Automated urine screening devices make urine sediment microscopy in diagnostic laboratories economically viable.

Automated urinalysis devices are reproducible, accurate and faster than the standard manual microscopy. Economic analysis has shown that decreases in turn-around-time and labour cost savings offered by these devices make them more economic than manual microscopy.

[Assessment of the capability of the fluid model of automatic blood cell analyzer in white blood cell count and classification].

OBJECTIVE: To evaluate the application of XT-4000i automatic blood cell analyzer in white cell count and classification of cerebrospinal fluid (CSF). METHODS: The fluid model of XT-4000i automatic blood cell analyzer was directly used to detect the white cell count and classification in 200 samples of CSF, and compared with the results obtained by manually microscopic counting method. White blood cell classification was performed by manual method under microscope with Wright's staining,and instrumental method with fluorescence staining and flow cytometry. RESULTS: There is no statistical difference between instrumental and manual method in detecting the absolute counting of WBC, RBC, mononuclear cell and multinucleate cells (P>0.05), and there is a good correlation between the two methods (r=0.987, 0.999, 0.981 and 0.983 for WBC, RBC, mononuclear cell and multinucleate cell counts). Tumor cells in the samples with high fluorescent staining by instrumental method can be identified with Wright's staining by microscope method, which were consistent with the clinical diagnosis. CONCLUSION: The fluid model of XT-4000i automatic blood cell analyzer was rapid and accurate in CSF white cell count and classification,and it also can provide preliminary information for tumor cells screening. The fluid model of XT-4000i automatic blood cell analyzer in white cell count and classification of CSF has the value of popularization in clinical application.

Validation of the Beckman Coulter AcT 5 diff analyzer in a reference laboratory.

At the Valle de Hebron Hospital's Central Laboratory, we have performed a study evaluating the performance, reliability, and practicability of the Beckman Coulter AcT 5 analyzer. The results observed with known controls showed within- and between-run imprecision of 1.05% to 6.97% for the basic hemogram parameters. With patient samples, the results were analogous, with within- and between-run imprecision of 1.33% to 5.98%. To complete the evaluation of the AcT 5 counter, we analyzed the influence of possible interfering factors such as the presence of jaundice, lipemia, hemolysis, platelet aggregates, and schistocytes on the results of the automated leukocyte differential as performed by the cell counter with the new chlorazol black stain. We studied the performance of the AcT 5 with regards to ease of use, speed, and cost. Finally, we evaluated the impact of introducing the AcT 5 counter into routine laboratory use as support to resolve problems raised with the Beckman Coulter GenS and LH-750 and the Bayer Advia 120 counters due to samples with interfering factors.

Use of a centrifuge-based automated blood cell counter for radiation dose assessment.

Hematological changes create early-response biomarkers for assessing radiation doses. Existing dose-prediction models are based on serial blood lymphocyte counts after acute whole-body exposure to gamma-radiation. Measurements of lymphocyte-depletion kinetics after possible exposures are useful for triaging patients and managing medical resources. The small-footprint QBC Autoread Plus System provides cost-effective hematological analyses with reproducibility, accuracy, and a broad dynamic range. QBC analysis measures centrifugally packed, whole blood cells in microhematocrit tubes and reports pooled lymphocyte and monocyte counts. Our objective was to modify this procedure to report pure lymphocyte counts for radiation biodosimetry applications. The CD14 antigen is strongly expressed on most human monocytes. Using anti-CD14-coated Dynabeads, we have devised a rapid method for depleting monocytes from whole blood without altering the lymphocyte viability or count. This simple dry procedure provides reliable lymphocyte counts for results that fall within the normal lymphocyte count range (1-4 x 10(9) cells per L) for radiation exposure assessment using lymphocyte-depletion kinetics.

A model for consolidation of clinical microbiology laboratory services within a multihospital health-care system.

To determine the cost-effectiveness of consolidating clinical microbiology services in a three-hospital health-care network while maintaining high-quality laboratory services, a retrospective review of the total costs of maintaining separate clinical microbiology laboratories within our health-care system was compared to the cost of providing these services after consolidation. Turnaround times before and after consolidation were compared to assess efficiency of the consolidated services. Input of clinicians was also solicited to ensure that quality of services and customer satisfaction remained high. The results of the consolidation project show that the net fiscal saving because of consolidation of clinical microbiology services within our health-care system will be approximately 100,000 dollars per fiscal year. This value includes increased courier charges as well as personnel savings. Although fiscal savings are an integral part of any laboratory consolidation plan, the financial considerations must be balanced by quality of service. The response to consolidation from clinicians was decidedly mixed before implementation of the plan because of fear of increased turnaround times and limited access to laboratory information. The consolidation process, however, was smooth with few physician complaints. The consolidation of our clinical microbiology services illustrates that significant financial savings can be achieved without compromise of efficiency or quality of service.

Flow cytometric validation of automated differentials in pediatric patients.

