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PubMed1990

Interpreting rodent clinical laboratory data in safety assessment studies: biological and analytical components of variation.

Evaluation of the biological and toxicological significance of clinical laboratory results obtained in safety assessment studies requires an understanding of factors unrelated to the treatment that may affect test results. Since the magnitude of the components of variation is usually unknown, the toxicologic significance of small, but statistically significant, differences between control and treatment group results can be difficult to assess. Over a 12-week period, components of variation were determined for a wide range of hematologic and clinical biochemical assays in clinically normal Sprague-Dawley-derived rats. Estimates of variance components and ratios were obtained for each test. While the intra-animal/inter-animal ratios (r ratios) revealed some important tests with a high or low degree of individuality, many hematologic and clinical biochemical tests had r ratios within the 95% confidence interval for equal variances. Analytical variance ratios revealed tests that are sensitive to the effects of experimental error and experimental design. Due to the diversity of the variance component patterns among clinical laboratory tests, complex experimental designs may be required to reduce the effects of analytical and biological variation on the statistical analysis of clinical laboratory data. The results of this study suggest that statistically significant clinical laboratory findings that are not biologically or toxicologically important will be present in many rodent safety assessment studies with a standard design. Overreliance on the result of standard prepackaged statistical analyses for determining the presence of toxicologically significant findings can lead to misinterpretation of clinical laboratory data. Sound medical judgment must be applied to clinical laboratory findings using appropriate statistical analyses as a tool for pattern recognition.

Animals↗

PubMed1995

Variation in performance of the EMG examination at six European laboratories.

The quality of the EMG examination might be improved by standardization. However, knowledge about interlaboratory differences in the performance of the EMG examination is a prerequisite for standardization. The aim of this study was to describe differences in EMG techniques used and number of muscles and nerves examined per patient at 6 European EMG laboratories. The EMG results of 595 patients were prospectively sampled. The average number of muscles examined per patient in different disorders varied from laboratory to laboratory, for example from 3.0 to 10.8 muscles in anterior horn cell disorders and from 2.0 to 5.5 muscles in myopathies. The average number of muscles examined by quantitative EMG varied from 0 to 4.3 in anterior horn cell disorders and from 0.0 to 4.5 in myopathies. Also the average number of nerve segments examined per patient varied from laboratory for example from 2.7 to 17.7 for motor segments and from 3.1 to 9.0 for sensory segments in polyneuropathies. The laboratories that used needle electrodes for nerve conduction studies and quantitative analysis of individual motor unit potentials examined a smaller number of muscles and nerves than laboratories using surface electrodes for nerve conduction studies and qualitative EMG studies. The results of this study may have impact on guidelines and examination protocols as well as on quality assurance.

Electromyography↗

PubMed2006

Value of routine admission laboratory tests to predict thirty-day mortality in patients with acute myocardial infarction.

Most risk-stratification instruments that have been developed to predict outcome after myocardial infarction do not make use of laboratory parameters, although several laboratory parameters have been shown to be predictors of adverse outcome. To assess the prognostic value of routine admission laboratory tests, we studied a sample of 264 of 3,746 patients with myocardial infarction from a coronary care unit database of 12,043 patients for differences between survivors and nonsurvivors at 30 days. In multivariate analyses, higher white blood cell count, higher levels of serum creatinine, glucose, and lactate dehydrogenase, and lower platelet count were identified as independent risk factors for 30-day mortality. The model that incorporated these risk factors (added laboratory parameters model) had a 17% higher predictive power than did the model that contained only conventional risk factors (conventional risk factor model). The added laboratory parameters model showed better discriminative ability than the conventional risk factor model according to the area under the curve (0.87 vs 0.80). In conclusion, routine admission laboratory tests hold significant prognostic information, with value in addition to conventional risk factors. Incorporating these tests in risk-stratification instruments will further improve risk assessment of patients with myocardial infarction.

Aged↗

PubMed2006

Evaluation of selected laboratory components of a comprehensive periodic health evaluation for veterans with spinal cord injury and disorders.

