摘要
目的 对一种呼吸道病毒核酸六重联检试剂的主要性能进行验证及评价,以满足临床检测需要.方法 依据中国合格评定国家认可委员会发布的《分子诊断检验程序性能验证指南(CN AS-GL039):2019》文件要求,对临床实验室使用的呼吸道病毒核酸六重联试剂的符合率、精密度、最低检出限、交叉反应和抗干扰能力进行验证和评价.结果 该检测试剂盒精密度良好,CV＜5％;对6种病原体随机组合的检出符合率均为100％;最低检出限为1.0 × 103 copies/mL;与临床常见病原体,如新冠病毒、EB病毒、肺炎支原体、人博卡病毒无交叉反应;干扰物加入25％的血液、0.15mg/mL的奥司他韦和142ng/mL的利巴韦林,检测结果与对照样本无显著差异.结论 呼吸道病毒核酸六重联检试剂的主要性能指标满足相关标准要求,可常规应用于临床检测.
Abstract
Objective To evaluate the main properties of a six-fold nucleic acid test reagent for respiratory tract virus in clinical detections.Methods In accordance with the CNAS-GL039:2019 Guidance for Performance Verification of Molecular Diagnostic Test Procedures,the compliance rate,precision,minimum detection limit,cross-reaction and anti-interference ability of a respiratory virus nucleic acid hexapline were evaluated by using specific reference products and fixed quality control products with known concentrations.Results The precision of the test kit was shown to be decent(CV＜5％).The detection rate of the kit for any number of samples of any combination of six pathogens was 100％.When the detection concentration was 1.0 × 103 copies/mL,the results were all positive,which met the minimum detection limit marked in the reagent manual.There was no cross-reaction with common clinical pathogens,such as novel coronavirus,Epstein-Barr virus,mycoplasma pneumoniae,and human Boca virus.There was no significant difference between the interference group with 25％blood,0.15mg/mL oseltamivir,142ng/mL of ribavirin and the control group,so the anti-interference evaluation was passed.Conclusion The main performance indexes of the respiratory virus nucleic acid six-fold test reagent is able to meet the requirements of relevant standards,so it can be used in clinical practices.
维普
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