{"id":11090,"date":"2026-09-26T02:04:43","date_gmt":"2026-09-26T02:04:43","guid":{"rendered":"https:\/\/medidirect.eu\/?post_type=product&#038;p=11090"},"modified":"2026-09-26T02:04:44","modified_gmt":"2026-09-26T02:04:44","slug":"prenatalsafe-5-nipt-blood-test","status":"publish","type":"product","link":"https:\/\/medidirect.eu\/es\/shop\/prenatalsafe-5-nipt-blood-test\/","title":{"rendered":"PrenatalSAFE 5 NIPT Blood Test"},"content":{"rendered":"<p data-path-to-node=\"13\">PrenatalSAFE\u00ae 5 occupies a key tier within the clinical PrenatalSAFE\u00ae family (which spans PrenatalSAFE 3, PrenatalSAFE Plus, Karyo, and Complete). While traditional national healthcare screening pathways (such as the NHS combined test) rely on maternal serum biochemical markers (PAPP-A, free <span class=\"math-inline\" data-math=\"\\beta\" data-index-in-node=\"293\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord mathnormal\">\u03b2<\/span><\/span><\/span><\/span><\/span>-hCG) paired with ultrasound nuchal translucency (NT) measurement\u2014yielding detection rates around 85% with a 5% false-positive rate\u2014PrenatalSAFE 5 utilizes massive parallel sequencing of placental DNA fragments in maternal circulation to achieve detection rates of up to 99.5% with false-positive rates below 0.1%.<\/p>\n<p data-path-to-node=\"14\"><b data-path-to-node=\"14\" data-index-in-node=\"0\">Diagnostic Scope &amp; Chromosomal Targets<\/b><\/p>\n<ul data-path-to-node=\"15\">\n<li>\n<p data-path-to-node=\"15,0,0\"><b data-path-to-node=\"15,0,0\" data-index-in-node=\"0\">Primary Autosomal Aneuploidies:<\/b><\/p>\n<ul data-path-to-node=\"15,0,1\">\n<li>\n<p data-path-to-node=\"15,0,1,0,0\"><b data-path-to-node=\"15,0,1,0,0\" data-index-in-node=\"0\">Trisomy 21 (Down Syndrome):<\/b> Most common viable autosomal aneuploidy (<span class=\"math-inline\" data-math=\"1\\text{ in }700\\text{ live births}\" data-index-in-node=\"69\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord\">1<\/span><span class=\"mord text\"><span class=\"mord\">\u00a0in\u00a0<\/span><\/span><span class=\"mord\">700<\/span><span class=\"mord text\"><span class=\"mord\">\u00a0live\u00a0births<\/span><\/span><\/span><\/span><\/span><\/span>), characterized by variable intellectual disability, congenital heart defects, and characteristic physical features.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"15,0,1,1,0\"><b data-path-to-node=\"15,0,1,1,0\" data-index-in-node=\"0\">Trisomy 18 (Edwards Syndrome):<\/b> Severe chromosomal condition (<span class=\"math-inline\" data-math=\"1\\text{ in }3,000\\text{ to }5,000\\text{ births}\" data-index-in-node=\"61\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord\">1<\/span><span class=\"mord text\"><span class=\"mord\">\u00a0in\u00a0<\/span><\/span><span class=\"mord\">3<\/span><span class=\"mpunct\">,<\/span><span class=\"mord\">000<\/span><span class=\"mord text\"><span class=\"mord\">\u00a0to\u00a0<\/span><\/span><span class=\"mord\">5<\/span><span class=\"mpunct\">,<\/span><span class=\"mord\">000<\/span><span class=\"mord text\"><span class=\"mord\">\u00a0births<\/span><\/span><\/span><\/span><\/span><\/span>) involving microcephaly, congenital cardiac and renal malformations, and high intrauterine lethality.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"15,0,1,2,0\"><b data-path-to-node=\"15,0,1,2,0\" data-index-in-node=\"0\">Trisomy 13 (Patau Syndrome):<\/b> Severe aneuploidy (<span class=\"math-inline\" data-math=\"1\\text{ in }6,000\\text{ to }10,000\\text{ births}\" data-index-in-node=\"48\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord\">1<\/span><span class=\"mord text\"><span class=\"mord\">\u00a0in\u00a0<\/span><\/span><span class=\"mord\">6<\/span><span class=\"mpunct\">,<\/span><span class=\"mord\">000<\/span><span class=\"mord text\"><span class=\"mord\">\u00a0to\u00a0<\/span><\/span><span class=\"mord\">10<\/span><span class=\"mpunct\">,<\/span><span class=\"mord\">000<\/span><span class=\"mord text\"><span class=\"mord\">\u00a0births<\/span><\/span><\/span><\/span><\/span><\/span>) characterized by holoprosencephaly, midline facial clefts, and polydactyly.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<li>\n<p data-path-to-node=\"15,1,0\"><b data-path-to-node=\"15,1,0\" data-index-in-node=\"0\">Sex Chromosome Aneuploidies (SCAs):<\/b><\/p>\n<ul data-path-to-node=\"15,1,1\">\n<li>\n<p data-path-to-node=\"15,1,1,0,0\"><b data-path-to-node=\"15,1,1,0,0\" data-index-in-node=\"0\">Monosomy X \/ <span class=\"math-inline\" data-math=\"45,X\" data-index-in-node=\"13\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord\">45<\/span><span class=\"mpunct\">,<\/span><span class=\"mord mathnormal\">X<\/span><\/span><\/span><\/span><\/span> (Turner Syndrome):<\/b> Complete or partial absence of one X chromosome in females, presenting with short stature, ovarian dysgenesis, and aortic coarctation.