Non-Invasive Prenatal Paternity Test (NIPPT)
Genetic analysis for reliable determination of biological kinship, tailored for clinical, legal, and forensic applications.
Contact usDescription
Paternity and family relationship testing is used to establish biological relationships between children and parents or other close family members. The tests are based on analysis of genetic markers enabling statistically supported kinship assessments.
The analysis covers paternity, maternity, sibling relationships, twin testing, and investigation of other family ties such as grandparents, aunts, uncles, and cousins. Complementary tests such as Y-STR or mitochondrial DNA (mtDNA) analysis can be employed when needed to strengthen conclusions.
This test is designed for laboratories and clinics providing kinship investigations within healthcare, legal, or forensic contexts, where high accuracy, reproducibility, and clear reporting are essential.
FOR LABORATORIES
iLab Medical Non-Invasive Prenatal Paternity Testing (NIPPT) utilizes advanced Next-Generation Sequencing (NGS) technology to determine biological paternity during pregnancy using cell-free fetal DNA (cfDNA) circulating in maternal blood. This method enables accurate, early, and risk-free assessment of paternity without the need for invasive procedures such as amniocentesis or chorionic villus sampling.
During pregnancy, small fragments of fetal DNA originating from the placenta are present in the maternal bloodstream. By analyzing these fragments and comparing them with the alleged father’s DNA profile, it is possible to determine paternity with a very high degree of accuracy. This test provides a safe alternative to traditional prenatal paternity testing and supports informed decision-making during pregnancy.
Benefits
Process
Sample collection is performed through standardized biological specimen acquisition, typically blood or saliva. Samples from multiple family members can be included depending on the case.
The laboratory analyzes a broad panel of genetic markers, typically STR markers, enabling comparison of DNA profiles across tested individuals. Additional analyses may be performed to increase statistical confidence.
Results are compiled into a report presenting the probability of kinship as a percentage, along with clear interpretation according to established genetic and statistical standards.
FOR LABORATORIES
Clinical Applications
1. Prenatal Paternity Determination
• Early confirmation of biological father during pregnancy
Clinical Impact:
• Provides clarity and reassurance
• Supports personal, legal, and medical decision-making
2. High-Risk Pregnancy Situations
Applicable in cases where invasive procedures are contraindicated
Clinical Impact:
• Eliminates risk of miscarriage associated with invasive sampling
• Safe for both mother and fetus
3. Legal and Ethical Contexts
May be used (depending on jurisdiction) for:
• Legal disputes
• Immigration cases
• Family law matters
Clinical Impact:
• Provides scientifically validated genetic evidence
• High level of accuracy and reliability
Specimen Requirements
Maternal Sample:
• Peripheral venous blood
• EDTA (lavender-top tube)
• Volume: 10 mL
Alleged Father Sample:
• Buccal swab (cheek swab) or blood sample
Optional (Recommended):
• Maternal reference sample (for better accuracy and filtering)
Testing Window
• Recommended from ≥10 weeks of gestation
• Requires sufficient fetal fraction for accurate analysis
Turnaround Time (TAT)
Approximately 7–10 working days after receipt of all samples.
Clinical Utility
Non-invasive prenatal paternity testing enables:
• Early and safe determination of paternity
• Elimination of invasive procedure risks
• High accuracy (>99.9% probability of inclusion)
• Reliable exclusion of non-paternity
• Support for informed clinical and personal decisions
This test represents a significant advancement in prenatal diagnostics by combining high sensitivity, safety, and precision.
Limitations
• Requires adequate fetal fraction (low fetal fraction may affect results)
• Multiple pregnancies (twins) may complicate interpretation
• Recent blood transfusion or transplantation may affect results
• Not intended for forensic use unless chain-of-custody procedures are followed
• Legal acceptance varies by country
How it works
After sample collection, DNA is extracted and analyzed using molecular genetic techniques. At least twenty genetic markers are examined to ensure high accuracy.
Results are reviewed by a specialist laboratory and calculated with statistical models tailored to the specific family relationship. In some cases, extended testing or inclusion of additional relatives is necessary to achieve a sufficiently conclusive result.
The final report is delivered to the ordering clinic, healthcare provider, or legal authority and serves as a decision-making tool in the relevant matter.
FOR LABORATORIES
Methodology
- Technology: Next-Generation Sequencing (NGS) with targeted SNP analysis
Biological Principle:
o Analysis of cell-free fetal DNA (cfDNA) in maternal plasma
o Comparison with maternal and alleged paternal DNA profiles
o Statistical evaluation of paternity index
Genomic Analysis:
o Thousands of Single Nucleotide Polymorphisms (SNPs) across the genome
o High-resolution discrimination between maternal and paternal alleles
Detection Capabilities:
o Identification of fetal-specific DNA fragments
o Determination of biological relationship with high statistical confidence
Bioinformatics & Interpretation:
o Advanced algorithms to separate fetal DNA from maternal background
o Calculation of Combined Paternity Index (CPI)
o Probability of paternity (>99.9%) or exclusion
Quality Control:
o Fetal fraction assessment
o Internal controls for sequencing quality and contamination