ABSTRACT
Objective To analyze result of the external quality assessment for laboratories of toxicological pathology diagnosis in organizations in China. Methods A total of 86 organizations that participated in the 2020-2021 external quality assessment in laboratory of toxicological pathology diagnosis (hereinafter referred to as "reference units") were selected as research subjects using convenient sampling method, and the assessment results were analyzed. Results The median of total score was 92, and the 0-100 percentiles were 64-100 in these 86 reference units. Among these reference units, 76 were rated as excellent, 10 as qualified, with the excellent and the qualified rate of 88.4% and 11.6%, respectively. No reference unit was rated as unqualified. The rates of excellence of the reference units in public health institutions, pharmaceutical research institutions, drug safety evaluation centers and testing companies were 95.7%, 84.2%, 85.7% and 86.7%, and the qualified rates were 4.3%, 15.8%, 14.3% and 13.3%, respectively. The distribution of excellence and qualification among the four types of reference units showed no statistical difference (P>0.05). The distribution of sample scores according to the three grades of poor, good, and excellent were 4.9%, 20.7%, and 74.5% in public health institutions, 8.6%, 23.7%, and 67.8% in pharmaceutical research institutions, 12.5%, 25.0%, and 62.5% in drug safety evaluation centers, and 5.4%, 17.5%, and 77.1% in testing companies. The proportion of excellence unit in public health institutions was higher than that in pharmaceutical research institutions (P<0.05). Conclusion The overall toxicological pathology diagnostic capabilities in China are good, and various types of reference units demonstrate comparable technical capabilities. However, there is a need for standardization of diagnostic terminology.
ABSTRACT
Objective The effect of different doses of ethylnitrosourea(ENU)and cyclophosphamide(CP)on the loss rate of CD59 on peripheral blood erythrocytes was explored to optimize the detection method of Pig-a gene mutation. Methods According to the weight and loss rate of CD59 on peripheral blood erythrocytes,rats were divided into 4 groups:the control group,CP 40 mg/kg group,ENU 10 mg/kg group and ENU 40 mg/kg group(n=6). The control group was injected i.p. with PBS,other groups were injected i.p. with corresponding solutions. The body weight of rats on days 0,7,14,21, 28, 42 and 56 were recorded. At the same time, blood samples were collected and incubated with antibodies,and the loss rate of RBCCD59-was detected by flow cytometry. Results Compared with the control group, at different time points, the body weight and weight gain of ENU 10 mg/kg group and ENU 40 mg/kg group had no statistically significant difference(P > 0.05),while those in the CP 40 mg/kg group were significantly decreased(P <0.05). The loss rate of RBCCD59-was significantly increased in the CP 40 mg/kg group at 28,42 and 56 days, ENU 10 mg/kg group at 42 and 56 days,and ENU 40 mg/kg group at 7,14,21,28,42 and 56 days,(P < 0.05). The results showed a dose-response relationship. Conclusions Under the conditions of this Pig-a mutation detection method,ENU is superior to CP on raising loss rate of RBCCD59-,ENU 40 mg/kg is better than 10 mg/kg,and 28 days is suitable as the test period.