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"15,1,1,1,0\"><b data-path-to-node=\"15,1,1,1,0\" data-index-in-node=\"0\"><span class=\"math-inline\" data-math=\"47,XXY\" data-index-in-node=\"0\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord\">47<\/span><span class=\"mpunct\">,<\/span><span class=\"mord mathnormal\">XX<\/span><span class=\"mord mathnormal\">Y<\/span><\/span><\/span><\/span><\/span> (Klinefelter Syndrome):<\/b> Presence of an extra X chromosome in males, leading to testicular dysgenesis, hypergonadotropic hypogonadism, tall stature, and gynecomastia.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"15,1,1,2,0\"><b data-path-to-node=\"15,1,1,2,0\" data-index-in-node=\"0\"><span class=\"math-inline\" data-math=\"47,XYY\" data-index-in-node=\"0\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord\">47<\/span><span class=\"mpunct\">,<\/span><span class=\"mord mathnormal\">X<\/span><span class=\"mord mathnormal\">YY<\/span><\/span><\/span><\/span><\/span> (Jacobs Syndrome):<\/b> Male phenotype featuring an additional Y chromosome, commonly associated with tall stature and variable neurodevelopmental delays.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"15,1,1,3,0\"><b data-path-to-node=\"15,1,1,3,0\" data-index-in-node=\"0\"><span class=\"math-inline\" data-math=\"47,XXX\" data-index-in-node=\"0\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord\">47<\/span><span class=\"mpunct\">,<\/span><span class=\"mord mathnormal\">XXX<\/span><\/span><\/span><\/span><\/span> (Triple X Syndrome):<\/b> Female phenotype characterized by an additional X chromosome, associated with tall stature and language\/learning differences.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<li>\n<p data-path-to-node=\"15,2,0\"><b data-path-to-node=\"15,2,0\" data-index-in-node=\"0\">Fetal Biological Sex Determination:<\/b> Optional analysis of Y-chromosome genetic markers to establish fetal biological sex in singleton and monozygotic twin gestations with <span class=\"math-inline\" data-math=\"&gt;99.9\\%\" data-index-in-node=\"170\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mrel\">&gt;<\/span><\/span><span class=\"base\"><span class=\"mord\">99.9%<\/span><\/span><\/span><\/span><\/span> accuracy.<\/p>\n<\/li>\n<\/ul>\n<p data-path-to-node=\"16\"><b data-path-to-node=\"16\" data-index-in-node=\"0\">Molecular Genetics &amp; Next-Generation Sequencing (NGS) Mechanics<\/b><\/p>\n<ol start=\"1\" data-path-to-node=\"17\">\n<li>\n<p data-path-to-node=\"17,0,0\"><b data-path-to-node=\"17,0,0\" data-index-in-node=\"0\">Biological Origin of <span class=\"math-inline\" data-math=\"cffDNA\" data-index-in-node=\"21\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord mathnormal\">c<\/span><span class=\"mord mathnormal\">ff<\/span><span class=\"mord mathnormal\">D<\/span><span class=\"mord mathnormal\">N<\/span><span class=\"mord mathnormal\">A<\/span><\/span><\/span><\/span><\/span>:<\/b> During pregnancy, syncytiotrophoblast cells of the placenta undergo continuous apoptosis, shedding short, fragmented extracellular DNA pieces (140 to 160 base pairs) into the maternal vascular bed.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"17,1,0\"><b data-path-to-node=\"17,1,0\" data-index-in-node=\"0\">Venipuncture &amp; Plasma Fractionation:<\/b> Maternal peripheral whole blood (<span class=\"math-inline\" data-math=\"8\\text{--}10\\text{ mL}\" data-index-in-node=\"70\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord\">8<\/span><span class=\"mord text\"><span class=\"mord\">\u2013<\/span><\/span><span class=\"mord\">10<\/span><span class=\"mord text\"><span class=\"mord\">\u00a0mL<\/span><\/span><\/span><\/span><\/span><\/span>) is drawn into dedicated blood collection tubes containing cell-stabilizing reagents (e.g., Streck Cell-Free DNA BCT\u00ae). The preservative prevents maternal nucleated white blood cells from lysing and diluting the fetal fraction. Centrifugation separates cell-free plasma from the cellular pelleted fraction.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"17,2,0\"><b data-path-to-node=\"17,2,0\" data-index-in-node=\"0\">Automated Library Preparation &amp; Barcoding:<\/b> High-yield automated magnetic bead systems isolate low-molecular-weight cell-free circulating DNA. Molecular adapters and unique sample-specific barcode sequences are ligated to DNA fragment ends to construct high-complexity sequencing libraries.