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PubMed2006

Live cell quality control and utility of real-time cell electronic sensing for assay development.

In this paper we have explored the utility of the real-time cell electronic sensing (RTCES, ACEA Biosciences Inc., San Diego, CA) system for monitoring the quality of live cells in cell-based assays as well as for assay development. We have demonstrated that each cell type displays unique growth kinetic profiles that provide a quantitative account of cell behavior and can be used as a diagnostic tool for cellular quality control. The utility of the specific signature patterns was shown by demonstrating the significant differences in primary cell behavior depending on the supplier. In addition, the RT-CES system was able to differentiate cell behavior depending on the passage stage of the cells. The utility of the RT-CES system as an assay development tool was demonstrated in cytotoxicity assays. The RT-CES system not only provides information regarding the potency of cytotoxic compounds, but in addition relates potency to the rate of the response for each concentration of the compound tested, which is important for understanding the mechanism of compound action. Moreover, real-time display of cytotoxicity data by the RT-CES system allows for calculation of real-time 50% inhibitory concentration (IC50) values or determination of optimal IC(50) value. In summary, the RT-CES system provides high content and information-rich data that are beyond the scope of single-point assays.

Biological Assay↗
PubMed1998

Modified preparation and rapid quality control test for technetium-99m-tetrofosmin.

OBJECTIVE: The objectives of this study were to: modify the preparation of 99mTc-tetrofosmin by using twice the amount of 99mTcO4- recommended by the manufacturer; evaluate the use of miniaturized rapid paper chromatography (MRPC) for quality control (QC) testing; and determine the in vitro stability of the modified preparation using MRPC. METHODS: Two preparations of 99mTc-tetrofosmin were made: one with 4.4-8.8 GBq (120-240 mCi) and the other with 13.9-17.6 GBq (380-480 mCi) 99mTcO4-, referred to as regular and modified preparations, respectively. Routine QC tests were performed using MRPC and instant thin-layer chromatography/silica-gel (ITLC/SG) systems. The preparations were injected into 58 patients. Planar and SPECT images of stress and rest studies were obtained. The technical quality of the SPECT images was graded visually by four observers. Heart-to-lung and heart-to-background ratios were calculated from the planar images. RESULTS: The QC testing procedure took 4.18 +/- 0.15 min with MRPC and 54 +/- 5.3 min with ITLC/SG systems. The percent labeling efficiency, as determined by both techniques, ranged from 95.6 +/- 1.6 to 97.2% +/- 0.8%. Both preparations were stable up to 6 hr after reconstitution. There was no difference between the cardiac-to-lung and cardiac-to-background ratios of the two preparations. CONCLUSION: The results indicate that MRPC is a faster and effective chromatographic technique for routine QC testing of 99mTc-tetrofosmin. Doubling the amount of 99mTcO4- used in preparing 99mTc-tetrofosmin did not affect its in vitro stability, its efficacious use in patients or the technical quality of the images.

Chromatography, Paper↗
PubMed2001

Optimal inoculation methods and quality control for the NCCLS oxacillin agar screen test for detection of oxacillin resistance in Staphylococcus aureus.

To define more precisely the inoculation methods to be used in the oxacillin screen test for Staphylococcus aureus, we tested agar screen plates prepared in house with 6 microg of oxacillin/ml and 4% NaCl using the four different inoculation methods that would most likely be used by clinical laboratories. The organisms selected for testing were 19 heteroresistant mecA-producing strains and 41 non-mecA-producing strains for which oxacillin MICs were near the susceptible breakpoint. The inoculation method that was preferred by all four readers and that resulted in the best combination of sensitivity and specificity was a 1-microl loopful of a 0.5 McFarland suspension. A second objective of the study was to then use this method to inoculate plates from five different manufacturers of commercially prepared media. Although all commercial media performed with acceptable sensitivity compared to the reference lot, one of the commercial lots demonstrated a lack of specificity. Those lots of oxacillin screen medium that fail to grow heteroresistant strains can be detected by using S. aureus ATCC 43300 as a positive control in the test and by using transmitted light to carefully examine the plates for any growth. However, lack of specificity with commercial lots may be difficult to detect using any of the current quality control organisms.