OBJECTIVE: To evaluate selected laboratory components of a comprehensive periodic health evaluation program for patients with spinal cord injury and disorders (SCI/D). DESIGN: A retrospective study. SETTING: A Department of Veterans Affairs spinal cord injury center. PARTICIPANTS: Community-dwelling male veterans with SCI/D (N=350). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Proportion of laboratory tests that resulted in new diagnoses (diagnostic yield) and proportion of laboratory tests that resulted in changes in management (therapeutic yield). RESULTS: Although abnormality rates for many routine laboratory tests were high (up to 31.5%), diagnostic and therapeutic yields were low (<1.5%), with the exception of glucose (therapeutic yield, 3.4%) and lipid tests (up to a 4.1% diagnostic and 15.2% therapeutic yield). CONCLUSIONS: Our data revealed that diagnostic and therapeutic yields for many laboratory components of the annual PHE program for veterans with SCI/D were low, consistent with findings in the general ambulatory population. Further data collection, particularly prospective longitudinal data, may help optimize the selection and frequency of laboratory tests performed as part of this program.

Adult↗

PubMed2004

Responses of benthic fish exposed to contaminants in outdoor microcosms--examining the ecological relevance of previous laboratory toxicity tests.

Previous laboratory studies indicate that coal combustion wastes (a mixture composed of fly ash and other lower volume wastes such as bottom ash; hereafter collectively referred to as ash) adversely affect the health of benthic fish (Erimyzon sucetta; lake chubsucker), but fish in these studies were provided with ample uncontaminated food resources. Because aquatic disposal of ash can also adversely affect food resources for benthic fish, we hypothesized that changes in resources might exacerbate the effects of ash on fish observed in laboratory studies. We exposed juvenile E. sucetta in outdoor microcosms to water, sediment, and benthic resources from an ash-contaminated site or a reference site for 45 days and compared our findings to previous laboratory studies. Benthic invertebrate biomass was nearly three times greater in controls compared to ash microcosms. Total organic content of control sediment (41%) was also greater than in ash sediments (17%), suggesting that additional benthic resources may have also been limited in ash microcosms. Benthic invertebrates isolated from the ash microcosms had trace element concentrations (As, Cd, Co, Cr, Cs, Se, Sr, and V) up to 18 times higher than in weathered ash used in laboratory studies. The concentrations of trace elements accumulated by fish reflected the high dietary concentrations encountered in the ash microcosms and were associated with reduced growth (final mass = 0.07 g) and survival (25%) compared to controls (0.37 g and 67%, respectively). Accumulation of trace elements, as well as reductions in growth and survival, were more pronounced than in previous laboratory studies, suggesting that resource conditions may be important in mediating ash toxicity. Taken together, our studies suggest that ash discharge into aquatic systems is a more serious threat to the health of benthic fish than previously predicted based upon laboratory toxicity tests.

Analysis of Variance↗

PubMed2004

The transition from an analog to a digital echocardiography laboratory: the Mayo experience.

Our echocardiography laboratory has completed the transition from an analog to a digital imaging laboratory. The process involved a thorough analysis of the practice and design of a complete digital solution. After an effective implementation of a robust reporting solution, the transition to digital imaging ensued. The implementation plan for digital imaging enabled the transition to be made without adversely affecting the practice, which has an average daily examination load of more than 200 patients. Full-load testing simulations were required on high-end image processing review workstations, high-speed local area network connections to each imaging suite, and new clustered imaging servers. We had to test the ability of approximately 100 ultrasound machines with 3 idiosyncratic ultrasound platforms to allow digital image transfer to the new imaging servers over the local area network. Our sonographer, allied health, and physician staff of more than 250 persons had to be trained to adapt to important changes that the digital echocardiographic image acquisition and review platform would have on their specific roles in the laboratory. The efficiency of the implementation, reporting, and imaging resulted in improved staff resource allocation. The lessons learned may benefit laboratories with a similar interest in making the transition to a digital imaging laboratory with minimal effect on patient scheduling and staff satisfaction. The effect of the transition to a completely digital laboratory on operating expenses, imaging, and reviewing systems and the impact on the clinical practice of echocardiography at our institution are presented, with emphasis on the particular aspects of transitioning to digital imaging.

Cardiology↗

PubMed2006

Current determinants of 30-day and 3-month mortality in over 2000 aortic valve replacements: Impact of routine laboratory parameters.

