Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.
Institute for Clinical Immunology and Transfusion Medicine, Justus-Liebig-University, Giessen, Germany.
BMC Pregnancy Childbirth. 2020 Feb 7;20(1):83. doi: 10.1186/s12884-020-2742-4.
All non-sensitized Rhesus D (RhD)-negative pregnant women in Germany receive antenatal anti-D prophylaxis without knowledge of fetal RhD status. Non-invasive prenatal testing (NIPT) of cell-free fetal DNA in maternal plasma could avoid unnecessary anti-D administration. In this paper, we systematically reviewed the evidence on the benefit of NIPT for fetal RhD status in RhD-negative pregnant women.
We systematically searched several bibliographic databases, trial registries, and other sources (up to October 2019) for controlled intervention studies investigating NIPT for fetal RhD versus conventional anti-D prophylaxis. The focus was on the impact on fetal and maternal morbidity. We primarily considered direct evidence (from randomized controlled trials) or if unavailable, linked evidence (from diagnostic accuracy studies and from controlled intervention studies investigating the administration or withholding of anti-D prophylaxis). The results of diagnostic accuracy studies were pooled in bivariate meta-analyses.
Neither direct evidence nor sufficient data for linked evidence were identified. Meta-analysis of data from about 60,000 participants showed high sensitivity (99.9%; 95% CI [99.5%; 100%] and specificity (99.2%; 95% CI [98.5%; 99.5%]).
NIPT for fetal RhD status is equivalent to conventional serologic testing using the newborn's blood. Studies investigating patient-relevant outcomes are still lacking.
在德国，所有未致敏的 RhD（D 抗原）阴性孕妇在不了解胎儿 RhD 状态的情况下接受产前抗-D 预防。母体血浆中游离胎儿 DNA 的无创产前检测（NIPT）可避免不必要的抗-D 治疗。本文系统评价了 NIPT 检测 RhD 阴性孕妇胎儿 RhD 状态的获益证据。
我们系统检索了多个文献数据库、试验注册处和其他来源（截至 2019 年 10 月），以获取关于 NIPT 检测胎儿 RhD 与常规抗-D 预防的对照干预研究。重点关注对胎儿和母体发病率的影响。我们主要考虑直接证据（来自随机对照试验），或者如果没有直接证据，则考虑关联证据（来自诊断准确性研究和调查抗-D 预防治疗或不治疗的对照干预研究）。诊断准确性研究的结果通过双变量荟萃分析进行汇总。
既没有直接证据，也没有足够的关联证据。约 60000 名参与者的数据的荟萃分析显示了高敏感性（99.9%；95%置信区间 [99.5%；100%]）和特异性（99.2%；95%置信区间 [98.5%；99.5%]）。
NIPT 检测胎儿 RhD 状态与使用新生儿血液的常规血清学检测相当。目前仍缺乏针对患者相关结局的研究。