Bacteriological Techniques↗
PubMed2003

Quality control and peak finding for proteomics data collected from nipple aspirate fluid by surface-enhanced laser desorption and ionization.

BACKGROUND: Recently, researchers have been using mass spectroscopy to study cancer. For use of proteomics spectra in a clinical setting, stringent quality-control procedures will be needed. METHODS: We pooled samples of nipple aspirate fluid from healthy breasts and breasts with cancer to prepare a control sample. Aliquots of the control sample were used on two spots on each of three IMAC ProteinChip arrays (Ciphergen Biosystems, Inc.) on 4 successive days to generate 24 SELDI spectra. In 36 subsequent experiments, the control sample was applied to two spots of each ProteinChip array, and the resulting spectra were analyzed to determine how closely they agreed with the original 24 spectra. RESULTS: We describe novel algorithms that (a) locate peaks in unprocessed proteomics spectra and (b) iteratively combine peak detection with baseline correction. These algorithms detected approximately 200 peaks per spectrum, 68 of which are detected in all 24 original spectra. The peaks were highly correlated across samples. Moreover, we could explain 80% of the variance, using only six principal components. Using a criterion that rejects a chip if the Mahalanobis distance from both control spectra to the center of the six-dimensional principal component space exceeds the 95% confidence limit threshold, we rejected 5 of the 36 chips. CONCLUSIONS: Mahalanobis distance in principal component space provides a method for assessing the reproducibility of proteomics spectra that is robust, effective, easily computed, and statistically sound.

Algorithms↗
PubMed2001

Variability in the levels of PML-RAR alpha fusion transcripts detected by the laboratories participating in an external quality control program using several reverse transcription polymerase chain reaction protocols.

BACKGROUND AND OBJECTIVES: The detection of PML-RAR by reverse transcription (RT) polymerase chain reaction (PCR) in acute promyelocytic leukemia (APL) patients who are in hematologic remission influences therapeutic decision making in several trials. In the light of this, the Spanish group has recently designed an external quality assessment program (EQAP) of RT-PCR detection of PML-RAR, which includes a study of sensitivity of the participating laboratories. DESIGN AND METHODS: Eighteen laboratories were involved in the program. Ten laboratories followed the method of Biondi et al., 5 employed that of Borrow et al. and the 3 remaining used other protocols. The sensitivity was studied in five rounds of quality control. The first two shipments consisted of dilutions of NB4 RNA into non-APL RNA. The third round consisted of serial dilutions of the NB4 cell line into HL60 cells. The fourth and five rounds consisted of plasmid dilutions containing the bcr1 and bcr3 PML-RAR isoforms. RESULTS: The results showed that the distinct methods allow detection of the PML-RAR hybrid up to a dilution of 10(-4), and exceptionally, up to 10(-5). The laboratories following the method of Biondi et al. usually detected the 10(-3) dilution and less frequently the 10(-4) one, whereas those using other methods usually detected PML-RAR transcript in the 10(-4) dilution, and less commonly in the 10(-5) dilution. However, each of the PCR methods used by EQAP participating laboratories successfully detected at least 50 copies of PML-RAR alpha fusion transcript in plasmid dilution controls. INTERPRETATION AND CONCLUSIONS: The results point to heterogeneous sensitivity amongst participating laboratories. This may reflect differences in methodology, although variations in sample quality may also account for discrepant findings.