OBJECTIVE: Haematological and biochemical measurements are performed routinely before surgery to exclude organ malfunction and blood cell and coagulation abnormalities. We aimed to test routinely obtained laboratory data as factors predicting operative risk. METHODS: Between 1996 and 2003, 2198 patients underwent aortic valve replacement (AVR) (908 of them with concomitant CABG) in our institute. The mean age of the study population was 69+/-11 years (range 13-91, 43% female). Clinical and laboratory parameters based on the consolidated data mart set were evaluated by multiple logistic regression analysis. RESULTS: The overall operative mortality (within 30 days) was 3.8% and the mortality after 3 months was 5.9%. In addition to clinical characteristics, the following laboratory values were identified as independent predictors of 30-day mortality: fasting blood glucose, antithrombine III, partial thromboplastine time and creatinine kinase. As independent predictors of 3-month mortality, the following laboratory values were indentified: fasting blood glucose, serum creatinine, antithrombine III, partial thromboplastine time, lactate dehydrogenase, sodium concentration and serum proteins. The discriminative power of the models increased if laboratory parameters were included in addition to preoperative clinical characteristics (from 0.75 to 0.79 and from 0.75 to 0.78 for 30-day and 3-month mortality, respectively). The discriminative power using the logistic EuroScore was lower (0.71 and 0.7, for 30-day and 3-month mortality, respectively). CONCLUSIONS: Laboratory parameters as objective markers for organ function and nutritional status are useful data for the prediction of 30-day and 3-month mortality after aortic valve replacement. Using modern methods of information technology, these valuable data which are stored electronically in most hospitals, can be used efficiently for research and quality control.

Adolescent↗

PubMed2005

Evaluation of rapid HIV testing strategies in under equipped laboratories in the Central African Republic.

Voluntary testing is described as being cornerstone to impact the spread of human immunodeficiency virus (HIV) infection if the person who tests positive is counseled. Therefore, simple, accurate and affordable diagnostic tests are required. The immunoblot test used in developed countries is too expensive for large-scale use in developing countries. Therefore, alternative strategies must be developed. A strategy based on two consecutive rapid tests was tested. This strategy used the Determine HIV-1/2 (Abbott Laboratories, Tokyo, Japan) rapid immunochromatographic test as a screening test and the Uni-Gold HIV test (Trinity Biotech, Dublin, Ireland), SDHO HIV 1/2 test (SDHO laboratories, Saint-Sauveur des Monts, Canada), HIV 1/2 Quick test (Cypress Diagnostics, Langdorp, Belgium) or Retrocheck HIV test (Qualpro Diagnostics, Goa, India) as a confirmatory test. Reference serum samples (HIV-positive and HIV-negative) were first used to evaluate the four confirmatory tests. Secondly, 159 serum samples were used to compare the "consecutive" testing strategy used in our laboratory with the two-test strategy. Thirdly, we tested the feasibility of using this two-test strategy in a under equipped laboratory. The sensitivity and negative predictive value of both test strategies were 100%. The specificity and positive predictive value of the four confirmatory tests were similar (>98%). The strategy used in our laboratory and the two-test strategy always gave identical results, regardless of where this strategy was performed (Institut Pasteur de Bangui or M'baïki hospital). This new strategy appears to be reliable, simple, feasible and rapid in under equipped laboratories. It allows counseling and results to be given on the same day, which should improve post-test counseling.

AIDS Serodiagnosis↗

PubMed1998

Laboratory and clinical evaluation of two glucose meters for the neonatal intensive care unit.

OBJECTIVE: To evaluate the analytical and clinical performance of the One Touch II and Advantage glucose meters for use in neonatal specimens. DESIGN AND METHODS: For the laboratory evaluation, a total of 96 umbilical cord whole blood specimens were analyzed on the One Touch II and/or Advantage meters. Samples were centrifuged after analysis on the meters and plasma glucose was determined on the Hitachi 917. For the clinical evaluation, a total of 64 infants had specimens analyzed on each of the meters as well as on the laboratory analyzer. RESULTS: In the laboratory and clinical evaluations, both meters correlated well (r > 0.9, p < 0.001) with the plasma values for the Hitachi 917. However, the mean difference between the Advantage and Hitachi 917 was lower than that of the One Touch II in both the laboratory (-0.23 vs -0.64 mmol/L) and the clinical evaluations (-0.08 vs -0.60 mmol/L). 53.1% of One Touch and 26.6% of Advantage results from the clinical study had a discrepancy of > 0.5 mmol/L from the laboratory value. CONCLUSIONS: For neonatal specimens, glucose meters must have good low end precision, sensitivity and accuracy, In this study, the Advantage meter had fewer discordant results and better correlation with the Hitachi 917. Overall, nursing and laboratory staff preferred the performance and characteristics of the Advantage meter.

