目的 通过对比实验，对新型肺炎支原体（mycoplasma pneumoniae，MP）核酸检测试剂（采用浓缩一步法处理样本，以下简称“浓缩一步法”）的临床使用进行评价。方法 用浓缩一步法试剂与煮沸法试剂对临床收集的样本进行MP DNA检测并对比其结果，同时，将两种试剂的检测结果分别与金标准培养法检测结果进行对比。 结果 新型肺炎支原体核酸检测试剂与煮沸法试剂的阳性一致性百分比为98.36%，阴性一致性百分比为96.80%，总一致性百分比为97.68%；对5例不符样本进行测序复核，并对复核后的结果进行Kappa检验一致性分析，结果Kappa值=1.000，表明新型试剂的检测结果与煮沸法试剂及复核检测的结果具有很好的一致性。在与金标准培养法检测结果的对比中，两种试剂均表现出较好的准确性。结论 新型肺炎支原体核酸检测试剂与已上市的煮沸法试剂检测结果具有很好的一致性，操作简单快速，减少污染环节，并具有内标控制假阴性，结果准确，符合临床检测要求，具有较高的临床应用价值。

Objective To evaluate the clinical application of a new mycoplasma pneumoniae DNA Diagnostic Kit (refer to as concentrate One-step method hereafter). Methods A total of 216 clinical specimens were detected by concentrated one-step method and another kind of fluorescence diagnostic kit using boiling method. The results were analyzed and compared. Simultaneously, the gold standard culture test results of these 216 specimens were gathered and compared with the results from the concentrated one-step and boiling method kits. Results The two kits showed excellent agreement The Positive consistency was 98.36%, the negative consistency was 96.80% and the total consistency was 97.68%. 5 cases of discrepant samples were sequenced review, and then the results were performed with the Kappa consistency analysis. The value of Kappa=1.000, showed good consistency between the two methods. In addition, compared with the gold standard culture test results, the two reagents both showed good accuracy. Conclusion The concentrated one-step method showed good consistency compared with the conventional boiling method. The operation is simple and quick and can avoid laboratory contaminations which occur often during routine DNA extraction process. The PCR detection system uses an internal positive control (internal control) to avoid a false negative result. With a simple procedure and precise results, this new diagnostic kit is suitable for routine clinical lab use.