ABSTRACT
【Objective】 To determine the reference red blood cells with weak agglutination intensity of low positive quality control products by comparing RhD antigen expression intensity difference according to the serological results. 【Methods】 The RhD(+ ) red blood cells were detected by microcolumn gel method with 1 500 times diluted anti-D typing reagent. The samples with weak and strong RhD antigen expression intensity were selected as the reference red blood cells for weak agglutination intensity of low positive quality control products, and verification was performed. 【Results】 Ten RhD(+ ) red blood cells were detected with diluted anti-D typing reagent, of which 8 were 1+ and 2 were ±. Red blood cells with agglutination intensity of 1+ were used as the benchmark to determine the maximum dilution ratio of anti-D typing reagent when their agglutination intensity was 1+. As the preparation standard of low positive quality control products, the agglutination intensity of red blood cells with low RhD antigen expression intensity was extremely weak ±, which was difficult to ensure the stability of its control limit properties. Based on red blood cells with agglutination intensity of ±, the maximum dilution ratio of anti-D typing reagent with agglutination intensity of 1+ was re-determined as the preparation standard of low positive quality control products, and the results met the requirements of quality control product setting. 【Conclusion】 Using red blood cells with low RhD antigen expression intensity as the benchmark to set the weak agglutination intensity of the low positive quality control products can avoid the loss of control due to the low target value.
ABSTRACT
【Objective】 To monitor the effectiveness and accuracy of the blood transfusion compatibility test system by self-made weakly positive internal quality control products. 【Methods】 Red blood cells from DAT(-) healthy subjects were selected, and B/RhD(-)E(-) red blood cells were selected as tube 1. A/RhD(+ )E(+ ) was selected as tube 2 to prepare blood group quality control products according to the principle of blood group antigen compatibility, and red blood cell preservation solution and corresponding ABO blood group reagent antibody were added to make the agglutination intensity of microcolumn gel method in reverse blood typing reach a low positive value (1+ ). Tube 3 and tube 4 were prepared with five different preservation media: plasma, serum, antibody diluent, mixture of equal plasma and antibody diluent, and mixture of equal serum and antibody diluent, respectively. IgM anti-E antibody was added to tube 3, and IgG anti-D antibody was added to tube 4, so that the agglutination intensity of microcolumn gel method reached a low positive value (1+ ). 【Results】 Comparison between the 5 different preservation media showed that the preservation medium of antibody diluent was the most stable for weakly positive antibody (F=11.35, P<0.05), Agglutination intensity 1+ is assigned 5 points by AABB Technical Manual, and its score was 5.25±1.75 points. 【Conclusion】 The use of self-made weakly positive quality control products can improve the effectiveness, accuracy and sensitivity of the monitoring system, thus achieving internal quality control and ensuring the safety of clinical blood use.
ABSTRACT
Objective To establish a new method for the verification of the interior quality control products of Medical Laborato ry by using the quality control data of the two groups to check the quality of the interior quality control products during the verification.Methods Take use of quality control data of HBsAg,HCV-Ab,Syphilis antibody and HIV antibody of two time periods before and after during the period of validity to analyze difference in the two groups before and after data and judge the stability of interior quality control products between the before and after.Results There was no significant difference between the two groups in the data of before and after(P＞0.05),indicating that the control products maintained stability during the process.The difference of the two groups of HBsAg was statistically significant(P＜0.05),indicating that the control product did not maintain good stability during this period,and measures should be taken.Conclusion Make statistical analysis of the mean((x)) and standard deviation(s) calculated from the quality control data obtained from the laboratory quality control,analyzing data whether the differences between the two time periods was statistically significant,so as to achieve internal quality control during product verification purposes
ABSTRACT
Objective To establish a new method for the verification of the interior quality control products of Medical Laborato ry by using the quality control data of the two groups to check the quality of the interior quality control products during the verification.Methods Take use of quality control data of HBsAg,HCV-Ab,Syphilis antibody and HIV antibody of two time periods before and after during the period of validity to analyze difference in the two groups before and after data and judge the stability of interior quality control products between the before and after.Results There was no significant difference between the two groups in the data of before and after(P＞0.05),indicating that the control products maintained stability during the process.The difference of the two groups of HBsAg was statistically significant(P＜0.05),indicating that the control product did not maintain good stability during this period,and measures should be taken.Conclusion Make statistical analysis of the mean((x)) and standard deviation(s) calculated from the quality control data obtained from the laboratory quality control,analyzing data whether the differences between the two time periods was statistically significant,so as to achieve internal quality control during product verification purposes
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Objective To investigate the preparation method of dry blood spots (DBS) control materials for steroids used for internal quality control by liquid chromatography tandem mass spectrometry (LC-MS/MS). Methods Whole blood was collected and the blood cells and plasma were separated. The blood cells were washed by saline. The activated charcoal was added to the plasma. Standard substance was added to make different concentrations (low, medium, and high) of DBS control materials for steroids. The precision, accuracy, stability, and differences among different blood spots were detected and analyzed by LC-MS/MS. Results The inter-day precision and accuracy of DBS control materials for steroids were 2.4%-7.0% and 102.0%-111.0%, respectively, and the intra-day precision and accuracy were 5.1%-9.8% and 99.0%-114.8% respectively. The DBS control materials for steroids were stored for 5 months, and there was no difference among the different months (P>0.05). The coefficients of variation among different blood spots were small, 3.3%-8.2%. Conclusions The DBS control materials for steroids has good precision, accuracy and stability. The difference among different blood spots is small and meet the requirements of indoor quality control products. They can be used for the internal quality control in steroids detection by LC-MS/MS.
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Objective To investigate the preparation of internal quality control products of NT‐proBNP by electrochemilumines‐cence detection .Methods The serum with high and normal levels of NT‐proBNP were collected and divided into low‐value group and high ‐value group .The expected target value ,inter‐batch duplicability ,imprecision and the stability within batch were detected . After effective verification ,we evaluated the bias between self developed internal quality control products and Roche factory quality control materials by comparative test .Results The repeatability ,stability and imprecision of self developed NT‐proBNP were all appropriate to internal quality control products and meeting meet the clinical testing standards .The control range was significantly less than that permitted by Roche ,so it can meet the internal quality control requirements .Conclusion The self developed NT‐proBNP internal quality control products can replace the imports quality control products .