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Resumen En el presente trabajo se muestran los resultados obtenidos durante los estudios dosimétricos de las etapas de calificación operacional y del comportamiento funcional de la instalación de irradiación semindustrial de Cuba después de su remodelación y recarga, así como el proceso de radioesterilización de un producto de uso médico.
Abstract The present work shows the results obtained during the dosimetric studies of the operational qualification stages and the functional behavior of the semi-industrial irradiation facility in Cuba after its remodeling and recharging, as well as the radio-sterilization process of a product for medical use.
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Objective To evaluate the performance verification of Mindary BC5390 hematology analyzer .Methods According to requirement of CLSI documents ,the precision ,accuracy ,linearity ,carryover were evaluated .Results The background counts all met the designed requirements of manufacturer .Precision ,accuracy ,linearity of the WBC ,RBC ,PLT ,Hb ,HCT ,MCV were good and the contamination carrying rates were low .Except for basophils ,the classification of leukocyte was well correlated with the artificial microscopy classification(r2 >0 .95) .Conclusion The BC5390 is a ideal automated hematology analyzer which has high precision and accuracy ,wide linearity ,low contamination carrying rate ,and it can be used for the blood samples analysis .
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Objective To evaluate analytical performance of homocysteine (Hcy) by circulating enzymatic method .Methods Re‐ferring to CLSI evaluation project and pertinent literature ,and by combining our actual works .we designed a verification procedure and experimental method .By using these above ,the precision ,accuracy ,analytical measurement range ,clinical reportable range of Hcy by circulating enzymatic method were evaluated .Results would be compared with the declaration of the manufacturer (NingBo Medical System Biotechnology Co .,Ltd) or desirable specifications derived from biologic variation .Results The results showed that the within‐run CV were 1 .26% and 0 .84% ,and the total CV were 1 .36% and 1 .32% ,less than 10% of the manufacturer′s statement .The relative bias between the results measured for calibrator at tow levels and target value was 3 .69% and 0 .69% ,less 10% .AMR was 3 .38-51 .81 μmol/L ,and the most suitable dilution rate was 1∶3 ,so the CRR was 3 .38-155 .43 μmol/L .Con‐clusion The analytical performance of Hcy analyzed by circulating enzymatic method is consistent with the standards which manu‐facturers has proclaimed ,so it is conform to the requirements of clinical .
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Objective To verify the performance of the ABI ViiA 7 Taqman HBV-DNA detecting system for confirming its sta-bility,accuracy and reliability.Methods According to the evaluation protocols of Clinical and Laboratory Standards Institute (CLSI),the performance of ABI ViiA 7 Taqman HBV-DNA detecting system was assessed in the aspects of precision,accuracy,lin-earity and comparability;the quantitative detection limit validation experiments was performed by diluting specimen until quantita-tive detection limit is lower than the lower limit of detection,and the detection results were compared with the quality target re-quirements and the analysis capability declared by manufacturers.Results The CV in within-run precision of this detection system was 1.485%,1.990% and 0.932% respectively;the total CV was 1.876%,3.361% and 1.891%,respectively;the maximum devia-tion of accuracy was -6.8%;the linear correlation coefficient was 0.998 3;the regression equation was Y =0.974 8X +0.050 7. The linear range was 1.00E2 - 2.00E8;the quantitative detection limit was 100 IU/mL;the comparability of ABIViiA7 and ABI7500:P =0.115,r2 =0.994,the linear regression equation was Y =0.987 2X +0.051 7.Conclusion The ABI ViiA 7 Taqman HBV-DNA detection system has excellent precision,accuracy,sensitivity and linearity and has a good correlation with ABI7500, which can be used for the detection of clinical specimens.
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Objective To perform the performance verification of the Sysmex XT-2000i hematology analyzer.Methods Accord-ing to requirements of NCCLS EP5-A2,EP15-A2,EP6-A2,EP9-A2 documents,the accuracy,precision and linearity of the Symex XT-2000i hematology were evaluated and the detection results were compared with those detected by the Sysmex XE-2100i which participated in the external quality assessment(EQA)of Ministry of Public Health for long time.Results The accuracy,precision, linearity and contamination rate all are within the permissible range.Conclusion The performance of Sysmex XT-2000i is good,the determination results are reliable.As a perfect hematology analyzer,it can satisfy the hematological analysis of hospital clinical la-boratory.