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PubMed2000

Evaluation of LabRespond, a new automated validation system for clinical laboratory test results.

BACKGROUND: Manual validation of laboratory test results is time-consuming, creating a demand for expert systems to automate this process. We have started to set up the program "LabRespond", which covers five validation levels: administrative, technical, sample, patient, and clinical validation. We present the evaluation of a prototype of an automated patient validation system based on statistical methods, in contrast to the commercially available program "VALAB", a rule-based automated validation system. METHODS: In the present study, 163 willfully altered, erroneous test results out of 5421 were submitted for validation to LabRespond, VALAB, and to a group of clinical chemists (n = 9) who validated these test results manually. The test results rejected by three or more clinical chemists (n = 281) served as a secondary reference standard. RESULTS: The error recovery rates of clinical chemists ranged from 23.9% to 71.2%. The recovery rates of LabRespond and VALAB were 77.9% and 71.8%, respectively (difference not significant). The false-positive rates were 82.7% for LabRespond, 83.6% for VALAB, and 27.8-86.7% for clinical chemists. Using the consensus of three or more clinical chemists as the secondary reference standard, we found error recovery rates of 64.8% for LabRespond and 72.2% for VALAB (P = 0.06). Compared with VALAB, LabRespond detected more (P = 0.003) erroneous test results of the type that were changed from abnormal to normal. CONCLUSIONS: The statistical plausibility check used by LabRespond offers a promising automated validation method with a higher error recovery rate than the clinical chemists participating in this study, and a performance comparable to VALAB.

Clinical Laboratory Techniques↗

PubMed1999

Automated Processing of 2-D Gel Electrophoretograms of Genomic DNA for Hunting Pathogenic DNA Molecular Changes.

We have developed the automated processing algorithms for 2-dimensional (2-D) electrophoretograms of genomic DNA based on RLGS (Restriction Landmark Genomic Scanning) method, which scans the restriction enzyme recognition sites as the landmark and maps them onto a 2-D electrophoresis gel. Our powerful processing algorithms realize the automated spot recognition from RLGS electrophoretograms and the automated comparison of a huge number of such images. In the final stage of the automated processing, a master spot pattern, on which all the spots in the RLGS images are mapped at once, can be obtained. The spot pattern variations which seemed to be specific to the pathogenic DNA molecular changes can be easily detected by simply looking over the master spot pattern. When we applied our algorithms to the analysis of 33 RLGS images derived from human colon tissues, we successfully detected several colon tumor specific spot pattern changes.

Journal Article↗

PubMed2000

Understanding the financial impact of covering new screening technologies. The case of automated Pap smears.

OBJECTIVE: To develop a decision tool facilitating understanding of the potential financial impact on managed care plans associated with automated primary screening for Pap smears. STUDY DESIGN: A baseline decision analytic model was developed with claims data from two managed care plans to replicate the treatment costs patients accrue subsequent to receiving a routine Pap smear with initial human review. Probabilities that a patient was at a particular decision point, as well as payments associated with that patient, were also determined empirically from the claims data. Clinical trial results for the AutoPap System (TriPath Imaging, Inc., Burlington, North Carolina) were incorporated into the model to develop an alternate scenario with 15% fewer false positives and 32% fewer false negatives. Sensitivity analyses were performed to model likely "real world" variation in laboratory results and treatment costs. Marginal costs associated with automated screening were calculated. Financial impacts were calculated in per member per month (PMPM) terms and included an incremental $20 payment for automated primary screening. Given that total PMPMs associated with health care delivery vary widely across the U.S., incremental impacts were also calculated from baseline PMPMs ranging from $80 to $160. RESULTS: PMPMs increased 5-10 cents, depending on baseline PMPM, test performance and treatment costs. CONCLUSION: Although costs rose with automated Pap smears, the costs shifted to the diagnosis and treatment of true positives.

Adolescent↗

PubMed2000

The automation of coding.

