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Background Ethical MedTech prescribes high standards for the participation of the in vitro diagnostics (IVD) industry in third-party organised educational events in terms of charitable donations, educational grants, scholarships and fellowships. We planned a survey to investigate the previous and current practice in terms of cooperation between professionals or professional societies and the IVD industry, as well as plans under the incorporation of the MedTech Europe Code. Methods Different questions, from general information to specific questions related to the practice and knowledge of the new Ethical MedTech Code, were included in two different surveys; for European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) National Societies' (NSs) representatives, and for their (NSs) individual members. Results Twenty-five out of 40 EFLM NS representatives replied; more than half declared that all different types of financial resources were available for supporting the continuing professional education of health care professionals (HCPs). In addition, 322 individual responses collected from 31 NSs, answered that the institutional director (50.3%) or laboratory chief (70.1%) made generally made a decision, without specific criteria. Conclusions The MedTech Europe Code is already adopted or is about to be adopted in numerous EFLM NSs, but most of them have not implemented it as yet. The use of the Code and better communication between IVD companies and HCPs are necessary to guarantee an improved and fair use of financial support, as well as better choices for the organisation and attendance at scientific events.

Background Despite advances in clinical chemistry testing, poor blood sample quality continues to impact laboratory operations and the quality of results. While previous studies have identified the preanalytical causes of lower sample quality, few studies have examined the economic impact of poor sample quality on the laboratory. Specifically, the costs associated with workarounds related to fibrin and gel contaminants remain largely unexplored. Methods A quantitative survey of clinical chemistry laboratory stakeholders across 10 international regions, including countries in North America, Europe and Oceania, was conducted to examine current blood sample testing practices, sample quality issues and practices to remediate poor sample quality. Survey data were used to estimate costs incurred by laboratories to mitigate sample quality issues. Results Responses from 164 participants were included in the analysis, which was focused on three specific issues: fibrin strands, fibrin masses and gel globules. Fibrin strands were the most commonly reported issue, with an overall incidence rate of ∼3%. Further, 65% of respondents indicated that these issues contribute to analyzer probe clogging, and the majority of laboratories had visual inspection and manual remediation practices in place to address fibrin- and gel-related quality problems (55% and 70%, respectively). Probe maintenance/replacement, visual inspection and manual remediation were estimated to carry significant costs for the laboratories surveyed. Annual cost associated with lower sample quality and remediation related to fibrin and/or gel globules for an average US laboratory was estimated to be $100,247. Conclusions Measures to improve blood sample quality present an important step towards improved laboratory operations.

Background: MALDI-TOF mass spectrometry (MS) is set to make inroads into clinical chemistry because it offers advantages over other analytical platforms. These advantages include low acquisition and operating costs, ease of use, ruggedness, and high throughput. When coupled with innovative front-end strategies and applied to important clinical problems, it can deliver rapid, sensitive, and cost-effective assays., Content: This review describes the general principles of MALDI-TOF MS, highlights the unique features of the platform, and discusses some practical methods based upon it. There is substantial potential for MALDI-TOF MS to make further inroads into clinical chemistry because of the selectivity of mass detection and its ability to independently quantify proteoforms., Summary: MALDI-TOF MS has already transformed the practice of clinical microbiology and this review illustrates how and why it is now set to play an increasingly important role in in vitro diagnostics in particular, and clinical chemistry in general., (© 2015 American Association for Clinical Chemistry.)

Predicting the future is a difficult task. Not surprisingly, there are many examples and assumptions that have proved to be wrong. This review surveys the many predictions, beginning in 1887, about the future of laboratory medicine and its sub-specialties such as clinical chemistry and molecular pathology. It provides a commentary on the accuracy of the predictions and offers opinions on emerging technologies, economic factors and social developments that may play a role in shaping the future of laboratory medicine., (Copyright © 2014 Elsevier B.V. All rights reserved.)

