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Documented problems with loose and inert Ir-192 seeds in nylon ribbons prompted us to develop a quality control program. Several problem cases are illustrated. A sample of ribbons from each shipment is measured in a radioisotope dose calibrator. Results of the measurements over a 46-month period are presented.
A protein complex deposited upstream of exon-exon junctions after pre-mRNA splicing may serve a dual role in mRNA quality control by directing mRNA nuclear export and, possibly, serving as a downstream 'mark' for nonsense-mediated decay.
We report results of a quality-control survey of radioimmunoassay (RIA) of eight analytes, participated in by 249 laboratories of various types throughout Japan. For the purpose of the external control survey, lyophilized specimens containing two different concentrations of each analyte were sent to the participating laboratories, which supplied both their assay values and their raw data for the standard curves and for the samples. The individual data for the standard curve were analyzed by the RIA data-processing program described by Faden and Rodbard. The precision profile obtained for the individual assay was used as the estimate of the quality of each assay. Although there was a wide scatter in assay values, the quality of the assay by the individual laboratories was not the major contributor to this scattering, because the values they reported for the assays and precision profiles of the standard curves were almost identical with those obtained from the kit manufacturers. When the reported assay values were analyzed according to the brand of kits, by analysis of variance, the treatment mean square due to difference in the make of the kits significantly exceeded the error mean square due to "within-kit" variation in the assay of insulin, thyroxin, thyrotropin, cortisol, gastrin, and digoxin. The CVs for "between-kit," "within-kit," "between-assay" and "within-assay" variations (the latter two aspects were studied in a representative laboratory, for convenience of comparison) were about 20, 15, 13, and 7%, respectively. Because the observed within-kit variation is of almost the same magnitude as that expected from the combination of within-assay and between-assay variation, the skill of the users probably was equal and the accuracy and precision of the kits probably had the greatest impact on assay variation. This survey also emphasizes the criteria for commercially available RIA kits.
This paper describes a method for SPET quality control that facilitates the determination of COR-offset, parallel y-shift and detector tilt by means of a single, comprehensive test using a special phantom consisting of three point sources. The evaluation of the method was performed by a series of measurements utilizing manually adjusted detector tilts and a simulation of y-shift by moving the phantom. The results show that y-shift and detector tilt are measured with reasonable accuracy, and that y-shift caused by variations in detector tilt can be differentiated from y-shift caused by other factors.
Tapasin plays an important role in the quality control of major histocompatibility complex (MHC) class I assembly, but its precise function in this process remains controversial. Whether tapasin participates in the assembly of HLA-G has not been studied. HLA-G, an MHC class Ib molecule that binds a more restricted set of peptides than class Ia molecules, is a particularly interesting molecule, because during assembly, it recycles between the endoplasmic reticulum (ER) and the cis-Golgi until it is loaded with a high affinity peptide. We have taken advantage of this unusual trafficking property of HLA-G and its requirement for high affinity peptides to demonstrate that a critical function of tapasin is to transform class I molecules into a high affinity, peptide-receptive form. In the absence of tapasin, HLA-G molecules cannot bind high affinity peptides, and an abundant supply of peptides cannot overcome the tapasin requirement for high affinity peptide loading. The addition of tapasin renders HLA-G molecules capable of loading high affinity peptides and of transporting to the surface, suggesting that tapasin is a prerequisite for the binding of high-affinity ligands. Interestingly, the "tapasin-dependent" HLA-G molecules are not empty in the absence of tapasin but are in fact associated with suboptimal peptides and continue to recycle between the ER and the cis-Golgi. Together with the finding that empty HLA-G heterodimers are strictly retained in the ER and degraded, our data suggest that MHC class I molecules bind any available peptides to avoid ER-mediated degradation and that the peptides are in turn replaced by higher affinity peptides with the aid of tapasin.
