The quantitative analysis methods validation of Paeonia Anomala L. Tincture / Монголын эм зүй, эм судлал

Introduction@#The development of analytical methods for evaluation of quality standard parameters of drugs and other health prophylactic, diagnostic, and therapeutic products is essential from the beginning in the process to release to the market finished product. Validation of developed analytical methods is one crucial part of the analysis.</br> Quantitative determination methods of the total main active compounds of the tincture prepared from the root and the herb of <i>Paeonia anomala</i> L. were developed. In order to verify whether the analytical procedure is suitable for its intended purpose parameters – accuracy, reproducibility, intermediate precision, and linearity were validated.@*Materials and methods@#The total phenolics in the tincture were determined by the reaction with Folin Chicolteau reagent and total monoterpene glycosides by the reaction with hydroxylamine in alkaline solution and ferric (III) chloride following spectrophotometric examination, respectively. Based on the achieved results of the developed quantitative methods which were validated according to the accepted and pursued technical documents in our country the Eurachem guide “The Fitness for Purpose of Analytical Methods” and Russian Pharmacopoeia 13 “Validation of analytical methodology”, where parameters as accuracy, precision – reproducibility, intermediate precision, and linearity are involved.@*Conclusions@#Statistical analysis of total phenolic compounds and total monoterpene glycosides in the <i>Paeonia anomala</i> tincture demonstrated that the bias calculated was for accuracy 0.674% and 0.703%, relative standard deviations were for reproducibility 0.896% and 0.798%, for inter- mediate precision 0.922% and 0.696%, respectively and the linearity – R²=0.9985 and R²=0.9997. All achieved results validated the appropriateness of the developed quantitative methods for the intended purpose.

Conditions for the determination of intrinsic uniformity and intrinsic spatial linearity of SPECT / 中国辐射卫生

Objective To address the absence of matrix specified for the determination of intrinsic uniformity in the current standard, and to investigate the effect of source distances on intrinsic spatial linearity, the intrinsic uniformity and intrinsic spatial linearity of 16 probes in eight SPECT devices were measured and analyzed with different matrices and source distances, in order to determine the optimal measurement conditions. Methods According to the standard Specification for Testing of Quality Control in Gamma Cameras and Single Photon Emission Computed Tomograph (SPECT) (WS 523—2019), the intrinsic uniformity was measured using 64 × 64 and 256 × 256 matrices and the intrinsic spatial linearity was measured using of 1.7 and 3 m source distances. Results When intrinsic uniformity was measured with the 64 × 64 matrix, more than 50% of the probes showed lower values. When intrinsic spatial linearity was measured with the 3 m source distance, more probes showed lower values. Conclusion The 64 × 64 matrix is recommended for the determination of intrinsic uniformity and a source distance of ＞5 FOV is recommended for the measurement of intrinsic spatial linearity.

¿Psicoanálisis y desarrollo? Aportes desde una perspectiva no lineal / Psychoanalysis and Development? Contributions from a non-Linear Perspective

Resumen El presente artículo problematiza la relación entre psicoanálisis freudiano y la perspectiva del desarrollo lineal, determinista y teleológica. A pesar de las impregnaciones evolucionistas del contexto histórico en que Freud gesta sus ideas, se encuentran conceptos que muestran una fuerte ruptura con la idea de un despliegue guiado por el ritmo de etapas prefijadas por edades. Así se postula la a-temporalidad de los procesos inconscientes y la Nachträglichkeit a la luz de las perspectivas no lineales emergentes desde las ciencias de la complejidad. Finalmente, se reflexiona sobre una psique que, en su carácter abierto y complejo, contempla lo aleatorio, lo impredecible y el azar en su devenir, y se transforma mediante trabajo elaborativo simbólico del yo. Así, sólo la historización, nunca lineal, contempla lo nuevo como posibilidad de (re)constituir la historia pasada.

Abstract This article problematizes the relationship between Freudian psychoanalysis and the linear, deterministic, and teleological perspective on development. Despite the evolutionist impregnations of the historical context in which Freud conceives his ideas, there are concepts that show a sharp break with the idea of an unfolding guided by a rhythm of stages prefixed by ages. Thus, the a-temporality of the unconscious processes and the Nachträglichkeit is postulated considering the non-linear perspectives that emerge from the sciences of complexity. Finally, we reflect on a psyche that, in its open and complex character, contemplates the fortuitous, the unpredictable and chance in its becoming, and is transformed through the elaborative symbolic work on the self. Like this, only the historicization, which is never linear, contemplates what is new as a possibility to (re)construct the past history.

