NIPT
NIPT?
Non-Invasive Prenatal Test (NIPT) detects fetal chromosomal abnormality using fetal DNA in maternal blood with Next Generation Sequencing (NGS).
Test Options
Comparison of NIPT
| Category | Test | Test Method | Test Period | Turnaround Time | Detection Rate |
|---|---|---|---|---|---|
| Non-Invasive Prenatal Test (NIPT) | Non-Invasive Chromosome Examination (NICE®) | Non-Invasive | After 10 Weeks | 7 – 10 Days | Over 99% |
| Blood Screening Test | Triple Test | Non-Invasive | 11 – 13 Weeks | 2 Days | 67% - 71% |
| Blood Screening Test | Quad Test | Non-Invasive | 14 – 22 Weeks | 2 Days | 79% – 81% |
| Integrated Screening Test | Integrated Test | Non-Invasive | 11 – 13 Weeks(1st) | 4 – 5 Weeks | 94% – 96% |
| Integrated Screening Test | Integrated Test | Non-Invasive | 14 – 22 Weeks(2nd) | 4 – 5 Weeks | 94% – 96% |
| Fetal Tissue Screening Test | Chorionic Villus Sampling | Invasive | 10 – 13 Weeks | 4 – 5 Weeks | Over 99% |
| Fetal Tissue Screening Test | Amniocentesis | Invasive | 16 – 21 Weeks | 4 – 5 Weeks | Over 99% |
Performance Data
Positive NIPT cases with confirmatory prenatal karyotype (n=6,238)
| Trisomy | TP(n) | FP(n) | FN(n) | Sensitivity % (95% CI) |
Specificity % (95% CI) |
PPV % (95% CI) |
Accuracy % (95% CI) |
Incidence % (95% CI) |
|---|---|---|---|---|---|---|---|---|
| T21 | 54 | 1 | 0 | 100 (93.40-100) |
99.98 (99.91-100) |
98.18 (88.38-99.74) |
99.98 (99.91-100) |
0.87 (0.66-1.14) |
| T18 | 14 | 0 | 0 | 100 (76.84-100) |
100 (99.94-100) |
100 | 100 (99.94-100) |
0.22 (0.12-0.38) |
| T13 | 2 | 0 | 0 | 100 (15.81-100) |
100 (99.94-100) |
100 | 100 (99.94-100) |
0.03 (0.00-0.12) |
| XO | 6 | 4 | 0 | 100 (54.07-100) |
99.94 (99.84-99.98) |
60 (36.03-79.98) |
99.94 (99.84-99.98) |
0.10 (0.04-0.21) |
| XXX | 1 | 0 | 0 | 100 (2.5-100) |
100 (99.94-100) |
100 | 100 (99.94-100) |
0.02 (0.00-0.09) |
| XXY | 4 | 0 | 0 | 100 (39.76-100) |
100 (99.94-100) |
100 (39.58-100) |
100 (99.94-100) |
0.06 (0.02-0.16) |
| XYY | 1 | 0 | 0 | 100 (2.5-100) |
100 (99.94-100) |
100 | 100 (99.94-100) |
0.02 (0.00-0.09) |
| Total | 82 | 5 | 0 | 100 (95.6-100) |
99.92 (99.81-99.97) |
94.25 (87.23-97.52) |
99.92 (99.81-99.97) |
1.31 (1.05-1.63) |
CAP Accreditation
By acquiring CAP accreditation, EDGC has been recognized with its technology and excellence and made its service reliability higher.
CAP is the accreditation program inspected by the College of American Pathologists (CAP), which is the American clinical pathology examination certificate authority since 1961. It can be acquired through a thorough site inspection about test accuracy and quality control in all the courses to provide clinical examination to patients.
CLIA Certification
EDGC has acquired the certificate of the Clinical Laboratory Improvement Amendments (CLIA) for Non-Invasive Prenatal Test (NIPT) for the first time in Korea.
The CLIA is the United States federal regulatory standards that verify regulatory requirements related to accuracy and reliability of laboratories performing genetic testing.
All the processes of the NIPT are controlled under the CLIA, and EDGC provides high reliability testing services for customers.
All the processes of the NIPT are controlled under the CLIA, and EDGC provides high reliability testing services for customers.
Patent and Thesis
| Patent | Country | Date of Registration | Registration Number |
|---|---|---|---|
| Method for Diagnosing Fetal Chromosomal Aneuploidy | South Korea | 2016.09.29 | 10-1663171 |
| Method of Detecting Chromosomal Abnormalities | South Korea | 2018.01.04 | 10-1817180 |
| Novel Method Capable of Differentiating Fetal Sex and Fetal Sex Chromosome Abnormality on Various Platforms | South Korea | 2018.01.05 | 10-1817785 |