A collaborative study conducted by the French National Agency for Quality Control in Parasitology (CNQP) and various manufacturers of ELISA kits, represented by the Association of Laboratory Reagent Manufacturers (SFRL) compared the toxoplasmosis IgG antibody titres obtained with different ELISA-IgG kits and determined the relationships between the titres obtained by these techniques and the titre defined in international units (IU). Fifty-one serum samples with toxoplasmosis antibody titres ranging from 0 to 900 IU were tested in two successive studies with 16 ELISA-IgG kits. For the negative sera, false-positive reactions were observed with one kit. For the positive sera, the titres observed in ELISA were generally higher than those expressed in IU. Above 250 IU, the very wide variability of the titres found with the different ELISA kits renders any comparative analysis impossible. For titres below 250 IU, the results are sufficiently homogeneous to permit the use of regression analysis to study how the results for each ELISA kit compare with the mean results for the other kits. The slope of the line of regression shows a tendency to over-titration or under-titration compared with the results of the other manufacturers; the ordinate at the origin reflects the positivity threshold of the reaction and can be used to assess the risk of a lack of sensitivity (high threshold) or of specificity (threshold too low). On the whole, the trends revealed for a given manufacturer are constant from one study to the other. Within this range of titres, regression analysis also reveals the general tendency of ELISA kits to overestimate the titres by comparison with immunofluorescence.(ABSTRACT TRUNCATED AT 250 WORDS)
In response to a need for monitoring the proficiency of public health laboratories in isolating and identifying Neisseria gonorrhoeae, a national external quality control program was developed. Essentially, three types of freeze-dried samples, representing different levels of challenge for identification, were sent to laboratories for testing. The quality of the samples was confirmed by external reference laboratories, and stability of the samples was confirmed by thermal degradation tests before the samples were sent to laboratories enrolled in the program. By analyzing laboratory results, we identified common errors and chronic problems in testing samples. As a group, laboratories testing small numbers of actual patient specimens did not perform as well in the program as did laboratories testing large numbers of specimens; however, the performance of laboratories testing small numbers of specimens improved over time. Overall, laboratories experienced the most difficulty with samples containing N. gonorrhoeae mixed with other microbial species. Laboratories that performed confirmatory tests committed fewer errors than did laboratories that performed presumptive tests only, but the failure to use pure cultures of gonococci for inoculation of cystine tryptic digest agar appeared to be a chronic problem in confirmatory carbohydrate testing. A review of the use of different plating media and confirmatory tests showed that the use of certain media and tests changed over time.
Synchrotron radiation imaging with the refraction-enhancement mode visualized structural inhomogeneities in phantoms used for image quality control of mammography. Eight phantoms were examined, all of which were manufactured in the United States and approved by the American College of Radiology as dedicated phantoms. In addition to fiber- and mass-mimicking test objects, each phantom has 5 groups of calcification specks of various sizes. Synchrotron radiation (SR) imaging was performed at Spring-8, a synchrotron radiation facility in Japan. Images were obtained with monochromatic 20-keV x-ray beams, a radiation field of 15 mm X 26 mm at a sample plane, a CCD camera with a resolution of 6 micrometers as a detector, and a sample-to-detector distance of 10 to 11 m. Two hundred and forty specks were evaluated in total in the SR images, and the surrounding area of each speck was also included. Evaluation of the images showed that 14 crack-like structures were depicted near specks, and there were 62 specks with attached void(s) or air bubble(s). Refraction-enhanced SR imaging sensitively detected structural inhomogeneities and abnormalities in phantoms which were implicitly agreed to have a homogeneous matrix and test objects without foreign substances. A possible manufacturing-dependent quality issue was identified. The effect of inhomogeneities detected by SR imaging on visual scoring of specks could not be identified in the tested phantoms; this should be assessed on images of other phantoms in a future study.
An international collaborative study was performed in order to propose quality control limits for fluconazole disk diffusion susceptibility tests on Mueller-Hinton agar with 2% glucose and 0.5 micro g of methylene blue per ml. The supplements may be added before autoclaving the agar, or Mueller-Hinton agar plates may be flooded with a glucose-methylene blue solution. Replicate tests on both types of agar plates generated data to propose zone size limits for tests of Candida parapsilosis ATCC 22019 (22 to 33 mm), C. tropicalis ATCC 750 (26 to 37 mm), and C. albicans ATCC 90028 (28 to 39 mm). C. krusei ATCC 6258 was not useful for this purpose.
An international collaborative study was performed in order to propose quality control limits for voriconazole disk diffusion tests on Mueller-Hinton agar with 2% glucose and 0.5 micro g of methylene blue per ml. The supplement may be added to the agar before autoclaving, or Mueller-Hinton agar plates may be flooded with a glucose-methylene blue solution. Replicate tests on both types of agar plates with 1- micro g voriconazole disks generated data to propose zone size limits for tests of Candida parapsilosis ATCC 22019 (28 to 37 mm), Candida albicans ATCC 90028 (31 to 42 mm), and Candida krusei ATCC 6258 (16 to 25 mm). Candida tropicalis ATCC 750 was not useful for this purpose.