Blood Glucose Self-Monitoring↗

PubMed1992

Monitoring human exposure to lead: an assessment of current laboratory performance for the determination of blood lead.

The performance of a small group (9-13) of experienced reference laboratories performing the determination of lead in blood is assessed by means of repeated analyses of lyophilized animal blood. Both interlaboratory precision and intralaboratory precision are reported for the reference laboratory group. Results indicate that at the new blood lead action level of 10 micrograms/100 ml, this group can achieve results that are accurate to within +/- 2 micrograms/100 ml. The capability of routine clinical laboratories participating in the New York State Department of Health's Proficiency Testing Program for Blood Lead from 1979 to 1991 is also examined. These data indicate a steady improvement in laboratory performance over the last 10 years. Analysis of the most recent data suggests that laboratories using anodic stripping voltammetry tend to underestimate the concentration of lead in blood at levels greater than 40 micrograms/100 ml (1.93 mumole/L). The accuracy and precision of electrothermal atomization and Delves-cup atomic absorption spectrometry for the determination of blood lead in one laboratory are compared and discussed.

Animals↗

PubMed1994

Laboratory aspects of immunology.

The field of clinical immunology is advancing rapidly and will continue to grow and benefit from the knowledge gained in different areas of basic immunology. The diagnosis and evaluation of a child with a suspected primary immune defect can be a challenging task that should be done carefully using the best available laboratory resources. Simple laboratory screening tests, available to most pediatricians, can be done initially and will provide an idea of the level of general immune competence. Referral for a more detailed evaluation should be made in selected cases. A basic understanding of the tests used in immune evaluation, as well as the fact that the results may be affected by multiple variables, is important. Of equal significance is the interaction of the physician with the laboratory in which the samples will be analyzed. Proper sample collection and handling as well as prompt processing by the laboratory are crucial. Equally important is the physician's interpretation of results in the context of the pediatric population. Tests like lymphocyte studies, WBC studies, immunoglobulin subclasses, response to antigenic challenge, and certain complement assays require a higher degree of expertise and should only be sent to laboratories with experience in performing them. Physicians need to gain confidence in the power of diagnosis that the immunology laboratory brings to their patients.

B-Lymphocytes↗

PubMed1985

Clinical laboratory--past, present, and future: an opinion.

In this review we have tried to identify some of the management issues affecting laboratories in the past, present, and future. In particular, we have focused on the increases in utilization and cost and have attempted to demonstrate some of the factors affecting the supply and demand sides of these issues. In the absence of a price mechanism to allocate resources, alternative strategies to evaluate and regulate laboratory use were discussed. Although promise is held out by some of these approaches, they are not, in our view, fully workable at this stage. We suggest that, in the interim, sound medical direction and management of the laboratory as a production function can be of benefit in inhibiting, if not actually controlling, cost increases. In particular, we recommend concentration on the management of technology because of its crucial role in laboratory costs and utilization. Emerging trends in clinical laboratory and monitoring technologies suggest that issues relating to decentralization, quality control, and funding will have to be addressed in the near future. The prime motivation for clinical laboratory use, i.e., the generation of answers to clinical questions, seems destined to continue and expand. The challenge for practitioners, researchers, and policy-makers is to harness, evaluate, and manage the technologies that can best contribute to both medical practice and health.

Forecasting↗

PubMed2002

Laboratory evaluation of hypercoagulable states in patients with central retinal vein occlusion who are less than 56 years of age.

