Performance evaluation of some domestically produced biochemical reagents / 中华检验医学杂志

Objective:To evaluation the performance of a total of 40 clinical biochemical reagents from three domestic manufacturers and two foreign manufacturers, and evaluate their clinical application value.Methods:The Beckman AU5400 automatic biochemical analyzer was used to verify the performance of 40 kinds of commonly used clinical biochemical reagents from three domestic manufacturers of Sichuan Maccura, Ningbo Medical System, and Shanghai Fosun Long March, and two foreign imported manufacturers of Roche and Japan′s Hitachi. The analysis samples were selected from the serum of patients who underwent clinical testing in Nanjing Drum Tower Hospital hospital from December 2021 to June 2022. Refer to China′s national health industry standards, China′s national pharmaceutical industry standards, the US Clinical Laboratory Standards Institute (CLSI) for the performance evaluation standards of in vitro diagnostic reagents, and the methods recommended in the relevant regulations of China′s State Food and Drug Administration on the management of in vitro diagnostic reagents. The precision, linear range, open bottle stability, interchangeability of calibrators and accuracy from different batches of 40 reagents were evaluated and validated. Simple linear regression analysis was used for linear regression, and P<0.05 indicated that the regression was statistically significant. Results:The overall precisions of 40 reagents were fine, except for one domestic reagent with low-level intra-batch coefficient of variation ( CV) exceeding the range declared in the specification. The intra-and inter-batch CVs of the remaining reagents were all smaller than those declared in their respective specifications. The linear ranges of domestic reagents and imported ones have achieved the linear ranges declared by each manufacturer. There were no statistical differences on the measurements between the reagents from open bottle of 30 days and the corresponding new ones for 40 reagents( P>0.05). The test values of domestic reagents and imported reagents after exchange of different batches of calibrators were within the ranges declared by each manufacturer. Both domestic reagents and imported reagents have passed the accuracy verification. Conclusions:The performance index of 27 biochemical detection indicators of the three domestic manufacturers are basically consistent with those of imported reagents, meeting the requirements of clinical biochemical laboratories. However, the bottle opening stability and anti-interference performance of some detection reagents needs to be improved.

Relación entre el índice urémico y la función renal en pacientes con enfermedad renal crónica y en personas sanas

Objetivo : Evaluar la relación entre el índice urémico (IU) y la función renal medida por el aclaramiento de creatinina (ClCr) en personas sanas y en pacientes con enfermedad renal crónica (ERC); asimismo, comparar con la función renal extrapolada según la creatinina sérica y la calculada por algunas fórmulas recomendadas en la literatura internacional. Material y métodos : Estudio transversal, de correlación, analítico y observacional. Se incluyeron pacientes atendidos de forma ambulatoria en el Hospital Cayetano Heredia, Lima, Perú entre junio del 2018 y junio del 2019. Se realizó correlación de Pearson entre el IU y el ClCr; para la comparación de las medias del IU, creatinina sérica y las fórmulas estandarizadas en función al ClCr estratificado se utilizó el test de ANOVA y el eta cuadrado. Resultados: El IU de la población fue 4,37 ± 4,99 mg/dl y presentó correlación lineal cuadrática estadísticamente significativa con el ClCr (r=-0,74, p=0,000). Asimismo, el IU y el Log IU mostraron un valor predictivo el ClCr superior a la creatinina sérica y a las diversas fórmulas recomendadas en la literatura. El IU presentó correlación significativa con el potasio sérico y su fracción excretoria de forma relevante en comparación con la creatinina sérica. Conclusiones: El IU es un indicador del estado metabólico y nutricional que refleja el ClCr con una precisión estadísticamente significativa en la persona sana y en el paciente con distintos grados de ERC. Además, traduce aspectos relevantes de la función tubular renal.

SUMMARY Objective : To evaluate the relationship between uremic index (UI) and renal function measured by creatinine clearance (CrCl) in persons with normal renal function and in those with chronic renal failure (CRF), as well as to compare the renal function extrapolated from serum creatinine and that calculated with equations internationally recommended. Methods : A cross sectional study was conducted including patients attended in outpatient clinics at Hospital Cayetano Heredia in Lima from June 2018 to June 2019. Pearson's correlation between UI and CrCl was calculated; comparison of means of UI, serum creatinine and standard equations was done by ANOVA and eta square. Results: the overall UI was 4.37 ± 4.99 mg/dl and correlated linearly with CrCl (r=-0.74, p=0.000). The UI and the log UI were significantly more predictive of CrCl than serum creatinine and the international equations used. The UI correlated significantly with serum potassium than serum creatinine. Conclusions : The UI is a good indicator of the metabolic and nutritional status in persons With normal renal function and with CRF and reflects more accurately the CrCl.

