characterization of PVC blood platelet bags.

The leaching of phthalate plasticizers from four types of blood platelet bags was investigated. The anticoagulant solutions used in the blood collection bags had pH values of 5.64 +/- .04 and contained no detectable amounts of phthalates. Platelet bag materials from each bag were soaked in normal salines for up to 5 days. The salines were tested for the leached phthalates from the bags but none could be found. However, di-(2-ethylhexyl) phthalate (DEHP) leached out of the PL-146 and Terumo bags into bovine calf serum used for soaking the bag materials. There was an increase in the amount of DEHP leached from about 1.1 mg at the end of one day to about 3.3 mg per gm of bag material at the end of a five day extraction with the serum. In PL-732 sets, a platelet bag made of a specialty polyolefin, the amount of DEHP leached out was less than 0.02 mg per g of bag material. CLX bags, which contained tri-(2-ethylhexyl) trimelliate (TETM) as a plasticizer, showed a negligible amount of it leaching into the calf serum. Infra-red spectra showed that PL-146 bags had been coated with a layer of a fatty acid amide while the Terumo bags contained a layer of a silicone fluid on their inner surfaces. CLX bags showed a coating of stearates, which were probably soaps of calcium or zinc. Scanning electron microscopy (SEM) showed that the inner surfaces of each brand of the bag were distinctly different morphologically. The two PVC bags were very similar whereas the surfaces morphology of PL-732 was rougher. Terumo bag had a different surface morphology than those of the other bags whereas the CLX bags had a very regular surface pattern. The exact significance of the surface morphology is not certain but excessively rough surfaces may not be desirable for the bags.

Benzoates

Receiver operator characteristic (ROC) curves and non-normal data: an empirical study.

This paper evaluates the performance of several diagnostic kits for assessing levels of serum prostatic acid phosphatase on patients at different stages of cancer of the prostate. Each patient was studied with several kits. We compare results obtained for receiver operator characteristic (ROC) curve methodology with data assumed to follow a normal distribution, with log-transformed data assumed to follow a normal distribution, and when neither of these assumptions holds. There were important differences between the results of the different approaches. For these data, the normal distribution assumption should be used with extreme caution. The log-transformed based results compared favourably with the non-parametric, but unconsidered application of the method should be avoided.

Acid Phosphatase

Desktop analysers: quality of results obtained by medical office personnel.

We carried out a study to evaluate the quality of results obtained by 14 nontechnical medical office personnel using desktop analysers. The instruments evaluated were the Reflotron analyser, the Seralyzer, the Vision analyser and the DT60 analyser. For precision studies low and high concentrations of control materials were used. For correlation studies the results obtained by the office personnel were compared with those obtained by a trained technologist. The coefficient of variation for the office personnel ranged from 3.0% to 8.1% with the Reflotron analyser, from 6.3% to 26.5% with the Seralyzer, from 1.0% to 4.1% with the Vision analyser and from 1.4% to 16.7% with the DT60 analyser. The correlation coefficient ranged from 0.970 to 0.997 with the Reflotron analyser, from 0.779 to 0.997 with the Seralyzer, from 0.975 to 0.998 with the Vision analyser and from 0.963 to 0.995 with the DT60 analyser. The proportion of results obtained by the office personnel that differed by more than 10% from those obtained by the technologist was 7% with the Reflotron analyser, 42% with the Seralyzer, 2% with the Vision analyser and 21% with the DT60 analyser. The instruments whose operation involves the least number of steps gave the most reliable results in the hands of medical office personnel.

Blood Chemical Analysis

Near-patient testing. Quality of laboratory test results obtained by non-technical personnel in a decentralized setting.

The authors evaluated the quality and reliability of four desktop analyzers in the outpatient clinic. Twenty-seven nontechnologists (NTs) participated in the study. These included nurses, physicians, and medical students. The instruments and tests evaluated were as follows: Reflotron (glucose, cholesterol, triglycerides, gamma-glutamyltransferase and urea); Seralyzer (creatinine, glucose, potassium, aspartate aminotransferase, and hemoglobin); Vision (glucose, urea, cholesterol, triglycerides, alkaline phosphatase, and uric acid); and DT60 (sodium, potassium, glucose, amylase, uric acid, bilirubin, and creatinine). For precision studies, low and high control material was used, and method comparison was done with methods in routine use in the laboratory. The range of coefficients of variation (CVs) for the analyzers with NTs was as follows: Reflotron: CV, 2.4-7.9%; Seralyzer CV, 1.4-18.7%; Vision: CV, 1.5-2.7%; DT60: CV, 2.5-46.8. The percentage results that is different by greater than 10% between the NTs and trained technologists was related to the complexicity of procedure for each analyzer and was the lowest for the Vision analyzer and greatest for the Seralyzer.

