新型冠状病毒灭活操作对利奈唑胺血药浓度的影响及一致性评价

Consistency and effect of SARS-CoV-2 virus inactivation on the blood concentration of linezolid

目的考察新型冠状病毒不同的灭活方式对利奈唑胺血药浓度的影响,评价未灭活操作与灭活操作后两者对临床实际血药浓度结果的一致性。方法以利奈唑胺的质控对照品、质控血浆样品和临床实测样本作为考察对象,分别经56℃水浴加热30 min或紫外照射60 min后,考察质控对照品溶液和质控血浆样品的稳定性;并采用组内相关系数、Passing-Bablok回归法和Bland-Altman分析法,对灭活前后临床实测样本浓度结果进行统计分析。结果紫外灭活条件下,利奈唑胺的质控对照品不稳定;湿热灭活法条件下,利奈唑胺的质控对照品和质控血浆样品均稳定。统计结果表明,临床实测样本在未灭活操作与湿热灭活法操作后,两者血药浓度结果的相关性与一致性良好。结论利奈唑胺的临床血药浓度检测样本可采用湿热病毒灭活法进行预处理,以减少实验室工作人员的病毒感染风险。

Objective To determine the effect of the COVID-19 virus inactivation on the blood concentration of linezolid,and evaluate the consistency of clinical blood concentration of linezolid before and after the virus inactivation.Methods The standards,plasma quality controls and clinical samples of linezolid were selected as the research objects.The stability of the samples was evaluated after water bath at 56℃for 30 min or irradiated by ultraviolet radiation for 30 min.Consistency of the concentration of clinical samples before and after the virus inactivation were evaluationed through intragroup correlation coefficient,Passing-Bablok regression and Bland-Altman analysis.Results The standard products of linezolid were unstable after being irradiated with UV inactivation.However,the standard products and quality control samples of linezolid were stable after damp heat inactivation.The three statistical methods all indicated good correlation and consistency of blood drug concentration before and after the virus inactivation.Conclusion To reduce the risk of virus infection of laboratory staff,damp heat virus inactivation could be a good pretreatment for therapeutic drug monitoring samples of linezolid.