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PubMed1982

[Automation of antibiograms. Effect on the response delay of bacteriologic tests].

The delay between in-coming requests and results of bacteriological examinations was measured in a hospital laboratory before and after automation with an Abbott MS-2 system. Paradoxically, using this apparatus, which performs certain tasks within 6 hours instead of 12, increased the delay, mainly because of the multiple problems associated with automation. On the other hand, the delay was significantly reduced when a rapid micro-organism identification method (Micro ID) was used concomitantly. It is concluded that maximum efficiency could be achieved if bacteriological laboratories combined automated antibiotic susceptibility testing with a rapid germ identification method.

Anti-Bacterial Agents↗
PubMed1999

A simple comparison of mass spectral search results and implications for environmental screening analyses

A simple assessment of the ability of environmental laboratories to perform automated library searching procedures on mass spectra of unknown pollutants was conducted. In this assessment, 10 laboratories analyzed a hexane solution containing eight organic chemicals using gas chromatography/mass spectrometry and searched their acquired mass spectral data against mass spectral reference libraries. The search results were used to evaluate the similarity of the lists of tentative identifications (TIDs) among the laboratories and to compare the observed searching success to the searching success reported in the literature using high-quality mass spectral data. A high degree of similarity was observed among the lists of TIDs reported by the laboratories for each chemical. The searching success observed in this study was slightly lower than that reported in the literature based on higher-quality mass spectral data. This simple comparison suggests that laboratories performing routine environmental analyses can successfully perform automated searching procedures for unknown sample components, and that the mass spectral searching component of analytical methods designed to screen for unknown organic pollutants should be successful, i.e., obtain similar and reproducible results among laboratories.

Journal Article↗
PubMed2005

Proposal of automation of candidate reference method for the accurate serum cholesterol assay in clinical laboratories.

BACKGROUND: In 2001, Japan Society of Clinical Chemistry (JSCC) recommended the cholesterol dehydrogenase (CD)-UV method as a comparative method for serum cholesterol measurement in Japan. Although the CD-UV method is intended to standardize routine laboratory tests, it requires complex manipulations, and has been difficult to use for the evaluation of clinical laboratories. We therefore attempted to automate this method using reagents specified by JSCC and developed a simple automated method. METHODS: We evaluated the simple automated method using 2 general instruments (JCA-BM12 and H-7170S). The linearity was confirmed for the range over 15.52 mmol/l. The coefficients of variation for 20 measurements of serum containing 2.5 and 6.1 mmol/l of cholesterol were < 1.0%, respectively. No interference by bilirubin, ditauro bilirubin, hemoglobin and chylomicrons was observed in this method. When measurement data with JCA-BM12 were compared with those using the comparative method, the correlation coefficient was 0.999 (n=23), the regression formula was y=0.992x - 0.0036 (mmol/l), and the bias was 0.8%. A similar data was obtained with H-7170S. Thus, in both comparisons, the bias was within the target (+/- 3.0%). CONCLUSIONS: This automated method provides a valid means of implementing the serum cholesterol measuring method recommended by JSCC.

Automation↗
PubMed1995

[A system of processing data of clinical microbiology laboratories].

The COBAS BACT automized system (Hoffman la Roche, Switzerland) was used in the practical work of the laboratory of clinical microbiology. The analyzer performed two functions i.e. the identification of gram-negative pathogens of the family Enterobacteriaceae and the rapid assay of their susceptibility to antibacterial drugs. The primary computer processing was embedded in the COBAS BACT machine. An information system providing the automatization of the secondary processing of the results of microbiological tests was developed. It included not only a system of the data bases for storage of the information and accumulation of the statistical data on the assays and their results but also the automized position of the microbiologist providing the possibility of the statistical information accumulation and reading. The CLIPPER program was used as a basis for the system development. The results of the secondary computer processing are illustrated by the actualities of the determination of the etiological factor of postoperative meningitis and septicemia carried out in 1993.

Clinical Laboratory Information Systems↗
PubMed1993

Automated solid-phase extraction of opiates from urine (II). Establishing criteria for the detection of opiate abuse.

Automation in the laboratory was taken one step further with the introduction of automated solid-phase extraction of opiates from urine using C18 bonded-phase columns as an alternative to traditional liquid-liquid partitioning. A comparison of the automated procedure with an established liquid-liquid extraction procedure showed a linear correlation between the two over the concentration range studied. Criteria for the identification of opiate abusers were established to adapt this new methodology to large-scale screening of urine specimens.