Las características dinámicas de la salud mental en adultos peruanos durante la cuarentena por COVID-19 / The dynamic characteristics of mental health in Peruvian adults during the COVID-19 quarantine

RESUMEN Fundamento La pandemia actual por SARS-CoV-2 contabiliza más de un millón de contagios, y ha causado la muerte, hasta ahora, a más de 300 000 personas. Además, ha tenido un gran impacto psicológico en el contexto latinoamericano. Objetivo describir las características dinámicas de la salud mental en adultos peruanos durante la cuarentena por COVID-19. Métodos estudio descriptivo, que exploró las características dinámicas de manera gráfica, mediante un instrumento de salud mental aplicado (online) a 763 adultos peruanos. Se aplicó un análisis de red mediante los paquetes qgrap y el gráfico LASSO. Resultados se observaron mayores medidas de centralidad de red en los reactivos vinculados a síntomas negativos en la salud mental, como el reactivo 9 (sentimiento de infelicidad y depresión) y el 10 (pérdida de confianza); así como la mayor conexión positiva entre los reactivos 3 (toma de decisiones y confianza) y 4 (sentido de vida); y la mayor relación negativa entre los componentes 1 (concentración) y 5 (tensión y angustia). Conclusión los sujetos participantes en el estudio manifestaron fundamentalmente sentimientos de infelicidad, depresión y pérdida de confianza, entre otros síntomas negativos. El estudio de la repercusión de la pandemia COVID-19 en la salud mental, adquiere mayor precisión y fundamento científico al aplicarse métodos como el análisis de redes.

ABSTRACT Background The current SARS-CoV-2 pandemic accounts for more than one million infections, and has caused the death, so far, more than 300,000 people. In addition, it has had a great psychological impact in the Latin American context. Objective to describe the dynamic characteristics of mental health in Peruvian adults during the COVID-19 quarantine. Methods descriptive study, which explored the dynamic characteristics graphically, using a mental health instrument applied (online) to 763 Peruvian adults. A network analysis was applied using the qgrap packages and the LASSO graph. Results higher network centrality measures were observed in the items related to negative symptoms in mental health, such as item 9 (feeling of unhappiness and depression) and item 10 (loss of confidence); as well as the greater positive connection between items 3 (decision making and trust) and 4 (meaning of life); and the highest negative relationship between components 1 (concentration) and 5 (tension and anguish). Conclusion the individuals participating in the study mainly manifested feelings of unhappiness, depression and loss of confidence, among other negative symptoms. The study of the impact of the COVID-19 pandemic on mental health acquires greater precision and scientific basis when applying methods such as network analysis.

Avaliação da implantação do acesso avançado nos indicadores de qualidade de uma unidade de saúde / Evaluación de la implementación del acceso avanzado en los indicadores de calidad de una unidad de salud / Evaluation of the implementation of advanced access on the quality indicators of a health unit

Objetivos: O objetivo principal foi analisar os indicadores de acesso da unidade de saúde (US) Sesc, antes e após a implantação do acesso avançado (AA). Como objetivo secundário, foram analisados os indicadores de desempenho da US Sesc, antes e após o AA. Métodos: Estudo transversal descritivo com análise dos dados obtidos mensalmente do sistema de informação em saúde do Grupo Hospitalar Conceição, comparando o período de novembro/16 -outubro/17 com novembro/17 - outubro/18. Resultados: Após o AA, o número de atendimentos médicos aumentou 8%, o absenteísmo nas consultas diminuiu de 6,9% para 3% e o número de pacientes diferentes atendidos teve um acréscimo de quase 5%. Em relação ao controle de doenças crônicas, o número de hipertensos atendidos cresceu e também houve um aumento na porcentagem de hipertensos controlados, passando de 74% para 77%. O número de diabéticos atendidos aumentou, assim como a porcentagem de diabéticos controlados subiu de 73% para 81%. Houve uma diminuição de quase 10% de atendimentos a pacientes vinculados à US nos serviços de atenção secundária de referência. Discussão: É possível considerar que a implantação do AA na US Sesc foi associada a uma melhoria dos indicadores de acesso, bem como da maior parte dos indicadores de desempenho analisados.

Objectives: The main objective was to analyze the access indicators of the Sesc health unit (HU), before and after the implementation of advanced access (AA). As a secondary objective, the performance indicators of the health unit Sesc HU were analyzed, before and after AA. Methods:Cross-sectional descriptive study with analysis of data obtained monthly from the health information system of Grupo Hospitalar Conceição, comparing the period of November/16 - October/17 with November/17 - October/18. Results: After AA, the number of medical appointments increased by 8%, absenteeism in consultations decreased from 6.9% to 3% and the number of different patients treated increased by almost 5%. Regarding the control of chronic diseases, the number of hypertensive patients seen increased and there was also an increase in the percentage of controlled hypertensive patients, from 74% to 77%. The number of diabetics treated increased, as did the percentage of controlled diabetics increased from 73% to 81%. There was a decrease of almost 10% in attendance to patients linked to the US in the reference secondary care services. Discussion: It is possible to consider that the implantation of AA in Sesc HU was associated with an improvement in access indicators, as well as most of the performance indicators analyzed.

