1.Application of the Anderson sampler in the inspection for the filtration efficiency for bacteria in medical mask
Di LEI ; Chen WANG ; Minjuan ZHANG ; Cunlin LONG ; Jian REN ; Zhijie ZHAO ; Yuwei LI ; Yun LING ; Xiaoning SUN ; Jing ZHAO
China Medical Equipment 2025;22(3):160-163
The medical mask,which is used as an important tool of preventing the spread of respiratory diseases,can effectively block the transmission of biological aerosols.The detection for the filtration efficiency of bacteria in medical mask is particular importance.The Andersen sampler,is one kind of device that samples microbial aerosols,is widely used in the inspection for the filtration efficiency for bacteria in medical masks.It mainly consists of six impactors with different pore sizes.It simulates the deposition process of the most of particles at different positions in respiratory system through the bacterial particles in biological aerosols impact respectively the surface of petri dishes with agar under different pore sizes.This paper explored the development background,structure and sampling principle,operation and counting procedures of the Andersen sampler,as well as its application and importance in the inspection for the filtration efficiency for bacteria in medical mask.
2.Performance verification of fully automated chemiluminescence immunoassay analyzer in measuring special sequence indicators of serum β-CTx
Di LEI ; Jian REN ; Minjuan ZHANG ; Xiaoning SUN ; Yingjun LI ; Xiaodong ZHANG ; Cunlin LONG
China Medical Equipment 2025;22(8):57-60
Objective:To verify the performance of MAGLUMI 4000 fully automatic chemiluminescence immunoassay analyzer in measuring special sequence of β-Collagen(β-CTx).Methods:Referring to a series of standards included WS/T 492-2016"Verification of performance for precision and trueness of quantitative measurements in clinical laboratories"and CNAS-GL037 2019"Guidance on the verification of quantitative measurement procedures used in the clinical chemistry",the precision,trueness,and linear interval of MAGLUMI 4000 fully automatic chemiluminescence immunoassay analyzer were verified in measuring β-CTx.Results:The intra batch precisions(repeatability)of MAGLUMI 4000 fully automatic chemiluminescence immunoassay analyzer were respectively 3.22%and 3.49%in measuring serum β-CTx samples with low and high values.The intermediate precisions(precision within laboratory)were respectively 4.35%and 3.29%,both of which met the requirements of laboratory.The results of trueness verification showed that the bias of samples with low concentration was-2.4%,and the bias of samples with high concentration was-2.1%.The expected values of the standards with low and high values were all between the corresponding up and low validation limits of them,which met the judgment criteria.The linear interval was 0.03-6.00 ng/mL,which was within the linear interval,and it can meet the requirements of manufacturer′s claim.Conclusion:The precision,trueness and linear interval of MAGLUMI 4000 fully automatic chemiluminescence immunoassay analyzer all passed the verification in measuring β-CTx,which indicates the performance of the project can meet the quality specifications.
3.Application of the Anderson sampler in the inspection for the filtration efficiency for bacteria in medical mask
Di LEI ; Chen WANG ; Minjuan ZHANG ; Cunlin LONG ; Jian REN ; Zhijie ZHAO ; Yuwei LI ; Yun LING ; Xiaoning SUN ; Jing ZHAO
China Medical Equipment 2025;22(3):160-163
The medical mask,which is used as an important tool of preventing the spread of respiratory diseases,can effectively block the transmission of biological aerosols.The detection for the filtration efficiency of bacteria in medical mask is particular importance.The Andersen sampler,is one kind of device that samples microbial aerosols,is widely used in the inspection for the filtration efficiency for bacteria in medical masks.It mainly consists of six impactors with different pore sizes.It simulates the deposition process of the most of particles at different positions in respiratory system through the bacterial particles in biological aerosols impact respectively the surface of petri dishes with agar under different pore sizes.This paper explored the development background,structure and sampling principle,operation and counting procedures of the Andersen sampler,as well as its application and importance in the inspection for the filtration efficiency for bacteria in medical mask.
4.Performance verification of fully automated chemiluminescence immunoassay analyzer in measuring special sequence indicators of serum β-CTx
Di LEI ; Jian REN ; Minjuan ZHANG ; Xiaoning SUN ; Yingjun LI ; Xiaodong ZHANG ; Cunlin LONG
China Medical Equipment 2025;22(8):57-60
Objective:To verify the performance of MAGLUMI 4000 fully automatic chemiluminescence immunoassay analyzer in measuring special sequence of β-Collagen(β-CTx).Methods:Referring to a series of standards included WS/T 492-2016"Verification of performance for precision and trueness of quantitative measurements in clinical laboratories"and CNAS-GL037 2019"Guidance on the verification of quantitative measurement procedures used in the clinical chemistry",the precision,trueness,and linear interval of MAGLUMI 4000 fully automatic chemiluminescence immunoassay analyzer were verified in measuring β-CTx.Results:The intra batch precisions(repeatability)of MAGLUMI 4000 fully automatic chemiluminescence immunoassay analyzer were respectively 3.22%and 3.49%in measuring serum β-CTx samples with low and high values.The intermediate precisions(precision within laboratory)were respectively 4.35%and 3.29%,both of which met the requirements of laboratory.The results of trueness verification showed that the bias of samples with low concentration was-2.4%,and the bias of samples with high concentration was-2.1%.The expected values of the standards with low and high values were all between the corresponding up and low validation limits of them,which met the judgment criteria.The linear interval was 0.03-6.00 ng/mL,which was within the linear interval,and it can meet the requirements of manufacturer′s claim.Conclusion:The precision,trueness and linear interval of MAGLUMI 4000 fully automatic chemiluminescence immunoassay analyzer all passed the verification in measuring β-CTx,which indicates the performance of the project can meet the quality specifications.

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