Automated coding is a rapidly growing technology. The implications of this technology for the clinical, business, and research areas of health care today are dramatic. Before a health care organization chooses an automated coding system it is important that the implications of each of the various types as well as the vocabulary to be chosen are understood. This article will discuss three types of automated coding systems that are currently available, but it will not discuss the merits of the various vocabularies available for use in an automated coding system.

Abstracting and Indexing↗

PubMed2001

Automated stereotactic standardization of brain SPECT receptor data using single-photon transmission images.

UNLABELLED: Intra- or intersubject registration of anatomically poorly defined SPECT data, such as in neuroreceptor imaging, is important for longitudinal or group analysis. However, accurate registration is difficult with only emission CT (ECT) data. We investigated fully automated registration using transmission CT (TCT) data as an intermediary image set. METHODS: The accuracy of TCT registration was compared to that of ECT registration for four types of data: gray-matter distribution (with [99mTc]ethylcysteinate dimer (ECD)), neocortical distribution (with [123I]R91150, a highly specific 5-HT2a receptor ligand), and striatal distribution of the D2-receptor ligand (with [123I]iodobenzamide (IBZM)) and the dopamine transporter ligand (with [123I]2beta-carbomethoxy-3beta-(4-fluorophenyl)tropane (CIT)). In total, 10 datasets of the various study types were used, all collected on a Toshiba GCA9300 gamma camera with super-high-resolution fanbeam collimators and 3 x 370 MBq of 153Gd transmission sources (4-min sequential TCT scanning for receptor studies and 20-min simultaneous scanning for [99mTc]ECD studies). Per dataset, 15 random misalignments of 9 rigid-body parameters (translation, rotation, and anisotropic scaling) were conducted. All coregistrations were done twice, both to the subject's original scan and to a study-specific template. This was done manually by two independent experienced observers and with three automated voxel similarity algorithms: mutual information (M.I.), count difference (C.D.), and uniformity index (U.I.). As an outcome measure, the impact of misregistration on semiquantification for the various study types was established. RESULTS: TCT matching allowed registration within 3.3 mm, 2.4 degrees, and 1.2% scaling (mean squared values for all directions) with an overall accuracy decrease in the following order: C.D. > M.I. > manual > U.I. For [99mTc]ECD and [123I]IBZM, TCT registration was as accurate as ECT registration, while it was far superior for the other receptor data types, especially for abnormal studies. The automated TCT registration accuracy corresponded to average quantification errors of 2.9% ([99mTc]ECD), 4.2% ([123I]BZM), 5.7% ([123I]R91150), and 6.1% ([123I]beta-CIT). CONCLUSION: Fully automated registration through intermediary TCT images is clinically feasible, fast, and accurate. In addition to nonuniform attenuation correction, TCT scanning therefore allows coregistration for group comparisons of SPECT receptor data on a standardized or pixel-by-pixel basis.

Adolescent↗

PubMed2001

[Percutaneous renal biopsy with a semi-automate device].

BACKGROUND: The percutaneous renal biopsy is a fundamental investigation in the diagnostic procedure for renal diseases. The introduction of the kidney localisation by real-time ultrasounds made the procedure more effective and safe. The use of semi-automated and automated biopsy devices seems to go in the same way. METHODS: In this paper a retrospective investigation is made on 118 renal biopsies performed at our Nephrology Unit from 1990 to 1999 with the semi-automated device Biopty Bard and with direct ultrasounds guidance. The number of post-biopsy complications have been evaluated. RESULTS: Any major complications (as surgical interventions and deaths) have been observed. The number of minor complications was low and in agreement with the literature data (post-biopsy macrohematuria = 6.8%, hemoglobin loss =/>20% = 0.8%, hematoma = 5.1%, lumbar pain 0.8%). The 98.4% of renal biopsies were diagnostic and 91.4% had a number of glomeruli =/>5. CONCLUSIONS: The automated ultrasound-guided procedure is a feasible and reliable technique for percutaneous renal biopsy. It gives a greater yield of diagnostic tissue without increasing the rate of clinical complications, even in Nephrology Units, such as ours, that perform a small number of biopsies every years.