Test and discussion on SPECT performance under the Chinese health industry standard WS523-2019 / 中华放射医学与防护杂志

Objective:To discuss the problems existing in the implementation of the Chinese health industry standard WS 523-2019 by testing SPECT device.Methods:Under the WS 523-2019 standards, a total of 10 SPECT devices were tested with regard to their SPECT reconstructed spatial resolution (SRSR), system planar sensitivity (SPS), system spatial resolution (SSR), whole body system spatial resolution (WSSR), intrinsic uniformity (IU), intrinsic count rate performance (ICR), intrinsic spatial resolution (ISR) and intrinsic spatial linearity(ISL).Result:Under the requirements of WS 523-2019 standards for qualified limits, there are 3 devices with ISL unqualified and the rest of the performances qualified. The new standards basically can meet the clinical requirements and reflected the overall performance of SPECT.Conclusions:The distance between the radiation source and the surface of the detector has great influence on the spatial resolution.In the measurement of ISL, there must be a lead grid separately in the x and y directions. The lead grids with the parallel slits shall be positioned on the detector with the center slit centered on the detector. It is suggested to add rotation center in the new standards.

Performance Evaluation of the CRE2 Reagent from Siemens for Serum Creatinine Measurement

BACKGROUND: For creatinine measurement, the enzymatic method is known to be more accurate than the Jaffe method; however, the latter is still widely used. We evaluated the performance of the CRE2 reagent (Siemens Healthcare Diagnostics Inc., USA), which uses a modified Jaffe method. METHODS: Three quality control standards were used for precision evaluations of CRE2 on Dimension VISTA 500 instrument (Siemens). Moreover, the linearity and carryover characteristics were assessed. Sixty-eight creatinine results obtained using the CRE2 and ECREA (enzymatic) reagents (Siemens) were compared with those obtained using the L-CRE (enzymatic) reagent (Shinyang Diagnostics, Korea). The accuracy of CRE2, ECREA, and L-CRE was evaluated using a standard reference material. RESULTS: The CV of within-run (0.7–2.4%), between-run (0.4–1.7%), between-day precision (0.7–0.9%) for three standards, and total CV for medium (1.6%) and high levels (1.3%) satisfied the analytical goal. The linearity for CRE2 was excellent (R2=0.999). Comparisons of CRE2 and ECREA to L-CRE were well correlated (r=0.996 and 0.997, respectively). In comparison with L-CRE, 5 CRE2 results and 15 ECREA results exceeded minimum bias goal (5.1%) in samples with creatinine levels of >1 mg/dL. The carryover rate was −0.04%. In terms of accuracy, the percent bias values of CRE2, ECREA, and L-CRE were 7.4, −6.4, and −3.4, respectively, for low level; and 3.9, −1.5, and 0.7, respectively, for high level. CONCLUSIONS: For creatinine measurements, the CRE2 reagent showed good performance. It can be used in the diagnosis, treatment monitoring, and risk assessment of kidney diseases.

Performance Evaluation of SENTiFIT 270 and FOB Gold Reagent for Detecting Fecal Occult Blood / 대한임상미생물학회지

BACKGROUND: Fecal occult blood tests have been widely used to screen for colorectal cancer. SENTiFIT 270 (Sentinel diagnostics, Italy) is a fecal occult blood test with an immunochemical method that utilizes FOB Gold reagents. We evaluated the performance of SENTiFIT 270 using the FOB Gold reagent. In addition, FOB Gold was evaluated with the HITACHI 7180 (Hitachi Ltd., Japan). METHODS: The precision and linearity of the SENTiFIT 270 was evaluated in accordance with applicable Clinical and Laboratory Standard Institute guidelines. The comparison study between SENTiFIT 270-FOB Gold and the OC-Sensor (Eiken chemical Co., Japan) was performed using stool specimens. RESULTS: In the precision evaluation, the total precision of SENTiFIT 270-FOB Gold was 4.94% and 2.54% at high and low concentrations, respectively. The HITACHI 7180-FOB Gold had excellent precision of 4.60% and 2.09% at high and low concentrations, respectively. Linearity was also excellent for the SENTiFIT 270-FOB Gold and HITACHI 7180-FOB Gold at 0.9987 and 0.9986, respectively. The SENTITIF 270-FOB Gold showed excellent agreement with a kappa value of 0.830 and a concordance rate of 93.6%. The HITACHI 7180-FOB Gold showed high agreement with a kappa value of 0.832 and a concordance rate of 93.9%. CONCLUSION: The SENTiFIT 270-FOB Gold showed excellent performance in accuracy, linearity, and comparative inspection ability.

