NIPT

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5

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.

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
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