Objective To produce an experimental information for the safety assessment of Vero cells during subculture. Methods Passage and freeze on Vero cells, and Vero cells in different passages in vitro and in vivo tumorigenicity were tested. The protein expression of different Vero cell passages was analyzed. Results Vero cells passaged to p270 and 14 cell banks were developed and stored for future evaluation. In vitro and in vivo tumorigenicity Lest results of Vero cells in different passages were negative. Conclusion Although the tumorigenicity test results in vitro and in vivo process were negative, the protein expression of more than p200 Vero cells were changed, which produced the experimental reference for the safety evaluation of the process during the Vero cell passage.

Objective To estimate the application value of a standard operating procedure (SOP) in the detection of syphilitic anticardiolipin reagin. Methods Clinical laboratories from 9 local hospitals in Shanghai participated the program. Quality control samples with unknown target value were qualitatively and quantitatively examined according to the uniform SOP in these laboratories with the same reagent and facility of horizontal reaction. External quality assessment (EQA) was carried out by using seven serum samples with no, or low (1∶ 128 dilution) to high (1∶1 dilution) concentrations of target before and after the implementation of SOP. The test results were statistically analyzed and the reasons for the detecting error were assessed. Results A total of 388 tests were performed in the 9 clinical laboratories. The total accuracy rate was 93.0%, including 40.2% in the detection of samples with 1 ∶ 8 dilution of target, 49.2% in the detection of samples with 1 ∶ 16 dilution of target, and 3.6% in the detection of samples with 1 ∶ 32 dilution of target. No forward bias was observed in these tests. There was a significant difference in the accuracy rate between the two times of EQA before and after the implementation of SOP (x2 = 4.17, P < 0.05). Conclusions The improved standard procedure for nontreponemal antigen test is beneficial to the decrease of testing error, and may provide a basis for the establishment of SOP and implementation of internal quality assessment.