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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.
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Objective To evaluate the long-term efficacy of neonatal immunoprophylaxis in children born from mothers infected with hepatitis B virus (HBV),and to clarify whether a booster vaccination is required.Methods Totally 252 children of HBV infected mothers,who were negative for hepatitis B surface antigen (HBsAg) tested in Nanjing Drum Tower Hospital in 2012,were enrolled to participate in this study from July to September,2017.Revaccination of hepatitis B vaccine was recorded and other relevant informations were collected.HBV serologic markers were detected in each child.Results Totally 198 children (78.6％) were followed up.They were (8.4 ± 2.2) years old and 112 cases were boys.All 198 children were negative for both HBsAg and hepatitis B core antibody (anti-HBc).The overall positive rate of hepatitis B surface antibody (anti-HBs) (≥ 10 IU/L) was 65.7％.During period of 2012 to 2017,53 children were boosted with hepatitis B vaccine.Their median anti-HBs titer in 2017 was higher than that in 2012 (327.95 IU/L vs.158.01 IU/L),and the difference was significant (Z =-4.480,P ＜0.05).The other 145 children were not revaccinated,their median anti-HBs titer was decreased from 214.19 IU/L in 2012 to 70.49 IU/L in 2017,and the difference was significant (Z =-6.575,P ＜ 0.05).Of 145 children who were not revaccinated,25 cases had anti-HBs levels ＜ 10 IU/L and 120 cases ≥ 10 IU/L in 2012,and the other 47 cases also showed the antibody ＜ 10 IU/L in 2017,but none of them was infected with HBV.Conclusions Neonatal immunoprophylaxis in infants from HBV-infected can provide long-term protection against hepatitis B.The children with anti-HBs ＜ 10 IU/L are still immune to HBV and booster vaccination for them seems unnecessary.