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"17,3,0\"><b data-path-to-node=\"17,3,0\" data-index-in-node=\"0\">Massively Parallel Shotgun Sequencing (MPSS):<\/b> Libraries undergo high-throughput Next-Generation Sequencing (Illumina platforms). Millions of sequence tags are generated per flow cell, reading individual <span class=\"math-inline\" data-math=\"cffDNA\" data-index-in-node=\"203\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord mathnormal\">c<\/span><span class=\"mord mathnormal\">ff<\/span><span class=\"mord mathnormal\">D<\/span><span class=\"mord mathnormal\">N<\/span><span class=\"mord mathnormal\">A<\/span><\/span><\/span><\/span><\/span> molecules.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"17,4,0\"><b data-path-to-node=\"17,4,0\" data-index-in-node=\"0\">Bioinformatic Alignment &amp; <span class=\"math-inline\" data-math=\"Z\" data-index-in-node=\"26\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord mathnormal\">Z<\/span><\/span><\/span><\/span><\/span>-Score Calculation:<\/b><\/p>\n<ul data-path-to-node=\"17,4,1\">\n<li>\n<p data-path-to-node=\"17,4,1,0,0\">Reads are computationally aligned against the reference human genome (<span class=\"math-inline\" data-math=\"\\text{GRCh38\/hg38}\" data-index-in-node=\"70\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord text\"><span class=\"mord\">GRCh38\/hg38<\/span><\/span><\/span><\/span><\/span><\/span>).<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"17,4,1,1,0\">The platform calculates the relative proportional representation of sequence fragments mapping to each specific chromosome.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"17,4,1,2,0\">A normalized chromosome value or <b data-path-to-node=\"17,4,1,2,0\" data-index-in-node=\"33\"><span class=\"math-inline\" data-math=\"Z\" data-index-in-node=\"33\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord mathnormal\">Z<\/span><\/span><\/span><\/span><\/span>-score<\/b> is computed: if fragments mapping to chromosome 21, 18, 13, X, or Y significantly exceed statistical expectations based on maternal background reference distributions, an aneuploidy is identified.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<div class=\"attachment-container unknown\">\n<div class=\"carousel-scroll-area\" role=\"group\">\n<div class=\"carousel-container\">\n<div class=\"carousel-card carousel-image spark-carousel-image ng-star-inserted\">\n<div class=\"spark-overlay-container\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/encrypted-tbn0.gstatic.com\/images?q=tbn:ANd9GcT00qG1SMbILzKnRU8PMvh4Shiq1U9FnqSHG76HiZRjQK0KW6gtTqmNYdo&amp;s=10\" alt=\"Prenatalsafe\u00ae: il test di screening prenatale non invasivo\" data-test-id=\"base-image\" \/><\/div>\n<div class=\"spark-carousel-caption ellipsis gds-extended-caption ng-star-inserted\" aria-hidden=\"true\">PrenatalSAFE Kit Packaging. <span class=\"spark-credit-line ng-star-inserted\">Source: OrizzonteNascita \/ Prenatalsafe\u00ae: il test di screening prenatale non invasivo <\/span><\/div>\n<\/div>\n<div class=\"carousel-card carousel-image spark-carousel-image ng-star-inserted\">\n<div class=\"spark-overlay-container\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/encrypted-tbn2.gstatic.com\/licensed-image?q=tbn:ANd9GcSaaIcClIzgljA1aQr10Gljv1JY1TSC7sGnT8sredCDvc9tLSIxBUai0tn5nwWBP9l4xPaaVbaqCC2H7ZU\" alt=\"\" data-test-id=\"base-image\" \/><\/div>\n<div class=\"spark-carousel-caption ellipsis gds-extended-caption ng-star-inserted\" aria-hidden=\"true\"><\/div>\n<\/div>\n<div class=\"carousel-card carousel-image spark-carousel-image ng-star-inserted\">\n<div class=\"spark-carousel-caption ellipsis gds-extended-caption ng-star-inserted\" aria-hidden=\"true\"><\/div>\n<\/div>\n<div class=\"carousel-card carousel-image spark-carousel-image ng-star-inserted\">\n<div class=\"spark-overlay-container\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/encrypted-tbn0.gstatic.com\/images?q=tbn:ANd9GcS277du5YMemA8lQtt1Wel9vLyG5CEj1Iv8Bpf2KyvfeZBEALTaW18EW6oQ&amp;s=10\" alt=\"PrenatalSafe 3 UK NIPT | Basic NIPT | Jeen Health\" data-test-id=\"base-image\" \/><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p data-path-to-node=\"22\">\n<div class=\"horizontal-scroll-wrapper\">\n<div class=\"table-block-component\">\n<div class=\"table-block has-export-button new-table-style has-scrollbar is-at-scroll-start\">\n<div class=\"table-content