Manual differential white blood cell (WBC) counting has been considered the gold standard and is routinely used to validate differentials obtained with other methodologies. To validate the accuracy of automated lymphocyte counts, we compared 2-part differentials using a Coulter HmX hematology analyzer and a Coulter XL flow cytometer to analyze 57 pediatric samples with WBC counts ranging from 0.7 k to 33.4 k. These data were compared with manual differential counts. We found excellent correlation between the two automated lymphocyte and monocyte counting methods that surpassed the manual correlations, indicating manual lymphocyte or monocyte counts are unnecessary in the setting of quality scatterplots. To evaluate the use of automated differentials for our most labor-intensive cases (low WBCs, which frequently require manual differentials) we then compared 3-part differentials using the HmX hematology analyzer and flow cytometer for 51 samples with total WBC < or = 1.1 x 10(9)/L. Manual differentials (< or = 100-cell counts) were available on 27 samples. Although the correlations for manual versus automated or flow differentials were good for all cell types, the correlation between the two automated methods was better, irrespective of the hematology analyzer scatterplot quality. Preliminary data provide additional evidence that automated differentials in samples with WBC of < or = 1.1 x 10(9)/L are acceptable for reporting, thus saving technologist time and improving patient care by decreasing the resulting turnaround time. These studies suggest that comparison with a standardized procedure like flow cytometry would be a better method for validation of automated differentials than comparison with the less precise, more laborious manual differential.

Experience with an external quality assessment programme for point-of-care-testing (POCT) devices for the determination of blood glucose.

This article describes the preparation and internal and external evaluation of materials, critical issues in the external quality assessment (EQA) of point-of-care testing (POCT) devices for measuring blood glucose. A comparison was made between different materials, both of natural and synthetic origin and with and without stabilisers. The aims were to produce a material which was compatible with as many POCT-devices as possible and so reduce the number of materials sent out in each campaign as well as to optimise the precision and comparability of results between methods and devices. Although the use of near natural material--sterile-filtered plasma spiked with glucose--survived internal testing, this material proved to be unsuitable for EQA surveys. The study resulted in the reduction of materials for each survey to stabilised whole blood for one device, stabilised plasma for two devices and a synthetic material based on a polyethylene glycol matrix for all other devices. Samples were sent as pairs six times annually. The POCT-devices tested measured precisely but inaccurately in the synthetic material, when compared with the reference method (gas-chromatography coupled with isotope-dilution mass-spectrometry; GC-IDMS), so that the devices could only be evaluated for precision. The construction of ratios between the concentrations measured on the two samples distributed allowed an indirect assessment of accuracy. The need for surveillance of POCT devices is stressed in this publication, which combines theory and practice in setting up and running an EQA programme for blood glucose.

Comparison of blood gas and electrolyte test results from the Gem-Premier and the ABL-70 versus a conventional laboratory analyzer.

Blood gas analyzers serve a critical role in providing information that reflects patient homeostasis. This study was undertaken to evaluate the accuracy, reliability, consistency, and bias of the Radiometer ABL-70 point of care blood gas analyzer. Thirty samples were gathered for analysis of pH, pCO2, pO2, sodium, potassium, sodium bicarbonate, and base excess. Twenty-nine samples were gathered for hematocrit, 31 for ionized calcium, and 33 for venous pO2 and saturations. The data were compared with the Gem-Premier point of care analyzer and the hospital blood gas machine and electrolyte analyzer. There was statistical significance between the pH, pCO2, sodium, potassium, calcium, hematocrit, and venous pO2 and saturations when comparing the ABL-70 with the Gem-Premier. When comparing the ABL-70 with the Corning 278/270 blood gas machine/Co-Ox, the AVL-9180, and the Dimension XL, there was statistical significance seen between the pH, pCO2, pO2, sodium, calcium, hematocrit, and base excess. Although this statistical significance was observed between the ABL-70 and the other analyzers, the significance was not of clinical importance. The ABL-70 demonstrated acceptable accuracy, reliability, consistency, and bias.

Comparison of three methods for measuring PEG-hirudin in blood.

Three methods for measuring pegylated hirudin (PEG-hirudin), a new antithrombotic agent, in blood were compared using clinical samples. The ecarin clotting time (ECT) was performed in whole blood using a point-of-care device (TAS analyzer). The ECT was also performed in plasma, using a clotting assay in a conventional automated coagulation analyzer. Finally, a chromogenic method was used, based on thrombin inhibition and the substrate S-2238. Both clotting assays showed a linear relationship between the ECT and the PEG-hirudin concentration up to 3.0 microg/ml. The chromogenic substrate method was linear only between 0.1 and 1.0 microg/ml PEG-hirudin. The intra-assay coefficient of variation was 3.0% for the automated ECT method, 6.4% for the point-of-care ECT method and 3.4% for the chromogenic method. The inter-assay coefficient of variation was approximately 10% for both clotting methods and 3.2% for the chromogenic method. There was a high correlation (r = 0.954) in PEG-hirudin concentration between both ECT methods over the entire measuring range. The correlation of the chromogenic method with any ECT was significantly less (r < 0.89), even if only PEG-hirudin concentrations < 1.0 microg/ml were taken into account (r < 0.92). Although we clearly prefer the conventional ECT, any of the other methods may be used for monitoring PEG-hirudin in patients treated with this drug, depending on the specific application and local circumstances.