Background: To assess the value of the practice of obtaining frequent electrolyte measurements in patients with extended stay in a neuroscience intensive care unit (NICU)., Methods: We identified consecutive patients 18 years or older, admitted to the NICU between January 1 and July 31, 2009 with length of stay ≥ 5 days. We collected potassium, sodium, magnesium, ionized calcium, phosphorus laboratory measurements and hemoglobin levels, and recorded electrolyte replacement orders and red blood cell transfusions. Average laboratory costs were estimated., Results: 93 patients were included in the study (54 men, mean age 54 years, range 18-85 years). Mean length of stay was 10.4 days (range 5-36 days). Sodium and potassium were the electrolytes most frequently measured (averages of 14.1 and 13.1 per patient, respectively). More than 75% of the results were within normal range for all electrolytes measured and critical values were extremely uncommon. The number of phlebotomies for electrolyte measurements was strongly associated with the degree of hemoglobin drop (P < 0.0001). Electrolyte panels were ordered much more often than individual electrolytes with average cost exceeding $2200 per patient. Replacing half of these electrolyte panels with single sodium or potassium orders would have resulted in savings greater than $100,000 in our population., Conclusions: Electrolytes measurements are very frequent in the NICU, but results are most often normal and only exceptionally critical. The phlebotomies required for these tests significantly worsen hemoglobin levels. A more conservative use of electrolyte measurements can result in reduction of blood loss and substantial cost savings.

Objective: We described an automated technique for measurement of serum nitrite/nitrate (NO(x)) using the Cobas Mira clinical chemistry analyzer., Design and Methods: NO(x) was measured by the modified Griess method. Precision, accuracy, linearity, instrument carry-over and lower limit of quantitation (LLOQ) were assessed., Results: The automated technique for measurement of serum NO(x) was linear, precise, and accurate. It has a LLOQ of 2.0 μmol/L., Conclusion: Serum NO(x) measured by the modified Griess method can be applied easily to the Cobas Mira clinical chemistry analyzer., (Copyright © 2010 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.)

Today, the increase of the blood concentration of cardiac troponins is designated as surrogate for cardiac necrosis and myocardial infarction, when an appropriate clinical and/or instrumental situation is present. As cardiac troponins reflect myocyte death, biomarkers of reversible myocardial damage in the absence of necrosis are, however, still needed to detect the presence of damage even before the irreversible injury is induced and identify "vulnerable" patients before major events occur, permitting adequate treatment. Markers of plaque destabilization and/or markers of myocardial ischemia could be enormously valuable in the emergency department setting if shown to contribute additional independent diagnostic information. However, a new cardiac biomarker is of definitive clinical value only if adequate assays for its measurement are available, its predictive value is defined in the right clinical context, optimal cut-off and release kinetics are known, demonstration of the marker incremental value is clear, there is consistency of marker performance across different settings, and, more importantly, there are data on the effect on patient management and outcome and on cost-effectiveness. Despite the emergence of multiple candidates, sufficient evidence for any of these has yet been demonstrated to recommend their adoption into clinical practice.

Background: The purpose of this study was to determine the diagnostic power of a newly available assay for amino-terminal pro-brain natriuretic peptide (NT-proBNP) to identify patients with acute heart failure. In addition, the influence of initial NT-proBNP measurements on economic consequences, diagnostic procedures and staff involvement was evaluated., Methods and Results: 401 patients presenting with acute dyspnea or peripheral edema in the emergency department were enrolled. NT-proBNP was measured after initial clinical evaluation. Clinical routine care and diagnostic assessment were blinded to NT-proBNP results. Two cardiologists independently validated the period of hospitalization, clinical examinations and medical therapies of each patient considering NT-proBNP results. The median NT-proBNP level among patients with acute congestive heart failure (CHF) (n=122) was 3497 pg/ml as compared to 320 pg/ml in patients without (n=279) (p<0.0001). An NT-proBNP cutoff level <300 pg/ml was optimal to rule out acute CHF (negative predictive value 96%; sensitivity 96%). NT-proBNP >or=300 pg/ml could strongly predict acute CHF when compared to patients' history or physical examination (odds ratio 9.5; p<0.0001) and diagnostic technical findings (odds ratio 14.7; p<0.05). In patients with NT-proBNP<300 pg/ml, 14% of the period of hospitalization could be saved, corresponding to savings of US $481 per patient. In addition, 9% of the number and time of staff involvement of clinical examinations and therapies could be saved, 10% of the costs of clinical examinations. Chest X-rays were saved in 34%, echocardiography in 9%., Conclusions: Measurement of NT-proBNP leads to multiple saving amounts and optimizes diagnostic pathways and resource allocation.