md-content\" data-hveid=\"0\" data-ved=\"0CAAQ3ecQahgKEwip7M3f0YWXAxUAAAAAHQAAAAAQ-zA\">\n<table data-path-to-node=\"23\">\n<thead>\n<tr>\n<th><span data-path-to-node=\"23,0,0,0\">Chromosomal Condition<\/span><\/th>\n<th><span data-path-to-node=\"23,0,1,0\">Clinical Sensitivity<\/span><\/th>\n<th><span data-path-to-node=\"23,0,2,0\">Analytical Specificity<\/span><\/th>\n<th><span data-path-to-node=\"23,0,3,0\">Positive Predictive Value (PPV)*<\/span><\/th>\n<th><span data-path-to-node=\"23,0,4,0\">Clinical Manifestation<\/span><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><span data-path-to-node=\"23,1,0,0\"><b data-path-to-node=\"23,1,0,0\" data-index-in-node=\"0\">Trisomy 21 (Down Syndrome)<\/b><\/span><\/td>\n<td><span data-path-to-node=\"23,1,1,0\">99.54%<\/span><\/td>\n<td><span data-path-to-node=\"23,1,2,0\">100%<\/span><\/td>\n<td><span data-path-to-node=\"23,1,3,0\">~99.3%<\/span><\/td>\n<td><span data-path-to-node=\"23,1,4,0\">Intellectual disability, cardiac defects, dysmorphic features<\/span><\/td>\n<\/tr>\n<tr>\n<td><span data-path-to-node=\"23,2,0,0\"><b data-path-to-node=\"23,2,0,0\" data-index-in-node=\"0\">Trisomy 18 (Edwards Syndrome)<\/b><\/span><\/td>\n<td><span data-path-to-node=\"23,2,1,0\">100%<\/span><\/td>\n<td><span data-path-to-node=\"23,2,2,0\">100%<\/span><\/td>\n<td><span data-path-to-node=\"23,2,3,0\">~98.9%<\/span><\/td>\n<td><span data-path-to-node=\"23,2,4,0\">Severe developmental delay, rocker-bottom feet, cardiac defects<\/span><\/td>\n<\/tr>\n<tr>\n<td><span data-path-to-node=\"23,3,0,0\"><b data-path-to-node=\"23,3,0,0\" data-index-in-node=\"0\">Trisomy 13 (Patau Syndrome)<\/b><\/span><\/td>\n<td><span data-path-to-node=\"23,3,1,0\">100%<\/span><\/td>\n<td><span data-path-to-node=\"23,3,2,0\">99.99%<\/span><\/td>\n<td><span data-path-to-node=\"23,3,3,0\">~82.2%<\/span><\/td>\n<td><span data-path-to-node=\"23,3,4,0\">Microphthalmia, cleft lip\/palate, holoprosencephaly<\/span><\/td>\n<\/tr>\n<tr>\n<td><span data-path-to-node=\"23,4,0,0\"><b data-path-to-node=\"23,4,0,0\" data-index-in-node=\"0\">Monosomy X (<span class=\"math-inline\" data-math=\"45,X\" data-index-in-node=\"12\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord\">45<\/span><span class=\"mpunct\">,<\/span><span class=\"mord mathnormal\">X<\/span><\/span><\/span><\/span><\/span> &#8211; Turner)<\/b><\/span><\/td>\n<td><span data-path-to-node=\"23,4,1,0\">98.11%<\/span><\/td>\n<td><span data-path-to-node=\"23,4,2,0\">99.98%<\/span><\/td>\n<td><span data-path-to-node=\"23,4,3,0\">~80.0%<\/span><\/td>\n<td><span data-path-to-node=\"23,4,4,0\">Webbed neck, lymphedema, short stature, primary amenorrhea<\/span><\/td>\n<\/tr>\n<tr>\n<td><span data-path-to-node=\"23,5,0,0\"><b data-path-to-node=\"23,5,0,0\" data-index-in-node=\"0\"><span class=\"math-inline\" data-math=\"47,XXY\" data-index-in-node=\"0\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord\">47<\/span><span class=\"mpunct\">,<\/span><span class=\"mord mathnormal\">XX<\/span><span class=\"mord mathnormal\">Y<\/span><\/span><\/span><\/span><\/span> (Klinefelter Syndrome)<\/b><\/span><\/td>\n<td><span data-path-to-node=\"23,5,1,0\">100%<\/span><\/td>\n<td><span data-path-to-node=\"23,5,2,0\">99.99%<\/span><\/td>\n<td><span data-path-to-node=\"23,5,3,0\">~94.4%<\/span><\/td>\n<td><span data-path-to-node=\"23,5,4,0\">Hypogonadism, tall stature, gynecomastia, infertility<\/span><\/td>\n<\/tr>\n<tr>\n<td><span data-path-to-node=\"23,6,0,0\"><b data-path-to-node=\"23,6,0,0\" data-index-in-node=\"0\"><span class=\"math-inline\" data-math=\"47,XYY\" data-index-in-node=\"0\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord\">47<\/span><span class=\"mpunct\">,<\/span><span class=\"mord mathnormal\">X<\/span><span class=\"mord mathnormal\">YY<\/span><\/span><\/span><\/span><\/span> (Jacobs Syndrome)<\/b><\/span><\/td>\n<td><span data-path-to-node=\"23,6,1,0\">100%<\/span><\/td>\n<td><span data-path-to-node=\"23,6,2,0\">99.99%<\/span><\/td>\n<td><span data-path-to-node=\"23,6,3,0\">~96.3%<\/span><\/td>\n<td><span data-path-to-node=\"23,6,4,0\">Accelerated growth velocity, learning\/speech differences<\/span><\/td>\n<\/tr>\n<tr>\n<td><span data-path-to-node=\"23,7,0,0\"><b data-path-to-node=\"23,7,0,0\" data-index-in-node=\"0\"><span class=\"math-inline\" data-math=\"47,XXX\" data-index-in-node=\"0\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord\">47<\/span><span class=\"mpunct\">,<\/span><span class=\"mord mathnormal\">XXX<\/span><\/span><\/span><\/span><\/span> (Triple X Syndrome)<\/b><\/span><\/td>\n<td><span