Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Disease, Peking University Hepatology Institute, Peking University People's Hospital, Beijing, China.
Prenatal Diagnosis Center, Peking University people's Hospital, Beijing, China.
Mol Genet Genomic Med. 2024 Jan;12(1):e2351. doi: 10.1002/mgg3.2351.
To explore reasons for the failure of noninvasive prenatal test (NIPT) for cell-free fetal DNA (cffDNA) in maternal peripheral blood, and discuss appropriate treatment schemes after the failure of the test.
Altogether 41,136 pregnant women participated in NIPT. Blood samples were taken again from pregnant women who failed the first blood collection upon their informed consent. Prenatal genetic counseling or prenatal diagnosis was recommended for pregnant women with final NIPT failure.
The first failure rate of NIPT was 0.737% (303/41136), and the reason for the failure was the low ratio of cffDNA in 135 (44.6%) of the 303 pregnant women. After the second or third blood sampling, the final failure rate was 0.182% (75/41136). The low ratio of cffDNA was the main reason for test failure in 42 (56.0%) of the 75 pregnant women who finally failed NIPT, among whom 44 (58.7%) had underlying diseases, including 21 (47.7%) with more than two coexisting underlying diseases. Only 27 (36.0%) of the 75 pregnant women with NIPT failure underwent interventional prenatal diagnosis.
The main reason for NIPT failure was the low ratio of cffDNA. Postponing the gestational weeks of blood collection may improve the success rate. Resampling and retesting upon informed consent in pregnant women who failed the first test could improve the success rate. For pregnant women who finally failed NIPT, it is suggested strengthening the genetic counseling, prenatal examination, and ultrasound evaluation, and carry out interventional prenatal diagnosis if necessary.
探讨母体外周血游离胎儿 DNA(cffDNA)无创产前检测(NIPT)失败的原因,并讨论检测失败后的适宜处理方案。
共有 41136 名孕妇参加了 NIPT。在知情同意的情况下,对首次采血失败的孕妇再次采集血样。对最终 NIPT 失败的孕妇建议进行产前遗传咨询或产前诊断。
NIPT 的首次失败率为 0.737%(303/41136),失败的原因是 135 例(44.6%)孕妇的 cffDNA 比值较低。在第二次或第三次采血后,最终失败率为 0.182%(75/41136)。cffDNA 比值较低是 42 例(56.0%)最终 NIPT 失败孕妇检测失败的主要原因,其中 44 例(58.7%)存在基础疾病,包括 21 例(47.7%)合并两种以上基础疾病。仅有 27 例(36.0%)NIPT 失败孕妇接受了介入性产前诊断。
NIPT 失败的主要原因是 cffDNA 比值较低。推迟采血的孕周可能会提高成功率。对首次检测失败的孕妇进行知情同意后的再次采样和重复检测可能会提高成功率。对于最终 NIPT 失败的孕妇,建议加强遗传咨询、产前检查和超声评估,如果有必要,进行介入性产前诊断。