DNA sequence analyses have become a major component in the diagnostic work-up of patients; however, limited consideration appears to be given to the possibility that reported results may in fact be wrong. Over the last four years we have carried out an External Quality Assessment scheme for mutation analysis in phenylketonuria. Each year, three DNA samples with previously characterized genotypes were mailed to participating laboratories. Indications for testing were either confirmation of diagnosis and prediction of disease severity, or carrier analysis. Each year there were several laboratories that failed to identify mutations because of methodological limitations. Of the participating laboratories that used comprehensive mutation detection methods, each year there was at least one that missed at least one mutation. Indeed, in the 2007 scheme almost 8% of reports from laboratories that used comprehensive mutation detection methods such as sequencing of all exons of the PAH gene contained incorrect genotypes. There were also serious deficiencies in the interpretation of genotype data: in the 2007 scheme, 6 out of 10 laboratories that obtained full genotyping marks for interpretation incurred a reduction of marks because information on the expected phenotype was missing or wrong. Several laboratories failed to appreciate the clinical relevance of a mutation associated with mild hyperphenylalaninaemia, which does not require treatment, and some discussed the option of prenatal diagnosis in the respective case. In conclusion, mutation analyses may be prone to errors and this demands careful interpretation of results in relation to clinical and biochemical findings.

Technologic innovations have substantially improved the productivity of clinical laboratories, but the services provided by clinical laboratories are increasingly becoming commoditized. We reflect on how current developments may affect the future of laboratory medicine and how to deal with these changes. We argue that to be prepared for the future, clinical laboratories should enhance efficiency and reduce costs by forming alliances and networks; consolidating, integrating, or outsourcing; and more importantly, create additional value by providing knowledge services related to in vitro diagnostics.

Phenylketonuria is an inherited metabolic disease, which is characterized by an increased level of serum phenylalanine. Quantitative measurement of phenylalanine in the serum of phenylketonuria patients is necessary to confirm the disease, and to distinguish phenylketonuria from other forms of hyperphenylalaninemia. In this study, we report a rapid and inexpensive micro-assay for simultaneous detection and quantitative measurement of serum phenylalanine on dry blood-spots. Analysis of the standard curve showed a broad linear range for phenylalanine from 120 to 1800 micromol/L. Application of this method, the standard Guthrie bacterial inhibition assay and a high-performance liquid chromatography (HPLC) method for analysis of 34 samples from phenylketonuria patients and control samples produced comparable results, with the regression equation Y = 0.994X + 0.996. The advantage of this method over the Guthrie bacterial inhibition assay is its ability to measure serum phenylalanine quantitatively without false positive results. The method was successfully applied to dried blood-spots, serum and whole blood. The cost per sample is approximately 20-50 US cents, which is much less than for HPLC and commercial enzyme kits. The method can be automated, and is thus suitable for neonatal and mass screening for phenylketonuria, especially in developing countries where funding is a limiting factor.

