Department of Infection Control, Affiliated Hospital of Academy of Military Medical Sciences, Beijing, People's Republic of China.
Department of Laboratory Medicine, Affiliated Hospital of Academy of Military Medical Sciences, Beijing, People's Republic of China.
BMC Infect Dis. 2018 Dec 12;18(1):651. doi: 10.1186/s12879-018-3580-0.
Nucleic acid amplification tests (NAAT) are well-accepted in diagnosis and surveillance of sexually infectious pathogens worldwide. However, performance differences between a RNA-based NAAT and DNA-based NAAT are rarely reported. This study compares the performances of the RNA-based SAT (simultaneous amplification and testing) assay and the DNA-based quantitative real-time polymerase chain reaction (qPCR) assay.
A total of 123 urogenital swabs were collected from outpatients with suspected genital infections in our hospital. Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Ureaplasma urealyticum (UU) in these swabs were simultaneously tested by SAT and qPCR. Any swabs were positive in the qPCR assay were further verified by following cloning and sequencing. All statistical analysis was performed using the SPSS software.
When the concentrations of CT, NG, or UU were more than 1 × 10 copies/ml, 100% agreements between SAT and qPCR were observed regardless of the pathogen. No discrepancy was found. However, the sensitivity of SAT is significantly higher than qPCR in samples with concentration less than 1 × 10 copies/ml. When tested by SAT and qPCR, 57.14 and 28.57% were positive for CT, 46.15% and 0 were positive for NG, 80% and 0 were positive for UU, respectively.
The SAT assay has better agreements and higher sensitivities when compared with the qPCR assay, and thus could be a better choice for screening, diagnosis, and surveillance of sexually transmitted diseases, especially for CT and NG.
核酸扩增检测(NAAT)在全球范围内被广泛用于性传播病原体的诊断和监测。然而,RNA 为基础的 NAAT 与 DNA 为基础的 NAAT 之间的性能差异很少有报道。本研究比较了基于 RNA 的 SAT(同时扩增和检测)检测法和基于 DNA 的定量实时聚合酶链反应(qPCR)检测法的性能。
我们从我院疑似生殖器感染的门诊患者中采集了 123 份泌尿生殖道拭子。使用 SAT 和 qPCR 同时检测这些拭子中的沙眼衣原体(CT)、淋病奈瑟菌(NG)和解脲脲原体(UU)。任何 qPCR 检测阳性的拭子均通过随后的克隆和测序进行验证。所有统计分析均使用 SPSS 软件进行。
当 CT、NG 或 UU 的浓度超过 1×10 拷贝/ml 时,SAT 和 qPCR 之间无论病原体如何,均观察到 100%的一致性。没有差异。然而,在浓度低于 1×10 拷贝/ml 的样本中,SAT 的灵敏度明显高于 qPCR。使用 SAT 和 qPCR 检测时,CT 的阳性率分别为 57.14%和 28.57%,NG 的阳性率分别为 46.15%和 0,UU 的阳性率分别为 80%和 0。
与 qPCR 检测相比,SAT 检测具有更好的一致性和更高的灵敏度,因此可能是筛查、诊断和监测性传播疾病的更好选择,特别是对于 CT 和 NG。