Selection and implementation for coagulation instruments/reagents in a multiple hospital/clinic network.

Selection, standardization, and implementation of instrumentation and reagents throughout a health care facility network can often be a difficult process. However, in today's ever-changing health care setting, it is often mandated. The Veteran's Integrated Systems Network 16 (VISN 16) was faced with such a task early in 1999, with the targeted area being its coagulation laboratories. The plan outlined in this paper was drafted to help facilitate the selection, standardization and implementation of coagulation systems for 17 health care facilities that make up the VISN 16 network. The VISN, encompassing 170,000 square miles, has 10 tertiary care hospitals, six of which have close relationships with affiliate universities. There are 299,733 patients enrolled in this health delivery system. The facilities range from large institutions performing both tertiary and outpatient care to small outpatient clinics. Because of the plan's detailed, comprehensive content, which included analyses of a large number of performance parameters as well as cost-efficiency, the selection process was carried out using a checklist that could be helpful to other organizations selecting equipment and reagents for coagulation studies. An implementation process was devised, resulting in coagulation standardization across the Integrated Health Network.

Evaluation of Sysmex UF-100 urine flow cytometer vs chamber counting of supravitally stained specimens and conventional bacterial cultures.

We evaluated the Sysmex UF-100 urine flow cytometer (TOA Medical Electronics, Kobe, Japan) with 269 uncentrifuged urine specimens by comparing it with Sternheimer staining and particle counting in 1-microL disposable chambers with both brightfield and phase-contrast microscopy (the reference method). Results of routine test strip analysis, sediment microscopy (182 specimens), and bacterial culture (204 specimens) were also available. Detection of urinary WBCs and RBCs was highly reliable with the UF-100 compared with manual chamber counting (r = .98 and .88, respectively). Identification of bacteria was equal to that with visual microscopy of uncentrifuged specimens; sensitivity was 55%, and specificity 90%, compared with bacterial cultures at a cutoff of > 10(3) colony-forming units per milliliter. Renal damage was difficult to evaluate even with manual methods because of the low counts of renal tubular cells and casts; with standard manual Sternheimer-stained sediment analysis, sensitivity was 65% to 69% and specificity 66% to 91%, compared with the uncentrifuged chamber method at a cutoff of 3 and 10 particles per microliter, respectively. Renal damage was demonstrated with the UF-100 with a sensitivity of 26% to 69% and specificity 92% to 94%, compared with chamber counts. Automated urinalysis with the UF-100 urine flow cytometer offers considerable savings in time and labor. When high sensitivity is needed, visual microscopic review should be performed to detect renal disease.

Evaluation of the Vega haematology analyser in a university hospital setting.

The performance of the ABX Vega haematology analyser was compared with that of the Sysmex NE-8000, with specific attention to flagging performance and ergonomics. Eight hundred routine samples underwent precision and interinstrument variability studies and 168 samples corresponding to various blood disorders were studied meanwhile. Results from the two instruments gave excellent correlation (r > 0.900) for most parameters except MCHC (r = 0.114), basophil and monocyte percentages (r = 0.617 and 0.552, respectively). The reproducibility, repeatability, linearity, carry-over and stability of the Vega were satisfactory; 'flagging' occurred in 31% of routine samples with sensitivity 88.8%, specificity 41.3% and positive predictive value 85.7%. Various flags appeared in 91% (42/46) of cases where blast cells were microscopically identified. In the four remaining cases, CBC anomalies would themselves have justified microscopic examination of a smear. On 'CBC only' mode reagent consumption was significantly reduced. In the laboratory the analyser was best appreciated for its user-friendliness.

Optimizing frequency and number of controls for automatic multichannel analyzers.

Sampling strategy fundamentally influences the effectiveness of quality control with control charts. This study shows a simple approach for optimizing the control strategy for automatic multichannel analyzers that takes into account cost-efficiency considerations. Our main focus is on the frequency of controls necessary. The methods used are based on a field study (on a Hitachi/BM 747), the views of experts, and computer simulations of customary cost-models together with a survey of the literature. We found that industrial cost-models are applicable only with distinct limitations, but-unlike the test-yield model-they offer consistent solutions. On the basis of the field study and the opinions of experts, we adjusted the control strategy to account for inadequacies in the theoretical models. The combined result is that, for effective operation, the number of samples between controls may reach values up to 100 and should not require controls more often than every 30 samples on comparable multichannel analyzers. For adequate statistical performance, a simple 3-SD Shewhart chart usually requires not more than two controls of the same material at each time.

An update on chemistry analyzers.

This update of six chemistry analyzers available to the clinician discusses several points that should be considered prior to the purchase of equipment. General topics include how to best match an instrument to clinic needs and the indirect costs associated with instrument operation. Quality assurance recommendations are discussed and common terms are defined. Specific instrument features, principles of operation, performance, and costs are presented. The information provided offers potential purchasers an objective approach to the evaluation of a chemistry analyzer for the veterinary clinic.