Humans↗
PubMed2025

Cytoplasmic mRNA decay and quality control machineries in eukaryotes.

mRNA degradation pathways have key regulatory roles in gene expression. The intrinsic stability of mRNAs in the cytoplasm of eukaryotic cells varies widely in a gene- and isoform-dependent manner and can be regulated by cellular cues, such as kinase signalling, to control mRNA levels and spatiotemporal dynamics of gene expression. Moreover, specialized quality control pathways exist to rid cells of non-functional mRNAs produced by errors in mRNA processing or mRNA damage that negatively impact translation. Recent advances in structural, single-molecule and genome-wide methods have provided new insights into the central machineries that carry out mRNA turnover, the mechanisms by which mRNAs are targeted for degradation and the general principles that govern mRNA stability at a global level. This improved understanding of mRNA degradation in the cytoplasm of eukaryotic cells is finding practical applications in the design of therapeutic mRNAs.

RNA Stability↗
PubMed1998

Statistical quality control methods in infection control and hospital epidemiology, part I: Introduction and basic theory.

This article is the first in a two-part series discussing and illustrating the application of statistical process control (SPC) to processes often examined by hospital epidemiologists. The basic philosophical and theoretical foundations of statistical quality control and their relation to epidemiology are emphasized in order to expand mutual understanding and cross-fertilization between these two disciplines. Part I provides an overview of quality engineering and SPC, illustrates common types of control charts, and provides references for further information or statistical formulae. Part II discusses statistical properties of control charts, issues of chart design and optimal control limit widths, alternate possible SPC approaches to infection control, some common misunderstandings, and more advanced issues. The focus of both articles is mostly non-mathematical, emphasizing important concepts and practical examples rather than academic theory and exhaustive calculations.

Humans↗
PubMed1976

A regional quality control program in microbiology. I. Administrative aspects.

Conventional proficiency testing programs in microbiology using recognizable materials yield limited information. To assess overall laboratory competence in the handling of routine clinical material, other methods are needed. This report describes the use of "blind," simulated clinical specimens in a regional quality control program. Details of the administration, including technics, costs, logistics, and limitations, are presented.

Canada↗
PubMed1997

Matrix-assisted laser desorption ionization time-of-flight mass spectrometry as a rapid quality control method in oligonucleotide synthesis.

Oligonucleotide synthesis is a major activity for a large number of laboratories throughout the world. Dimethoxytrityl-deprotection monitors on instruments give the operator a measure of synthetic efficiency, but cannot be considered as a reliable indicator of the final quality of the cleaved and deprotected oligonucleotide. We have therefore adapted and developed methods of analyzing oligonucleotides by matrix-assisted laser desorption ionization mass spectrometry to the quality control situation, resulting in the ability to analyze 20 oligonucleotides up to at least 40 bases long in less than an hour. Most oligonucleotides can be analyzed automatically using the automatic scanning feature of a Kratos MALDI III analyzer.

Electrophoresis, Capillary↗
PubMed2003

[Quality control of outpatient imaging examinations in North Rhine-Westphalia, Part II].