Movement patterns of humpback whales (Megaptera novaeangliae) reoccupying a Brazilian breeding ground / Padrões de movimento das baleias-jubarte (Megaptera novaeangliae) reocupando uma área reprodutiva brasileira

Abstract: The population of humpback whales from breeding stock A is increasing, and little is known about the routes used by humpbacks that move north of the main calving area of Brazil, the Abrolhos Bank. The aim of this study was to describe the movements of humpback whales in a reoccupation wintering area (Serra Grande, Bahia state, Brazil) based on land-based surveys to test if movement patterns change during the season and between years, due to group composition, behavioral state, and distance to the coast. The mean leg speed of the groups sighted was 6.88 (±2.92) km/h, and leg speed was positively correlated with distance to the coast. There was an increase in leg speed and distance to the coast with increasing number of escorts in the groups with calves. The mean linearity value for group trajectory was 0.81 (±0.19) and the mean reorientation rate was 25.72 (±19.09) º/min. We observed a predominance of trajectories heading south throughout the study. Groups exhibiting more erratic movements early in the season, and groups moving south showed more linear trajectories than groups moving north, indicating the beginning of their migration back to the feeding grounds. Energy conserving strategies and social context affect the movements of humpback whales in Serra Grande, resulting in the observed patterns of the reoccupation of available and suitable habitat north of Abrolhos. Thereby, special attention should be given managing activities with the potential to disturb or displace whales using the region to calve and breed.

Resumo: A população das baleias-jubarte do estoque reprodutivo A está aumentando, e pouco se sabe sobre as rotas usadas pelas baleias que se movem a norte da maior área de reprodução do Brasil, o Banco dos Abrolhos. O objetivo deste estudo foi descrever os movimentos das baleias-jubarte em uma área de reocupação (Serra Grande, estado da Bahia, Brasil) através do monitoramento por ponto fixo para testar se os padrões de movimento mudam ao longo da temporada e entre os anos, devido à composição de grupos, estado comportamental, e distância à costa. A média da velocidade da pernada dos grupos observados foi de 6,88 (±2,92) km/h, apresentando uma correlação positiva com a distância à costa. Houve um aumento da velocidade da pernada e da distância à costa com o aumento do número de escortes nos grupos com filhotes. A linearidade média das trajetórias dos grupos foi de 0,81 (±0,19) e a taxa média de reorientação foi de 25,72 (±19,09) º/min. Observamos uma predominância das rotas com rumo para sul ao longo do estudo. No início da temporada, os grupos apresentaram movimentos mais erráticos, e os grupos se deslocando para sul apresentaram trajetórias mais lineares que grupos se movendo para norte ou para outras direções, indicando o início da migração de volta ao seu sítio alimentar. Estratégias para economizar energia e o contexto social afetam o movimento das baleias-jubarte em Serra Grande, resultando nos padrões observados de reocupação de habitat disponível e adequado a norte de Abrolhos. Desse modo, uma atenção especial deve ser dada para a gestão de atividades com o potencial para perturbar ou deslocar as baleias que usam a região para se reproduzir.

A study of non-reduced SDS-PAGE purity method of conbercept / 药学学报

A non-reduced SDS-PAGE purity method for quantitation of conbercept fragments was established based on gel screening, comparison of gel imaging system, linearity range of main band, screening of destaining conditions. The results indicated that the bands could be separated effectively with good clearness and flatness on 4%-15% gradient concentration gel, the peaks of all bands could be separated from baseline using high-distinguishability gel imaging system, the signal intensity of a main band had shown a good linearity with ≤ 3 μg of loading amount, and that the destaining was set as a total of ≤ 3 h with exchanging 100 mL destaining buffer every 60 min. The established non-reduced SDS-PAGE method could demonstrate the purity of conbercept more objectively. After validation, the established non-reduced SDS-PAGE method was submitted to FDA in the form of supplementary materials, which laid a quality basis for the direct entry of conbercept to the clinical Ⅲ study in the United States.