Objetivos: El objetivo principal era analizar los indicadores de acceso de la unidad de salud (US) Sesc, antes y después de la implementación del acceso avanzado (AA). Como objetivo secundario, se analizaron los indicadores de rendimiento de la US Sesc, antes y después del AA. Método: Estudio descriptivo transversal con análisis de datos obtenidos mensualmente del sistema de información de salud del Grupo Hospitalar Conceição, comparando el período Noviembre/16 - Octubre/17 con Noviembre/17 - Octubre/18. Resultados: Después del AA, el número de citas médicas aumentó en un 8%, el absentismo en las consultas disminuyó del 6,9% al 3% y el número de pacientes diferentes tratados aumentó en casi 5%. Con respecto al control de enfermedades crónicas, el número de pacientes hipertensos vistos aumentó y también hubo un aumento en el porcentaje de pacientes hipertensos controlados, del 74% al 77%. El número de diabéticos tratados aumentó, al igual que el porcentaje de diabéticos controlados aumentó del 73% al 81%. Hubo una disminución de casi 10% en la asistencia a pacientes vinculados a la US en los servicios de atención secundaria de referencia. Discusión: Es posible considerar que la implantación del AA en la US Sesc se asoció con una mejora en los indicadores de acceso, así como en la mayoría de los indicadores de desempeño analizados.

The performance evaluation of four Lp-PLA2 activity assays / 中华检验医学杂志

Objective To evaluate the analytical performance of four lipoprotein associated phospholipase A2(Lp-PLA2)activity reagents on Beckman AU5800 automatic biochemical analyzer. Methods The remaining serum samples of 214 patients and 140 apparently healthy individuals were collected from March to July 2017 in Peking Union Medical College Hospital.These samples were used for method comparison and reference interval evaluation.According to the guidelines of EP15-A,EP6-A,EP-17 and EP7-P from Clinical and Laboratory Standards Institute(CLSI)standards,the precision, linearity, sensitivity and common interferences(e.g free bilirubin, conjunct bilirubin, hemoglobin and chyle)were assessed.According to EP9-A2,method comparisons of differents regents(Evermed,DiaSys,Hengxiao and Zhongyuan were labeled as A,B,C and D,respectively)were conducted and the differences were estimated at medical decision levels(328U/L,391U/L and 485U/L).Results The precision of four reagents were acceptable.The repeatability(CV%)of A to D were 0.5%-1.7%, 0.7%-3.0%, 0.9%-2.0% and 0.5%-3.3%,respectively.The reproducibility(CV%)were 0.7%-2.9%, 1.4%-3.2%, 1.3%-1.9%and 0.8%-4.1%,respectively.Both of those achievedlaboratory defined quality objective(<5%).The linearity of A to D were 44 -1 992 U/L,39 -1 798 U/L,13 -540 U/L and 75-1 717U/L,respectively.The regression coefficient R2 was between 0.997 and 1.000, and the correlation coefficient(r)was between 0.998 and 1.000.The interference of chyle were acceptable among these four reagents andmet the manufacturer′s requirementsor clinical needs.In a low level of Lp-PLA2,bilirubin had an obvious interferenceonreagent C;B and C were negatively affected when the hemoglobin was 4.5 g/L; and D was positively affected when the hemoglobin was 2.45 g/L.The regression coefficients R2 of A,C,D compared with B were between 0.978 and 0.995,and the correlation coefficients(r)were between 0.989 and 0.998. The expected differences at medical decision levels ranged from -240 U/L to 113 U/L.For A to D,the Lp-PLA2 activity results of 131(93.6%), 140(100%), 82(58.6%), and 128(91.4%)cases were analysed within the manufacturer′s claimed reference intervals.Conclusion The precision and linearity of the four Lp-PLA2 activity detection reagents used in automatic biochemical analyzer are good, but the anti-interference ability needs to be improved.

Preparation of cholesterol and glycerol reference materials in cyclodextrin aqueous solution / 中华检验医学杂志

Objective Preparation of aqueous reference materials for cholesterol and glycerol.Methods Study on reference materials.The certified reference materials GBW09203b and GBW09149 were weighed accurately and dissolved into 20% of methyl cyclodextrin aqueous solution to prepare six kinds of candidate reference materials of cholesterol and glycerol according to the concentration.The materials were tested for homogeneity and stability using routine methods.The reference methods of isotope dilution liquid chromatography tandem mass spectrometry (ID-LC/MS/MS) were used to determine the concentration of cholesterol and glycerol to evaluate the accuracy of the certified values.Meanwhile, the blank verification test was carried out.The expanded uncertainty was the combination of standard uncertainty of measurement, unhomogeneity and instability.Results It showed that the six candidate reference materials were homogeneous and stable for at least 1 year at-70 ℃ and-20 ℃.The certified values (reference value ± expanded uncertainty,mmol/L) were as follows,for cholesterol:0.65±0.01,1.31 ±0.01,2.57±0.02,5.21±0.06,7.71±0.08,10.24±0.06;for glycerol:0.29±0.01,0.58±0.01,1.22±0.02,2.24±0.02,3.46±0.04,4.52 ±0.04.The results of reference methods were consistent with the certified values.Blank validation tests showed that the concentration of the analytes would not be affected by the reagent and the blank matrix.Conclusions Certified reference materials for cholesterol and glycerol in aqueous solution have been prepared successfully.These materials are homogeneous and stable, and the certified values are reliable.Therefore the materials have been approved to be the Certificate Reference Materials of GBW 09823, GBW 09824, GBW 09825, GBW09826, GBW09827 and GBW 09828.