Background: Troponin measurements are now central to the diagnosis of acute coronary syndromes and for the stratification of the severity of cardiac disease. Some laboratories have quickly adopted the new testing strategies, which include troponin measurement for the diagnosis of acute myocardial infarction, while others are still developing appropriate protocols for cardiac testing that they can support financially. However, it is not known how widespread is the adoption of these new strategies across the UK., Methods: The National Audit Committee of the Association of Clinical Biochemists commissioned two surveys in 1999 and 2001 to assess the status of cardiac markers currently being offered by laboratories in the UK and how this service might develop in the future., Results: The results show that many laboratories are continuously adapting and improving their cardiac marker testing in line with current recommendations for acute myocardial infarction. Although most laboratories are confident in the use of troponin measurement in the diagnosis of myocardial infarction, they are less confident in the use of biochemical markers in assessing prognostic outcome in the other cardiac conditions., Conclusions: Finance, staffing and equipment constraints may offer significant impediments to troponin testing with a 1-h turnaround time.

Background: Urinalysis is a fundamental test in internal medicine and nephrology. Figures for costs are available in the general laboratory, where biochemical and microscopic urinalysis are commonly performed as semiautomated screening tests. Information on costs is lacking in the nephrology laboratory, where a time-consuming morphological analysis is usually preferred. This study analyses the costs of urinalysis in a nephrology laboratory., Methods: In the nephrology laboratory at the University of Turin - Italy, biochemical urinalysis consists of multi-property strip and proteinuria/creatininuria, done by laboratory technicians. Phase-contrast microscopy is done by a nephrologist or biologist. Time dedicated to the tests was recorded by the same operator over 20 working days, during which 350 urine samples were processed (median 19/day, range 842). The production costs were calculated with the logic bottom-up technique., Results: Overall time needed was 11.9 minutes/sample. Biochemical urinalysis required 6.6 minutes/sample; time required and samples processed were inversely related (< or =19 samples: 7.95 minutes/sample; >19 samples: 5.6 minutes/sample, p=0.01). Microscopic urinalysis took 5.3 minutes/slide; the best time-to-samples ratio was at 18-22 samples per day (with peak efficiency at 21 samples: 4.6 minutes). Cost of reagents and disposables was Euro1.06/sample. Time accounted for euro 5.32/sample (technicians, nephrologist-biologist), with total direct cost of euro 6.38/sample., Conclusion: In a nephrology laboratory, microscopic urinalysis is a time-consuming, expensive test. Analysis of cost and modalities may be useful, in a time of budget constrains, to maintain a role for this precious semeiotic art.

The Institute of Medicine (IOM) of the National Academy of Sciences was commissioned by Congress to study the current system for the payment of diagnostic clinical laboratory services provided to Medicare beneficiaries. The current system was established in 1984 and has grown in complexity and is of diminishing contemporary relevance. The IOM recommended that a single, rational, nationalfee schedule be established and that it be initially based on the National Limitation Amount (NLA) currently mandated as the national fee cap. To estimate the potential budgetary impact of this recommendation, we merged the 1999 Part B Extract and Summary System and the 1999 Clinical Diagnostic Laboratory Fee Schedule (CLFS). By using an estimated 193 million allowed services from this data set and the current mean fee of $9.14 per test, current spending is approximately $1,768 million. The impact of raising the CLFS to the NLA will be approximately $1,792 million, or $9.26 per test. The estimated cumulative budgetary effect, factoring in the current forecast for the Consumer Price Index, is an increase of approximately $993 million over 5 years and $2,359 million over 10 years.

The story of T-lymphocyte subset immunophenotyping technology is reviewed on the occasion of the 20th anniversary of CD4 T-cell enumeration. Over time, immunophenotyping has evolved into precise, reliable, but complicated and expensive technology requiring fresh blood samples. The gating technologies that were universally adapted for clinical flow cytometry for the past decade relied on rapidly deteriorating morphological scatter characteristics of leukocytes. This special issue dedicated to CD4 T-cell enumeration features most of the available new options that will have a significant impact on how this technology will be implemented within the first decade of the 21st century. In a series of original publications, including the new NIH guideline for T-cell subset enumeration, contemporary gating protocols that use immunologically logical parameters are presented as part of the more reliable and affordable immunophenotyping alternative. Some of the improvements addressed here include the costs of the assays and the capacity to monitor interlaboratory and intralaboratory performances. It is clear that an effective attack on the human immunodeficiency virus (HIV) epidemic has to embrace resource-poor regions. Reducing the cost of the assay while improving reliability and durability is a move in the right direction., (Copyright 2002 Wiley-Liss, Inc.)