Desarrollo y estandarización de métodos de calibración para equipos utilizados en salud visual (queratómetros, lensómetros y tonómetros), implementados en el hospital universitario de san vicente fundación / Development and standardization of calibration methods for equipment used in visual health (keratometers, lensometers and tonometers), implemented in the hospital universitario de san vicente fundación / Desenvolvimento e estandardização de métodos de calibração para equipamentos utilizados em saúde visual (keratometômetros, lensômetros e tonômetros), implementados no hospital universitario san vicente fundación

Resumen En el campo de la salud visual se utilizan una serie de equipos que ayudan al diagnóstico de la patología del paciente, pero actualmente no existe un método de calibración estandarizado para asegurar las mediciones que se realizan con estos dispositivos. El objetivo era estandarizar métodos de calibración para algunos de los equipos utilizados en el campo de la salud visual como son: queratómetros, lensómetros y tonómetros. Para la calibración de los tres tipos de equipos incluidos en este desarrollo, se utilizaron métodos de comparación directa de la indicación con la magnitud de los patrones utilizados que tenían trazabilidad con laboratorios nacionales e internacionales acreditados bajo la Norma NTC-ISO/IEC 17025:2005. Las mediciones realizadas por cada uno de los técnicos a los diferentes tipos de equipos en condiciones de repetibilidad y utilizando el método adoptado, se hicieron estadísticamente con la herramienta Anova Simple de Statgraphics, arrojando resultados satisfactorios con un valor-P por encima de 0,05, igualmente se realizaron pruebas de exactitud, linealidad y robustez con resultados positivos. Los métodos adoptados fueron exitosamente validados y posteriormente estandarizados bajo la acreditación en la Norma NTC-ISO/IEC 17025:2005.

Abstract In the field of visual health a series of equipment are used to aid in the diagnosis and treatment of the patient's pathology. Urrently there is no standardized calibration method to ensure the measurements performed with these devices. The objective was to standardize calibration methods for some of the equipment used in the field of visual health such as keratometers, lensometers and tonometers. For the calibration of the three types of equipment included in this development, methods of direct comparison were used of the indication with the magnitude of the standards that had traceability with national and international laboratories accredited under the NTC-ISO / IEC 17025: 2005 standard. The measurements made by each of the technicians to the different types of equipment were done under repeatable conditions and using the adopted methods. Results were analyzed statistically with the simple Anova tool of Statgraphics, yielding satisfactory outcomes with a P-value above 0.05. Tests of accuracy, linearity and robustness were also performed with positive results. The adopted methods were successfully validated and later standardized under the accreditation in NTC-ISO / IEC 17025: 2005 standard.

Resumo No campo da saúde visual utilizam-se uma série de equipas que ajudam ao diagnóstico da patologia do paciente, mas, atualmente não existe um método de calibração padronizado para assegurar as medidas que se realizam com estes dispositivos. O objetivo foi estandardizar métodos de calibração para alguns das equipas utilizadas no campo da saúde visual como são: ceratômetro, lenteômetros e tonometros. Para a calibração dos três tipos de equipamentos incluídos neste desenvolvimento, utilizaram-se métodos de comparação direta da indicação com a magnitude dos padrões utilizados que tinham rastreabilidade com laboratórios nacionais e internacionais acreditados baixo a Norma NTC-ISO/IEC 17025:2005. As medidas realizadas por cada um dos técnicos aos diferentes tipos de equipamentos em condições de repetir-se e utilizando o método adoptado, se analisaram estatisticamente com a ferramenta anova simples de statgraphics, produzindo resultados satisfatórios com um valor-P acima de 0,05, igualmente se realizaram provas de exatidão linearidade e robustez com resultados positivos. Os métodos adoptados foram validados de maneira exitosa e posteriormente padronizados baixo a acreditação na Norma NTC-ISO/ IEC 17025:2005.

