Internal quality control of a turbidimetric immunoassay for canine serum C-reactive protein based on pooled patient samples

2004 ◽  
Vol 33 (3) ◽  
pp. 139-144 ◽  
Author(s):  
Mads Kjelgaard-Hansen ◽  
Asger Lundorff Jensen ◽  
Annemarie T. Kristensen
Author(s):  
Fumeng Yang ◽  
Wenjun Wang ◽  
Qian Liu ◽  
Xizhen Wang ◽  
Guangrong Bian ◽  
...  

Background The Six Sigma theory is an important tool for laboratory quality management. It has been widely used in clinical chemistry, haematology and other disciplines. The aim of our study was to evaluate the analytical performance of plasma proteins by application of Sigma metric and to compare the differences among three different allowable total errors in evaluating the analytical performance of plasma proteins. Methods Three different allowable total error values were used as quality goals. Data from an external quality assessment were used as bias, and the cumulative coefficient of variation in internal quality control data was used to represent the amount of imprecision during the same period. Sigma metric of analytes was calculated using the above data. The quality goal index was calculated to provide corrected measures for continuous improvements in analytical quality. Results The Sigma metric was highest using the external quality assessment standards of China: it was sigma ≥6 or higher in 57.1% of plasma proteins. But Sigma metric was lower by using RiliBÄK or biological variation standards. IgG, C3 and C-reactive protein all required quality improvements in imprecision. A single-rule 13s for internal quality control was recommended for IgA, IgM, C4 and rheumatoid factor, whereas multiple rules (13s/22s/R4s) were recommended for IgG, C3 and C-reactive protein, according to the external quality assessment standards of China. Conclusions Different quality goals can lead to different Sigma metric for the same analyte. As the lowest acceptable standard in clinical practice, the external quality assessment standard of China can guide laboratories to formulate reasonable quality improvement programmes.


2018 ◽  
Vol 33 (1) ◽  
pp. e22643 ◽  
Author(s):  
Huizhen Sun ◽  
Wei Wang ◽  
Haijian Zhao ◽  
Chuanbao Zhang ◽  
Falin He ◽  
...  

2021 ◽  
Vol 6 (2) ◽  
pp. 115-118
Author(s):  
Kafil Akhtar ◽  
Radhika Arora ◽  
Umrah Malik ◽  
Ankita Parashar ◽  
Murad Ahmad ◽  
...  

Quality control describes steps taken by blood and component bank to ensure that tests are performed correctly. Primary goal of quality control is transfusion of safe quality of blood. It is to ensure availability of efficient supply of blood and blood components. Internal quality control is the backbone of quality assurance program. To analyze the internal quality control of blood components in modern blood banking as an indicator of our blood bank performance. An observational cross sectional study conducted at the Blood and Component Bank, JN Medical College and Hospital from 2018 to 2020. Each blood component was arbitrarily chosen during the study on monthly basis. Selection criteria was 1.0% of total collection or minimum 4 bags per month. Packed red cells were evaluated for hemoglobin, hematocrit, RBC count; platelet concentrates for pH, yield and culture; fresh frozen plasma and cryoprecipitate were evaluated for unit volume, factor VIII and fibrinogen concentration. The mean HCT of packed red cells was 65.75+7.42%, volume was 238+26.25ml, Hb was 20.5+0.15g/dL and RBC count of 5.89x10+0.30x10. The mean platelet yield was 5.7x10, pH was ≥6.8+0.175 and volume was 82.5+13.75ml; cultures were negative and swirling was present in all the platelet units tested. Mean factor VIII and fibrinogen levels were found to be 95.25 +7.37and 307.5+41.37gm/l for FFP respectively. Mean volume, PT and APTT were 215+32.5ml, 14.15+0.325 sec and 29.50+1.5 sec respectively. The quality control of blood components ensures the timely availability of a blood component of high quality with maximum efficacy and minimal risk to potential recipients.


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