液基夹层杯技术用于基层实验室结核病诊断的可行性研究

Feasibility study of the Liquid-based Peng's interlayer vessel technique on diagnosis of tuberculosis in primary level laboratory

目的评价液基夹层杯法在基层实验室用于结核病诊断的可行性及安全性。方法在泰兴、江阴CDC两个县级结核病实验室,对385例疑似肺结核患者的754份痰标本同时采用液基夹层杯法与直接痰涂片法进行镜检,结合临床诊断,比较2种方法的阳性检出率。采用四格表Fisher确切概率法进行比较,并进一步比较两种方法对不同性状、不同时间收集的痰标本的阳性率。选取12份阳性痰标本,设定不同的痰消化液比例,不同的消化时间,加热与否处理痰标本,将处理后的消化液接种到罗氏培养基,37℃培养,通过比较生长情况评价液基法的安全性。结果液基夹层杯法、直接痰涂片法对754份痰标本的阳性检出率分别为23.5%(177/754)、16.8%(127/754),检测结果差异有统计学意义(χ2=48.02,P=0.000);比较不同性状、不同时间采集的痰标本采用两种方法的检测结果,得出脓痰直涂法阳性检出率为40.9%(81/198),液基法阳性检出率为47.5%(94/198),两种方法对于脓痰的检测结果差异有统计学意义(Fisher确切概率法,P确切概率<0.001);非脓性痰(包括血痰、黏液痰、口水痰)直涂法阳性检出率为4.7%(9/193),液基法阳性检出率为13.5%(26/193),差异有统计学意义(P确切概率值均<0.001)。安全性试验发现经消化液处理的痰标本,培养8周后未见结核分枝杆菌生长。结论液基夹层杯法提高了疑似肺结核患者细菌学检查的阳性检出率,且操作简单、安全性高,适合在基层实验室应用并便于开展质量控制,是一种很有推广价值的检测方法。

Objective To evaluate the feasibility and security of Liquid-based Peng＇s interlayer vessel technique used for diagnosis of tuberculosis in primary level laboratory.Methods In two primary level laboratories of Taixing and Jiangyin Center for Disease Control and Prevention,754 sputum samples from 385 suspect TB patients were tested simultaneously by two methods： sputum smear and acid-fast staining microscopy examination（direct AFB） and Liquid-based Peng＇s interlayer vessel technique.According to clinical diagnosis,the positive rates of the two methods for the sputum samples with different traits or collected at different times were compared by Fisher probabilities in 2×2 table.12 bacterium-positive sputa were treated with different proportion of digestion liquid,different digestion time,and heating or not.Then the digestive sputa were inoculated at Roche medium at 37 ℃.The security of the liquid-based method was evaluated by preparing the growth of mycobacteria.Results The posi-tive rates of Liquid-based Peng＇s interlayer vessel technique and the direct AFB were 23.5%（177/754） and 16.8%（127/754） respectively,which had significant difference（χ^248.02,P=0.000）.The positive rates of these two methods in purulent sputa were 47.5%（94/198） and 40.9%（81/198）,which had significant differences（P0.001）.The positive rates for the non-purulent sputa（including bloody sputa,mucus sputa and saliva sputa） were 13.5%（26/193） and 4.7%（9/193）（P0.001）.The sputum samples treated with the digestive liquid were not found the growth of Mycobacteria after the culture for 8 weeks.Conclusion Liquid-based Peng＇s interlayer vessel technique can improve the positive detection rate in suspect TB patients.It is simple,safe,and suitable for the application at primary laboratory for the diagnosis of tuberculosis and convenient for quality control.