比较自我采集的阴道拭子和尿液样本中用于诊断生殖支原体和大环内酯类耐药突变的检测方法。
Comparison of Assays for the Diagnosis of Mycoplasma genitalium and Macrolide Resistance Mutations in Self-Collected Vaginal Swabs and Urine.
机构信息
From the St Joseph's Healthcare Hamilton/McMaster University, Hamilton, Ontario.
National Microbiology Laboratory/Public Health Agency Canada (NML, PHAC), Winnipeg, Manitoba.
出版信息
Sex Transm Dis. 2020 Oct;47(10):705-711. doi: 10.1097/OLQ.0000000000001226.
BACKGROUND
The objective was to compare commercial assays on clinical specimens for Mycoplasma genitalium (MG) detection and macrolide resistance mutation (MRM) frequency.
METHODS
Three self-collected vaginal swabs (VS) and a first-void urine (FVU) from 300 consented women were tested by Aptima MG (AMG), ResistancePlus MG (RPMG) and Seeplex STD6 ACE (STD6) for detection of MG. Aptima MG and STD6 MG positives were tested for MRM using MG 23S rRNA polymerase chain reaction with Sanger sequencing (23SMGSS) compared with MRM determination in the RPMG assay. Unique AMG positives were tested with confirmatory Aptima assays.
RESULTS
M. genitalium prevalence ranged from 7.1% to 19.7%, influenced by the assay used and the specimen tested. Overall agreements for MG detection were 96.3% (κ = 0.91) for VS and 93.3% (κ = 0.72) for FVU between AMG and RPMG with lower agreements with STD6. Using a rotating reference standard, sensitivities on VS and FVU were 100% and 100% for AMG, 100% and 83.3% for RPMG, and 54.2% and 48.4% for STD6. Specificities were high for RPMG and STD6 and AMG detected extra positives, most of which were confirmed. Macrolide resistance mutation frequency rates testing VS and FVU were 50% (24/48) and 58.1% (18/31) by RPMG compared with 52.5% (31/59) and 23.5% (12/51) by 23SMGSS. MRM overall agreements between RPMG and 23SMGSS were 73.2% (κ = 0.41) for VS and 76.0% (κ = 0.52) for FVU.
CONCLUSIONS
Aptima MG detected more cases of MG infections. ResistancePlus MG detection was more effective on VS than on FVU. Seeplex STD6 ACE performance was inferior. The MRM detection component of RPMG agreed with results from 23SMGSS most of the time.
背景
本研究旨在比较商业检测方法在临床标本中检测解脲支原体（MG）和大环内酯类耐药突变（MRM）频率的差异。
方法
300 名同意参与的女性自行采集阴道拭子（VS）和首次中段尿（FVU）各 3 份，采用 Aptima MG（AMG）、ResistancePlus MG（RPMG）和 Seeplex STD6 ACE（STD6）进行 MG 检测。使用 MG 23S rRNA 聚合酶链反应结合 Sanger 测序（23SMGSS）对 Aptima MG 和 STD6 MG 阳性标本进行 MRM 检测，并与 RPMG 检测中的 MRM 结果进行比较。对 AMG 阳性标本进行确证性 Aptima 检测。
结果
MG 流行率为 7.1%~19.7%，受检测方法和标本类型的影响。AMG 与 RPMG 检测 VS 和 FVU 的 MG 总体一致性分别为 96.3%（κ=0.91）和 93.3%（κ=0.72），与 STD6 的一致性较低。采用轮转参考标准，AMG 在 VS 和 FVU 的灵敏度为 100%和 100%，RPMG 为 100%和 83.3%，STD6 为 54.2%和 48.4%。RPMG 和 STD6 的特异性较高，AMG 检测到更多的阳性标本，其中大部分得到确证。与 23SMGSS 相比，RPMG 在 VS 和 FVU 检测到的 MG 耐药突变频率分别为 50%（24/48）和 58.1%（18/31），而 23SMGSS 为 52.5%（31/59）和 23.5%（12/51）。RPMG 与 23SMGSS 之间的 MRM 总体一致性分别为 VS 为 73.2%（κ=0.41）和 FVU 为 76.0%（κ=0.52）。
结论
Aptima MG 检测到更多的 MG 感染病例。RPMG 在 VS 上的检测效果优于 FVU。Seeplex STD6 ACE 的性能较差。RPMG 的 MRM 检测组件与 23SMGSS 的结果大部分时间一致。
Zotero 插件