Department of Prenatal Diagnosis, Women's Hospital of Nanjing Medical University, Nanjing Maternity and Child Health Care Hospital, Nanjing, China.
Genesky Diagnostics (Suzhou) Inc., Suzhou, China.
J Mol Diagn. 2021 Jan;23(1):38-45. doi: 10.1016/j.jmoldx.2020.10.002. Epub 2020 Oct 15.
Embryonic chromosomal abnormalities are the major cause of miscarriage. An accurate, rapid, and cheap method of chromosome analysis in miscarriage is warranted in clinical practice. Thus, a high-throughput ligation-dependent probe amplification (HLPA)-based method of detecting aneuploidies and copy number variations in miscarriage was developed. A total of 1060 cases of miscarriage were assessed. Each specimen was subjected to quantitative fluorescence (QF)-PCR/HLPA and chromosomal microarray analysis (CMA) in parallel. All 1060 samples were successfully analyzed using both methods; of these samples, 1.7% (18/1060) were identified as having significant maternal cell contamination. Among the remaining 1042 cases without significant maternal cell contamination, QF-PCR/HLPA reached a diagnostic yield of 59.6% (621/1042), which is comparable to the yield of 60.3% (628/1042) with CMA. Compared with CMA results, the sensitivity and specificity of QF-PCR/HLPA in the identification of total pathogenic chromosomal abnormalities were 98.9% and 100%, respectively. Furthermore, the overall prevalence of chromosomal abnormalities in cases of spontaneous abortion was not significantly different from that in cases of recurrent miscarriage (61.3% versus 58.5%). In summary, QF-PCR/HLPA rapidly and accurately identified chromosomal abnormalities at a comparable performance and lower cost as compared with CMA. Combining simplicity and accuracy with cost-effectiveness, QF-PCR/HLPA may serve as a promising approach to routine genetic testing in miscarriage in clinical practice.
胚胎染色体异常是流产的主要原因。在临床实践中,需要一种准确、快速且廉价的方法来分析流产组织中的染色体。因此,开发了一种高通量连接依赖性探针扩增(HLPA)方法,用于检测流产组织中的非整倍体和拷贝数变异。共评估了 1060 例流产病例。每个标本均同时进行定量荧光(QF)-PCR/HLPA 和染色体微阵列分析(CMA)。所有 1060 个样本均成功地通过两种方法进行了分析;其中 1.7%(18/1060)被鉴定为存在显著的母体细胞污染。在没有显著母体细胞污染的其余 1042 例中,QF-PCR/HLPA 的诊断率达到 59.6%(621/1042),与 CMA 的 60.3%(628/1042)相当。与 CMA 结果相比,QF-PCR/HLPA 在识别总致病性染色体异常方面的灵敏度和特异性分别为 98.9%和 100%。此外,自然流产病例中染色体异常的总体患病率与复发性流产病例无显著差异(61.3%对 58.5%)。综上所述,与 CMA 相比,QF-PCR/HLPA 快速、准确地识别染色体异常,具有相当的性能和更低的成本。结合了简便性、准确性和成本效益,QF-PCR/HLPA 可能成为临床实践中流产常规遗传检测的一种有前途的方法。