PURPOSE: In the state of North Rhine-Westphalia (NRW), Germany, a survey was conducted on radiologic examinations ordered by general practitioners (GPs). Part II of this study aims to determine the quality of the process and outcome. The reference standard is the assessment of both radiologists and physicians without board certification in radiology working at a university hospital and in outpatient facilities. MATERIALS AND METHODS: AllGPs in NRW were asked to cooperate. Participating GPs filled out a questionnaire for each patient. The patients recorded the symptoms prompting the imaging examinations. The radiologists or other physicians performing the examinations were asked to provide the images and written reports and to complete a questionnaire. A file was created for each of the 394 patients with image documentation of at least one examination. Each file, which included medical history, physical findings, imaging documentation and written report, was sequentially forwarded to a board-certified radiologist and to a physician without board certification in radiology working in a university hospital and in an outpatient facility. All physicians were requested to complete a structured questionnaire for each file. RESULTS: The referral diagnoses were rated as medically plausible in 81%, the indications for imaging found correct in 76%, the examination techniques considered appropriate in 69%, the clinical question answered in 63%, the interpretation judged medically correct in 50% and all incidental findings documented in 49%. In retrospect, 32 % of the examinations were judged superfluous. The sequence of multiple examinations performed on a particular patient was rated as appropriate in 51%. The interpretation revealed specialty-related differences. The plausibility of the referral diagnoses had a significant impact on the appropriateness of subsequent diagnostic investigations. Marked deficits showed sonography, performance by non-radiologists, self-referrals by GPs, gastroenterologic radiology and the ICD-10 coding (suspicion of cardiovascular disease). CONCLUSION: In the "best-case" scenario, the process quality proved to have moderate deficiencies and the outcome quality severe deficiencies. In consequence, GPs and radiologists should be more communicative by sharing information and exchanging opinions. GP self-referrals should be restricted. Sonography and examinations performed by physicians without board certification in radiology should undergo stricter quality controls. A more intensive interdisciplinary collaboration is needed to determine the optimum implementation of diagnostic imaging of gastroenterologic and cardiovascular diseases.

Ambulatory Care↗
PubMed1994

Quality control in mammography: an initiative in France.

The ultimate effectiveness of any mass screening campaign is directly related to strict compliance with certain rules and technical protocols designed for radiological installations. Concerning radiological screening, the primary technical objective is to ensure reproducibly high quality images at low radiation dose to the patient. This paper describes the methodology followed for the implementation of a quality control (QC) programme of 48 mammography installations used within the context of the breast cancer screening campaign in the Bas-Rhin region of eastern France. In order to demonstrate the efficacy of such a programme, results of QC tests and procedures relating to each element of the radiological imaging chain are presented and compared for four control visits carried out at 6 month intervals over a period of 2 years. A reduction of 50% (from 16 mGy to 7.5 mGy) of breast entrance doses (normalized to a breast thickness of 4.5 cm) and a significant improvement of detectability of high contrast details are discussed. The importance of encouraging an extension of a similar process to the other screening experiments currently underway in France is emphasized.

Aged↗
PubMed1994

[Applications of the quality control program in diagnostic radiology. Confirmation of results, clinical and managerial benefits].

The Health Physics Department developed and implemented a QA program to test the X-ray equipment in Policlinico S. Orsola-Malpighi, Bologna, Italy. The program was aimed at achieving "total quality" in diagnostic radiology. To this purpose, suggestions were taken from: the code of practice of the leading international committees; our personal experience over several years in measuring and evaluating radiologic equipment and finally data relative to the maintenance procedures for radiologic equipment. The Integrated Quality Assurance Program (IQAP) manages two different quality control sub-procedures: the first one (QF) monitors equipment performance with a view to providing more pieces of diagnostic information and to reducing both patient and staff dose; the other one (QG) plans maintenance service to reduce running costs. QF included: i) practical tests for X-ray equipment; ii) analysis, interpretation and comparison of results; iii) tolerance limits. QG provided information on: i) inventory; ii) user-service relationship; iii) suitability of any corrective actions. The data relative to the last four years are reported in the text. The regular and correct use of this integrated protocol is very useful to monitor the factors affecting image quality and to improve diagnostic radiology. Finally, the protocol allowed us to plan our "yearly maintenance contracts" better and to save money on running costs.

Program Evaluation↗
PubMed2004

External quality control assessment in PCR diagnostics of dengue virus infections.