data-path-to-node=\"23,7,1,0\">100%<\/span><\/td>\n<td><span data-path-to-node=\"23,7,2,0\">100%<\/span><\/td>\n<td><span data-path-to-node=\"23,7,3,0\">High<\/span><\/td>\n<td><span data-path-to-node=\"23,7,4,0\">Tall stature, microcephaly, variable speech\/motor delays<\/span><\/td>\n<\/tr>\n<tr>\n<td><span data-path-to-node=\"23,8,0,0\"><b data-path-to-node=\"23,8,0,0\" data-index-in-node=\"0\">Fetal Sex Concordance<\/b><\/span><\/td>\n<td><span data-path-to-node=\"23,8,1,0\">100%<\/span><\/td>\n<td><span data-path-to-node=\"23,8,2,0\">100%<\/span><\/td>\n<td><span data-path-to-node=\"23,8,3,0\"><span class=\"math-inline\" data-math=\"&gt;99.9\\%\" data-index-in-node=\"0\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mrel\">&gt;<\/span><\/span><span class=\"base\"><span class=\"mord\">99.9%<\/span><\/span><\/span><\/span><\/span><\/span><\/td>\n<td><span data-path-to-node=\"23,8,4,0\">Male (<span class=\"math-inline\" data-math=\"XY\" data-index-in-node=\"6\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord mathnormal\">X<\/span><span class=\"mord mathnormal\">Y<\/span><\/span><\/span><\/span><\/span>) vs. Female (<span class=\"math-inline\" data-math=\"XX\" data-index-in-node=\"22\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord mathnormal\">XX<\/span><\/span><\/span><\/span><\/span>) phenotypic classification<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<div class=\"table-footer hide-on-print hide-from-message-actions\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<p data-path-to-node=\"24\"><i data-path-to-node=\"24\" data-index-in-node=\"0\">*Note: Positive Predictive Value (PPV) reflects the probability that a positive screening result represents an affected fetus and is modulated by maternal age and prior baseline risk.<\/i><\/p>\n<p data-path-to-node=\"25\"><b data-path-to-node=\"25\" data-index-in-node=\"0\">Pre-Analytical Requirements &amp; Clinical Workflow<\/b><\/p>\n<ul data-path-to-node=\"26\">\n<li>\n<p data-path-to-node=\"26,0,0\"><b data-path-to-node=\"26,0,0\" data-index-in-node=\"0\">Gestational Age Cut-Off:<\/b> Validated for performance starting strictly at <b data-path-to-node=\"26,0,0\" data-index-in-node=\"72\">10 full weeks of gestation<\/b> (<span class=\"math-inline\" data-math=\"10+0\\text{ weeks}\" data-index-in-node=\"100\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord\">10<\/span><span class=\"mbin\">+<\/span><\/span><span class=\"base\"><span class=\"mord\">0<\/span><span class=\"mord text\"><span class=\"mord\">\u00a0weeks<\/span><\/span><\/span><\/span><\/span><\/span>, calculated via first-trimester dating ultrasound scan). Sampling prior to week 10 risks non-informative results due to insufficient circulating fetal fraction.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"26,1,0\"><b data-path-to-node=\"26,1,0\" data-index-in-node=\"0\">Fetal Fraction Threshold:<\/b> The assay requires a minimum fetal fraction (typically <span class=\"math-inline\" data-math=\"\\ge 4\\%\" data-index-in-node=\"81\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mrel\">\u2265<\/span><\/span><span class=\"base\"><span class=\"mord\">4%<\/span><\/span><\/span><\/span><\/span>). If maternal plasma contains an inadequate fetal fraction, a &#8220;no-call&#8221; or test failure occurs, requiring a redraw at a later gestational week.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"26,2,0\"><b data-path-to-node=\"26,2,0\" data-index-in-node=\"0\">Turnaround Window:<\/b> Laboratory processing is typically completed within <b data-path-to-node=\"26,2,0\" data-index-in-node=\"71\">3 to 7 business days<\/b> from specimen arrival at the sequencing facility.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"26,3,0\"><b data-path-to-node=\"26,3,0\" data-index-in-node=\"0\">Pregnancy Modalities Supported:<\/b> Validated for singleton pregnancies conceived naturally or via assisted reproductive technologies (IVF, ICSI), including autologous or egg-donor\/sperm-donor conceptions.<\/p>\n<\/li>\n<\/ul>\n<p data-path-to-node=\"27\"><b data-path-to-node=\"27\" data-index-in-node=\"0\">Diagnostic Limitations &amp; Complex Biological Confounders<\/b><\/p>\n<ul data-path-to-node=\"28\">\n<li>\n<p data-path-to-node=\"28,0,0\"><b data-path-to-node=\"28,0,0\" data-index-in-node=\"0\">Screening vs. Diagnostic Modality:<\/b> NIPT is a high-accuracy <i data-path-to-node=\"28,0,0\" data-index-in-node=\"59\">screening<\/i> tool, not a definitive diagnostic test. A &#8220;Low Risk&#8221; (negative) result significantly lowers statistical probability but cannot guarantee the absence of all chromosomal defects. A &#8220;High Risk&#8221; (positive) result <b data-path-to-node=\"28,0,0\" data-index-in-node=\"278\">mandates confirmatory diagnostic testing<\/b> via invasive procedures (chorionic villus sampling [CVS] or amniocentesis with karyotyping or chromosomal microarray) before any irreversible medical decisions are made.