Blood Chemical Analysis

Comparison of hospital staff performance when using desk top analysers for "near patient" testing.

The quality and reliability of four desk top analysers were evaluated. In the context of an outpatient clinic, intensive care unit, and a mock up of a physician's office. Seventeen nurses, 14 physicians, and 12 medical office personnel took part in the study. The instruments and tests evaluated were Reflotron (glucose, cholesterol, triglycerides, gamma-glutamyl transferase), Seralyzer (creatinine, glucose, potassium, aspartate aminotransferase), Vision (glucose, (creatinine, glucose, potassium, aspartate aminotransferase), Vision (glucose, urea, cholesterol, triglycerides alkaline phosphatase, uric acid), and DT60 (sodium, potassium, glucose, amylase, uric acid and creatinine). Of the 320 tests performed on the Vision, only two differed by more than 10% between the specialist staff and other groups. For those performed on the Seralyzer, 95 of 254 results differed by more than 10%, 19 of 199 by more than 10% for the Reflotron, and 50 of 318 by more than 10% for the DT60. In general, the nurses were more adept at using the analysers than the physicians and medical office personnel.

Blood Chemical Analysis

Degradation of explanted polyurethane cardiac pacing leads and of polyurethane.

Polyurethane cardiac pacing leads explanted at autopsy and from reoperated patients were examined for degradation in the insulation. Scanning electron microscopy (SEM) analysis showed cracks on the polyurethane surface which were both parallel and perpendicular to the longitudinal axis of the lead. Surface analyses of leads were performed using Fourier-Transform Infra-red (FT-IR) spectrophotometry in the attenuated total reflectance mode. The FT-IR spectra of visibly deteriorated polyurethane from explanted lead sheaths were compared with that of unused polyurethane tubing used for such sheaths. Changes were most evident in the regions of 3000-2800, 1730 and 1368 cm-1. The observed alterations in the FT-IR spectra were consistent with a degradation mechanism involving oxidative chain cleavage in the polyurethane amorphous regions. New polyurethane tubing (Pellethane-Type 80A) was exposed to sodium hypochlorite to simulate a possible in-vivo process and generate reference material. Degradation with associated decreases in tensile strength and molecular weight was recorded. This study showed that polyurethane insulation used in pacing leads is susceptible to oxidative degradation.

Biocompatible Materials

A physician office analyzer. Evaluation of quality of results obtained by technical and nontechnical personnel.

We evaluated the Abbott Vision analyzer (Abbott Laboratories, North Chicago, Ill) both in a controlled laboratory setting and with several untrained individuals. We used control serum samples supplied by the manufacturer. Method comparison was performed with methods currently in use in our laboratory. The analytes evaluated were glucose, urea nitrogen, urate, cholesterol, triglycerides, and alkaline phosphatase. In the laboratory, the within-run precision (coefficient of variation) of all methods ranged from 0.8% to 3.4%; the range for between-run precision was 1.2% to 3.3%. Correlation between the Abbott Vision analyzer and routine methods was excellent. The upper limit of linearity for all methods was as stated by the manufacturer. The coefficient of variation obtained by ten nontechnical personnel ranged from 0.0% to 3.9%. The correlation between results obtained by the nontechnologist were excellent. Our study indicates the Abbott Vision analyzer is extremely easy to operate and provides reliable results in the hands of nontechnical personnel.

Allied Health Personnel

Physician office analyzers. Do they satisfy medically useful criteria for analytical performance of laboratory tests?

The coefficients of variation (CVs) for several tests on physician office analyzers were compared with published data for medically useful criteria of these tests. Medically useful CVs were based on physicians' opinions of significant changes in laboratory tests. Precision studies using control material were carried out on four physician office analyzers by both a trained technologist and nontechnical personnel, such as physicians, nurses, and medical office personnel. This study was carried out during a six-month period. The instruments that were evaluated were the Reflotron, Seralyzer, Vision, and DT60. Low and high concentrations of quality control material, supplied by the manufacturer and those in use in the study laboratory (Omega I and II, Cooper Biomedical, Fairhaven, NJ), were used. With few exceptions, all instruments satisfied the medically useful CVs criteria, ie, the precision obtained by both the technologist and nontechnical personnel either equaled or exceeded the precision requirements set by physicians.

Autoanalysis