BACKGROUND: Increased travelling to countries endemic for dengue fever (DF) demands efficient laboratory diagnostics. Nucleic acid amplification techniques (NAT) are now frequently used for rapid diagnosis of imported viral diseases. Different PCR systems are available. OBJECTIVES: In order to assess the quality of molecular diagnostics of dengue virus infections, an external quality assurance (EQA) in PCR diagnostics was conducted. STUDY DESIGN: A panel of 10 human plasma samples was prepared and spiked with dengue virus types DEN-1 to DEN-4. In addition, a 10-fold dilution series (1:10-1:10(4) ) of DEN-3 virus was included. The panel was pre-tested by nested RT-PCR, in-house real-time PCR, and a commercial real-time PCR kit. The samples were inactivated by gamma irradiation and shipped in freeze dried state. Thirteen laboratories, within the European network for the diagnostics of imported viral diseases (ENIVD) took part using either single-round, nested, or real-time RT-PCR methods. Two laboratories used two methods in parallel, summarising up to 15 comparable results. RESULTS: 33-100% correct results were achieved. All laboratories detected DEN-2 correctly, followed by DEN-1 (14 positive results of 15), DEN-3 (12/15) and DEN-4 (11/15). Testing of the serial dilution revealed low sensitivity in many labs, with results ranging from 33 to 80% of correctly tested samples. CONCLUSION: The EQA gives a feedback of the quality of the RT-PCR system used by each respective laboratory. The different test systems and amplification conditions demonstrate the importance of external quality control measures.

Animals↗
PubMed1995

Quality control in the secretory pathway.

Whereas newly synthesized proteins that have acquired a properly folded and assembled structure are transported from the endoplasmic reticulum to their final destinations, incompletely folded and assembled proteins are, as a rule, retained and eventually degraded. The molecular mechanisms of this unique molecular sorting phenomenon, called 'quality control', have been illuminated by recent studies.

Animals↗
PubMed1991

External quality control of mycobacterial laboratories in the Czech and Slovak Federal Republic and in the former German Democratic Republic.

Simulated samples of sputa respectively negative sputa artificially contaminated with mycobacteria were sent to mycobacteriological laboratories in CSFR and the former GDR for the purpose of conducting an external quality control of the process employed in bacteriological examination. The average percentage of positive results corresponding with the reference material came to 75.7% in CSFR and 92.0% in former GDR. Methodological differences influencing the results of external laboratory control in both countries are discussed. Systematic external controls are recommended as an invaluable aid for improvement of the bacteriological demonstration of mycobacterial infections.

Bacteriological Techniques↗
PubMed2006

[Blood pressure measurement: the experience of personnel training and quality control in the Pro-Saúde Study].

The adequacy of medical management and the validity of epidemiological inference on arterial hypertension depend crucially on the accuracy of measurement procedures. This article reports on our experience with the procedures used for personnel training and quality control of blood pressure measurements in the Pro-Saude Study phase 2, which was conducted among 3,574 civil servants at a university in Rio de Janeiro, Brazil, in 2001. We utilized mercury sphygmomanometers and standard techniques according to international protocols. We monitored the technicians' adherence to adopted guidelines, final digit preference, differences between subsequent measurements, and proportion of missing data. Overall, these procedures helped minimize the potential for systematic errors related to the auscultatory method of blood pressure measurement, thus allowing valid analyses of factors associated with hypertension.

Blood Pressure Determination↗
PubMed2003

Friedel-Crafts acylation as a quality control assay for steroids.

The rapid Friedel-Crafts chromogenic acylation of alkene groups at ambient temperatures using a 25:1 mixture of 98% acetyl chloride and 70% perchloric acid is shown to have all the properties needed to serve as a potential quality control reagent that can be used to routinely discriminate among steroid analogs. Although ostensibly a non-selective reagent, from these and prior applications in terpenes and polyunsaturated acid esters, it is seen that the reaction is capable of discriminating bewteen geometric isomers and even enantiomers. The selectivity towards acylation of the alpha- over the beta-position at C-17 makes the method adaptable to screening for anabolic steroids. Reactions at that position produce the more unusual results, including a positive color reaction for alpha-methyltestosterone even though there is no alkene functional group in the vicinity of C-17. For molecules with more than one alkene, concurrent acylations are independent one from the other and, in the absence of any interferences, their spectral properties are found to be additive.

Acylation↗