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Nutritional adequacy and quality control of rodent diets.

One of the most often neglected variables in experimental investigations using rodents is the diet. Recent observations that diets can influence the response of a rodent to the drug, chemical or other factors under study, with biased interpretation of results, have drawn great interest. In order to be assured that the biologic response observed is a reflection of the material or condition under study, it is imperative that the diet provide essential nutrients in the proper proportions and that contaminants be kept to a minimum. Quality control is the key to these requirements; rodent diets can provide adequate nutrition, free of significant contamination. The diets which can be provided vary according to the degree of refinements; the three major types are (1) natural product, (2) semipurified and (3) chemically defined diets. Natural product diets may be open or closed formula, depending on the amount of information that the label reveals. Guaranteed analyses of proximate nutrients are provided but are of little use in assessing the nutrient value of the formulation. The National Academy of Sciences, National Research Council publications on laboratory animal nutrient requirements should be available to all investigators using experimental animals to help them evaluate the nutritional adequacy of the diets they use. Rats and mice may be considered together under some circumstances relative to crude dietary needs, but the Syrian golden hamster should be treated separately for purposes of diet. This species appears to digest foods more like a ruminant. An ideal diet for rodents is not on the horizon because of variable needs relative to different types of research and holding. Storage and shelf life of rodent diets also play important roles in providing adequate nutrition. Variations in moisture, temperature and exposure to other chemicals can affect the quality of the feed and research results. In addition, a number of chemical and biological contaminants have been found in rodent diets, and surveillance over such variables must be a part of all laboratory animal diet quality control. Federal regulatory mandates now require that investigators assure that nutrient requirements of animals are met and that diets are reasonably free from contamination. Accepted practices in good management, formulation, shipping and storage will help achieve these commendable goals.

Animal Feed↗

A laboratory evaluation of four quality control devices for radiographic processing.

Quality assurance programmes for radiographic processing traditionally employ expensive sensitometric and densitometric techniques. However cheap and simple devices for monitoring radiographic processing are available. The aim of this study was to make a comparison of four such devices in terms of their ability to detect variations in radiographic density of clinical significance. Three of the devices are commercially available while the fourth is easily manufactured from waste materials. Ideal bitewing exposure times were selected for four different kilovoltage/film speed combinations. Phantom bitewing radiographs, exposed using these exposure times, were processed using a variety of times and developer temperatures to simulate variations in radiographic quality due to inadequate processing conditions. Test films, produced using the four monitoring devices, were exposed and processed under identical conditions. The phantom bitewings were judged to have 'acceptable' quality when the optical density of that part of the film not showing calcified structures was within +/- 0.5 of that of the film processed under optimal conditions. The efficacy of the monitoring devices in indicating the adequacy of processing was assessed by a comparison of their readings with those made from the phantom bitewings. None of the monitoring devices was ideal for all the kilovoltage/film speed combinations tested, but the homemade device proved to be the most generally effective. We conclude that guidelines to dentists on radiographic quality assurance should include reference to and details of this simple device.

Densitometry↗

[Quality assurance, quality management or quality control?].

The current concept of quality in the German health care system dates back to the period of the 1950s and 1960s, also including current legislation. Nevertheless, quality initiatives are in full progress. The German health care system is supposed to learn from experiences described in the fields of industry, technology and commerce. The philosophy and technology of quality management can provide an ideal solution to the common problems of the health care system.

Delivery of Health Care↗

Combination of 768-well microplate array diagonal gel electrophoresis with duplex PCR of X and Y chromosome markers for quality control of epidemiological DNA banks.

Large DNA banks for human epidemiological studies have become an increasingly important research tool. The power of genotype-phenotype studies is dependent both on the quality of phenotyping and of genotyping and of correct linking of phenotypes to genotypes. Samples must be tracked through numerous steps between subject or patient and post-genotypic data. Only one phenotype, sex, has a perfect and binary correlation with genotype. In mixed sex studies, it may be advantageous for purposes of quality control to keep sexes mixed during the steps from acquisition to DNA bank, in order to be able to check later for sample swaps. We have designed a duplex PCR combining an amplicon from MAOA marking the X chromosome and an amplicon from DDX3Y marking the Y chromosome. We combined this with a simple economical palmtop sized 768-well microplate compatible electrophoresis system developed in-house for examination of duplex PCR products. We applied this quality control test in the validation of two DNA banks.