The performance evaluation on 3 hemoglobin analyzers / 中国输血杂志

Objective To carry out the performance evaluation on 3 hemoglobin analyzers-URIT-12,HemoCue Hb301 and CompoLab TS.Methods Verification of inter-run precision,intra-day precision,and correlation of the 3 analyzers using samples with different concentrations.Results The lower values of inter-run precision of URIT-12,HemoCue Hb301 and CompoLab TSoft were 1.46％,1.45％ and 1.32％,respectively,and the median values were 1.43％,0.56％ and 1.49％,respectively.The lower values of intra-day precision were 1.86％,1.62％ and 1.32％ respectively for URIT-12,HemoCue Hb301 and CompoLab TSoft,with the median values of 1.45％,1.95％ and 1.78％ and the higher values of 1.86％,1.74％ and 1.81％.Based on the results of Beckman-Coulter AcT5diff automatic blood cell analyzer,linear regression equation and correlation coefficient was calculated and expressed as y=0.960 2x+3.201 3,R2=0.973 4;y=1.112 1x-6.767 9,R2 =0.990 7;y=1.031 5x+0.634 7,R2=0.980 3,respectively.Conclusion The 3 hemoglobin analyzers have better inter-run precision and intra-day precision as well as good correlation with automatic blood analyzer,and thus can be applied in physical examinations before blood donation.

An innovative, simple, fast, and less toxic high-performance liquid chromatographic method for determination of prednisone in capsules

ABSTRACT Prednisone is an anti-inflammatory steroid drug widely used in clinical practice. However, no high-performance liquid chromatographic (HPLC) method has been described in the literature for the determination of prednisone in capsules until now. Thus, an HPLC method was developed using a C18 (250x4.0, 5 µm) column, with methanol:water (70:30) as mobile phase at a flow rate of 1 mL/min and detection at 240 nm. The developed method was validated following current Brazilian legislation. Additionally, linearity was assessed by evaluating the assumptions of normality, homoscedasticity, and independency of residuals, and the fit to the linear model. The method showed linearity (r2>0.99) over the range of 14.0-26.0 µg/mL, selectivity, precision (RSD<2.0%), robustness, and accuracy (average recovery of 100.05%). The chromatographic procedure was applied for assay and uniformity content determination of three different batches of prednisone capsules, showing to be suitable for their quality control.

Performance evaluation of Mindray BS-820 automatic biochemical analyzer / 重庆医学

Objective To evaluate the analytical performance of Mindray BS‐820 automatic biochemical analysis system used in primary hospitals in Guangzhou area for verifying whether its performance meeting the clinical requirements .Methods Accord‐ing to the EP5‐A2 ,EP6‐A ,EP7‐A2 and EP‐17A files recommended by CLSI and the Pharmaceutical Industry Standard of the Peo‐ple′s Republic of China YY/T0654‐2008 ,the precision ,linear rang ,anti‐interference capability ,sensitivity and carry‐over rate of the Mindray BS‐820 automatic biochemical analysis system were evaluated by adopting 16 routine biochemical items .Results The pre‐cision results of all 16 analyzing items conducted by the Mindray BS‐820 automatic chemical analysis system conformed to the re‐quirements .The results of 15 items showed good linear relation during the testing range (r≥0 .997 9) .In 16 biochemical items ,the anti‐interference capability of TBIL ,TP ,TC ,TG ,LDL ,HDL ,UREA and Ca to bilirubin ,triglyceride and hemoglobin conformed to or were higher than the anti‐interference capability declared by manufacturer ,but among other 8 items ,the anti‐interference capabil‐ity of 3 items was lower than that declared by manufacturer .The limit of blank(LOB) of all 16 analyzing items was less than LOB in the kit instruction .The carry‐over rate of Glu was 0 .02% ,less than 0 .50% .Conclusion This instrument has good precision , sensitivity and low carry‐over rate(0 .02% ) ,the linear range is ideal ,r≥0 .997 9 ,the anti‐interference capability basically satisfies the clinical needs .Therefore this instrument is suitable for the use in the middle‐small scale laboratory department .