PURPOSE: To investigate whether hypercoagulability plays a role in thrombus formation in patients with central retinal vein occlusion (CRVO) who are less than 56 years of age. DESIGN: Prospective, observational case series with retrospective comparative controls. PARTICIPANTS AND CONTROLS: Participants included 55 consecutive patients with CRVO less than 56 years of age. The laboratory's age-matched control groups were used to compare results for the same tests. METHODS: Fifty-five patients with CRVO less than 56 years old (mean age, 44 years) underwent laboratory evaluation for homocysteine, activated protein C resistance, protein C activity, protein S activity, antithrombin III activity, antiphospholipid antibodies, and anticardiolipin antibodies. The results were compared with previously drawn age-matched control groups obtained by the same laboratory for statistical significance. MAIN OUTCOME MEASURES: Patients were considered to have a positive test if their results were outside the laboratory's established range. RESULTS: Fifteen of 55 patients (27%) had one positive test result suggesting hypercoagulability. Compared with the control groups, these patients less than 56 years old with CRVO had a higher incidence of coagulation abnormalities by laboratory testing. Among the parameters tested, hyperhomocysteinemia and circulating antiphospholipid antibodies were significantly more common in the CRVO patients (P < 0.05) compared with age-matched controls. CONCLUSIONS: Hypercoagulability may play a role in the pathogenesis of CRVO in patients less than 56 years old. The cause of CRVO remains multifactorial, and laboratory tests suggesting hypercoagulable states alone cannot account for the cause in most of these patients less than 56 years of age. The authors recommend examining blood pressure, intraocular pressure, complete blood count, glucose levels, and a lipid panel on all patients with CRVO. When tests for these common risk factors for CRVO are negative, consider ordering selected tests in young patients with CRVO to rule out thrombophilias, especially in patients with bilateral CRVO, a history of previous thrombosis, or family history of thrombosis.

Activated Protein C Resistance↗

PubMed2000

A quality control program for crossmatching procedures for solid organ transplantation. The participating laboratories of the Australasian and South Asian Tissue Typing Association.

The National Kidney Matching Scheme (NKMS) allows matching and allocation of donor organs throughout Australia. Sera from potential recipients are distributed to each interstate tissue typing laboratory on a monthly basis for crossmatching in the event of a cadaver donor. Therefore, it is essential there is consensus for results between these laboratories in order for donated organs to be allocated appropriately. A quality control program conducted under the auspices of ASEATTA was undertaken for (1) panel reactive antibody characterization; (2) routine T lymphocyte crossmatching; and (3) characterization of antibody isotype by DTT treatment. These aims were achieved by distribution of (1) six sera for the determination of PRA activity; (2) 20 scrambled trays including replicate dilutions of a strongly positive lymphocytotoxic serum, high titer monoclonal antibody and negative sera and; (3) 20 trays containing sera with IgG and/or IgM antibodies. These were then evaluated by each laboratory on a panel of T cells. There was concordance between laboratories for PRA levels and antibody characterization. However, there was considerable variation in crossmatch sensitivity and reproducibility, several laboratories had carryover and others could not detect weak IgM antibodies. These results demonstrate the utility and need for ongoing crossmatch exchange programs, particularly for laboratories participating in organ exchange programs.

Dithiothreitol↗

PubMed2003

Induction of IgE antibody responses by protein allergens: inter-laboratory comparisons.

There is a growing interest in the development of methods for the evaluation of the allergenic potential of novel proteins. One approach is the measurement of specific IgE antibody production stimulated by systemic (intraperitoneal; i.p.) exposure of BALB/c strain mice. In the current investigations, inter-laboratory comparisons have been performed of IgE antibody production induced in mice by food proteins of differing sensitizing potential. Female BALB/c strain mice (n=5) were exposed to 0.1% peanut agglutinin, an allergenic constituent of peanuts, to 2% ovalbumin (OVA), a major allergenic constituent of hens' egg, or to a protein considered to lack significant allergenicity, potato agglutinin (5%). Specific IgE antibody was measured by homologous passive cutaneous anaphylaxis assay and IgG and IgG1 antibody production was analysed by enzyme-linked immunosorbent assay (ELISA). Two independent experiments were conducted in each laboratory, but with all serological analyses conducted in one of the laboratories. Each of the proteins induced vigorous IgG and IgG1 antibody responses, with no statistically significant differences in titres recorded between laboratories. Furthermore, OVA and potato agglutinin induced responses of equivalent immunogenicity with respect to both IgG and IgG1 antibody titres. Administration of peanut agglutinin and OVA each stimulated marked IgE antibody responses in every experiment. In the two laboratories, titres ranged from 1:32 and 1:64 for peanut agglutinin, and from 1:8 and 1:32 for OVA. In contrast, exposure to potato agglutinin failed to induce vigorous IgE production, with no detectable IgE (negative with neat serum), or titres of 1 (positive with neat serum only) recorded. These data demonstrate that the induction of IgE antibody by food proteins of differing allergenic potential is a relatively robust phenomenon and transferable between laboratories. Furthermore, these results provide additional evidence that the measurement of antibody (IgE) responses in BALB/c mice may allow discrimination between allergens and those materials that apparently lack allergenicity.

