{"title":"评估用于检测 B 群链球菌的同步扩增和检测试验的性能:与实时 PCR 和 ddPCR 试验进行比较。","authors":"Loukaiyi Lu, Yisheng Chen, Qiang Wang, Jing Gao, Chunmei Ying","doi":"10.1186/s12941-024-00726-y","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>To evaluate the performance of simultaneous amplification and testing (SAT) assay for the detection of group B Streptococcus (GBS) in maternal vaginal and perianal swabs compared with real-time polymerase chain reaction (RT-PCR).</p><p><strong>Methods: </strong>We obtained vaginal and perianal swabs from 1474 pregnant women at the Obstetrics and Gynecology Hospital of Fudan University (Shanghai, China) between April 2023 and June 2023. Vaginal and perianal swabs were collected at 35-37 weeks of gestation. Swabs were tested for GBS simultaneously by using the SAT assay and RT-PCR, and a comparative analysis (kappa coefficient) was performed. Furthermore, we conducted additional droplet digital PCR (ddPCR) tests to confirm the results when there were controversial results between SAT and RT-PCR. In addition, we compared the limit of detection, technical specificity, repeatability and reproducibility of SAT-GBS with those of routine RT-PCR assays.</p><p><strong>Results: </strong>In our study, the detection rate of clinical GBS according to the SAT assay was 11.5% (169/1471). The SAT assay showed a sensitivity of 91.8%, a specificity of 99.9%, a diagnostic accuracy of 98.9%, a positive predictive value (PPV) of 99.4% and a negative predictive value (NPV) of 98.8%. The kappa value between RT-PCR and SAT was 0.917.</p><p><strong>Conclusions: </strong>This SAT assay for the detection of group B Streptococcus is not only easy to perform but can also detect GBS sensitively and specifically and may be used in the regular molecular diagnosis of GBS infection among pregnancies.</p>","PeriodicalId":8052,"journal":{"name":"Annals of Clinical Microbiology and Antimicrobials","volume":"23 1","pages":"65"},"PeriodicalIF":4.6000,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11264765/pdf/","citationCount":"0","resultStr":"{\"title\":\"To evaluate the performance of simultaneous amplification and testing assay for group B Streptococcus detection: comparison with real-time PCR and ddPCR assays.\",\"authors\":\"Loukaiyi Lu, Yisheng Chen, Qiang Wang, Jing Gao, Chunmei Ying\",\"doi\":\"10.1186/s12941-024-00726-y\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>To evaluate the performance of simultaneous amplification and testing (SAT) assay for the detection of group B Streptococcus (GBS) in maternal vaginal and perianal swabs compared with real-time polymerase chain reaction (RT-PCR).</p><p><strong>Methods: </strong>We obtained vaginal and perianal swabs from 1474 pregnant women at the Obstetrics and Gynecology Hospital of Fudan University (Shanghai, China) between April 2023 and June 2023. Vaginal and perianal swabs were collected at 35-37 weeks of gestation. Swabs were tested for GBS simultaneously by using the SAT assay and RT-PCR, and a comparative analysis (kappa coefficient) was performed. Furthermore, we conducted additional droplet digital PCR (ddPCR) tests to confirm the results when there were controversial results between SAT and RT-PCR. In addition, we compared the limit of detection, technical specificity, repeatability and reproducibility of SAT-GBS with those of routine RT-PCR assays.</p><p><strong>Results: </strong>In our study, the detection rate of clinical GBS according to the SAT assay was 11.5% (169/1471). The SAT assay showed a sensitivity of 91.8%, a specificity of 99.9%, a diagnostic accuracy of 98.9%, a positive predictive value (PPV) of 99.4% and a negative predictive value (NPV) of 98.8%. 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引用次数: 0
摘要
研究背景目的:与实时聚合酶链反应(RT-PCR)相比,评估同步扩增检测(SAT)法检测孕产妇阴道拭子和肛周拭子中乙型链球菌(GBS)的性能:2023年4月至2023年6月期间,我们在复旦大学附属妇产科医院(中国上海)采集了1474名孕妇的阴道和肛周拭子。阴道拭子和肛周拭子在妊娠 35-37 周时采集。我们同时使用 SAT 检测法和 RT-PCR 对拭子进行了 GBS 检测,并进行了比较分析(卡帕系数)。此外,当 SAT 和 RT-PCR 检测结果存在争议时,我们还进行了额外的液滴数字 PCR(ddPCR)检测以确认结果。此外,我们还比较了 SAT-GBS 与常规 RT-PCR 检测方法的检出限、技术特异性、重复性和可重复性:结果:在我们的研究中,SAT 检测法的临床 GBS 检出率为 11.5%(169/1471)。SAT 检测法的灵敏度为 91.8%,特异度为 99.9%,诊断准确率为 98.9%,阳性预测值(PPV)为 99.4%,阴性预测值(NPV)为 98.8%。RT-PCR 与 SAT 的卡帕值为 0.917:这种检测 B 群链球菌的 SAT 方法不仅操作简便,而且能灵敏、特异地检测出 GBS,可用于妊娠 GBS 感染的常规分子诊断。
To evaluate the performance of simultaneous amplification and testing assay for group B Streptococcus detection: comparison with real-time PCR and ddPCR assays.
Background: To evaluate the performance of simultaneous amplification and testing (SAT) assay for the detection of group B Streptococcus (GBS) in maternal vaginal and perianal swabs compared with real-time polymerase chain reaction (RT-PCR).
Methods: We obtained vaginal and perianal swabs from 1474 pregnant women at the Obstetrics and Gynecology Hospital of Fudan University (Shanghai, China) between April 2023 and June 2023. Vaginal and perianal swabs were collected at 35-37 weeks of gestation. Swabs were tested for GBS simultaneously by using the SAT assay and RT-PCR, and a comparative analysis (kappa coefficient) was performed. Furthermore, we conducted additional droplet digital PCR (ddPCR) tests to confirm the results when there were controversial results between SAT and RT-PCR. In addition, we compared the limit of detection, technical specificity, repeatability and reproducibility of SAT-GBS with those of routine RT-PCR assays.
Results: In our study, the detection rate of clinical GBS according to the SAT assay was 11.5% (169/1471). The SAT assay showed a sensitivity of 91.8%, a specificity of 99.9%, a diagnostic accuracy of 98.9%, a positive predictive value (PPV) of 99.4% and a negative predictive value (NPV) of 98.8%. The kappa value between RT-PCR and SAT was 0.917.
Conclusions: This SAT assay for the detection of group B Streptococcus is not only easy to perform but can also detect GBS sensitively and specifically and may be used in the regular molecular diagnosis of GBS infection among pregnancies.
期刊介绍:
Annals of Clinical Microbiology and Antimicrobials considers good quality, novel and international research of more than regional relevance. Research must include epidemiological and/or clinical information about isolates, and the journal covers the clinical microbiology of bacteria, viruses and fungi, as well as antimicrobial treatment of infectious diseases.
Annals of Clinical Microbiology and Antimicrobials is an open access, peer-reviewed journal focusing on information concerning clinical microbiology, infectious diseases and antimicrobials. The management of infectious disease is dependent on correct diagnosis and appropriate antimicrobial treatment, and with this in mind, the journal aims to improve the communication between laboratory and clinical science in the field of clinical microbiology and antimicrobial treatment. Furthermore, the journal has no restrictions on space or access; this ensures that the journal can reach the widest possible audience.