Performance Evaluation of Two Automated Quantitative Fecal Occult Blood Tests

BACKGROUND: The performance of the fecal occult blood test (FOBT) has recently improved with the use of quantitative immunochemical assays. We evaluated the two latest immunochemical FOBTs: OC-Sensor PLEDIA (Eiken Chemical, Japan) and NS-Prime (Alfresa Pharma, Japan). METHODS: The precision was evaluated by using the quality control materials at two levels and carry-over rates were measured at high and low concentrations of the sample, prepared from the calibrators. Linearity was measured by using five concentrations of human hemoglobin (0-1,000 ng/mL), prepared from erythrocyte lysates. Correlation between the two systems was analyzed by testing approximately 50 selected stool specimens per day and comparing the results obtained with those of the currently used analyzer, OC-Sensor DIANA (Eiken Chemical), for 10 consecutive working days. RESULTS: The variation for repeatability, between-run, between-day, and intermediate precision at both levels was 0.99 for both systems. In total, 499 stool specimens were analyzed, of which 127 (25.5%), 130 (26.1%), and 129 (25.9%) specimens tested positive by DIANA, PLEDIA, and NS-Prime, respectively. The agreement between PLEDIA and NS-Prime was 98.4%. Quantification by PLEDIA was linear to that by NS-Prime (y=1.0372x+17.744; r²=0.9064). CONCLUSIONS: The analytical performances of PLEDIA and NS-Prime warrant their use as diagnostic tests. They showed excellent categorical agreement; however, the quantitative value obtained by NS-Prime was lower than that obtained by PLEDIA.

Evaluación de los parámetros de desempeño de un contador hematológico / Evaluation of performance parameters of an automated hematology analyzer / Avaliação dos parâmetros de desempenho de um analisador da hematologia

El primer paso para obtener seguridad en los resultados emitidos por el laboratorio clínico es confirmar que los procedimientos de medida utilizados tienen un desempeño analítico aceptable. Para conseguirlo se verificó el contador hematológico Beckman Coulter LH 750 de acuerdo con las especificaciones del fabricante y con los requisitos de calidad de este laboratorio. Los parámetros de desempeño evaluados, tanto en modo manual como automático, fueron: porcentaje de arrastre, según protocolo CLSI H26-A2, precisión en condiciones de repetibilidad, precisión en condiciones de precisión intermedia y veracidad, según protocolo CLSI EP15-A2 utilizando controles BIO-RAD, intervalo de medición, según protocolo CLSI EP6-A, límite de cuantificación, según protocolo CLSI EP17-A2 e intervalos de referencia, según protocolo CLSI EP28-A3C. Los datos se analizaron mediante LinChecker y GraphPad 5. En los ensayos realizados se cumplió con las especificaciones estipuladas por el fabricante, como así también con el requisito de calidad de este laboratorio que es variabilidad biológica mínima. También se verificaron los intervalos de referencia para individuos adultos. De esta manera, se logró realizar la verificación del contador hematológico, evidenciando que los parámetros analíticos evaluados tienen un desempeño aceptable.

The first step for safety in the results issued by the clinical laboratory is to confirm that all analytical measurement procedures have shown an acceptable analytical performance. A quality performance evaluation of automated hematology analyzer Beckman Coulter LH 750 was performed according to the quality requirements of our laboratory and manufacturer's specifications. The performance parameters evaluated by both manual and automatic mode were: carryover according to CLSI H26-A2 protocol; repeatability, intermediate precision and trueness according to CLSI EP15-A2 protocol and using BIO-RAD controls; linearity according to CLSI EP6-A protocol; quantification limits according to CLSI EP17-A2 protocol; and reference intervals according to CLSI EP28-A3C protocol. Data were analyzed using LinChecker and GraphPad5 programs. The tests performed complied with the requirements stipulated by the manufacturer and the quality requirements of our laboratory like minimal biological variability. Reference intervals for adult individuals were also checked. Consequently, performance evaluation of the automated hematology analyzer showed that the assessed laboratory parameters have acceptable performance.

O primeiro passo para obter segurança nos resultados emitidos pelo laboratório clínico é confirmar que os processos de medição utilizados tenham um desempenho analítico aceitável. Para obtê-los foi verificado o analisador hematológico Beckman Coulter LH 750 de acordo com as especificações do fabricante e os requisitos de qualidade deste laboratório. Os parâmetros de desempenho avaliados, tanto em modo manual quanto automático, foram: percentual de arrastamento, de acordo com o protocolo CLSI H26-A2, em condições de repetitibidade, precisão em condições de precisão intermediária e veracidade, conforme o protocolo CLSI EP15-A2 usando controles Bio-Rad, intervalo de medição segundo o protocolo CLSI EP6-A, limite de quantificação, de acordo com CLSI EP- 17-A2 e intervalos de referência, de acordo com o protocolo CLSI EP28-A3C. Os dados foram analisados através de LinChecker e GraphPad 5. Nos ensaios realizados foram obsevadas as especificações estabelecidas pelo fabricante, bem como a exigência de qualidade deste laboratório que é variabilidade biológica mínima. Os intervalos de referência para indivíduos adultos também foram verificados. Desta forma, foi possível realizar a verificação do analisador hematológico, que demonstra que os parâmetros analíticos avaliados têm um desempenho aceitável.

