Discordant SOX-1 antibodies results in paraneoplastic Lambert-Eaton syndrome diagnosis by the clinical laboratory.

BACKGROUND: Anti-Sry-like high mobility group box 1 (anti SOX-1) proteins are rare onconeural antibodies associated with paraneoplastic Lambert-Eaton myasthenic syndrome (LEMS). Few patients with anti-SOX-1 antibodies and negative anti-glial nuclear antibody reactivity have been described to date. CASE SUBJECT AND METHODS: Our case involves a 72-year-old female patient with progressive girdle weakness, sensation of heaviness in the lower limbs, predominantly distal and associated with circulatory problems together with instability when walking, with a high suspicion of an autoimmune myopathic disorder. Immunoblot test for autoimmune myopathies antibodies detection were all negative. Onconeuronal antibodies were determined in serum by indirect immunofluorescence being negative as well. Given the high suspicion, we also checked for the presence of other antineuronal antibodies whose patterns are not visible by IIF. RESULTS: Onconeuronal antibodies by immunoblot for the following antibodies: Hu, Ri, Yo, Zic4, Tr, PCA-2, MA-TA, CV2, GAD65, Zic4, Titin, SOX1, Recoverin and Amp, revealed an unexpected clear band in SOX-1, which are highly suggestive of paraneoplastic LEMS. DISCUSSION: We hypothesize that discordant onconeuronal antibodies results were due to the fact that positivity in IIF is associated with other SOX-B group proteins (normally related to cases of non-paraneoplastic neuropathy), while negativity in IIF and subsequent confirmed presence of specific SOX1 antibody by immunoblot could indicate an underlying tumor.

Computer physician order entry (CPOE) as a strategy to estimate laboratory activity and costs associated with cancer clinical trials.

INTRODUCTION: Most of clinical laboratories are not properly reimbursed for their activity related to clinical trials (CTs) conducted in their institutions due to a lack of measurement strategies. We implemented a specific computer physician order entry (CPOE) environment for CTs in order to facilitate ordering to providers and estimate the associated costs to be compared with the standard of care (SOC). MATERIALS AND METHODS: Four specific electronic formularies, restricted to two new virtual CTs clinical services (onco - CT and haemo - CT), were implemented in January 2015. For each clinical trial displayed in the panels there were several box-cells that contained several profiles based on the different phase of the trials. Tests included in the profiles were the tests required by protocol. Laboratory costs (€) per patient were compared between the CTs services and their regular outpatients clinical services (onco - Out and haemo - Out, considered the SOC) for three years. RESULTS: Costs per patient were higher for CTs services and increased progressively each year (25%, 70% and 70% and 0.6%, 2.7% and 17% in 2015, 2016 and 2017 for Oncology and Haematology, respectively). Taking into account all these differences and the number of patients attending a total difference in expense of + 130,377.7 € for the period 2015-2017 was obtained between CTs and outpatients services. CONCLUSIONS: Strategies through CPOE systems based on restricted and specific profiles for CTs ordering are a promising tool that can improve laboratory associated costs estimation and provide robust evidence in reimbursement negotiation processes with CTs sponsors.

"Send & hold" clinical decision support rules improvement to reduce unnecessary testing of vitamins A, E, K, B1, B2, B3, B6 and C.

BACKGROUND: We assessed the impact of several "send & hold" clinical decision support rules (CDSRs) within the electronical request system for vitamins A, E, K, B1, B2, B3, B6 and C for all outpatients at a large health department. METHODS: When ordered through electronical request, providers (except for all our primary care physicians who worked as a non-intervention control group) were always asked to answer several compulsory questions regarding main indication, symptomatology, suspected diagnosis, vitamin active treatments, etc., for each vitamin test using a drop-down list format. After samples arrival, tests were later put on hold internally by our laboratory information system (LIS) until review for their appropriateness was made by two staff pathologists according to the provided answers and LIS records (i.e. "send & hold"). The number of tests for each analyte was compared between the 10-month period before and after CDSRs implementation in both groups. RESULTS: After implementation, vitamins test volumes decreased by 40% for vitamin A, 29% for vitamin E, 42% for vitamin K, 37% for vitamin B1, 85% for vitamin B2, 68% for vitamin B3, 65% for vitamin B6 and 59% for vitamin C (all p values 0.03 or lower except for vitamin B3), whereas in control group, the majority increased or remained stable. In patients with rejected vitamins, no new requests and/or adverse clinical outcome comments due to this fact were identified. CONCLUSIONS: "Send & hold" CDSRs are a promising informatics tool that can support in utilization management and enhance the pathologist's leadership role as tests specialist.