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"28,1,0\"><b data-path-to-node=\"28,1,0\" data-index-in-node=\"0\">Confined Placental Mosaicism (CPM):<\/b> Because circulating <span class=\"math-inline\" data-math=\"cffDNA\" data-index-in-node=\"56\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord mathnormal\">c<\/span><span class=\"mord mathnormal\">ff<\/span><span class=\"mord mathnormal\">D<\/span><span class=\"mord mathnormal\">N<\/span><span class=\"mord mathnormal\">A<\/span><\/span><\/span><\/span><\/span> originates from placental syncytiotrophoblasts rather than the fetus proper, chromosomal discordance can occur. In 1% to 2% of pregnancies, genetic mutations or aneuploid cell lines are confined solely to the placenta while the fetus remains euploid, generating a false-positive NIPT result.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"28,2,0\"><b data-path-to-node=\"28,2,0\" data-index-in-node=\"0\">Vanishing Twin Syndrome:<\/b> In pregnancies that began as multiple gestations where one sac underwent early demised resorption, apoptotic <span class=\"math-inline\" data-math=\"cffDNA\" data-index-in-node=\"134\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord mathnormal\">c<\/span><span class=\"mord mathnormal\">ff<\/span><span class=\"mord mathnormal\">D<\/span><span class=\"mord mathnormal\">N<\/span><span class=\"mord mathnormal\">A<\/span><\/span><\/span><\/span><\/span> from the demised twin can persist in maternal circulation for weeks, yielding false-positive trisomy or discordant sex chromosome readings.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"28,3,0\"><b data-path-to-node=\"28,3,0\" data-index-in-node=\"0\">Multiple Gestations (Twin Restrictions):<\/b> PrenatalSAFE 5 can evaluate basic trisomies in twin pregnancies; however, sex chromosome aneuploidy (SCA) evaluation is restricted to singleton gestations. In dichorionic twins, the assay can verify the presence or absence of the Y chromosome, but cannot attribute sex chromosome aneuploidies to an individual fetus.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"28,4,0\"><b data-path-to-node=\"28,4,0\" data-index-in-node=\"0\">Maternal Genomic Aberrations:<\/b> Maternal sex chromosome mosaicism (e.g., undiagnosed low-level maternal <span class=\"math-inline\" data-math=\"45,X\/46,XX\" data-index-in-node=\"102\"><span class=\"katex\"><span class=\"katex-html\" aria-hidden=\"true\"><span class=\"base\"><span class=\"mord\">45<\/span><span class=\"mpunct\">,<\/span><span class=\"mord mathnormal\">X<\/span><span class=\"mord\">\/46<\/span><span class=\"mpunct\">,<\/span><span class=\"mord mathnormal\">XX<\/span><\/span><\/span><\/span><\/span>), maternal copy number variations (CNVs), or occult maternal hematologic malignancies can shed discordant cell-free DNA into plasma, resulting in false-positive aneuploidy calls.<\/p>\n<\/li>\n<\/ul>\n<p data-path-to-node=\"29\"><b data-path-to-node=\"29\" data-index-in-node=\"0\">Regulatory Framework &amp; Post-Test Clinical Care<\/b><\/p>\n<ul data-path-to-node=\"30\">\n<li>\n<p data-path-to-node=\"30,0,0\"><b data-path-to-node=\"30,0,0\" data-index-in-node=\"0\">Laboratory Standards &amp; Markings:<\/b> Processed in ISO 15189, CAP-accredited, and CLIA-certified medical genetics laboratories. Reagent panels and analytical workflows operate under European In Vitro Diagnostic Medical Device certifications (CE-IVD).<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"30,1,0\"><b data-path-to-node=\"30,1,0\" data-index-in-node=\"0\">Genetic Counseling Mandate:<\/b> Clinical protocol requires access to formal pre-test and post-test genetic counseling. Certified genetic counselors interpret complex positive predictive value calculations, discuss biological limitations (such as mosaicism), and guide referrals for diagnostic amniocentesis.<\/p>\n<\/li>\n<\/ul>\n\n    <div class=\"xs_social_share_widget xs_share_url after_content \t\tmain_content  wslu-style-1 wslu-share-box-shaped wslu-fill-colored wslu-none wslu-share-horizontal wslu-theme-font-no wslu-main_content\">\n\n\t\t\n        <ul>\n\t\t\t        <\/ul>\n    <\/div> \n","protected":false},"excerpt":{"rendered":"<div class=\"rich-text\">The PrenatalSAFE 5 NIPT blood test is a comprehensive, non-invasive test for expectant mothers to check for the main health conditions that can affect your baby. It also includes gender identification to tell you the sex of you baby or babies &#8211; from only 10 weeks of pregnancy.