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.

A new screening method for proteinuria using Erythrosin B and an automated analyzer--rapid, sensitive and inexpensive determination.

BACKGROUND: In spite of the urgent necessity for a screening test of urinary protein for the early diagnosis of kidney diseases, a rapid, accurate and cost-effective method for their detection has yet to be developed. METHODS: A solution containing a buffer agent (pH 2.3) and surfactants and a solution of Erythrosin B are added to a urine sample. After letting the mixture stand for 5 min at 37°C, the dye-bound protein is measured by a spectrophotometer at 546 nm using a Hitachi 7170S automated analyzer. RESULTS: The calibration curve was linear with human serum albumin concentration in the range of 2.4-200 mg/l. The detection limit, 2.4 mg/l was superior to conventional dye-binding methods by one order of magnitude and comparable to the turbidimetric immunoassay (TIA). Spot urine samples from 70 patients who showed (-) or (±) in the dip-stick screening test for proteinuria and 79 healthy volunteers were analyzed. There was an excellent correlation (r=0.978, n=149) between the results given by the proposed method and those by the TIA. CONCLUSIONS: This method provides a viable alternative to the conventional immunoassay-based methods for urinary protein measurement, and will be useful in the diagnosis of early stage kidney disease.

Detecting undiagnosed diabetes using glycated haemoglobin: an automated screening test in hospitalised patients.

OBJECTIVE: To assess the utility of glycated haemoglobin (HbA(1c)) level as an automated screening test for undiagnosed diabetes among hospitalised patients and to estimate the prevalence of undiagnosed diabetes among hospitalised patients. DESIGN, PARTICIPANTS AND SETTING: A 3-month prospective study of all adult patients admitted to a tertiary hospital. An HbA(1c) test was automatically undertaken on admission for all patients with a random plasma glucose (RPG) level ≥ 5.5 mmol/L. Demographic, admission and biochemical data were obtained from hospital databases. A subset of patients was recruited for an oral glucose tolerance test (OGTT) after discharge. MAIN OUTCOME MEASURES: Prevalence of undiagnosed diabetes (defined as HbA(1c) ≥ 6.5% in accordance with International Expert Committee and American Diabetes Association recommendations) and utility of automated HbA(1c) testing. RESULTS: The prevalence of undiagnosed diabetes was 11% (95% CI, 9.8%-12.4%) (262/2360) during the study period. A further 312 patients with known diabetes were admitted. The prevalence of undiagnosed diabetes was highest in the 65-74-years age group. The HbA(1c) test cost was $152 per new diagnosis of diabetes. Conservatively assuming an annual incidence of undiagnosed diabetes of 0.8%, the ongoing cost of testing hospitalised patients would be $2100 per new diagnosis of diabetes. RPG testing was not sensitive or specific in diagnosing diabetes. Patients were poorly compliant with the post-discharge OGTT (27% completion rate). CONCLUSIONS: HbA(1c) is a simple, inexpensive screening test that can be automated using existing clinical blood samples. Hospital screening for diabetes needs to be coupled with resources for management in the community.

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.

Lipid and lipoprotein testing in resource-limited laboratories.

The role of total cholesterol (TC) and lipoproteins in the assessment of coronary heart disease (CHD) is firmly established from population and intervention studies. Total and low-density lipoprotein cholesterol (LDLC) levels are positively associated with CHD, and high-density lipoprotein cholesterol (HDLC) levels are negatively associated with CHD. Efforts to identify and treat people at increased risk based on cholesterol and lipoprotein levels have led to more lipid testing and the need for very reliable test results. Thus, quality laboratory services are an essential component of healthcare delivery and play a vital role in any strategy to reduce morbidity and mortality from CHD. In laboratories with limited resources, establishing laboratory capability to measure CHD risk markers may be a considerable challenge. Laboratories face problems in selecting proper techniques, difficulties in equipment availability and maintenance, and shortage of supplies, staffing, and supervision. The Centers for Disease Control and Prevention (CDC) has been providing technical assistance for more than 30 years to laboratories that measure lipids and lipoproteins and is willing to provide technical assistance as needed for other laboratories to develop this capability. CDC can provide technical assistance to establish lipid and lipoprotein testing capability to support a CHD public health program in areas with limited laboratory resources. This assistance includes: selecting a suitable testing instrument; providing training for laboratory technicians; establishing a simple quality control plan; and instructing staff on how to prepare frozen serum control materials suitable for assessing accuracy of lipid and lipoprotein testing.