Utility of routine laboratory preoperative tests based on previous results: Time to give up.

INTRODUCTION: The usefulness and cost-effectiveness of routine laboratory preoperative tests (POTs) have been challenged recently. In fact, the American Society of Anesthesiologists (ASA) Task Force has stated that test results obtained from the medical record within 6 months of surgery generally are mostly acceptable. The aim of our study was to evaluate the degree of utility of POTs and their clinical benefit based on this recommendation. MATERIAL AND METHODS: We studied retrospectively every routine POT request from 8 randomly selected weeks in 2016. Every POT contained glucose, creatinine, haemoglobin and coagulation tests (PT-INR). Each pathological result for these tests was registered and classified as "expected" (if previous pathological result within 6 months existed for that test) or "unexpected" (if previous pathological result within 6 months did not exist for that test). Results of ASA physical status classification (a system for assessing the fitness of patients before surgery) and changes in patient management after POTs were retrieved from medical history as well. RESULTS: A total of 4516 tests (from 1129 patients) were analysed and 498 results were found pathological (11%). Of these, 403 were expected (8.9%) and 95 unexpected (2.1%). There was not any change in anaesthetic management for any patient due to these findings. CONCLUSIONS: Routine POTs are an inefficient and low-value service. POTs have to be always ordered selectively after a previous consideration of specific information obtained from several sources (medical records, interviews, examinations, type of surgery) and only if the information obtained will result in changes in the management of the patient.

Failure to review STAT clinical laboratory requests and its economical impact.

BACKGROUND: Failure to follow-up laboratory test results has been described as one of the major processes contributing to unsafe patient care. Currently, most of the laboratories do not know with certainty not only their rate of missed (or unreviewed) requests but the economical cost and impact that this issue implies. The aim of our study was to measure that rate and calculate the resulting costs. MATERIAL AND METHODS: In January 2015, we checked in our Laboratory Information Management System (LIMS) for every emergency request from 1(st) July 2011 to 30(th) June 2014, if they had been reviewed by any allowed user or not. 319,064 requests were ordered during that period of time. Results were expressed as "ordered requests", "missed requests" and its percentage. Additionally, total cost of missed requests was calculated in euros (€). "Non-productive days" were theorised (as the days producing requests that were not reviewed) based on these results. RESULTS: 7924 requests (2.5%) were never reviewed by clinicians. This represented a total cost of 203,039 € and 27 "non-productive" days in three years. Significant differences between inpatients, outpatients and emergency department as well as different emergencies units were found after application of statistical analysis. CONCLUSIONS: In terms of resources, never reviewed or missed requests appear to be a not negligible problem for the clinical laboratory management. Electronic result delivery, with electronic endorsement to indicate follow-up of requests along with better systems of electronic requesting should be investigated as a way of improving patient outcomes and save unnecessary expenses.

When an Analytical Interference Is a Useful Diagnostic Tool: Finding Monoclonal Gammopathies in Routine Analysis.

BACKGROUND: The daily productivity of a clinical laboratory depends on the large number of interferences that affect analytical accuracy. Obviously, they have always been considered as a very important aspect to keep accuracy under control. Nevertheless, we wondered if this aspect would be beneficial. In this article, we propose a method for finding monoclonal gammopathies that are based on the fact that the presence of paraprotein in the sample may interfere with routine laboratory assays, specifically, with the quantification of uric acid and conjugated bilirubin. METHODS: Over a 5-month period, we evaluated 18,278 sera samples of patients from primary care. None of them were suspected of having plasma cell dyscrasias (not observed hypercalcemia, renal failure, anemia, and/or lytic bone lesions). Although biochemical findings suggested paraprotein interference, we carried out serum capillary electrophoresis (CE) and quantification of immunoglobulins and serum-free light chains (SFLCs). We also confirmed the results obtained by performing the corresponding immunofixation electrophoresis (IFE). Flow cytometry analyses were conducted for immunophenotypic characterization of plasma cells from these patients. RESULTS: The proposed detection method allowed us to identify eight patients with previously undiagnosed monoclonal gammopathy. CONCLUSIONS: The results show that it is possible to use analytical interference for diagnostic purposes, and most importantly, almost all cases were identified at an early stage of the disease, when associated clinical manifestations were not yet observed.