Base Sequence↗

[Dosage monitoring as a quality control instrument in digital radiography].

PURPOSE: Automatic image processing procedures ensure a constant image quality. Overexposed images constitute a danger zone on account of a subjectively better image appearance (improved signal-to-noise ratio). We have examined the software "Dose-Monitoring" both for the identification of false exposures and as a quality control tool. MATERIALS AND METHODS: Firstly the correlation between dose and present IgM (mean grey tone from the crude histogram of a 12-bit image) was examined by exposing phantoms. A further-reaching comparison of the present IgM values of some MTRAs with the department average (nominal IgM) should detect tendencies for over- and underexposure. Finally a dose reduction in 12 forms of X-ray examination was evaluated with regard to IgM course controls (median IgM). RESULTS: A high correlation (0.987) between dose and mean grey tone (IgM). In some MRTAs tendency for over-/underexposure was detected. The dose reduction of defined types of X-ray examination lead to a trend to lower mean IgM values. DISCUSSION: Numerous factors have an influence on the IgM value thus making its evaluation difficult, even so it is a suitable parameter for uncovering tendencies to incorrect exposure and for identifying processes requiring optimization. CONCLUSIONS: The value of this tool lies in the quality assurance of dose fluctuations and a possible dose reduction.

Humans↗

Quality control slide for potassium hydroxide and cellufluor fungal preparations.

An opaque, water-insoluble quality control material with a skinlike microscopic appearance was prepared by inoculating melted xanthine (0.4%) agar with filamentous fungi and dispensing drops onto glass slides. After solidification of the agar, the material was rapidly cleared by 10% KOH, revealing fungal elements stained by Cellufluor reagent.

Fluorescent Dyes↗

Calibration of kVp meters used in quality control tests in diagnostic radiology by spectrometry.

A non-invasive calibration methodology of quality control instruments for diagnostic radiology was established and applied to different kinds of commercial kVp meters. The method uses the measurement of the spectrum endpoint as a reference. The results showed a variation of 10% between the responses of the instruments calibrated and the spectrometric system, a fact that demonstrates the need for instrument calibration.

Calibration↗

Practical experience in electromagnetic hyperthermia quality control procedures within the context of international guidelines.

Recent international guidelines on hyperthermia (HT) quality assurance have pointed out the necessity of defining standard operative procedures and technical checks to guarantee an accurate performance of HT treatments. In the present paper, experience is described of quality control procedures that are performed in agreement with the more general guidelines concerning thermometry, sensor positioning, phantoms, applicator characterisation, and electromagnetic (EM) radiation leakage. This practical experience comes from the use of equipment for superficial and loco-regional HT working in the range 13.56-915 MHz.

Evaluation Studies as Topic↗

Quality control of estrogen receptor assays.

Four types of material have been used for the quality control of routine assays of estrogen receptors in human breast tumors. Pieces of hormone-dependent Nb rat mammary tumors gave a precision about 40%. Rat uteri and rat tumors pulverized at liquid nitrogen temperature and stored as powder yielded precision about 30%. Powdered and lyophilised human tumors appear the best with precision as good as 17%.

Animals↗

Multicentre quality control of polymerase chain reaction for detection of HIV DNA.

OBJECTIVE: Seven French laboratories tested the specificity and sensitivity of the polymerase chain reaction (PCR) for the detection of HIV-1 DNA. METHODS: Following its own PCR protocols, each laboratory independently tested blind two panels of 20 coded peripheral blood mononuclear cell samples collected from HIV-1-seropositive individuals and from HIV-1-seronegative individuals at high or low risk of HIV infection. For the first panel, laboratories were free to select type and number of primers; for the second, all were required to use the two primer pairs Pol 3/4 and MMy 9/10' (Nef 1). RESULTS: False-positive and false-negative results were observed in all laboratories (concordance with serology ranged from 40 to 100%). In addition, the number of positive PCR results did not differ significantly between high- and low-risk seronegatives. The use of crude cell lysates in DNA preparation produced the same PCR results as phenol-extracted DNA. Discrepancies between laboratories indicated that factors other than primer pairs contributed strongly to laboratory variability. CONCLUSIONS: Our results emphasize the importance of both positive and negative controls in PCR and demonstrate the value of multicentre PCR quality control.