Metrological traceability in clinical laboratory / Rastreabilidade metrológica no laboratório clínico

ABSTRACT Introduction: Metrological traceability is a little-known and little-discussed metrology theme in clinical laboratories, although it is the basis for comparable results. It is associated with certified reference material (CRM) and reference method (RMet). When it is used in the supply chain by diagnostic kit manufacturers, it ensures accuracy of the results yielded by laboratories. Objective: This study shows the availability of information on metrological traceability provided by diagnostic kit manufacturers. Method: It was done with the information obtained in kits of glucose, urea, creatinine, uric acid and cholesterol participants in a proficiency testing program throughout 2012 and 2013. Results and conclusion: In the research, 18 producers of reference materials (RMs) and 204 measurands available for laboratory medicine were found. In the study of metrological traceability, the preferential use of CRM was demonstrated by kit manufacturers (glucose 60%, urea 69%, creatinine 60%, uric acid 50%, and cholesterol 43%). An important factor is that there are a significant number of kits that do not report traceability (glucose 16%, urea 19%, creatinine 16%, uric acid 13%, and cholesterol 5%), although it is a requirement for product registration in Brazil. We hope that this study will contribute to sensitize the laboratory community to the need for a more comprehensive knowledge of this subject, and that it will stimulate institutions involved in the dissemination of knowledge in laboratory medicine to hold discussions on this topic.

RESUMO Introdução: Rastreabilidade metrológica é um tema da metrologia pouco conhecido e discutido nos laboratórios clínicos, apesar de ser a base para resultados comparáveis; associa-se a material de referência certificado (MRC) e a método de referência (MetR). Quando usada na cadeia de suprimentos pelos fabricantes de conjuntos diagnósticos, atua na garantia da exatidão dos resultados produzidos pelos laboratórios. Objetivo: Apresentar a disponibilidade das informações sobre rastreabilidade metrológica fornecidas pelos fabricantes de conjuntos diagnósticos. Método: O estudo foi feito com as informações obtidas nos conjuntos diagnóstico de glicose (GLI), ureia (URE), creatinina (CRE), ácido úrico (AU) e colesterol (COL) participantes de um programa de ensaio de proficiência ao longo de 2012 e 2013. Resultados e conclusão: Na pesquisa sobre produtores de materiais de referência (MRs) e de produtos disponibilizados, foram encontrados 18 produtores e 204 analitos para a área de laboratórios clínicos. No estudo sobre rastreabilidade metrológica, foi demonstrado o uso preferencial de MRC pelos fabricantes de conjuntos diagnósticos (GLI 60%; URE 69%; CRE 60%, AU 50% e COL 43%), bem como o dado importante de que há um número expressivo de conjuntos diagnósticos que não informa rastreabilidade (GLI 16%; URE 19%; CRE 16%, AU 13% e COL 5%), embora ela seja requisito em norma nacional que regulamenta o registro de produtos. Esperamos que este estudo contribua para sensibilizar a comunidade laboratorial da necessidade de conhecimento mais abrangente acerca deste assunto e que estimule as instituições relacionadas com a disseminação de conhecimento na área de laboratório clínico a promover discussões sobre o tema.

The correlation between S/CO ratios of different chemiluminescence assays and recombinant immunoblot in anti-HCV antibody detection / 中华检验医学杂志

Objective To investigate relationships between signal/cutoff (S/CO) ratios of antiHCV recombinant immunoblot assay (RIBA) and their positivity with different chemiluminescence immunoassay(CLIA) reagents.Methods A case-control study was performed.From March 2014 to March 2015,anti-HCV antibody was detected in 2 616 serum of outpatients and inpatients coming from Department of Clinical Laboratory,Qilu Hospital of Shandong University by three kinds of homemade CLIA reagents and one imported CLIA reagents.The positive samples were further tested by RIBA.The correlation between the positivity and the S/CO ratios was analyzed.The difference between different reagents were compared by x2 method.Results The predicted positivities of Shandong Laibo were 97.8％ and 33.3％ with S/CO ratio ≥ 26.8 and 1 to 26.8,respectively;The predicted positivities of Beijing Yuande were 96.7％ and 20％ with S/CO ratio ≥ 16.6 and 1 to 16.6,respectively;The predicted positivities of Beijing Kemei were 97.0％ and 9.8％ with S/CO ratio ≥ 16.7 and 1 to16.7,respectively;The predicted positivities of Abbott were 96.9％ and 12.8％ with S/CO ratio≥5 and 1 to 5,respectively.Conclusions Anti-HCV CLIA S/CO ratio and RIBA confirmatory test results have some relevance.Domestic reagents also can refer to import reagents determine the relationship between the positivity and the S/CO ratio.Different domestic reagent of positivity has different S/CO ratio.Although each reagent S/CO ratio to the same positivity has large difference,suggesting each manufacturer should set their products corresponding values according to the situation,providing reference for the clinical use of unit in result determination of the clinical trials.