Codeine↗
PubMed1980

Clinical laboratory evaluation of the Abbott MS-2 automated antimicrobial susceptibility testing system: report of a collaborative study.

The MS-2 system (Abbott Diagnostics, Division of Abbott Laboratories, Dallas, Tex.) was evaluated for its efficacy in determining the susceptibilities of both clinical and selected challenge (nonfastidious, facultative, and aerobic) isolates. The MS-2 results were compared with standard Kirby-Bauer disk diffusion and microdilution results by using fresh clinical isolates. For gram-positive isolates other than enterococci, overall agreement between MS-2 and reference results was 93 to 98%. With enterococci, MS-2 agreement with disk diffusion was 68% but with microdilution was 86% (agreement between disk diffusion and microdilution was 73%). The main discrepancies with enterococci were with cephalothin, penicillin, gentamicin, and kanamycin. With clinical gram-negative isolates, the overall agreement was 91 to 93%, with most discrepancies occurring with Enterobacter spp. and beta-lactam antibiotics (MS-2 versus disk diffusion, 84%; MS-2 versus microdilution, 84%; disk diffusion versus microdilution, 87%) and with Serratia spp. and colistin (false-susceptible results). The agreement of MS-2 results with established reference antibiograms of a special collection of challenge strains was 91 to 97% for the gram-positive cocci and 86 to 98% for the gram-negative strains. (With Enterobacter spp., agreement was 86%, but was greater than 90% for all other organism groups.) Of the 98 finite MS-2 minimum inhibitory concentrations (MICs) that could be directly compared with microdilution MICs, 77 (79%) were within +/- 1 well of the geometric mean microdilution MIC. MS-2 analysis time ranged from 2.8 to 6.5 h (mean, 4.2 h). On the basis of these results, we conclude that the MS-2 can be expected to yield rapid and accurate results with most nonfastidious, facultative, and aerobic pathogens.

Anti-Bacterial Agents↗
PubMed1996

Evaluation of automated COBAS AMPLICOR PCR system for detection of several infectious agents and its impact on laboratory management.

We evaluated the COBAS AMPLICOR (CA) PCR system (Roche Diagnostic Systems) designed for automated PCR amplification and detection of nucleic acids from infectious agents in clinical samples. The Roche AMPLICOR microwell plate (MWP) PCR was the reference method. CA amplifies target nucleic acid, captures the biotinylated amplification products by using magnetic particles coated with specific oligonucleotide probes, and detects the bound products colorimetrically. For Mycobacterium tuberculosis, the correlation of the results of CA tests with those of MWP tests was 100% with 230 samples, including 20 culture-positive samples. For hepatitis C virus, the correlation was 100% with 214 samples, including 60 positive samples. MultiPlex CA analysis of 199 cervical specimens for Chlamydia trachomatis, Neisseria gonorrhoeae, and the internal control gave 100% concordance. These samples included 19 C. trachomatis and 3 N. gonorrhoeae culture-positive samples. Overall, the agreement between PCR methods for all 842 comparisons was 100%. Compared with culture, the sensitivities of the assays for C. trachomatis and M tuberculosis were > or = 95%. After spiking alternating amplification tubes in the CA system with 10(14) copies of the Chlamydia amplicon per ml, we were unable to demonstrate any carryover cross-contamination of negative samples. Using the criteria of the College of American Pathologists workload recording method, we found that the total hands-on time to produce CA PCR results was 4.4, 7.9, and 3.3 min for M. tuberculosis, hepatis C virus, and the MultiPlexed assay for chlamydia plus gonorrhea and an internal control, respectively. The CA system brings true PCR automation to laboratories. In addition to the accuracy of automated results, the CA system provides labor savings, provides containment of the amplification and detection components of PCR, and supports both MultiPlex amplification and sequential algorithm (ReFlex) detection of analytes.

Automation↗
PubMed1988

Laboratory Information Management Systems--part I. Concepts.