Base Sequence↗

Contemporary assessment of antimicrobial susceptibility testing methods for polymyxin B and colistin: review of available interpretative criteria and quality control guidelines.

The emergence of infections caused by multidrug-resistant Pseudomonas aeruginosa and Acinetobacter spp. has necessitated the search for alternative parenteral agents such as the polymyxins. The National Committee for Clinical Laboratory Standards (NCCLS) documents do not currently provide interpretative criteria for the testing of the polymyxins, colistin and polymyxin B. Therefore, an evaluation of the antimicrobial activity of colistin and polymyxin B was initiated using 200 bloodstream infection pathogens collected through the SENTRY Antimicrobial Surveillance Program. All susceptibility tests were performed according to the NCCLS recommendations. Polymyxin B and colistin displayed a nearly identical spectrum of activity, exhibiting excellent potency against P. aeruginosa (MIC(90), 2 microg/ml) and Acinetobacter sp. (MIC(90), 2 microg/ml). In contrast, they showed limited activity against some other nonfermentative bacilli such as Burkholderia cepacia (MIC(90), >/=128 microg/ml). Excellent correlation was achieved between broth microdilution and agar dilution tests (r = 0.96 to 0.98); 94.3% of the results were +/-1 log(2) dilution between the methods used for both compounds. At a resistance breakpoint of >/=4 microg/ml for both agents, unacceptable false-susceptible or very major errors were noted for colistin (5%) and polymyxin B (6%). Modified zone criteria for colistin (</=11 and >/=14 mm) and polymyxin B (</=10 and >/=14 mm) were suggested, but some degree of error persisted (>/=3.5%). It is recommended that all susceptible disk diffusion results be confirmed by MIC tests using the preferred reference NCCLS method. The quality control (QC) ranges listed in the product package insert require an adjusted range by approximately 3 mm for both NCCLS gram-negative quality control strains. This evaluation of in vitro susceptibility test methods for the polymyxin class drugs confirmed continued serious testing error with the disk diffusion method, the possible need for breakpoint adjustments, and the recalculation of disk diffusion QC ranges. Clinical laboratories should exclusively use MIC methods to assist the therapeutic application of colistin or polymyxin B until disk diffusion test modifications are sanctioned and published by the NCCLS.

Anti-Bacterial Agents↗

Quality control in haemostasis.

Laboratory investigation of the haemostatic system deserves particular procedures in the quality control of analytical variables as well as preanalytical variables. This paper reviews the precautions that have to be taken in the blood prelevement, the transport of the tubes and the performance of the laboratory tests aimed to investigate the haemostatic system in order to obtain reliable results.

Blood Coagulation Tests↗

Effective and quality-controlled use of digital radiography in dental practice.

During the last years, the number of commercially available digital radiographic systems has increased rapidly. Nevertheless, they are hardly used in practice because several drawbacks still hinder dental practitioners from using digital radiography effectively in their routine work. In order to allow effective use of such systems in the dental practice, they must be integrated into the daily routine in an ergonomically optimal way and be driven by software following the rules of cognitive ergonomy and perception. The most important prerequisite for meaningful use of digital radiography in the dental practice is that it supports instead of disturbs daily clinical work. The underlying software should be easily comprehensible and intuitively applicable. This paper discusses advantages and disadvantages of digital compared to conventional radiography and how the introduction of digital radiography in dental practice affects clinical work. A concept is introduced that enables effective and quality-controlled use of digital radiographic systems in the dental practice by taking cognitive ergonomic aspects of the clinical work situation into account. This concept comprises the design of image databases for efficient storage and retrieval, the quality-controlled use of image manipulation methods adapted to the clinical requirements during diagnostic interpretation, and the usage of decision support systems for diagnosis and therapy of radiographic lesions.

Databases as Topic↗

[The selection of the indicators for a quality control policy in parenteral nutrition starting from clinical follow-up].