Adolescent↗

PubMed2002

Validation of an automated method for assessing brachial artery endothelial dysfunction.

BACKGROUND: Endothelial dysfunction is an early finding in diverse vascular diseases and can be measured noninvasively using brachial ultrasound. There is great interest in the potential use of this parameter for assessing interventions or cardiovascular prognosis. Automated image analysis of the ultrasound images would facilitate implementation of such measurements in high throughput clinics and/or large clinical trials. OBJECTIVES: To compare a new method designed to assess brachial artery diameter and percentage diameter changes through automated, beat-by-beat image processing (Brachial Tools, Medical Imaging Applications, USA), with a nonautomated method (Prosound System, Jet Propulsion Laboratory, USA). PATIENTS AND METHODS: Brachial ultrasound tapes from 12 patients undergoing endothelial function assessment using forearm cuff-occlusion, measurement of flow-mediated dilation and responses to nitroglycerin were analyzed by both methods. RESULTS: The correlation between the two systems was excellent for both the measurement of absolute diameters (r=0.995, P<0.001) and percentage diameter changes (r=0.973, P<0.001). The automated method demonstrated no bias compared with the frame-by-frame method and excellent precision (0.07 mm and 1.62 percentage diameter change). CONCLUSIONS: The automated method provides valid data while substantially diminishing analysis time.

Adult↗

PubMed2002

Evaluation of two automated methods for measurement of the ristocetin cofactor activity of von Willebrand factor.

We have evaluated two automated methods for measuring ristocetin cofactor activity (VWF:RCo) on an automated coagulation analyzer (STAR, Diagnostica Stago Inc., Parsippany, NJ). A modification of the BC von Willebrand Reagent method (Dade Behring Inc., Newark, Delaware) was compared with a standard method using a platelet aggregometer, and an in-house automated method was developed using commercially available components. The STAR measures the change in optical density (OD) caused by agglutination of platelets. Change in OD was linear for plasma dilutions between .25 and .04 U/mL. Coefficient of variation compared favorably with that of the standard method. In 123 normal women, the correlation coefficient (r) = .905. In menorrhagia cases, r = .901. In 20 VWD patients, r = .93. The CDC in-house method was compared to the BC Reagent method in 79 additional menorrhagia cases, with r = .94. The automated methods produced results equivalent or superior to those of traditional methods of measuring VWF:RCo.

Electronic Data Processing↗

PubMed2002

Using the automated biopsy gun with real-time ultrasound for native renal biopsy.

BACKGROUND: The use of an automated biopsy system for renal biopsy has recently gained popularity, but its safety in single functioning kidneys is unclear. OBJECTIVE: To report our experience with the automated system for closed renal biopsy during a 5 year period. METHODS: Eighty-five patients underwent percutaneous native renal biopsy with the automated biopsy gun (16G needle) under real-time ultrasound. They were chronologically divided into two groups: 41 patients (group A), using an older ultrasound machine; and 44 patients (group B), using a newer ultrasound machine. Nine patients biopsied with a manual 14G Tru-cut needle served as the control (group C). RESULTS: The number of "attempted" passes at the kidney was 4.0 +/- 0.1 in group B, 4.7 +/- 0.3 in group A (P < 0.05 vs. group B), and 5.8 +/- 0.5 in group C (P < 0.01 vs. group B). The number of successful passes did not differ (3.3 +/- 0.1, 3.3 +/- 0.1, 3.1 +/- 0.2). The ratio of "attempted/successful" was 1.28 +/- 0.07 in group B, 1.95 +/- 0.38 in A, and 1.90 +/- 0.21 in C (P < 0.01 vs. B). The number of glomeruli obtained was similar in the three groups. Adequate tissue was obtained in 95%, 98%, and 100%, respectively. Hemoglobin decreased by 4.3 +/- 1.1% in group B, 6.9 +/- 1.3% in group A, and 11.3 +/- 1.8% in group C (P < 0.05 vs. B). Perinephric/subcapsular hematoma occurred in 5 patients (11.4%) in group A (2 taking aspirin), in 2 patients (4.9%) in group B, and in none in group C. The necessity for blood transfusion post-biopsy was similar in all groups. Four of five patients with single functioning kidneys (one in group A and four in group B) had uneventful biopsies, and adequate tissue was obtained in three. CONCLUSIONS: The use of the automated biopsy gun is effective, safe and has a low rate of major complications. It may be used safely in single functioning kidneys.

