Source PDF: SOP_VanGenes NIPPT_Special Circumstances Guidance for CSR Teams.pdf
VanGenes NIPPT_Special Circumstances Guidance for CSR
Teams
This document provides guidance for Customer Service Representatives when handling enquiries
relating to special pregnancy circumstances for the VanGenes Non-Invasive Prenatal Paternity
Test (NIPPT).
Certain pregnancies require additional information or modified analysis procedures. These
circumstances must be clearly declared before testing begins so the laboratory can apply the
correct analytical method.
The most important points to confirm with the client are:
- Whether the pregnancy involves twins
- Whether the pregnancy involves IVF or surrogacy
Once these two points are confirmed, the appropriate testing option can be selected.
If a twin pregnancy is confirmed but the type of twins is not yet known, the case can initially be
submitted as a Twin pregnancy, and the specific type can be clarified later if the information
becomes available.
It is important that clients inform us of the pregnancy circumstances before testing begins, as
special sample requirements may apply, and additional costs may apply depending on the case.
Quick Decision Guide for CSR
When speaking with a client about prenatal paternity testing, the CSR should confirm the following
information first.
Step 1
Confirm whether the pregnancy involves twins.
Step 2
Confirm whether the pregnancy involves IVF or surrogacy.
Step 3
Select the correct testing option based on the pregnancy circumstances.
If the situation is unclear, the case should be reviewed internally before samples are collected.
Special Circumstances Overview
Situation What CSR Must Confirm Key Requirement
Fraternal twins may require
Twins Identical or fraternal twins
samples from all alleged fathers
Whether the mother's own egg Testing may involve father and
IVF Pregnancy
was used fetus, or both parents
Pregnancy must usually be over
Whether an egg donor is
Surrogacy Pregnancy 10 weeks and additional
involved
samples may be required
- Surrogacy Pregnancies
Surrogacy pregnancies require special handling because the pregnant individual is not
genetically related to the fetus.
Standard prenatal paternity testing assumes that the fetus is genetically related to the pregnant
mother. In surrogacy pregnancies, this assumption does not apply, which requires a different
analytical approach and additional internal quality control procedures.
For this reason, it is essential that surrogacy cases are clearly declared before testing begins.
If surrogacy is not disclosed, internal laboratory quality checks may fail, which may prevent the
analysis from proceeding.
Gestational Age Requirement
Surrogacy cases generally require the pregnancy to be more than 10 weeks of gestation before
samples are collected.
TESTING OPTIONS IN SURROGACY CASES
Option 1
Test between the alleged father and the fetus
This analysis evaluates whether the alleged father is the biological father of the fetus.
Option 2
Test between fetus, alleged father, and egg donor
This option evaluates the genetic relationship between:
- the fetus
- the alleged father
- the egg donor
This scenario requires an additional DNA sample from the egg donor. The egg donor sample uses
the same sample type as the alleged father, typically buccal swabs.
Important Reporting Limitation
Reports for surrogacy cases do not include SNP data tables.
This is because the laboratory's appendix format assumes that the fetus is genetically related to
the pregnant mother, which is not applicable in surrogacy pregnancies.
In addition, if the analysis does not support the declared relationship, the laboratory will not
issue a written report.
This policy exists to reduce the risk of disputes relating to donor declarations or surrogacy
arrangements.
2. FRATERNAL TWIN PREGNANCIES
Fraternal twins develop from two separate eggs, meaning each fetus has a different genetic
profile.
Because of this, the laboratory must analyse each fetus independently.
Biological Consideration
In rare cases, it is biologically possible for each fetus to have a different biological father. This
phenomenon is known as heteropaternal superfecundation.
For this reason, the laboratory recommends submitting samples from all possible alleged
fathers if more than one father may be involved.
INTERPRETATION WHEN ONLY ONE ALLEGED FATHER IS TESTED
If only one alleged father's sample is submitted:
- A supported result means the alleged father is highly likely to be the biological father, however
there remains a very small possibility that the second fetus could have a different father.
- A not supported result indicates that the alleged father is not the biological father of either
fetus.
Submitting samples from all alleged fathers allows the laboratory to provide a more definitive
interpretation.
- IVF Pregnancies
For IVF pregnancies where the mother used her own egg, two testing options may be available.
Option 1
Test between the alleged father and the fetus
This option follows the standard testing process.
Maternal DNA is already present in the maternal plasma sample, which allows the laboratory to
perform the analysis without requiring an additional maternal reference sample.
Option 2
Test between both parents and the fetus
This option includes an additional reference sample from the mother.
Including the mother's sample may sometimes provide additional confirmation of the relationship.
However, in certain cases, it may increase the likelihood that the analysis cannot be reported if
testing conditions are not optimal.
REPORTING LIMITATION FOR IVF MATERNITY ANALYSIS
Maternity reports for IVF cases do not include SNP data tables.
The laboratory appendix format is designed for parent-child triads, assuming maternal
compatibility, which cannot always explain maternal relationships in IVF scenarios.
