Determinación de hierro sérico: Evolución del desempeño de los laboratorios participantes del Sub-Programa PEEC-Hematología / Iron serum determination: evolution of performance of participating laboratories of the PEEC-Hematology Sub-Program / Determinação de ferro sérico: Evolução do desempenho dos laboratórios participantes do Sub-Programa PEEC-hematologia

El objetivo de este trabajo fue determinar la evolución del desempeño analítico en la determinación de hierro sérico, de los laboratorios participantes del Sub- Programa PEEC-Hematología (PEEC-H) del Programa de Evaluación Externa de Calidad Prof. Dr. Daniel Mazziotta de la Fundación Bioquímica Argentina, mediante el análisis de los resultados de ferremia en 6 encuestas (E) realizadas en los meses de julio entre los años 2010 y 2015 (E 77, 81, 85, 89, 93 y 97). Hasta el 2011 se utilizaban métodos con y sin desproteinización, siendo estos últimos los más utilizados (94%). En 2015 en la red de laboratorios se emplearon solamente métodos directos sin desproteinización, siendo los colorimétricos los más utilizados (aproximadamente 95%). El Desvío Relativo Porcentual aceptable (DRPa) fue de ±10% en todas las encuestas analizadas. El 56% de los laboratorios tuvieron un desempeño promedio aceptable en las E 77, 81 y 85, evolucionando 3 años después, a 70% en las E 89, 93 y 97. Según estas consideraciones, al presente no es necesario ajustar el DRPa para el analito hierro, ya que con este valor los laboratorios aún deben trabajar para lograr una mejoría en su desempeño.

The aim of this work was to evaluate the evolution of the analytical performance of serum iron determination by the laboratories participating in the Sub- Program PEEC-Hematology (PEEC-H) EQAS Program Prof. Dr. Daniel Mazziotta of the Argentine Biochemical Foundation. To this end, results of serum iron determinations from July 2010 to July 2015 (surveys #77, 81, 85, 89, 93 and 97) were used. Up to 2011, there were methods both with and without deproteinization, the latter being the most used (94%). In 2015, only one commercial method without deproteinization was used, with colorimetric methods employed in 95% of the cases. In all the surveys analyzed, the acceptable DRP was ±10%. In surveys 77, 81 and 85, 56% of the laboratories had an acceptable performance percentage, and it evolved to a 70% in the surveys 89, 93 and 97, three years later. According to these considerations, there is no need to adjust the acceptable DRP for the iron analyte. In this way, laboratories will continue to work in order to improve their performance.

O objetivo deste estudo foi determinar a evolução do desempenho analítico na determinação de ferro sérico, dos laboratórios participantes no Sub-Programa PEEC-Hematologia (PEEC-H) do Programa de Avaliação Externa de Qualidade Prof. Dr. Daniel Mazziotta da Fundación Bioquímica Argentina, através da análise dos resultados de ferremia em 6 pesquisas de opinião (E) realizadas nos meses de julho entre os anos 2010 a 2015 (Pesquisa No. 77, 81, 85, 89, 93 e 97). Até 2011 eram empregados métodos com e sem desproteinização, sendo os colorimétricos os mais utilizados (aproximadamente 95%). O Desvio Relativo Percentual aceitável (DRPa) foi de ±10% em todas as pesquisas analisadas. 56% dos laboratórios tiveram desempenho médio aceitável nas pesquisas 77, 81 e 85, progredindo para 70% nas pesquisas de 89,93 e 97, 3 anos mais tarde. De acordo com estas considerações, hoje não é necessário ajustar o DRPa para o analito ferro, visto que com esse valor os laboratórios ainda devem trabalhar para alcançar uma melhoria no seu desempenho.

Quality assessment of cellular therapies: the emerging role of molecular assays

Cellular therapies are becoming increasingly important in treating cancer, hematologic malignancies, autoimmune disorders, and damaged tissue. These therapies are becoming more effective and are being used more frequently, but they are also becoming more complex. As a result, quality testing is becoming an increasingly important part of cellular therapy. Cellular therapies should be tested at several points during their production. The starting material, intermediate products and the final product are usually analyzed. Products are evaluated at critical steps in the manufacturing process and at the end of production prior to the release of the product for clinical use. In addition, the donor of the starting biologic material is usually evaluated. The testing of cellular therapies for stability, consistency, comparability and potency is especially challenging. We and others have found that global gene and microRNA expression analysis is useful for comparability testing and will likely be useful for potency, stability and consistency testing. Several examples of the use of gene expression analysis for assessing cellular therapies are presented.

Annual Report on External Quality Assessment in Urinalysis in Korea (2009) / 임상검사와정도관리

Three external quality assesment trials which composed of 16 control materials(12 chemical materials and four sets of microscopic photograph of urinary sediment) for interlaboratory quality control assesment in urinalysis were performed with 796, 823, and 841 participants, in each, in the year of 2009. The response rate were 97.1% (796/820), 95.5% (823/862) and 97.1% (841/866), in the first, the second and the third trials, in each. The test items include pH, glucose, protein, ketone, bilirubin, blood, urobilinogen, nitrite, leukocyte estrase, specific gravity and four microscopic photographs of urinary sediment. The survey results are summarized as follows: 1. The chemical quality control test in urinalysis revealed generally good concordance. 2. The percentage of using urinalysis analyzer was slightly decreased as 82.3% and the distribution of using reagent strip was similar to the previous year. 3. The percentage of response rate of microscopic photographs of urinary sediment was 83.5% (702/841) and the percentage of good performance of these tests ware 83.6% to 99.1%.