Adolescent↗

PubMed1975

Automated method for the determination of niacin and niacinamide in cereal products: collaborative study.

In a collaborative study, an automated method for the determination of niacin and niacinamide in cereal products was compared with the official final action microbiological (43.121-43.125) and chemical (43.044-43.046) methods. Ten samples of cereal products, including enriched flour, yeast-leavened baked products, fortified breakfast cereals, and baked pet food products, were submitted to 14 laboratories. Nine laboratories reported values by the automated method, 6 reported values by the microbiological method, and 7 reported values by the chemical method. The results from the microbiological method were not subjected to analysis of variance because of the unusually large between-laboratory variation. The between-laboratory coefficients of variation for the automated and chemical methods were 10.90 and 10.18%, on the basis of results from 7 and 4 laboratories, respectively. There was no significant (p greater than 0.05) difference between methods when results from the 4 laboratories who used both methods were compared. The automated chemical method has been adopted as official first action.

Autoanalysis↗

PubMed2003

A rapid method for manual or automated purification of fluorescently labeled nucleic acids for sequencing, genotyping, and microarrays.

Fluorescent dyes provide specific, sensitive, and multiplexed detection of nucleic acids. To maximize sensitivity, fluorescently labeled reaction products (e.g., cycle sequencing or primer extension products) must be purified away from residual dye-labeled precursors. Successful high-throughput analyses require that this purification be reliable, rapid, and amenable to automation. Common methods for purifying reaction products involve several steps and require processes that are not easily automated. Prolinx, Inc. has devel oped RapXtract superparamagnetic separation technology affording rapid and easy-to-perform methods that yield high-quality product and are easily automated. The technology uses superparamagnetic particles that specifically remove unincorporated dye-labeled precursors. These particles are efficiently pelleted in the presence of a magnetic field, making them ideal for purification because of the rapid separations that they allow. RapXtract-purified sequencing reactions yield data with good signal and high Phred quality scores, and they work with various sequencing dye chemistries, including BigDye and near-infrared fluorescence IRDyes. RapXtract technology can also be used to purify dye primer sequencing reactions, primer extension reactions for genotyping analysis, and nucleic acid labeling reactions for microarray hybridization. The ease of use and versatility of RapXtract technology makes it a good choice for manual or automated purification of fluorescently labeled nucleic acids.

Base Sequence↗

PubMed1992

A flexible automated data acquisition system for ophthalmic electrophysiology.

An automated system for performing VER, ERG and EOG measurements has been developed and is now in clinical use. Considerable effort has been made to retain the flexibility of non-automated systems while providing an easily followed procedure for standard tests which can be undertaken by staff with minimal training. Clinical experience has shown that the standard parameters for data acquisition which are optimal for normal subjects are not always suitable for patients who are uncooperative or have poor vision. These parameters are under software control and can be amended interactively if necessary. The five main functions of the software, namely data acquisition, data selection and commentary, report generation, patient database operation and waveform archiving are written as separate modules and called as required. During data acquisition the software rejects gross artefacts and in the case of EOG's warns of patient non-cooperation. After an ERG or VER has been acquired the operator identifies features in the waveforms and the computer measures them whereas for EOG's the measurement process has been automated. When the waveforms are subsequently reviewed by the operator they are presented in a logical sequence, a sequence which does not depend on the order in which they were acquired, and this sequence is maintained when they are printed out later in the completely automated report phase.