Validated method for estimation of irbesartan in bulk and dosage form by high performance liquid chromatography technique

A simple, specific, accurate and precise new high performance liquid chromatographic method was developed for the estimation of irbesartan in bulk and its developed dosage form. The mobile phase containing acetonitrile: Phosphate buffer pH 3.5 in proportion of 50:50 v/v was employed with flow rate of1.0 ml/min and eluting medium was monitored at 240 nm. The method was validated for linearity, accuracy, precision, limit of detection, limit of quantification and robustness for irbesartan. A linear response was observed in the range of 5- 40µg/ml. Linear regression of absorbance on concentration gave equation y = 101.9x + 195.3 with a regression co-efficient r2 =0.993. The method was validated for different parameters as per the ICH guidelines. The degradation studies were carried out by using the developed method. Thus the method was found to be useful for the determination of irbesartan in bulk as well as for dosage forms.

Dose calibrator linearity test: 99mTc versus 18F radioisotopes / Teste de linearidade em medidor de atividade: utilização do radioisótopo 99mTc versus 18F

Objective: The present study was aimed at evaluating the viability of replacing 18F with 99mTc in dose calibrator linearity testing. Materials and Methods: The test was performed with sources of 99mTc (62 GBq) and 18F (12 GBq) whose activities were measured up to values lower than 1 MBq. Ratios and deviations between experimental and theoretical 99mTc and 18F sources activities were calculated and subsequently compared. Results: Mean deviations between experimental and theoretical 99mTc and 18F sources activities were 0.56 (± 1.79)% and 0.92 (± 1.19)%, respectively. The mean ratio between activities indicated by the device for the 99mTc source as measured with the equipment pre-calibrated to measure 99mTc and 18F was 3.42 (± 0.06), and for the 18F source this ratio was 3.39 (± 0.05), values considered constant over the measurement time. Conclusion: The results of the linearity test using 99mTc were compatible with those obtained with the 18F source, indicating the viability of utilizing both radioisotopes in dose calibrator linearity testing. Such information in association with the high potential of radiation exposure and costs involved in 18F acquisition suggest 99mTc as the element of choice to perform dose calibrator linearity tests in centers that use 18F, without any detriment to the procedure as well as to the quality of the nuclear medicine service. .

Objetivo: Avaliar a viabilidade de substituir o radioisótopo 18F pelo 99mTc no teste de linearidade em medidores de atividade. Materiais e Métodos: O teste foi realizado empregando-se fontes de 99mTc (62 GBq) e 18F (12 GBq), cujas atividades foram mensuradas até valores abaixo de 1 MBq. As razões e desvios entre as atividades experimentais e teóricas foram calculados e comparados. Resultados: Os desvios médios entre as atividades experimentais e teóricas para o 99mTc e 18F foram, respectivamente, 0,56 (± 1,79)% e 0,92 (± 1,19)%. A razão média entre as atividades indicadas pelo equipamento para a fonte de 99mTc quando mensurada no equipamento pré-ajustado para medir o 99mTc e 18F foi 3,42 (± 0,06), e para o 18F este valor foi 3,39 (± 0,05), razões consideradas constantes ao longo de todo o período de medida. Conclusão: Os resultados do teste utilizando o 99mTc são compatíveis com os adquiridos com o 18F, implicando na possibilidade de utilização de ambos os radioisótopos na realização do teste de linearidade. Esta informação, aliada ao elevado potencial de exposição e custos de aquisição do 18F, sugere que o 99mTc seja empregado na realização do teste de linearidade para clínicas que utilizam 18F, sem prejuízo para o procedimento e garantia da qualidade de um serviço de medicina nuclear. .

Development and Validation of RP-HPLC Method for the Determination of Amlodipine.