<\/div>\n<section class=\"ProductBullets_root__L4edp\">\n<div class=\"ProductBullets_list__pBBGG\">\n<ul>\n<li>Comprehensive and non-invasive<\/li>\n<li>Free post-test genetic counselling included for positive results<\/li>\n<li>Highly accurate, with up to 99.32% accuracy for detecting Down Syndrome<\/li>\n<\/ul>\n<\/div>\n<\/section>","protected":false},"featured_media":11092,"comment_status":"open","ping_status":"closed","template":"","meta":{"postBodyCss":"","postBodyMargin":[],"postBodyPadding":[],"postBodyBackground":{"backgroundType":"classic","gradient":""}},"product_brand":[],"product_cat":[793],"product_tag":[],"class_list":["post-11090","product","type-product","status-publish","has-post-thumbnail","product_cat-accessories","instock","sale","shipping-taxable","purchasable","product-type-simple"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.5 (Yoast SEO v28.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>PrenatalSAFE 5 NIPT Blood Test<\/title>\n<meta name=\"description\" content=\"Buy PrenatalSAFE 5 NIPT blood test: Cell-free fetal DNA screening for Down, Edwards, Patau syndromes, sex chromosome aneuploidies, fetal sex.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/medidirect.eu\/es\/shop\/prenatalsafe-5-nipt-blood-test\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PrenatalSAFE 5 NIPT Blood Test\" \/>\n<meta property=\"og:description\" content=\"The PrenatalSAFE 5 NIPT blood test is a comprehensive, non-invasive test for expectant mothers to check for the main health conditions that can affect your baby. It also includes gender identification to tell you the sex of you baby or babies - from only 10 weeks of pregnancy.     Comprehensive and non-invasive  Free post-test genetic counselling included for positive results  Highly accurate, with up to 99.32% accuracy for detecting Down Syndrome\" \/>\n<meta property=\"og:url\" content=\"https:\/\/medidirect.eu\/es\/shop\/prenatalsafe-5-nipt-blood-test\/\" \/>\n<meta property=\"og:site_name\" content=\"European Pharmacy\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-26T02:04:44+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/medidirect.eu\/wp-content\/uploads\/2026\/09\/prenatalsafe3nipt.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"750\" \/>\n\t<meta property=\"og:image:height\" content=\"646\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/medidirect.eu\\\/nl\\\/shop\\\/prenatalsafe-5-nipt-blood-test\\\/\",\"url\":\"https:\\\/\\\/medidirect.eu\\\/nl\\\/shop\\\/prenatalsafe-5-nipt-blood-test\\\/\",\"name\":\"PrenatalSAFE 5 NIPT Blood Test\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/medidirect.eu\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/medidirect.eu\\\/nl\\\/shop\\\/prenatalsafe-5-nipt-blood-test\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/medidirect.eu\\\/nl\\\/shop\\\/prenatalsafe-5-nipt-blood-test\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/medidirect.eu\\\/wp-content\\\/uploads\\\/2026\\\/09\\\/prenatalsafe3nipt.webp\",\"datePublished\":\"2026-09-26T02:04:43+00:00\",\"dateModified\":\"2026-09-26T02:04:44+00:00\",\"description\":\"Buy PrenatalSAFE 5 NIPT blood test: Cell-free fetal DNA screening for Down, Edwards, Patau syndromes, sex chromosome aneuploidies, fetal sex.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/medidirect.eu\\\/nl\\\/shop\\\/prenatalsafe-5-nipt-blood-test\\\/#breadcrumb\"},\"inLanguage\":\"es-ES\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/medidirect.eu\\\/nl\\\/shop\\\/prenatalsafe-5-nipt-blood-test\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es-ES\",\"@id\":\"https:\\\/\\\/medidirect.eu\\\/nl\\\/shop\\\/prenatalsafe-5-nipt-blood-test\\\/#primaryimage\",\"url\":\"https:\\\/\\\/medidirect.eu\\\/wp-content\\\/uploads\\\/2026\\\/09\\\/prenatalsafe3nipt.webp\",\"contentUrl\":\"https:\\\/\\\/medidirect.eu\\\/wp-content\\\/uploads\\\/2026\\\/09\\\/prenatalsafe3nipt.webp\",\"width\":750,\"height\":646},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/medidirect.eu\\\/nl\\\/shop\\\/prenatalsafe-5-nipt-blood-test\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/medidirect.eu\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Shop\",\"item\":\"https:\\\/\\\/medidirect.eu\\\/shop\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"PrenatalSAFE 5 NIPT Blood