Adult↗

PubMed2004

[Comparison of sonographically guided vacuum-assisted and automated core-needle breast biopsy methods].

PURPOSE: To compare the diagnostic accuracy and complication rates of sonographically guided vacuum-assisted and automated core-needle breast biopsy methods. MATERIALS AND METHODS: Sonographically guided biopsy was performed in 125 solid breast lesions found at mammography and observed at ultrasonography. Vacuum-assisted biopsy was performed in 61 lesions, while automated core-needle biopsy was performed in 64 lesions. The lesions with a benign histological diagnosis were followed radiologically. Those lesions with a histological diagnosis of malignancy or atypical ductal hyperplasia underwent surgical treatment. RESULTS: In the vacuum-assisted biopsy group, 62.3% of the lesions were totally removed. Four lesions in vacuum-assisted biopsy group and two lesions in the automated core-needle biopsy group were diagnosed as atypical ductal hyperplasia histologically. Of the 4 BI-RADS category lesions, three lesions from each group were noted to be malignant. Histological results were not significantly different between the two groups (p>0.05). In both groups, lesions diagnosed as atypical ductal hyperplasia or malignancy showed no difference in the histological diagnosis after excisional biopsy. Complication rates were not significantly different between the two biopsy methods (p>0.05). CONCLUSION: No significant difference was found between sonographically guided vacuum-assisted and automated core-needle breast biopsy methods in terms of diagnostic accuracy and complication rates. However, vacuum-assisted biopsy can be preferred for total removal of the benign lesions.

Adult↗

PubMed2004

Use of an automated hematology analyzer and flow cytometry to assess bone marrow cellularity and differential cell count.

The automated analysis of bone marrow aspirates was performed to estimate the bone marrow cellularity and differential cell count. Total nucleated cell count (TNC) was measured using an automated hematology analyzer. TNC of the bone marrow correlated well with the bone marrow cellularity estimated by microscopic examination (r = 0.590, p <0.001). The bone marrow cellularity was readily confirmed as <30%, from 30 to 70%, or >70% according to TNC. Differential count of bone marrow cells was done with the combination of CD45 monoclonal antibody and propidium iodide using flow cytometry. Excellent correlations were obtained for the population distributions of normoblasts, eosinophils, lymphocytes, and blasts between the results of flow cytometry and manual differential counts. The percentage of mature granulocytes in flow cytometry showed good correlation with the manual percentage of metamyelocytes + neutrophils. The percentage of immature granulocytes by flow cytometry showed good correlation with the manual percentage of blasts + promyelocytes + myelocytes. These results demonstrate that analysis of bone marrow aspirates using an automated hematology analyzer is valuable in the determination of bone marrow cellularity. Moreover, as flow cytometry provides objective findings for percentages of major cell populations, it can serve as a method to automate bone marrow differentials.

Antigens, CD↗

PubMed2004

Automated peak tracking for comprehensive impurity profiling in orthogonal liquid chromatographic separation using mass spectrometric detection.

The presence and quantity of impurities in pharmaceutical drugs can have a significant impact on their quality and safety. With the continuous pressure for increased industry productivity, there is urgent need for a systematic and comprehensive drug impurity profiling strategy. We report here our development of the fully automated Comprehensive Orthogonal Method Evaluation Technology (COMET) system. The system includes five columns, seven orthogonal HPLC methods, and hyphenated UV-MS detections, which provides automated generic impurities screening for any drug sample. An automated MS peak tracking approach by program-based mass spectral interpretation is devised to unambiguously track impurities among all orthogonal HPLC methods. The program passes electro-spray ionization mass spectra (ESI-MS) through four sequential decision-making mass ion tests and determines molecular weights for every peak. The system reduces the time required to obtain impurity profile from weeks to days, while the automated MS peak tracking takes only minutes to interpret all MS spectral data of interest. Up-to-date, impurity contents of 56 in-development drug candidate samples have all been successfully illustrated by COMET, which contained more than 500 chemical entities. The program is able to track more than 80% of the compounds automatically with majority of the failure due to insufficient ionization for some impurities by ESI. This system is well suited for efficient drug development and ensuring the quality and safety of drug products.