The present paper describes a simple isocratic RP-HPLC method for the determination of Amlodipine in tablet dosage form. Best symmetric peak shape was obtained with column Zodiac C18 column (250 mm x 4.6 mm, 5μ) at 245nm with retention time of 5.53min. The mobile phase used was Methanol: Water: Acetonitrile 60:20:20 (v/v/v) with flow rate of 1.0 ml/min. The method for estimation of Amlodipine in tablet dosage form was found to be linear, accurate, precise, sensitive and selective. The linearity range was from 60μg/ml to 210μg/ml. Method was found to be highly sensitive as LOD and LOQ were found to 0.4μg/ml and 1.3μg/ml. The repeatability and reproducibility were within the range i.e. less than 2%. The %recovery values were found to be in the range of 98.82-100.93%. The percentage of assay was calculated for market formulation was 99.19%.

The application of different linear evaluation method for clinical chemistry measurement / 国际检验医学杂志

Objective To explore the application of different linear evaluation methods for clinical chemistry measurement .Meth‐ods The analytical measurement ranges of clinical common items ,including alanine aminotransferase(ALT) ,creatine kinase(CK) , glucose(Glu) ,urea(Urea) and uric acid(UA) were established by using visual method ,modified Doumas method ,and according to′Guide to linearity evaluation of clinical chemistry analyzers′(health profession standard method) and Clinical and Laboratory Stand‐ards Institute(CLSI) EP6‐A document(EP6‐A method) .Results The visual method shown that the expected values and the meas‐ured values of these inspection items were probably in a straight line .The modified Doumas method shown that nonlinearity be‐tween expected values and measured values of CK was found ,but linearity was evaluated when discarding the last two points ;and the rest of inspection items all had linearity .The health profession standard method indicated that nonlinearities between expected values and measured values of CK and Urea were found ,but could not determine whether the nonlinearities of the two items were clinically acceptable ;and the rest of inspection items all had linearity .The EP6‐A method shown that linearities were directly found between expected values and measured values of ALT ,Glu and UA ,while CK and Urea had clinical acceptable linearities and linear‐ities were evaluated when discarding the maximum values .Conclusion The linearity evaluation is integrated with clinical objectives through EP6‐A document .Through setting methodology allowable deviation ,the EP6‐A method could expand the scope of accredi‐tion of linearity within the clinical acceptable range ,which has higher clinical practicability .

Performance evaluation and results analysis of chemiluminescence method for detecting plasma BNP / 国际检验医学杂志

Objective To analyze and evaluate the precision ,accuracy and linearity of the chemiluminescence method for detec‐ting plasma BNP .Methods According to the experimental schemes of CLSI EP15‐A2 ,EP6‐A files and other relevant documents , the precision ,accuracy and linearity of the Siemens Centaur XP chemiluminescence instrument for detecting BNP ,and the detection results were compared with the performance declared by manufacturer or the quality target formulated by laboratory .Results The imprecision of BNP detected by the chemiluminescence method was less than 1/3 TEa regulated by the Clinical Laboratory Center of Ministry of Health (allowable total error);the variation coefficient index (CVR) of internal quality control data was less than ± 2;the relative bias of the results of external quality control blind samples with the target values were less than Tea regulated by the Ministry of Health ;the linear evaluation results showed that BNP was once linearity in the range of 5 .3‐4696 .7 pg/mL .Conclusion The precision ,accuracy and linearity of the Siemens Centaur XP chemiluminescence instrument for detecting BNP can accord withthe quality objectives requirements and meet the clinical needs .

The investigation on equipment (SPECT) performance in nuclear medicine / 中国医学装备

Objective:Through 51 SPECT and SPECT/CT systems for performance test results of the collation and analysis, to understand the status of the operation of the SPECT and SPECT/CT systems, and in-depth analysis of indicators and find out the weak links and puts forward suggestions for improvement. Methods:According to the NEMA standards and requirements of the manufacturer, the systems have been tested on intrinsic uniformity, intrinsic spatial linearity, intrinsic spatial resolution, maximum count rate, system sensitivity, system spatial resolution and tomographic spatial resolution. Results:The results show that the majority of SPECT or SPECT/CT systems can pass the test;the failure rate is 9.80%. And the failures mainly show intrinsic uniformity and intrinsic spatial linearity. Conclusion:It is effective to improve the equipment performance by doing well in the daily quality control, regular maintenance and calibration, reducing factors that influence the inherent uniformity and inherent linear.