| 英文摘要 |
As the newest prenatal screening “Non-invasive prenatal testing (NIPT)” for common autosomal aneuploidy moves into obstetrical practice and continues to advance, reaching nearly diagnostic levels of accuracy (> 99%) otherwise only achieved by invasive procedures like chorionic villus sampling (CVS) or amniocentesis, but requiring only a sample of extracted maternal blood (10ML) at ten weeks of gestation period, from which cell-free fetal DNA fragments obtained, isolated, amplified, subjected to next-generation DNA sequencing followed by algorithms, the legal issues, arising from the elements of essence, obligations, quality of work, informed patient choice, performance interest, damages incurred due to contractors’ negligence, and the allocation of burden of proof, in standard undertaking contracts between clinical laboratories and pregnant women who was misled by false negative results to refrain from seeking an invasive diagnosis, and ended up with being deprived of “Reproductive Rights” established by “Genetic Health Act” section 9, are well worth a comprehensive analysis.
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