The purpose of this analytical survey is to give a summary of some of the main design features that can be incorporated into a Laboratory Information Management System (LIMS), in the context of the total automation of the laboratory. Additionally it will give potential purchasers of such systems some essential background knowledge and a summary of our experiences. The survey is presented in two parts: the first covers the features and the possible concepts that could be used in a LIMS system. This is followed in the second part by an outline of the stages of acquisition, validation and benefits of such a system. Together the two articles provide the information required to aid the design and installation of a LIMS. This first section deals with the possible features that a laboratory could include when contemplating the installation of such a system: the basic tools that are required for a LIMS, the database and the computer equipment are discussed. This is followed by the interfacing of analytical instruments and central versus distributed processor philosophy. The various screen formats available and the use of bar codes as a means of identifying samples and for rapid data entry into the computer system are discussed.

Journal Article↗
PubMed2003

[Laboratory-based evaluation of a fully automated microbiology system, RAISUS for species-identification and antimicrobial susceptibility tests].

A fully automated microbiology system, RAISUS newly developed (Nissui Pharmaceuticals Co., Ltd., Tokyo) was evaluated for gram-positive and gram-negative clinical isolates. In the species-identification, the RAISUS comparably identified 200 of 202 isolates (99.0%) consisting of 10 species of gram-positive cocci and of 16 species of gram-negative bacilli. When compared to the MicroScan Walk/Away, which resulted in six misidentifications, the RAISUS showed higher accuracy in species-identification. In the evaluation of antimicrobial susceptibility test, the RAISUS gave comparable minimum inhibitory concentrations (MICs) and category interpretations. Of 693 testings for gram-positive and of 721 testings for gram-negative isolates, 655 (94.5%) and 688 (95.4%) testings gave comparable interpretations to the reference microdilution test, respectively. Most identification results were reported within 5-hour incubation by RAISUS, and susceptibility test results were 4 to 7 hour-incubations. With these results obtained through laboratory-based evaluation, it became apparent that the RAISUS has enough accuracy and rapidity to determine species-identification and antimicrobial susceptibility, and is applicable to the routine testing in clinical laboratories.

Bacteriological Techniques↗
PubMed1988

Evaluation of the CellSoft automated semen analysis system in a routine laboratory setting.

The sperm concentration and percentage motility values generated by version 3.2 of the CellSoft (Cryo Resources Ltd., New York, NY) automated semen analyzer on 200 ejaculates were compared with those obtained by standardized traditional methods. Overall, CellSoft gave mean concentrations that were 20.9 x 10(6)/ml lower (95% range of differences = -112.6 to +154.4 x 10(6)/ml). However, the difference between methods was not systematic. Below 50 x 10(6)/ml, CellSoft more often gave higher values, and above 100 x 10(6)/ml, it usually gave lower values. In the middle range, differences were randomly distributed. For motility, the CellSoft values were usually higher than those obtained by visual counting (mean difference = -17.5%, 95% range = -56.0% to +21.0%). Multiple regression analyses revealed a strong concentration dependency such that reliable values will probably be obtained only if all samples are diluted (with homologous seminal plasma) before CellSoft analysis. This upper concentration limit is of the order of 30 to 50 x 10(6)/ml. Without such dilution, this version of CellSoft will not provide sufficiently accurate values for basic semen characteristics and cannot be accepted as a routine diagnostic method.

Humans↗
PubMed2002

Automated production of an on-line laboratory reference manual from a laboratory information system.

Laboratories provide information beyond test results, including information related to patient preparation, specimen collection and handling, test methodology, test availability, and interpretation of results. Most laboratories publish reference manuals to distribute this information to clients, while relying on the laboratory information system to provide this information to laboratory staff. Maintaining duplicate sources of information is expensive and error-prone, and printed materials become rapidly outdated. We developed a process to automate the production of a web-based reference manual directly from the laboratory information system, using a combination of MUMPS programs and HTML templates. We now focus our resources to assure that the laboratory information system database is accurate and complete, and then with minimal additional effort or expense produce an up-to-date on-line reference manual. We are therefore able to provide better sources of information in a sustainable manner.

Clinical Laboratory Information Systems↗
PubMed2005

Automation and validation of DNA-banking systems.