AIM: To compare the performance of a direct digital mammography system with normal-view and magnified-view conventional screen-film methods using quality control phantoms. MATERIALS AND METHODS: Using a Siemens Mammomat((R))3000 and an Opdima((R))digital spot imaging and biopsy attachment, film and direct digital images of two phantoms [DuPont and TOR (MAM)] were obtained under normal operating conditions. These were assessed by three groups of observers with differing expertise - radiologists, radiographers and medical physicists. Each observer was asked to compare the direct digital image with films taken in standard view and magnified view, providing scores for object visibility and confidence. For the digital images, observers were allowed to vary the image presentation parameters. RESULTS: Both phantoms showed that overall the direct digital view and the magnified view film performed significantly better (P < 0.05) than standard view film. For certain small or low contrast objects the differences became very highly significant (P < 0.001). CONCLUSION: Only the TOR (MAM) phantom showed any significant difference between digital and magnified modalities, with magnified views performing better for fine, faint filaments and digital acquisition better for low contrast objects. Almost no difference existed between the three observer groups. Undrill, P. E. (2000). Clinical Radiology53, 782-790.
PURPOSE: Despite advances in assisted reproduction, there is no progress in quality control bioassays. The objectives were to develop a comet assay to measure DNA fragmentation in thawed cryopreserved oocytes and compare this assay with one-cell mouse embryo bioassay. METHODS: Thawed hamster oocytes from a commercial source were incubated in culture media with either 0-, 50-, or 100-microM hydrogen peroxide, or, in media exposed to different contact materials and unknown proficiency analytes. Incubation time was 1.5 h at 37 degrees C. The oocytes were dried, fixed, stained with acridine orange, embedded in a mini-agarose layer and electrophoresis was carried out. Fluorescent images were analyzed. The results were compared with standard one-cell mouse assay data. RESULTS: The 100-microM hydrogen peroxide treatment caused greatest DNA fragmentation in the hamster oocytes at Hours 1 and 2. A dose response was observed. Intraassay coefficient of variation was 5.7%. Only one of the five materials tested passed both assays. The data for the unknown proficiency analytes were similar for both assays. CONCLUSIONS: The oocyte comet assay demonstrated DNA fragmentation in the presence of toxic substances. The detection of toxicity in two materials that passed the mouse bioassay suggested increased sensitivity in the new assay. The oocyte comet assay and the mouse bioassay results matched in the proficiency test. However, more studies are still needed to determine optimal sensitivity.
The Italian Society for Cytometry (Gruppo Italiano di Citometria, GIC) promoted this nationwide large-scale quality control trial on cellular immunophenotyping and flow cytometer performance in 1991. The aim of this independent study was to evaluate instrument performance with calibrated fluorescence microbeads (minimum threshold for FITC, linearity, coefficients of variation and resolution indexes for fluorescence), and to correlate it to the measurement of lyophilized lymphocyte surface immunofluorescence staining with a wide spectrum of antibodies (percentage of positive cells and fluorescence mean intensity). A single send-out was made to 306 laboratories with 350 instruments throughout Italy. Each kit included anonymous vials containing premixed calibrated microbeads, lyophilized human lymphocytes and small aliquots of conjugated monoclonal antibodies, for both single FITC and double FITC/PE staining. Participants were also asked to use their own anti-CD4 monoclonal. A valid answer was returned by 209 laboratories with 221 instruments. Gating was not an assay variable. The minimum sensitivity threshold for FITC ranged from 26.6 to 11,293 MESF, with marked instrument heterogeneity as far as the relationship between FITC threshold and coefficients of variation for fluorescence was concerned. A low FITC threshold also correlated with a good resolution index for low intensity stainings. No performance comparisons among instrument brands and models were made. The lyophilized lymphocyte analysis showed an overall frequency of outliers ranging from 3.2% to 19.7%, with a maximum for CD2 FITC (19.7%) and CD3 + HLA-DR + (12.1%). A strongly negative relationship was evident between the FITC threshold and the number of CD2+ cells, whereas the sensitivity threshold had virtually no effects on the measured level of higher antigen density markers like CD4 and many others. Absolute fluorescence intensity measurements of CD4+ and CD19+ were also made. This study design proved valid and suitable for a large-scale evaluation of both instrument performance and cytometer operators' skill. A number of practical problems were identified among participants, thus stressing the need for more effective educational programmes and technical guidelines.