Comparison of automated short tandem repeat and manual variable number of tandem repeat analysis of chimerism in bone marrow transplant patients.

Hematopoietic chimerism can be monitored in bone marrow transplant patients at DNA polymorphic sites. In this study, allele detection and quantification by ethidium bromide-stained agarose gels were compared with automated fluorescent sizing on an artificially mixed system and on chimeric post-transplant whole blood and sorted cell populations. A panel of five variable number of tandem repeats (VNTRs) were amplified and quantified visually on an ethidium bromide-stained gel. The ten short tandem repeats (STRs) were amplified as a multiplex polymerase chain reaction (PCR) and fluorescently detected on a DNA sequencer. Fluorescent band intensities were converted to fluorescent peak areas for allele quantification. Using mixed DNA of different proportions, both STRs and VNTRs showed linearity and appeared equally sensitive. However, case studies showed STRs to be more sensitive (<5%) than VNTRs (<10%). The STRs more accurately quantified the minor DNA component at low concentrations.

Economic impact of automated primary screening for cervical cancer.

OBJECTIVE: To construct a markovian model to project the marginal cost of the AutoPap System as compared to manual cervical cytologic screening. STUDY DESIGN: Data from a clinical trial and published literature were entered into a seven-state markovian decision-analytic model to estimate the marginal cost per year of life saved that could be attributed to changes in primary screening technology. RESULTS: Annual screening with AutoPap produced a meaningful increase in life expectancy of 32.1 days relative to manual screening at a marginal savings of $628 per person (or a marginal savings of $7,144 per life-year saved). Less frequent screening yielded lower positive savings. CONCLUSION: Automated screening for cervical cancer has the potential to significantly improve health care outcomes and reduce cost.

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.

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.

Automating clinical lab boosts quality and volume, allows more efficient use of labor.

The clinical lab at the University of Nebraska Medical Center has a robot of its own. And it's on the cutting edge of robotics with the recent addition of an automated vehicle that transports patient specimens to the lab's testing sites. The result? Staffing has been reduced and quality has gone up. Learn how UNMC was used as a test site to develop a state-of-the-art system that's already being snapped up by other organizations.

Characterization of antibodies using N-terminally truncated peptides produced in an automatic protein sequencer.

Antibodies raised against short peptides coupled via their C-terminus will often be specific for the N-terminus. Peptides lacking one or two N-terminal residues seemed useful for characterization of such antibodies. A simple method for N-terminal truncation of nmol amounts of peptides is described. An automatic protein sequencer was used as a suitable reactor. The method is generally versatile, but some structural features of the peptides limited the yields. Thus, purification and careful identification of the products was needed. The specificities of several antibodies were characterized by incubation with the singly and doubly truncated versions of the peptides used for immunization and/or standards. The results disclosed dependency on the N-terminal residue(s) varying from none to more than 10(4) times reduced binding.

Technological diffusion in primary health care.

The paper contains a theoretical and empirical analysis of the driving forces behind the diffusion of dry chemical laboratory equipment in Norwegian primary health care. The empirical analysis is embedded in a theoretical model of a dynamic investment problem focusing on heterogeneity in the potential adopters' profit functions. The empirical analysis indicates that most adopters are too late in adopting the new technology. A logit analysis of the diffusion process lends some support to the notion that profit function heterogeneity influences the diffusion process. An offspin of the empirical analysis is information on the reimbursement system, indicating that this system does not promote efficient resource allocation in the sector.