[Prostate Specific Antigen (PSA) use in a national health department]. / USO DEL ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) EN UN DEPARTAMENTO DE SALUD NACIONAL.

OBJECTIVES: PSA is a frequently used marker in the daily clinical practice for the diagnosis and management of prostate cancer. We analysed the use of PSA in our health department in patients with and without prostate cancer diagnosis. METHODS: The registry of all PSA petitions in our health department during 2011 and 2012 was used. Demographic data were used to establish each year's population and the data corresponding to the prevalence of prostate cancer patients, performing a descriptive study. Thus, the use of PSA in patients with or without prostate cancer was studied. RESULTS: 25.700 PSA petitions are issued annually in our department over a total of 67.000 males older than 45. This entails a cost of 332.815 Euros annually. Within the group of patients with no prostate cancer diagnosis, it was noticed that the percentage of individuals with at least one annual PSA petition per decade of age is of 23% in males in their fifties, 40% in their sixties, 46% in their seventies, and 36% in their eighties or successive decades. Furthermore, in these cancer-free patients, around 3.800 annual petitions fall on individuals over 75 and with PSA under 4 ng/ml, from which 20% are repeated petitions over the same individual in the same year. Over 1100 males under 45 have an annual PSA. Regarding the average PSA value for decade of age in cancer-free patients, it is of 0.89 +/- 0.4 ng/ml in the forties decade, 1.26 +/- 1.07 ng/ml in the fifties, 1.67 +/- 1.38 ng/ml in the sixties, 1.96 +/- 1.78 ng/ml in the seventies, and 2.24 +/- 2.16 ng/ml in the eighties. We ascertained, also, that for every 144 PSA petitions one prostate cancer case is diagnosed. Regarding the use of this marker in cancer patients, 1.800 petitions are destined to patients follow up annually, and over 200 fall on the newly diagnosed cases. CONCLUSIONS: Even though annually less than 50% of males get PSA petitions in any decade of age, its use is sometimes incorrect, including repeated petitions in a short period of time or in individuals of extreme age.

Uso del antígeno prostático específico (PSA) en un departamento de salud nacional / Prostate Specific Antigen (PSA) use in a national health department

OBJETIVO: El PSA es un marcador de uso frecuente en la práctica clínica diaria, para el diagnóstico y manejo del cáncer de próstata. Analizamos el uso que se hace del PSA en nuestro departamento sanitario en pacientes con y sin diagnóstico de cáncer de próstata. MÉTODOS: Se recurrió a los registros de todas las peticiones analíticas de PSA en nuestro departamento sanitario durante 2011 y 2012. Se utilizaron los datos demográficos para establecer la población en cada año, y los datos correspondientes a la prevalencia de enfermos con cáncer de próstata, realizándose un estudio descriptivo. De esta forma, se estudió el uso que se hace del PSA en pacientes con cáncer y sin él. RESULTADOS: Existen unas 25.700 peticiones anuales de PSA en nuestro departamento sobre un total de 67.000 varones mayores de 45 años. Esto supone un coste de 332.815 euros anuales. Dentro del grupo de pacientes sin diagnóstico de cáncer de próstata se observó que, el porcentaje de individuos con al menos una petición de PSA anual por década de edad es del 23% de varones en la década de los 50 años, 40% en los 60 años, 46% en los 70 años, y 36% en la década de los 80 o sucesivas. Además, en estos pacientes sin cáncer, unas 3.800 peticiones anuales recaen sobre sujetos mayores de 75 años y con PSA por debajo de 4 ng/ml, de las cuales un 20% son peticiones repetidas en el mismo año sobre el mismo sujeto. A más de 1.100 varones menores de 45 años se les pide un PSA anualmente. En cuanto a la media de PSA por década de edad en pacientes sin cáncer, es de 0,89 +/- 0,4ng/ml en la década de los 40, 1,26+/- 1,07 ng/ml en los 50,1,67 +/- 1,38 ng/ml en los 60, 1,96 +/- 1,78 ng/ml en los 70, y 2,24 +/- 2,16 ng/ml en los 80. Comprobamos, además, que por cada 144 solicitudes de PSA se diagnostica un cáncer de próstata. Respecto al uso de este marcador en pacientes con cáncer, 1.800 peticiones se destinan al año a seguimientos de enfermos, y más de 200 recaen sobre los nuevos diagnosticados anualmente. CONCLUSIONES: Aunque no se sobrepasa un 50% de varones con peticiones de PSA anuales en ninguna década de edad, el uso que se hace del mismo es en ocasiones, incorrecto, incluyendo peticiones repetidas en poco tiempo o en individuos con edades extremas