Test\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/medidirect.eu\\\/#website\",\"url\":\"https:\\\/\\\/medidirect.eu\\\/\",\"name\":\"European Pharmacy\",\"description\":\"Order Medication &amp; 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Comprehensive and non-invasive  Free post-test genetic counselling included for positive results  Highly accurate, with up to 99.32% accuracy for detecting Down Syndrome","og_url":"https:\/\/medidirect.eu\/es\/shop\/prenatalsafe-5-nipt-blood-test\/","og_site_name":"European Pharmacy","article_modified_time":"2026-09-26T02:04:44+00:00","og_image":[{"width":750,"height":646,"url":"https:\/\/medidirect.eu\/wp-content\/uploads\/2026\/09\/prenatalsafe3nipt.webp","type":"image\/webp"}],"twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/medidirect.eu\/nl\/shop\/prenatalsafe-5-nipt-blood-test\/","url":"https:\/\/medidirect.eu\/nl\/shop\/prenatalsafe-5-nipt-blood-test\/","name":"PrenatalSAFE 5 NIPT Blood Test","isPartOf":{"@id":"https:\/\/medidirect.eu\/#website"},"primaryImageOfPage":{"@id":"https:\/\/medidirect.eu\/nl\/shop\/prenatalsafe-5-nipt-blood-test\/#primaryimage"},"image":{"@id":"https:\/\/medidirect.eu\/nl\/shop\/prenatalsafe-5-nipt-blood-test\/#primaryimage"},"thumbnailUrl":"https:\/\/medidirect.eu\/wp-content\/uploads\/2026\/09\/prenatalsafe3nipt.webp","datePublished":"2026-09-26T02:04:43+00:00","dateModified":"2026-09-26T02:04:44+00:00","description":"Buy PrenatalSAFE 5 NIPT blood test: Cell-free fetal DNA screening for Down, Edwards, Patau syndromes, sex chromosome aneuploidies, fetal sex.","breadcrumb":{"@id":"https:\/\/medidirect.eu\/nl\/shop\/prenatalsafe-5-nipt-blood-test\/#breadcrumb"},"inLanguage":"es-ES","potentialAction":[{"@type":"ReadAction","target":["https:\/\/medidirect.eu\/nl\/shop\/prenatalsafe-5-nipt-blood-test\/"]}]},{"@type":"ImageObject","inLanguage":"es-ES","@id":"https:\/\/medidirect.eu\/nl\/shop\/prenatalsafe-5-nipt-blood-test\/#primaryimage","url":"https:\/\/medidirect.eu\/wp-content\/uploads\/2026\/09\/prenatalsafe3nipt.webp","contentUrl":"https:\/\/medidirect.eu\/wp-content\/uploads\/2026\/09\/prenatalsafe3nipt.webp","width":750,"height":646},{"@type":"BreadcrumbList","@id":"https:\/\/medidirect.eu\/nl\/shop\/prenatalsafe-5-nipt-blood-test\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/medidirect.eu\/"},{"@type":"ListItem","position":2,"name":"Shop","item":"https:\/\/medidirect.eu\/shop\/"},{"@type":"ListItem","position":3,"name":"PrenatalSAFE 5 NIPT Blood Test"}]},{"@type":"WebSite","@id":"https:\/\/medidirect.eu\/#website","url":"https:\/\/medidirect.eu\/","name":"European Pharmacy","description":"Order Medication &amp; Pills Online","publisher":{"@id":"https:\/\/medidirect.eu\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/medidirect.eu\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es-ES"},{"@type":"Organization","@id":"https:\/\/medidirect.eu\/#organization","name":"European Pharmacy","url":"https:\/\/medidirect.eu\/","logo":{"@type":"ImageObject","inLanguage":"es-ES","@id":"https:\/\/medidirect.eu\/#\/schema\/logo\/image\/","url":"https:\/\/medidirect.eu\/wp-content\/uploads\/2026\/09\/WhatsApp-Image-2026-09-07-at-18.41.53.jpeg","contentUrl":"https:\/\/medidirect.eu\/wp-content\/uploads\/2026\/09\/WhatsApp-Image-2026-09-07-at-18.41.53.jpeg","width":1254,"height":1254,"caption":"European Pharmacy"},"image":{"@id":"https:\/\/medidirect.eu\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/medidirect.eu\/es\/wp-json\/wp\/v2\/product\/11090","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medidirect.eu\/es\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/medidirect.eu\/es\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/medidirect.eu\/es\/wp-json\/wp\/v2\/comments?post=11090"}],"version-history":[{"count":1,"href":"https:\/\/medidirect.eu\/es\/wp-json\/wp\/v2\/product\/11090\/revisions"}],"predecessor-version":[{"id":11093,"href":"https:\/\/medidirect.eu\/es\/wp-json\/wp\/v2\/product\/11090\/revisions\/11093"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medidirect.eu\/es\/wp-json\/wp\/v2\/media\/11092"}],"wp:attachment":[{"href":"https:\/\/medidirect.eu\/es\/wp-json\/wp\/v2\/media?parent=11090"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/medidirect.eu\/es\/wp-json\/wp\/v2\/product_brand?post=11090"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/medidirect.eu\/es\/wp-json\/wp\/v2\/product_cat?post=11090"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/medidirect.eu\/es\/wp-json\/wp\/v2\/product_tag?post=11090"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}