Measurement of urine total polyphenol by solid phase extraction and Folin-Ciocalteu Assay / 中华检验医学杂志

Objective To develop a solid phase extraction and Folin-Ciocalteu method for the measurement of total polyphenols in urine samples.Methods From a group of individuals attending an annual physical examination at Beijing hospital, 123 healthy volunteers (52 males and 71 females, ranging in age from 18 to 81 years ) were recruited during the period from December 2013 to April 2014.Urine samples were stored in 0.5%HCl at -80 ℃.For analysis, samples were applied to the Plexa PAX solid phase extraction cartridge, to purity the polyphenols through washing, evaporating and reconstituting.Total polyphenols were measured by Folin-Ciocalteu colorimetric assay, calculated by gallic acid standard curve, and corrected by urine creatinine concentrations.The relationship between total polyphenols and fruits and vegetable intake and cardiovascular disease risk factors were analyzed. Results Gallic acid standard solution and urine samples were stable in 0.5% HCl for 48 h at RT and 7days at 4 ℃, respectively.The PAX cartridge effectively eliminated the possible interfere materials in urine and had better recovery for most of the polyphenol types.The inter assay and total CVs for the measurement of total polyphenols were 2.7%-3.8% and 2.4%-4.6 %, respectively.Total polyphenol concentrations of 123 healthy subjects were 114.13(82.97-146.70) mg GAE/g Crea.Total polyphenol levels positively correlated with both HDL-C (r=0.194, P=0.032) and apoAI (r=0.312,P<0.001), and negatively correlated with serum uric acid levels(r=-0.220,P=0.014).Conclusions We established a measurement of total polyphenols in urine samples using solid phase extraction and Folin-Ciocalteu method.This simple, precise method reliable and may be use to assess dietary polyphenols intake.

Variations in different thyroid stimulating hormone and free thyroxine detection kits for evaluating thyroid function during pregnancy / 中华围产医学杂志

Objective To assess the variations in different thyroid stimulating hormone(TSH) and free thyroxine (FT4) detection kits for evaluating thyroid function during pregnancy and to establish the corresponding normal reference ranges.Methods This study was based at the International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiaotong University School of Medicine.A total of 200 pregnant women who visited the hospital between June,2011 and September,2012 were recruited in this study according to the National Academy of Clinical Biochemistry (NACB) criteria.Blood samples were sequentially collected from the women at the first (T1,9-12 weeks),second (T2,16-24 weeks) and third (T3,32-36 weeks) trimesters to determine the serum TSH and FT4 levels using four different detection kits (Siemens-C,Siemens-Ⅰ,Abott and Roche).A linear trend test was used to analyze serum TSH and FT4 levels with four different kits.A percentile range of P2.5 to P97.5 was used to establish the normal trimester-dependent reference ranges of TSH and FT4 levels for different detection kits.The Bootstrap method was used to compare the differences in the four reference ranges.Results Similar dynamic changes in TSH and FT4 levels during pregnancy were detected among the different kits (F=0.950,P=0.595; F=11.640,P=0.081,respectively).Among the four reference ranges of TSH,the Roche kit showed the most remarkable fluctuation during pregnancy,while Roche kit in the first trimester and Siemens C kit in the second and third trimesters showed larger fluctuations in reference ranges of FT4.More importantly,the reference ranges of TSH and FT4 showed significant variations among the four different kits in each trimester (TSH:T1:F=2 945.390,P ＜ 0.01; T2:F=2 826.260,P ＜ 0.01; T3:F=1 698.360,P ＜ 0.01.FT4:Tl:F=1 145.440,P ＜ 0.01; T2:F=2 260.240,P ＜ 0.01; T3:F=1 439.920,P ＜ 0.01).Conclusions TSH and FT4 measurement using four different commercial kits showed similar trimester-dependent dynamic changes.However,it is necessary to establish trimester-dependent and detection kit dependent normal reference ranges of TSH and FT4 for thyroid function evaluation for pregnant women.

The clinical evaluation of a new diagnostic kit for hepatitis B virus YMDD mutation DNA detection / 中国医师杂志

Objective To evaluate the clinical application of a novel hepatitis B virus YMDD mutation DNA diagnostic kit (magnetic beads method kit).Methods A total of 324 HBV clinical serum samples was tested with the magnetic beads method kit and another kind of fluorescence diagnostic kit (boiling method).Accuracy, specificity, and sensitivity were compared.Results The consistency of positive detection rate of two kits was 100％ (95％ CI : 98.0％ ～ 100％), negative consistency was 97.12％ (95％ CI : 92.8％ ～99.2％) and the total consistency was 98.76％ (95％ CI : 96.9％ ～99.7％).Four cases of discrepant samples were confirmed by sequencing, and statistical analysis performed by Kappa test (Kappa =0.975) shows good consistency between the two methods.Conclusions The magnetic beads method kit has good consistency compared to the regular boiling method kit, and the polymerase chain reaction (PCR) detection system contains an internal positive control (internal control) to avoid a false negative resuit, which is more suitable for clinical diagnosis.