Annual Report on External Quality Assessment in Urinalysis in Korea (2008) / 임상검사와정도관리

Three external quality assesment trials which composed of 16 control materials (12 chemical materials and four sets of microscopic photograph of urinary sediment) for interlaboratory quality control assesment in urinalysis were performed with 699, 718, and 732 participants, in each, in the year of 2008. The response rate were 95.4% (699/733), 96.6% (718/743) and 95.3% (732/767), in the first, the second and the third trials, in each. The test items include pH, glucose, protein, ketone, bilirubin, blood, urobilinogen, nitrite, leukocyte estrase, specific gravity and four microscopic photographs of urinary sediment. The survey results are summarized as follows: 1. The chemical quality control test in urinalysis revealed generally good concordance. 2. The percentage of using urinalysis analyzer was slightly decreased as 83.0% and the distribution of using reagent strip was similar to the previous year. 3. The percentage of response rate of microscopic photographs of urinary sediment was 81.3% (571/732) and the percentage of good performance of these tests ware 32.9% to 80.5%.

Annual Report on External Quality Assessment in Urinalysis in Korea (2005) / 임상검사와정도관리

Three external quality assesment trials which composed of 16 control materials (12 chemical materials and four microscopic photographs of urinary sediment) for interlaboratory quality control assesment in urinalysis were performed with 451, 452, and 476 participants, in each, in the year of 2005. The response rate were 95.6% (451/472), 91.9% (452/492) and 95.6% (476/498), in the first , the second and the third trials, in each. The test items include pH, glucose, protein, ketone, bilirubin, blood, urobilinogen, nitrite, leukocyte estrase, specific gravity and four microscopic photographs of urinary sediment. The survey results are summarized as follows: 1. The chemical quality control test in urinalysis revealed generally good concordance. 2. The percentage of using urinalysis analyzer was slightly increased as 91.2% and the distribution of using reagent strip was similar to the previous year. 3. The percentage of response rate of microscopic photographs of urinary sediment was 76.5%(387/498) and the percentage of good performance of these tests ware 63.6% to 86.5%.

Annual Report on External Quality Assessment in Urinalysis in Korea (2004) / 임상검사와정도관리

Three external quality assesment trials which composed of 16 control materials(12 chemical materials and four microscopic photographs of urinary sediment) for interlaboratory quality control assesment in urinalysis were performed with 446, participants, in each, in the year of 2004. The response rate were 93.4% (422/452), 91.7% (411/448) and 91.7% (410/447), in the first , the second and the third trials, in each. The test items include pH, glucose, protein, ketone, bilirubin, blood, urobilinogen, nitrite, leukocyte estrase, specific gravity and four microscopic photographs of urinary sediment. The survey results are summarized as follows: 1.The chemical quality control test in urinalysis revealed generally good concordance. 2.The percentage of using urinalysis analyzer was slightly increased as 87.9% and the distribution of using reagent strip was similar to the previous year. 3.The percentage of response rate of microscopic photographs of urinary sediment was 80.7% and the percentage of good performance of these tests ware 85.8% to 95.8%.

Annual Report on External Quality Assessment in Urinalysis in Korea (2003) / 임상검사와정도관리

Three external quality assesment trials which composed of 12 control materials(12 chemical materials) for interlaboratory quality control assesment in urinalysis were performed with 446, participants, in each, in the year of 2003. The response rate were 92.4% (414/448), 91.9% (419/456) and 91.3% (408/447), in the first, the second and the third trials, in each. The test items include pH, glucose, protein, ketone, bilirubin, blood, urobilinogen, nitrite, leukocyte estrase and specific gravity. The survey results are summarized as follows: 1. The chemical quality control test in urinalysis revealed generally good concordance. 2. The percentage of using urinalysis analyzer was slightly increased as 86.8% and the distribution of using reagent strip was similar to the previous year.

Annual Report on External Quality Assessment in Urinalysis in Korea (2002) / 임상검사와정도관리

Three external quality assesment trials which composed of 12 control materials(12 chemical materials) for interlaboratory quality control assesment in urinalysis were performed with 446, participants, in each, in the year of 2002. The response rate were 91.5% (408/446), 90.8% (405/445) and 90.4% (403/446), in the first , the second and the third trials, in each. The test items include pH, glucose, protein, ketone, bilirubin, blood, urobilinogen, nitrite, leukocyte estrase and specific gravity. The survey results are summarized as follows: 1.The chemical quality control test in urinalysis revealed generally good concordance. 2.The percentage of using urinalysis analyzer was slightly decreased as 79.0% and the distribution of using reagent strip was similar to the previous year.