INTRODUCTION: the concept of quality is basic to any type of clinical/care activity and with parenteral nutrition (NP), the notion is of particular significance in the field of its clinical monitoring. The aim of this paper is to reveal the NP care level based on our experience in clinical monitoring in 1988, and to select the indicators to be evaluated for initiating NP quality control. MATERIAL AND METHODS: An analysis is made of the existing structure in our hospital, formed by the NP Unit and the NP and Enteral Nutrition Commission, which are subject to a policy of coordination in order to ensure their function. The process is divided into two aspects for the analysis - teaching and care. The clinical monitoring data of NP patients in 1988 were taken as reference in defining the indicators. RESULTS: The indices are presented which were obtained from the analysis of the data of a general nature, from an assessment of the degree of compliance with the procedure, and from the quantification of complications and the indicators elected as quality parameters. DISCUSSION: Although the clinical monitoring of the PN began with the general wish to evaluate different aspects associated with nutritional therapy, this focus later evolved toward the notion of quality. Not all the data gathered during the clinical monitoring can be taken as quality criteria: only those deemed to be more relevant, or of greater clinical significance, and which can be reliably measured, can be treated thus.

Evaluation Studies as Topic↗

Error models and quality control performance.

As an alternative to the oversimplified error schemes currently adopted in establishing quality control (QC) strategies, a complex model was assumed implying (a) the distribution of errors (critical error is regarded as a value discriminating between "effective errors" to be detected and "subcritical errors" which do not interfere with the medical decision whose detection is considered as a false-reject signal), and (b) the possibility of simultaneous losses of precision and accuracy. The control data recorded for digoxin radioimmunoassay over a one-year period were used for (1) deriving the probability density functions of random and systematic errors, through a within-run across-level normalisation procedure; (2) obtaining the functional relationships between the critical random or systematic error and the QC performance statistics (sensitivity, specificity, predictive value), weighted for the error prevalences, through integration of the probability density functions and the power functions associated with an exemplifying control rule; and (3) describing the functions which correlate the corrected performance statistics with the allowable error (whose individual values account for all possible combinations of critical random errors and critical systematic errors), by extending to the tridimensional space the above procedures. Analysis of the resulting data shows that it is necessary to revise the criteria for the choice and optimisation of QC schemes.

Analysis of Variance↗

Quality control of peak flow meters for multicenter clinical trials. The Asthma Clinical Research Network (ACRN).

Although peak expiratory flow (PEF) measurements are recommended for monitoring and assessing treatment of asthmatic patients, and widely employed to assess outcome in clinical trials and epidemiologic studies, information about performance of peak flow meters (PFM) under field conditions is lacking. We describe a simple testing system consisting of a testing chamber, a spirometer, and a calibration syringe to evaluate the relative accuracy or median relative bias (MRB), precision, or inter-quartile range (IQR) of the mini-Wright PFM. The relative accuracy ranged from -4.4 to 13.2% (mean, 4.1%) and the precision from 0.06 to 11.5% (mean, 1.2%). Durability of this PFM was assessed during a 26-wk clinical trial in 255 asthmatic subjects at five centers. Seventy-one PFM (19.9%) were identified as having failed to meet acceptance criteria, predominantly because of loss of relative accuracy, by the clinics at follow-up visits (n = 36), and by the Data Coordinating Center on retrospective review of quality control measurements submitted by the clinics (n = 35). This study indicates that a simple device can be used to evaluate the relative accuracy and precision of a given PFM and to ensure the quality of PEF measurements during a clinical trial. To the extent that one can extrapolate these data to other devices, our findings indicate that the failure rate of PFM over time can be high, indicating that quality control of a PFM over time is absolutely essential in clinical trials as well as in routine clinical care.

Asthma↗

A knowledge-based system for real-time quality control and fault diagnosis of multitest analyzers.

A PC-based real-time quality control (QC) system for multitest analyzers has been developed as a prototype. The system is built with use of a relational database management system (DBMS). Control values from the various analytical channels are stored and administrated with use of the DBMS. The control values collected during various stages of control are filtered through statistical control procedures and the control status of the instrument is continuously presented in color-coded fields indicating the possible presence of critically sized systematic or random analytical errors. The knowledge about rational trouble-shooting of a specific instrument is represented in a network structure and stored in relational tables of the DBMS. An inference engine performs alternating backward and forward reasoning in the network and guides the operator in trouble-shooting.

Artificial Intelligence↗