OBJECTIVES: PSA is a frequently used marker in the daily clinical practice for the diagnosis and management of prostate cancer. We analysed the use of PSA in our health department in patients with and without prostate cancer diagnosis. METHODS: The registry of all PSA petitions in our health department during 2011 and 2012 was used. Demographic data were used to establish each year's population and the data corresponding to the prevalence of prostate cancer patients, performing a descriptive study. Thus, the use of PSA in patients with or without prostate cancer was studied. RESULTS: 25.700 PSA petitions are issued annually in our department over a total of 67.000 males older than 45. This entails a cost of 332.815 Euros annually. Within the group of patients with no prostate cancer diagnosis, it was noticed that the percentage of individuals with at least one annual PSA petition per decade of age is of 23% in males in their fifties, 40% in their sixties, 46% in their seventies, and 36% in their eighties or successive decades. Furthermore, in these cancer-free patients, around 3.800 annual petitions fall on individuals over 75 and with PSA under 4 ng/ml, from which 20% are repeated petitions over the same individual in the same year. Over 1100 males under 45 have an annual PSA. Regarding the average PSA value for decade of age in cancer-free patients, it is of 0.89 +/- 0.4ng/ml in the forties decade, 1.26 +/- 1.07 ng/ml in the fifties, 1.67 +/- 1.38 ng/ml in the sixties, 1.96 +/- 1.78 ng/ml in the seventies, and 2.24 +/- 2.16 ng/ml in the eighties. We ascertained, also, that for every 144 PSA petitions one prostate cancer case is diagnosed. Regarding the use of this marker in cancer patients, 1.800 petitions are destined to patients follow up annually, and over 200 fall on the newly diagnosed cases. CONCLUSIONS: Even though annually less than 50% of males get PSA petitions in any decade of age, its use is sometimes incorrect, including repeated petitions in a short period of time or in individuals of extreme age

Reactividad cruzada de preparados de insulina recombinante con 2 inmunoanálisis comerciales para determinación de insulina en sangre / Cross-reactivity of recombinant insulin preparations with two commercial insulin inmunoassays

Introducción: Existe gran variabilidad en la capacidad de detección de análogos de insulina e insulinas recombinantes por los inmunoanálisis comerciales para determinación de insulina. Conocer qué preparados de insulina pueden detectar un método, y cuáles no, es necesario para interpretar algunos resultados de laboratorio. Objetivo: Determinar la reactividad cruzada de insulina soluble, insulina NPH, glulisina y detemir con los inmunoanálisis de insulina Elecsys/E170 (Roche) y Architect (Abbott). Material y métodos: Se prepararon diluciones (rango 20---1.000 mU/l) de glulisina, detemir, insulina soluble e insulina NPH. Se analizaron con los inmunoanálisis de insulina Elecsys/E170 (Roche) y Architect (Abbott). Se calculó la reactividad cruzada (%) para cada dilución. Resultados: Con Elecsys/E170 la reactividad cruzada de glulisina y detemir fue < 5% en todas las diluciones; para insulina soluble, el promedio de la reactividad cruzada fue de 120% y para insulina NPH de 106%. En Architect, el promedio de la reactividad cruzada de glulisina fue del 12,6%; detemir 130% para 20 mU/l y > 240% para 100 mU/l; insulina soluble 99% e insulina NPH 153%. Conclusiones: Elecsys/E170 detecta las 2 insulinas de secuencia humana y no detecta glulisina ni detemir. Architect detecta las insulinas de secuencia humana y el análogo detemir; para glulisina, el promedio de reactividad cruzada es del 12,6%. La colaboración entre laboratorios que utilizan diferentes inmunoanálisis puede ser útil para aclarar algunos cuadros clínicos de hipoglucemia, en los que se sospecha sobredosis o administración indebida de preparados de insulina (AU)