Allergens↗

PubMed2002

The mycobacteriology laboratory and new diagnostic techniques.

Use of the most rapid and reliable laboratory tests for mycobacterial detection, identification, and susceptibility testing is important for TB control. In 1993, CDC experts made recommendations regarding optimal methods of mycobacterial testing (i.e., stains for AFB, culture, identification, and susceptibility testing of M. tuberculosis) and turnaround times for reporting results. Various technical advances have enhanced the diagnostic capability of the laboratory and/or improved laboratory efficiency since then. The commercial NAA tests for direct detection of MTBC have the greatest potential to impact patient care. To assist physicians, CDC experts have published recommendations concerning use of the NAA tests for management of patients with suspected TB, with emphasis on the MTD assay, which is approved for both AFB smear-positive and smear-negative specimens. With regard to mycobacterial culture, totally automated, nonradiometric systems are commercially available. For mycobacterial identification, various molecular techniques have been developed, but at present, they are used predominantly in research or large reference laboratories. Molecular tests also have proved useful for better understanding the epidemiology of TB and investigating episodes of suspected laboratory cross-contamination. With regard to mycobacterial susceptibility testing, use of the new automated culture systems for testing MTBC is under evaluation, but only one such system has been approved for this purpose. In addition, laboratory guidelines for susceptibility testing of MTBC and certain NTM have recently been published by the NCCLS.

Bacteriological Techniques↗

PubMed2001

Laboratory diagnosis of community-acquired lower respiratory tract infection.

This article has focused on the evaluation of outpatients with lower respiratory illness. In large part, the need for microbiological work-up is host-dependent. Healthy patients usually do well, and laboratory data are often unnecessary. The abnormal host requires a different approach and, in general, the more compromised the host, the more aggressive the laboratory evaluation. A renal transplant patient with respiratory symptoms often follows the dictum that "common things happen commonly;" however, the clinician needs that extra level of assurance in this case. Some transplant patients may have respiratory illness caused by strongyloidiasis. Cystic fibrosis is another example of the need for a more comprehensive laboratory evaluation. Specialized selective media and additional susceptibility studies may be needed to evaluate isolates associated with exacerbation of symptoms in these patients. The clinical laboratory should be forewarned of any materials coming from invasive diagnostic techniques, so they can prepare and offer useful advice regarding specimens, transport, and follow-up. Microbiological laboratories are often most knowledgeable regarding what type of testing is appropriate. Direct communication with the laboratory is essential to assure the best patient care.

Bacterial Infections↗

PubMed1990

Home nebulizers: can optimal therapy be predicted by laboratory studies?

Twenty patients (six severe asthma, 14 chronic obstructive pulmonary disease, COPD) were referred for consideration of domiciliary nebulized treatment. A double blind laboratory assessment demonstrated similar subjective and objective responses to nebulized salbutamol (5 mg), ipratropium bromide (IB) (0.5 mg) or a mixture of these medications in both groups of patients. The patients subsequently self-administered each treatment four times daily for one month. Fourteen patients requested long-term home nebulizer treatment (three salbutamol, four ipratropium bromide, seven mixture), and nine of these had their highest domiciliary peak flow recordings during home nebulizer treatment. However, subjective and objective laboratory assessments did not clearly predict the patients long-term choice of therapy in any case. There was little overall correlation between the laboratory response and the domiciliary response to treatment (Spearman correlation coefficient; subjective score, laboratory vs. home, r = 0.27, P = 0.03; peak flow response 30 min after treatment, laboratory vs. home, r = 0.31, P less than 0.02). The hospital study was also unreliable in predicting side effects during domiciliary nebulizer use. We conclude that prospective laboratory studies are of little value in the assessment of patients for home nebulizer therapy; these assessments must be made by carefully supervised domiciliary trials of nebulized treatment.

Adult↗

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