In addition, if the analysis does not support the expected relationship, the laboratory may
not issue a written report, similar to the policy applied in surrogacy cases.
- Additional Information CSR Should Confirm
When discussing prenatal testing with clients, CSR teams should confirm certain factors that may
affect the amount of fetal DNA available for analysis.
These factors do not prevent testing but may influence when sample collection should take place.
Important information to confirm includes:
- Whether the mother's weight exceeds 80 kg
- Whether the mother has had a recent illness, such as a cold or infection
- Whether the mother is taking long-term medication
If any of these conditions may affect fetal DNA levels, the laboratory recommends collecting
samples after 10 weeks of pregnancy to ensure sufficient fetal DNA is available for analysis.
SITUATIONS WHERE TESTING CANNOT BE PERFORMED
Prenatal paternity testing cannot be performed when:
- The alleged fathers are close blood relatives
- The case involves incest
VANISHING TWIN SYNDROME (VTS)
If one embryo disappears before 8 weeks of pregnancy, sample collection can generally be
performed after an interval of 8 weeks.
This waiting period allows fetal DNA levels to stabilise before analysis.
What CSR Should Never Promise
CSR should avoid making guarantees about the following situations.
CSR should not promise that a written report will always be issued, particularly in cases
involving:
- Surrogacy pregnancies
- IVF maternity analysis where the relationship cannot be confirmed
CSR should also avoid confirming complex cases without review if:
- The pregnancy circumstances are unclear
- Multiple alleged fathers are involved
- Surrogacy arrangements involve multiple donors
In these situations, the case should be reviewed internally or discussed with the laboratory before
samples are collected.
CSR Escalation Guidance
CSR should escalate the case internally if:
- The pregnancy circumstances are unclear
- The client cannot confirm whether the pregnancy involves surrogacy or IVF
- Multiple alleged fathers are involved in a twin pregnancy
- The client requests written confirmation regarding reporting limitations
The laboratory can review specific cases and advise on the most appropriate testing option before
samples are collected.
CSR Call Logic Guide
How to Identify the Correct NIPPT Option
When a client contacts us regarding prenatal paternity testing, the CSR should ask the following
questions in order.
Question 1
Is the pregnancy a twin pregnancy?
If yes, confirm:
- Whether the twins are identical or fraternal
- If unknown, the case can initially be recorded as a twin pregnancy
If the twins are fraternal, ask whether there may be more than one possible father, as the
laboratory recommends providing samples from all alleged fathers.
Question 2
Is the pregnancy related to IVF or surrogacy?
If yes, confirm:
- Whether the pregnancy is IVF using the mother's own egg
- Whether the pregnancy involves surrogacy
- Whether an egg donor is involved
This information determines which testing option must be selected and whether additional samples
are required.
Question 3
What is the current gestational age of the pregnancy?
Some special circumstances require testing to be performed after 10 weeks of pregnancy,
particularly in cases involving:
- Surrogacy
- IVF analysis involving both parents
- Situations where fetal DNA levels may be lower
ADDITIONAL INFORMATION CSR SHOULD CONFIRM
During consultations with clients, CSRs should also confirm certain factors that may influence the
amount of fetal DNA available for testing.
These factors do not prevent testing but may affect when sample collection should take place.
CSR should ask whether:
- The mother's weight exceeds 80 kg
- The mother has had a recent illness, such as a cold or infection
- The mother is currently taking long-term medication
If any of these factors may affect fetal DNA levels, it may be recommended to collect samples
after 10 weeks of pregnancy to ensure sufficient fetal DNA for analysis.
Important Risk Awareness for CSR
CSR should be aware of several laboratory policies that apply specifically to certain special
pregnancy circumstances.
These policies are designed to protect the laboratory, testing partners, and clients from potential
misunderstandings or disputes.
REPORTING LIMITATIONS IN SURROGACY CASES
In surrogacy pregnancies, the pregnant individual is not genetically related to the fetus. This
changes the assumptions normally used in prenatal paternity testing analysis.
For this reason:
- Surrogacy reports do not include SNP data tables
- If the result does not support the declared relationship, the laboratory may not issue a
written report
CSR should avoid promising that a written report will always be issued in surrogacy cases.
REPORTING LIMITATIONS IN IVF MATERNITY ANALYSIS
In IVF cases involving maternal confirmation:
- Maternity reports do not include SNP data tables
If the analysis does not support the expected relationship, the laboratory may not issue a
written report, as the circumstances are considered similar to surrogacy cases.
When CSR Should Escalate the Case
CSR should escalate the case internally or consult management if:
- The pregnancy circumstances are unclear
- The client cannot confirm whether the pregnancy involves IVF or surrogacy
- Multiple alleged fathers are involved in a twin pregnancy
- The client requests confirmation about written reporting policies
- The case involves complex donor or fertility arrangements
In these situations, the laboratory can review the details and recommend the most appropriate
testing option before samples are collected.