Algorithms↗

PubMed2005

Pupil examination: validity and clinical utility of an automated pupillometer.

Pupillary size and reactivity have long been a critical component of the clinical assessment of patients with neurological disorders. The pupillary examination may provide critical information related to new or worsening intracranial pathology and facilitate prompt intervention to minimize further neuronal damage. With this in mind, intensive care nurses caring for neurologically impaired patients frequently must perform pupillary examinations in concert with assigning a Glasgow Coma Scale score. The purpose of this study was to test the accuracy and reliability of an automated pupillometer compared with the standard manual examination as a preliminary step in assessing the usefulness of automated pupillometry in the critical care setting. Twenty patients in the intensive care units of a teaching hospital were examined by two groups of three examiners using both the manual examination with a penlight or similar light source and a portable automated pupillometer capable of measuring pupil size and reaction. Measurements by a static pupillometer before and after each pupillary examination were used to determine the mean "true" size of the pupil. This study found that the automated pupillometer is more accurate and reliable than the manual examination in measuring pupil size and reactivity. For these reasons, such a device may be a beneficial addition in the clinical assessment of neurologically impaired patients.

Adolescent↗

PubMedDate not supplied

Automated method for generating the arterial input function on perfusion-weighted MR imaging: validation in patients with stroke.

BACKGROUND AND PURPOSE: The choice of arterial input function (AIF) can have a profound effect on the blood flow maps generated on perfusion-weighted MR imaging (PWI). Automation of this process could substantially reduce operator dependency, increase consistency, and accelerate PWI analysis. We created an automated AIF identification program (auto-AIF) and validated its performance against conventional manual methods. METHODS: We compared the auto-AIF against manually derived AIFs from multisection PWIs of 22 patients with stroke. Time to peak, curve width, curve height, and voxel location determined with both techniques were compared. The time to maximum of the tissue residue function (Tmax) and cerebral blood flow (CBF) were computed on a per-pixel basis for each AIF. Spatial patterns of 528 map pairs were compared by computing Pearson correlation coefficients between maps generated with each method. RESULTS: All auto-AIF-derived PWI map parameters, including bolus peak, width, and height, were consistently superior to manually derived ones. Reproducibility of the auto-AIF-based Tmax maps was excellent (r = 1.0). Paired Tmax maps and CBF maps from both techniques were well correlated (r = 0.82). Time to identify the AIF was significantly shorter with the auto-AIF method than with the manual technique (mean difference, 72 seconds; 95% confidence interval: 54, 89 seconds). CONCLUSION: An automated program that identifies the AIF is feasible and can create reliably reproducible and accurate Tmax and CBF maps. Automation of this process could reduce PWI analysis time and increase consistency and may allow for more effective use of PWI in the evaluation of acute stroke.

Adult↗

PubMed2006

Cholesterol crystals causing falsely elevated automated cell count.

This is a report of 3 cases of body fluid containing numerous cholesterol crystals that caused falsely elevated cell counts on an automated cell counter. Two of the cases were pleural effusion fluid from patients with long-standing rheumatoid arthritis. Fluid in the third case was from upper extremity cystic lesions of a patient with squamous cell carcinoma of the head and neck. Microscopic examination revealed abundant cholesterol crystals in all fluid samples. In all 3 cases, initially, the automated cell counter reported very elevated WBC and RBC counts that were much higher than those from the manual count. This interference by cholesterol in the automated cell counter is discussed. In addition, possible pathophysiology of cholesterol formation in the body fluid is discussed and chylous and pseudochylous (chyliform) effusions are reviewed. Finally, the use of automated instruments in the evaluation of body fluid is reviewed.

Aged↗