The effect of different staining reagent and time on acid fast bacilli staining and its quality control significance / 重庆医学

Objective To observe the effect of different staining reagent and time on acid fast bacilli staining and study its quality control measures.Methods We collected 38 cases for positive acid fast bacilli stain.Every wax blocked into 4 pieces,with different staining reagent and time of acid fast staining.Results Using xylene and ethanol staining for 20 minutes,acid fast bacilli was discontinuous and red punctate.Zero cases were positive and the positive rate was 0%.Turpentine dyeing for 1 5 minutes group,acid fast bacilli was clear,bright red,slightly bent branched,and easy to identify.A total of 34 cases were positive and posi-tive rate was 89%.Turpentine dyeing process for 20 minutes,the whole background was red,and was not easy identification.A total of 28 cases were positive and the positive rate was 74%.Turpentine dyeing for 30 minutes,the background was entirely deep red, and was hard to discern the acid fast bacilli.A total of 27 cases were positive and the positive rate was 71%.Conclusion Different staining reagent and time had different positive staining results.Suitable turpentine process was stained for 1 5 minutes for acid fast bacilli.

Evaluation of quantitative and qualitative fecal occult blood reagent in colorectal cancer screening / 中华消化杂志

Objective To investigate the application effects of quantitative and qualitative fecal occult blood (FOB) reagent in colorectal cancer screening.Methods With the platform of colorectal cancer screening for early diagnosis and treatment,the original screening methods and process were not changed,individuals underwent colorectal cancer screening,aged from 40 to 74 years old,from four villages of Haining City in Zhejiang Province were selected as study objects.Initial screening included medical history questionnaire and FOB test.The first stool samples were examined both with quantitative and qualitative FOB test,one week later the second samples were detected with qualitative FOB test.History positive or once of any type of reagent positive was considered as initial screening positive.The individuals with initial screening positive received fine screening (colon endoscope examination).The effects evaluation included the positive rate of FOB,intestinal lesion detection rate,sensitivity,specificity and Youden index.The health economic analysis was calculated.Chi-square test was performed for comparisons between the two groups.Results A total of 8 427 history survey were completed,the positive rate of history was 8.48％(715/8 427) ; 6 644 underwent quantitative detection of FOB and the positive rate was 4.44 ％ (295/6 644) ; qulitative test was conducted in 12 633 samples were conducted and the positive rate was 2.56 ％ (324/12 633),the difference was statistically significant (x2 =49.27,P＜ 0.01).A total of 854 individuals with initial screening positive underwent electronic colonoscopy examination,the total intestinal lesion detection rate was 22.72％ (194/854),of which the intestinal lesion detection rate of quantitative group was 34.55％ (66/191),and that of qualitative group was 17.73％ (36/203),the difference was statistically significant (x2 =14.53,P＜0.01).The detection rate of both quantitative and qualitative test positive was 43.75 ％ (14/32).The colorectal cancer detection rates of quantitative and qualitative FOB test were 3.66％ (7/191) and 0.99％ (2/203),advanced adenoma detection rates were 8.38 ％ (16/191) and 5.91％,there were no significant differences (x2 =2.08 and 0.96,both P＞0.05).The sensitivity of quantitative and qualitative FOB test in advanced adenoma and cancer detection rate was 45.10％ and 27.45％,respectively.The average cost of quantitative and qualitative FOB test in intestinal lesions detection was 5 874.50 and 1 432.14 yuan.Conclusion The effects of quantitative FOB test in colorectal cancer screening was better than that of qualitative reagent,however on the cost of screening,the former was 4.10 times of the latter.

Technical requirements for point-of-care testing in vitro diagnostic reagents registration / 中华检验医学杂志

POCT in vitro diagnostic reagents featuring with easy operation , on-site testing, low requirements for specimen processing , fast results , usually applied small testing equipment , is a strong complement to high-throughput , large automated tests in clinical laboratory centers.According to the State Council issued in 2014 “Supervision and Regulation of Medical Devices ” and series regulations and management practices issued by the China Food and Drug Administration , conduct an investigation in POCT IVD registration relevant technical requirements and give some advice for the relevant personnel of register work.

Technical requirements of the pathogen-specific IgM qualitative detection reagents / 中华检验医学杂志

To offer the guidance of the registration application of in vitro diagnostic (IVD) reagents,the technical requirements for registration of the pathogen-specific Immunoglobulin M (IgM) qualitative test reagents were discussed.The application paperwork including the evaluation of analytical performance was analyzed based on the the legal requirement from the China Food and Drug Administration (CFDA)and the experience of the IVD registration.