DNA banking is one of the central capabilities on which modern genetic research rests. The DNA-banking system plays an essential role in the flow of genetic data from patients and genetics researchers to the application of genetic research in the clinic. Until relatively recently, large collections of DNA samples were not common in human genetics. Now, collections of hundreds of thousands of samples are common in academic institutions and private companies. Automation of DNA banking can dramatically increase throughput, eliminate manual errors and improve the productivity of genetics research. An increased emphasis on pharmacogenetics and personalized medicine has highlighted the need for genetics laboratories to operate within the principles of a recognized quality system such as good laboratory practice (GLP). Automated systems are suitable for such laboratories but require a level of validation that might be unfamiliar to many genetics researchers. In this article, we use the AstraZeneca automated DNA archive and reformatting system (DART) as a case study of how such a system can be successfully developed and validated within the principles of GLP.

Automation↗
PubMed2002

Practical protocols for stepwise solid-phase synthesis of cysteine-containing peptides.

This study details a series of conditions that may be applied to ensure 'safe' incorporation of cysteine with minimal racemization during automated or manual solid-phase peptide synthesis. Earlier studies from our laboratories [Han et al. (1997) J. Org. Chem. 62, 4307-4312] showed that several common coupling methods, including those exploiting in situ activating agents such as N-[(dimethylamino)-1H-1,2,3-triazolo[4,5-b]pyridin-1-ylmethylene]-N-methylmethanaminium hexafluorophosphate N-oxide (HATU), N-[1H-benzotriazol-1-yl)-(dimethylamino)methylene]-N-methylmethanaminium hexafluorophosphate N-oxide (HBTU), and (benzotriazol-1-yl-N-oxy)tris(dimethylamino)phosphonium hexafluorophosphate (BOP) [all in the presence of N-methylmorpholine (NMM) or N,N-diisopropylethylamine (DIEA) as a tertiary amine base], give rise to unacceptable levels (i.e. 5-33%) of cysteine racemization. As demonstrated on the tripeptide model H-Gly-Cys-Phe-NH(2), and on the nonapeptide dihydrooxytocin, the following methods are recommended: O-pentafluorophenyl (O-Pfp) ester in DMF; O-Pfp ester/1-hydroxybenzotriazole (HOBt) in DMF; N,N'-diisopropylcarbodiimide (DIPCDI)/HOBt in DMF; HBTU/HOBt/2,4,6-trimethylpyridine (TMP) in DMF (preactivation time 3.5-7.0 min in all of these cases); and HBTU/HOBt/TMP in CH(2)Cl(2)/DMF (1:1) with no preactivation. In fact, several of the aforementioned methods are now used routinely in our laboratory during the automated synthesis of analogs of the 58-residue protein bovine pancreatic trypsin inhibitor (BPTI). In addition, several highly hindered bases such as 2,6-dimethylpyridine (lutidine), 2,3,5,6-tetramethylpyridine (TEMP), octahydroacridine (OHA), and 2,6-di-tert-butyl-4-(dimethylamino)pyridine (DB[DMAP]) may be used in place of the usual DIEA or NMM to minimize cysteine racemization even with the in situ coupling protocols.

Chromatography, High Pressure Liquid↗
PubMed1992

Auditing quality control procedures in a chemical pathology laboratory--a multiple regression analysis.

We undertook a retrospective analysis of the monthly test rejection rates and the monthly external quality assessment scheme performance indices for our laboratory's two automated analysers, and examined the association of these variables with measures of laboratory workload, manpower, staff training, instrument servicing, seasonal and temporal factors and changes of calibration, method and assigned internal quality control values. Using multiple linear regression and stepwise multiple linear regression, we found that test rejection rates differed significantly between instruments, and were highest on the instrument performing the widest variety and lowest volume of tests. On that instrument, rejection rates were significantly associated with the introduction of new staff and laboratory manpower levels, and also showed a highly significant trend upwards over the study period, independent of the effects of the other variables examined. External quality assessment scheme performance indices showed small trends over the study period. They were not related to the test rejection rates on either analyser but also showed a significant association with the introduction of new staff and a small but significant association with laboratory workload. We conclude that the training and introduction of new staff and decreased laboratory manpower levels may significantly increase the level of test rejection, and adherence to appropriate quality control protocols effectively maintains the quality of the laboratory's results, but may not be completely successful in filtering out the effects of some assignable causes of variation in test results. It is suggested that clinical laboratories use the statistical approach adopted here to identify factors which may be adversely affecting quality performance and running costs and to provide evidence that quality control procedures are both cost- and quality-effective.

Clinical Laboratory Techniques↗