Nucleic acid amplification tests (NAATs) have created a revolution in our ability to diagnose chlamydial infections. They are markedly more sensitive (while maintaining exquisite specificity) than previously used tests. They can be used with noninvasively collected specimens (first-catch urine for men or women and vaginal swabs from women). This allows their use in screening asymptomatic individuals who represent the bulk of prevalent infections. Mishandling of urine specimens can lead to false-negative results and few are aware of that potential for getting incorrect results. The leading deterrent to the acceptance of NAATs has been their perceived cost. This is based on the purchase price of tests and fails to consider the total cost of testing, which also includes costs of specimen collection, where NAATs have a major advantage.

To play their role as essential tools for the achievement of comparability and traceability of measurements, the upcoming generation of certified reference materials will continue to be the subject of increased requirements related to their preparation, characterization, monitoring, documentation, and distribution. An analysis is made of the most important aspects not only related to the physical form of future CRMs, the determination of their shelf-life, and their certification, but also to increased requirements related to their distribution, including required additional documentation. Two examples of cost breakdown demonstrate the need for improved productivity of certification projects and more efficient marketing.

Many hospital laboratories are unable to offer a cardiac troponin service because of the cost of providing this assay in addition to existing cardiac enzyme profiles: we circumvented this problem by withdrawing the conventional cardiac enzyme service and substituting cardiac troponin T. By ensuring that only one specimen for cTnT is analysed per episode of chest pain. substantial financial savings have been achieved.

Substitutions of codon 306 in the gene embB are the most common mutations found in ethambutol resistant Mycobacterium tuberculosis. The characterization of these mutations has been hampered by the need for prior cultivation of the mycobacteria, or the need for DNA sequencing, or both. Here, we describe a simple and culture-independent technique to detect embB codon 306 mutations directly from sputum samples, requiring little more than a PCR machine and a simple agarose minigel. There is no need for labelled probes or DNA sequencing. In a preliminary test of feasibility, interpretable results were obtained from 21 of 24 selected sputum samples, 12 of which were determined to contain ethambutol resistant M. tuberculosis after culture. All of six samples with embB codon 306 mutations were correctly identified. Although an exact validation of this technique is beyond the scope of this technical report, we conclude from well-known embB codon 306 mutation prevalence figures that approximately one half of EMB resistant cases could already be predicted within 2 working days, with little equipment or hands-on time needed, instead of weeks required for conventional resistance testing., (Copyright 2001 Academic Press.)

Two rapid and simple procedures for the quantitative analysis of GDP-l-fucose (GDP-Fuc) are described. The methods are based on time-resolved fluorescence and microplate assay technology. The first assay relies on measuring the enzyme activity of alpha1, 3-fucosyltransferase. In this assay, transfer of fucose from GDP-Fuc converts sialyllactosamine to sialyl Lewis x tetrasaccharide, which is detected and quantified by relevant antibodies on a microplate. The formation of the reaction product is directly dependent on the presence of GDP-Fuc in the concentration range of 10-10,000 nM. In the second method GDP-Fuc inhibits the binding of fucose-specific Aleuria aurantia lectin to fucosylated glycan on a microwell. The lectin-based assay is less sensitive than the enzyme assay, but it is cheaper and faster. We used these assays in monitoring the amount of GDP-Fuc in crude lysates of transgenic yeast, which expresses the enzymes producing GDP-Fuc. The newly developed assays are versatile and applicable to measure also other nucleotide sugars or glycosyltransferase activities in a high-throughput manner., (Copyright 2000 Academic Press.)