A comparative study on the clinical performance of three fourth generation HIV diagnostic reagents / 中华检验医学杂志

Objective To compare the performance of fourth generation HIV antigen/antibody combined detection reagents for HIV early infection samples,international HIV seroconversion panel samples and routine clinical screening samples.Methods Thirty seven early HIV infected samples from the followup gays in Shen Yang between 2009 and 2011,66 seroconversion panel samples from BBI company (U.S.A),NABI company(U.S.A) and NIBSC company(U.K) and 703 routine HIV screening samples in the first hospital of China medical university in October 2010 were collected.All kinds of samples were tested by three diagnostic reagents based on chemiluminescence assay (CLIA),electrochemiluminescence assay (ECLIA) and enzyme-linked immunosorbent assay (ELISA) respectively.The detection sensitivity and specificity of these assays were analyzed.Results For 59 early infected and seroconversion samples,the sensitivities of both ECLIA and CLIA reagent were 96.61％ (95％ CI 91.5％-100.0％),higher than that of the ELISA kit (95％ CI 75.0％-92.9％) (x2 =5.341,P ＜ 0.05),which is 83.93％ ; Comparison among the three reagents for different subtypes of the antibody seroconversion samples showed that ECLIA had the highest sensitivity while CLIA was the lowest ; Detection sensitivity of the three reagents for the P24 antigen is CLIA ＞ ECLIA ＞ ELISA; With detection of 703 clinical routine screening samples,the specificities of three reagents were 100％ (CLIA),99.86％ (ECLIA) and 99.71％ (ELISA) respectively.Conclusions For the sensitivity of the fourth HIV diagnostic reagents CLIA and ECLIA are better than ELISA.The former two reagents are more suitable for identifying earlier HIV infection in clinic.

How to respond to the incoming new era of the new generation, high sensitive cardiac troponin test / 中华检验医学杂志

The new generation test of high sensitivity cardiac troponin has been used by European clinicians nearly for four years.In 2011,it was recommended by the latest ESC clinical guidelines for rapid exclusion of NSTE-ACS.In China,high-sensitivity cardiac troponin test has been oppreciated in many hospitals for three years actually,but it's not utilized well due to the poor communication between clinical laboratory and clinicians.Clinicians have various opinions about this new test,Some doctors are interested in this new test,while some doctors do not know much about it.Consensus has been reached on the importance of cardiac troponin for the diagnosis and treatment for ACS.The new generation test solves many problems of the previous generations,such as low sensitivity,accuracy and delayed diagnosis.Therefore it could give doctors more help.In order to utilize this useful test well,the clinical laboratory should study it well first and then introduce it to clinicians.

The signification and method of HBeAg gray zone setting and its cut-off verification in chemiluminescent assay / 中华检验医学杂志

Objective To explore the signification and method of Cut-off verification and gray zone setting in chemiluminescent assay.Methods NCCLS EP-12 A2 document defines that C50 is the analyte concentration of cut off value for immunology qualitative test and C5-C95 interval is the range of analyte concentration that yields 5％ positive results to 95％ positive results for immunology qualitativc test.The C50 and C5-C95 interval of HBeAg in ARCHITECT i2000 were worked out according to the cut off value provided by HBeAg reagent calibrated in ARCHITECT i2000,which were verified to approve the character declaimed by manufactory or not.Gray zone was set and the procedure of cut off verification and gray zone set in chemiluminescent were built; A set of quality control was detected 20 times with two different lot HBeAg reagent kits,S/CO was caculated and compared with t test.Results C50 and C5-C95 interval of reagent (lot 06087L100,96378HN00) were 0.171 PEI U/ml,0.125 PEI U/ml; ＞0.154 PEI U/ml to 0.188 PEI U/ml,0.119 PEI U/ml to ＜0.150 PEI U/ml,respectively.S/CO of negative quality control and positive quality control were (0.550 ±0.038),(2.422 ±0.084) and(0.334 ±0.063),(3.587 ±0.321),respectively.They all approved the character (the sensitivity at cut off was less than 0.5 PEI U/ml)declaimed by manufactory,and the results of S/CO between two lot kits were obvious difference (t =9.944,15.499,P ＜0.01).Conclusion C50 and C5-95 interval can be used to verify cut off value and set gray zone in chemiluminescent assay;They may vary in different lot reagents and they must be verified to approve the character declaimed by manufactory.

Impacts of different creatinine detection methods on the efficacy of different GFR estimation equations / 中华检验医学杂志