Introduction: The large variability in cross-reactivities of recombinant insulin preparations with different commercial assays is noteworthy. It is imperative to know which recombinant insulin preparations a method can detect and which ones it cannot, to interpret certain laboratory results. Objective: To asses the cross-reactivity of soluble insulin, insulin NPH, glulisina and detemir with insulin inmunoassays Elecsys/E170 (Roche) and Architect (Abbott). Material and methods: Solutions of glulisine, detemir, soluble insulin and insulin NPH (20 - 1000 mU/L) were prepared and analized with insulin inmunoassays Elecsys/E170 (Roche) and Architect (Abbott). The cross-reactivity percentage was calculated for each solution. Results: With Elecsys/E170, the cross-reactivity of glulisine and detemir was < 5% for all solutions. The cross-reactivity of soluble insulin was 120% and insulin NPH 106%. With Architect, the cross-reactivity of glulisine was 12,6%; detemir 130% for 20 mU/L and >240% for 100 mU/L; soluble insulin 99% and insulin NPH 153%. Conclusions: Elecsys/E170 detects both preparations of insulin of human sequence but it does not detect gluisine nor detemir. Architect detects both preparations of insulin of human sequence and detemir; for gluisine the average of cross-reactivity is 12,6%. Colaboration between laboratories employing different immunoassays may be useful to throw light on some hypoglycemia profiles, where overdose or misadministration of insulin preparations is suspected (AU)

Vitamin D status is linked to biomarkers of oxidative stress, inflammation, and endothelial activation in obese children.

OBJECTIVE: To examine vitamin D, parathyroid hormone, and serum calcium-phosphorus levels relationships to biomarkers of oxidative/nitrosative stress, inflammation, and endothelial activation, potential contributors for vascular complications in obese children. STUDY DESIGN: Cross-sectional clinical study of 66 obese Caucasian children aged 7 to 14 years. Cardiovascular risk factors were assessed. Malondialdehyde and myeloperoxidase as measures of oxidative stress, and plasma nitrite+nitrate, urinary nitrate, and 3-nitrotyrosine as markers of nitrosative stress were measured. Adipocytokines, inflammatory molecules (high-sensitivity C-reactive protein, interleukin-6, and tumor necrosis factor-α), endothelial activation molecules (soluble intercellular adhesion molecule-1, soluble vascular cell adhesion molecule 1 [sVCAM-1]), E-selectin, and vascular endothelial growth factor were also investigated. Serum 25-hydroxy-cholecalciferol [25(OH)D], intact parathormone, and calcium-phosphorus levels were determined in these children and in a comparison group of 39 non-obese children. RESULTS: Obese children had a significantly lower 25(OH)D level (P = .002) and a higher intact parathormone (P = .011) than non-obese children. Phosphorus and the calcium-phosphorus product were also significantly higher (P < .0001). Insufficient serum concentrations of 25(OH)D (<20 ng/mL) were detected in 5% of normal children and in 30% of the obese children. In the obese children with vitamin D insufficiency, malondialdehyde, myeloperoxidase, 3-nitrotyrosine, interleukin-6, and sVCAM-1 were substantially elevated. A partial correlation analysis showed an inverse relationship of 25(OH)D levels with 3-nitrotyrosine (r = -0.424, P = .001), and sVCAM-1 (r = -0.272, P = .032). CONCLUSIONS: Insufficient 25(OH)D levels were detected in severely obese children with increased markers of oxidative/nitrosative stress, inflammation, and endothelial activation.

Programa de Evaluación Externa de la Calidad de los Laboratorios Clínicos de la Comunidad Valenciana / No disponible

El Programa de Evaluación Externa de la Calidad de los Laboratorios Clínicos de la Comunidad Valenciana (EECLCCV) fomenta la calidad y transferibilidad de los resultados de los laboratorios participantes, informando de su calidad analítica y grado de homogeneidad de sus resultados. El presente artículo describe su origen y funcionamiento y su reciente transformación usando tecnología Web, que ha permitido su expansión en cuanto a número de laboratorios, tipos análisis, muestras, etc. gracias a su gestión automática (AU)

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