Hospitals in Sweden differ greatly in their use of laboratory tests. These differences seem to be due to traditions and regional differences. The cost of a single laboratory test is often low, but since many tests are used in great numbers, the consequences of false or misleading results can be very costly. Recently, several intervention studies have been carried out in Sweden with the aim of optimizing clinical chemistry testing routines in primary care. These studies show that it is possible to reduce the cost to primary care by SEK 100 million per year while increasing clinical utility. SEK 100 million is approximately 10% of the total cost of clinical chemistry testing in primary care. It should also be possible to reduce this cost in secondary and tertiary care. Hospitals order more tests than primary care, and thus the potential savings are larger. We have studied ordering routines at eleven Swedish hospitals. Comparisons were made in the form of ratios between related laboratory tests, in order to reduce the effects of differences of scale between the laboratories that were studied. The large variation between hospitals indicates that an ongoing discussion between clinicians and laboratories could reduce costs. We have used the figures from this comparison and calculated the potential savings for seven frequently used tests. The potential yearly savings in Sweden for these tests alone is approximately SEK 150 million. We estimate that this is just half of the amount that could be saved if all tests were included.

Increased numbers of requests for serological investigation of coeliac disease, and a local trend to request both anti-gliadin antibodies (AGA) and anti-endomysium antibodies (AEA) simultaneously, resulted in cost pressures that prompted a review of our practice. Serology results from all patients (771 children, 511 adults) investigated for coeliac disease over a 3-year period were compared with small intestine histology where available. IgG AGA and IgA AGA were measured by enzyme-linked immunosorbent assay (in-house), IgA AEA by immunofluorescence (send-away contract). Overall diagnostic performance was as follows: AGA sensitivity 84%, specificity 88%, positive predictive value (PPV) 24%, negative predictive value (NPV) 99%; AEA sensitivity 88%, specificity 97%, PPV 65%, NPV 99%. Results showed AGA, with its high NPV, to be a suitable first-line test to exclude coeliac disease. The high specificity of AEA makes it a suitable confirmatory test when AGA is positive. Introduction of this step-wise approach to coeliac disease investigation resulted in cost savings of at least Pound Sterling 5000 per year without detriment to the clinical service.

There is a need for the development of reliable tumor markers in bladder cancer. A number of studies this past year focused on the evaluation of urinary markers that hold promise as noninvasive adjuncts to traditional diagnostic or surveillance techniques, principally urinary cytology and cystoscopy. Tests for bladder tumor antigen, NMP22, and fibrin degradation products, as well as the Immunocyt test, are commercially available. Other urinary marker tests discussed in this review include telomerase, cytokeratins, and vascular endothelial growth factor. Although these tests in many instances have improved sensitivity in detecting bladder cancer compared with urinary cytology, none have become widely accepted in routine clinical practice. Nonetheless, with further refinement and prospective validation in multicenter trials, markers such as these may provide information that would permit tailoring on an individual basis the type of as well as interval of surveillance examinations. Furthermore, they may also provide information allowing the appropriate selection of therapy based on predicted response. In addition to urinary markers, intense research efforts have also focused on developing clinically useful molecular prognostic markers. A number of cell-cycle regulatory proteins, including p53 and p21, have received much attention in this regard. Emerging data suggests that it may soon be possible to determine the molecular phenotype of both superficial and invasive bladder cancers, thereby providing information regarding tumor behavior on an individual basis. As with urinary markers, however, no molecular markers have been incorporated as yet into day-to-day patient care. Assurances of reproducibility, standardization, and prospective validation studies are urgently needed. It is only through this type of rigorous evaluation that the level of confidence sufficient to base treatment decisions on marker status will be attained.