ObjectiveTo investigate the impacts of different serum creatinine detection methods,including Jaffe and enzymatic methods,on the efficacy of different GFR estimation equations in CKD patients in China.MethodsrGFR of 176 patients with CKD were determined by dual plasma sample method 99mTc-diethylenetriamine pentaacetic acid (99mTc-DTPA) plasma clearance rate.Serum creatinine was detected with four kinds of creatinine reagents from different manufacturers.Cockcroft-Gault Equation corrected for body surface area (CG/BSA),simplified Modification of Diet in Renal Disease (MDRD) Study equation,IDMS-traceable MDRD equation,CKD epidemiology collaborative research (CKD-EPI) equation and two Chinese simplified MDRD equation (project group equation 1,2) were applied to calculate estimated GFR (eGFR)respectively.eGFRwerecomparedwithrGFRforthecorrelation, deviation, precisionand30％ accuracy.ResultsThe mean rGFR of 176 patients with CKD,was [ 40.70 ( 19.41 -84.35 ) ] ml · min- 1 ·( 1.73 m2 ) -1.For all GFR estimation equations,there were significant differences in eGFR results between enzymatic method and Jaffe method,when analyzed by the Wilcoxon signed-rank test.eGFR results assessed by two enzymatic creatinine detection systems showed no significant difference,while eGFR results analyzed by two Jaffe detection system were significantly different.The intraclass correlation coefficient (ICC) of eGFR and rGFR ranged from 0.879 to 0.923 by Jaffe method,while from 0.925 to 0.946 by enzymatic creatinine method.ICC and Pearson correlation analysis revealed a significant correlation between eGFR and rGFR,and the correlation was better when using enzymatic method.Bland-Altman plots indicated that large deviation occurred in the high value area of GFR using various equations.However,deviation with the enzymatic creatinine method was smaller than that with the Jaffe method. When rGFR ≥ 60 ml · min- 1 ·(1.73 m2) -1,the 30％ accuracy of eGFR using enzymatic creatinine method for all six equations was between 68.3％ and 90.0％,while it was between 41％ and 75％ when using Jaffe method. The 30％ accuracy of eGFR using enzymatic creatinine method was significantly higher than that using picric acid method for these equations except for the project group equation 1.When rGFR ＜60 ml · min -1 · ( 1.73 m2 ) -1,the 30％accuracy of eGFR using both methods was between 39.7％ -49.1％,40.5％ -52.6％respectively,and the difference of data showed no statistical significance.For the same equation,there was a significant differernce in 30％ accuracy of eGFR between two enzymatic creatinine detection systems,while there was no significant differernce between two Jaffe creatinine detection systems.ConclusionsA significant difference was demonstrated in the same GFR evaluation equation using two different creatinine detection methods (Jaffe method and enzymatic method).The correlation between rGFR and eGFR,the degree of deviation,and accuracy of eGFR results assessed by enzymatic creatinine method were better than those by Jaffe method.The eGFR results assessed by different enzymatic detection systems revealed no significant difference.

Analytical performance of three cysteine proteinase inhibitor c reagents applied in the automatic biochemistry analyzer / 中华检验医学杂志

Objective To validate the analytical performance of three Cys C reagents with particle-enhanced turbidimetric immunoassay(PETIA) method used on the automatic biochemistry analyzer for preliminary clinical application.Methods The performance of three Cys C reagents (labeled as A, B, C) with PETIA method from Shanghai Jing Yuan Co., Beijing Leadman Co. and Beijing Jiuqiang Co. on OlympusAU2700 automatic biochemistry analyzer were assessed.According to the standard of CLSI EP6-A, EP15-A and EP7-P, the precision, linearity range, disturbance (bilirubin, hemoglobin, chyle) were assessed, and compared with those of Cys C reagent based on particle-enhanced nephelometric immunoassay(PENIA) from Dade Behring Co.. The reference ranges for Cys C in serum of 120 healthy individual were evaluated.Results The within-run CVs of the three reagents (A, B and C) were 3.08%-3.2%, 2.3%-4.15% and 1.38%-1.53% respectively.The total CV in A, B and C were 3.29%-3.44%, 2.65%-5.18% and 1.67%-1.69% respectively, lower than the stated.Limits of quantitative determination (LOQ) of the three reagents were 0.41, 0.23 and 0.07 mg/L, basically meeting the testing requirement.The linearity range was 0.22-7.26 mg/L(r=0.996), 0.20-7.72 mg/L(r=0.999)and 0.20-7.62 mg/L(r=0.997)in the three reagents, which demonstrated a sound linear correlation. For interference tests, no remarkable interference (<±10%) of reagent C was detected when bilirubin≤684 μmol/L, hemoglobin≤9.7 g/L and Chyle turbidity≤6 200 FTU; and no significant interference of reagent B was found when bilirubin≤684 μmol/L, hemoglobin≤6.79 g/L and Chyle turbidity≤6 200 FTU; when bilirubin≤684 μmol/L, hemoglobin≤4.85 g/L and Chyle turbidity≤1 240 FTU reagent A was not interfered significantly. The comparison afte and before the high-speed centrifugation reveals that the average percentage of bias for reagents A, B, C measured Cys C in chylous serum samples of patients was -8.31%, 1.52%, 1.32%, respectively.In method comparison tests, the regression equations of the three reagents compared with Dade Behring PENIA Cys C reagent were as follows:Y=0.787X+0.492 (R2=0.976), Y=1.098X+0.137 (R2=0.982) and Y=1.037X+0.249 (R2=0.996), respectively. Agreement rates of the high Cys C in reagent A, B, C and Dade Behring Cys C reagent were 80% (Kappa=0.615,P=0.000), 100% (Kappa=1.000,P=0.000), 91.2% (Kappa=0.824,P=0.000); While for reference range of preliminary clinical assessment, diagnosis coincidence rate of reagent A increased to 98.8% (Kappa=0.974,P=0.000). Conclusions When used in automatic biochemical analyzer, the three Cys C reagent with PETIA showed high precision,sensitivity, and sound correlation with Dade Behring PENIA reagents.The three reagents are all able to meet clinical test requirements, nevertheless, anti-interference capability were diffierent and the reference range should be further validated.