This article discusses the impact of surgery-related factors on the outcome of breast cancer patients and the experience of the EORTC in assessing the quality of breast cancer surgery. Furthermore an overview is given of the surgical quality control in the EORTC-AMAROS trial NR 10981.
BACKGROUND: The Symmetry aortic connector uses a nitinol implant to create proximal anastomoses with saphenous vein grafts. Multiple detector-row cardiac computed tomography (MDCT) is used as a noninvasive method of quality control at our institution. METHODS: In 50 elective coronary artery bypass grafting patients who participated in a randomized trial comparing automated with conventionally hand-sewn proximal anastomoses, MDC T was performed on postoperative day 5. Fifty-three automated Symmetry anastomoses were created in 34 patients (group 1). Twenty-five conventionally hand-sewn anastomoses created in 16 patients served as controls (group 2). Graft patency and the presence or absence of high-grade stenosis at the proximal anastomotic site were evaluated. RESULTS: In group 1, 2 (3.8%) of the grafts were found occluded at MDCT or coronary angiography, and no further relevant stenosis was observed. In group 2, at postoperative MDCT all grafts were found patent without significant narrowing of the proximal anastomotic site. CONCLUSIONS: The feasibility of proximal anastomoses using the Symmetry device has been reported. Patency control with invasive angiography has been performed by other groups. With MDCT, noninvasive evaluation of proximal anastomotic quality and graft patency is possible, even if nitinol is implanted.
A beta-lactamase-negative, ampicillin-resistant strain of Haemophilus influenzae is currently used for quality control of broth microdilution tests performed with Haemophilus test medium (HTM). Studies with eight lots of HTM broth documented the fact that MIC limits for some antimicrobial agents are unrealistically stringent; i.e., only three of eight lots of HTM broth were satisfactory for testing cefaclor. An alternative, ampicillin-susceptible strain of H. influenzae (ATCC 49766) was found to provide much more reproducible results with five problematic drugs (cefaclor, cefuroxime, cefamandole, loracarbef, and cefonicid). Multilaboratory studies defined MIC control limits for both control strains tested against 12 antimicrobial agents.
The malted rice, koji, is an indispensable material for the brewing of sake. It saccharifies rice starch and supplies vitamins for the yeast in sake brewing. Since the quality of sake depends strongly on the quality of koji, quality control of koji is very important in the brewing. There are some methods to measure the activity of enzymes and the quantity of vitamins with the quality of koji. None of these methods, however, directly relate to the yeast metabolism. We constructed a sensor system to monitor the yeast metabolism in sake brewing by use of immobilized Saccharomyces cerevisiae and a Surface PhotoVoltage device (SPV). In this system, S. cerevisiae K701 and K9, designed for use in sake brewing by the Brewing Society of Japan, were employed as immobilized microbe. The pH change due to the production of organic acids in sake brewing is measured using the SPV. A linear relationship was observed between decrease in the photocurrent (the metabolism response) and the concentration to less than 60 mM of glucose (r=0.990). Then we measured the koji extract and observed the difference of response between K701 and K9 which corresponded to the productivity of acidic substances by batch test.
The data coordinating center (DCC) of the Asthma Clinical Research Network (ACRN) is responsible for the support of 11 pulmonary-function testing systems and two quality control systems. Pulmonary-function data from these systems are used as outcome indicators in studies conducted by the ACRN. Each of these systems is composed of a spirometer, a personal computer for data acquisition from the spirometer, a modem, and a printer. These systems are located at six clinical centers nationwide. An analysis conducted at the beginning of the first ACRN protocol identified the following requirements: (1) standard pulmonary-function testing, (2) standard methacholine-challenge testing, (3) the ability to handle simultaneous multiple protocols as well as have data from non-ACRN subjects, (4) the ability to separate data from different protocols as well as separate ACRN and non-ACRN data, (5) the ability to transmit data from the remote clinical centers to the DCC, (6) the ability to ensure quality data and to report on those results, and (7) the ability to provide remote support.