Background: The use of high-density lipoprotein cholesterol (HDL-C) levels as a risk factor for coronary heart disease necessitates an accurate and precise method for measuring HDL-C. The Centers for Disease Control and Prevention HDL-C reference method (RM) and designated comparison method (DCM) are time-consuming, expensive, and impractical for routine clinical use. We evaluated the Liquid N-geneous (LN-gen) HDL-C assay (Genzyme Diagnostics, Cambridge, Mass) to determine if this homogeneous reagent meets the National Cholesterol Education Program requirements for HDL-C evaluation., Design: Accuracy of the LN-gen HDL-C assay was compared in combination with phosphotungstic acid (PTA) precipitation with DCM HDL-C for normotriglyceridemic serum specimens (triglycerides < 2.0 g/L) and with RM HDL-C for specimens with triglycerides levels > or = 2.0 g/L., Setting: Genzyme Diagnostics (with RM and DCM assayed by Pacific BioMetrics Inc, Seattle, Wash) and the Lipid Reference Laboratory of the University Hospital Rotterdam, The Netherlands., Results: Linear regression to DCM (n = 90) was (LN-gen = 1.015 DCM + 0.01 g/L, r = 0.993, SE = 0.015 g/L) and (PTA = 1.004 DCM - 0.017 g/L, r = 0.980, SE = 0.025 g/L), with a mean percent bias to DCM of 3.3% and -2.8% for LN-gen and PTA, respectively. The comparison with RM (n = 69) showed an increased mean bias for PTA (-5.8%) as compared with LN-gen (1.5%). The correlation and regression equations were (LN-gen = 1.020 RM - 0.002 g/L, r = 0.985, SE = 0.017 g/L) and (PTA = 1.042 RM - 0.032 g/L, r = 0.984, SE = 0.018 g/L). The precision of LN-gen was confirmed at < 2.1% coefficient of variation, and the total error was calculated to be < or = 7.7% for both normotriglyceride and elevated triglyceride specimens at HDL-C decision points of 0.35 g/L and 0.60 g/L., Conclusions: The LN-gen HDL-C assay offers a cost-effective convenient method for meeting the 1998 precision, bias, and total error recommendations of the National Cholesterol Education Program.

The urinary iodine is the best laboratory measure of iodine nutrition. Several simple methods are suitable for developing countries. The present article reviews these briefly. It also presents preliminary information on "Fast B", a rapid method that puts samples into convenient ranges rather than giving absolute values for individuals. This grouping by ranges is satisfactory for many epidemiological purposes and is considerably more rapid than other approaches. The choice among methods depends on the intended application, the number of samples, the cost and the technical capability. Having several different methods available allows the user to select the one best suited to specific needs. Further development of simple methods and appropriate combinations of steps from different ones deserve encouragement as a means of improving monitoring in the campaign to achieve sustainable elimination of iodine deficiency.

New assay development should be directed toward answering fundamental clinical questions. Caveats that must be considered before initiating assay development projects are: New assays should allow the clinician to interact with and treat a patient more effectively, thereby improving medical outcome; and new assays should facilitate recapture of system resources, enabling cost savings or reinvestment of resources. Defining the clinical questions and consideration of the caveats permit a means of prioritizing assay development activities. Laboratorians are faced with evaluating several types of development activities that lead to assay implementation in routine clinical testing. Assays can be prioritized for up-grading to newer cost-effective technologies, provided the changes maintain or improve analytical and clinical performance. Predicting which research assay will have future value is difficult when clinical performance is not fully validated. However, such assay development has the greatest potential for changing the delivery of healthcare by a clinician.

We studied laboratory internal quality control (QC) processes using the College of American Pathologists Q-Probes program. Over 500 institutions participated, providing practices based on approximately 710,000 cholesterol, 880,000 calcium, 400,000 digoxin, and 1,180,000 hemoglobin QC results. The costs of QC included participant median control samples rates comprising 9.1, 9.4, 37.0, and 6.8% for the four analytes respectively, repeat patient test rates of 0.36% for hemoglobin to 0.65% for digoxin, and median delays in reporting results when QC exceptions occurred of 15.8 min for calcium to 24.7 min for hemoglobin. Quality control practices were complex and highly variable among participants and frequently differed from internal laboratory protocols and from long-established quality guidelines. We conclude that QC is costly, and laboratorians frequently do not follow established QC practices, in part because they are complex. To improve compliance, we believe QC practices must be simplified.