
PRENATAL SCREENING BACKGROUND
• Every pregnant woman carry a certain degree of risk that her fetus/baby may have certain chromosomal defect/ abnormalities. Diagnosis
of these fetal chromosomal abnormalities requires confirmatory testing by thorough analysis post amniocentesis or Chorionic Villous
Sampling (CVS).
• However, amniocentesis and CVS procedures carry some degree of risk for miscarriage or other pregnancy complications (Tabor and
Alfirevic, 2010).
• Therefore in routine practice, prenatal screening tests are offered to a pregnant woman to provide her a personalized risk for the most
common chromosomal abnormalities (T21-Down syndrome, T18- Edwards' syndrome, T13- Patau syndrome) using her peripheral blood
sample. Based on this risk assessment, if the risk is high or intermediate, you can take informed decision of opting for invasive procedure
such as amniocentesis or CVS followed by confirmatory diagnostic test(s), as per discussion with your clinician.
Lilac Insights Pvt. Ltd. 301-302, Building A-1, Rupa Solitaire Millennium Business Park, MIDC Industrial Area, Sector-1, Navi Mumbai, Maharashtra 400710.
Phone: +91 22 41841438; Website: www.lilacinsights.com; For queries or complaints, please email: info@lilacinsights.com
END OF REPORT
Note:
• Quality of the Down’s Syndrome & ONTD screening program (Biochemical values, MoMs and Risk assessments) monitored by UKNEQAS on an ongoing basis.
• This interpretation assumes that patient and specimen details are accurate and correct.
• Lilac Insights does not bear responsibility for the Ultra sound measurements.
• This is a risk estimation test and not a diagnostic test. An increased risk result does not mean that the fetus is affected and a low risk result does not mean that
the fetus is unaffected. Reported risks should be correlated and adjusted according to the absence/presence of sonographic markers observed in the
anomaly/malformation scan.
• This interpretation assumes that patient and specimen details are accurate and correct. In all cases where an assessment of increased risk is based on LMP
dates, the gestational age must be by ultrasound before further action is taken.
• It must be clearly understood that the results represent risk and not diagnostic outcomes. Increased risk does not mean that the baby is affected and further
tests must be performed before a firm diagnosis can be made. A low risk result does not exclude the possibility of Down's Syndrome or other abnormalities, as
the risk assessment does not detect all affected pregnancies.
• Lilac Insights does not bear responsibility for ultrasound measurements. The company strongly recommends that ultrasound scan is performed as per fetal
Medicine Foundation (UK) Guidelines.
Quadruple
Integrated Screening
IS
QUAD
DISCLAIMERS
Limitations of the Test:
As prenatal screening tests are not confirmatory diagnostic tests, the possibility of false positive or false negative results can not be denied. The
results issued for this test does not eliminate the possibility that this pregnancy may be associated with other chromosomal or sub-
chromosomal abnormalities, birth defects and other complications.
Nuchal Translucency is the most prominent marker in screening for Trisomy 13, 18, 21 in the first trimester and should be measured in
accordance with the Fetal Medicine Foundation (UK) guidelines. Nuchal Translucency or Crown Rump Length measurement, if not performed
as per FMF (UK) imaging guidelines may lead to erroneous risk assessments and Lilac Insights bears no responsibility for errors arising due to
sonography measurements not performed as per these criteria defined by international bodies such as FMF (UK), ISUOG.
It is assumed that the details provided along with the sample are correct. The manner in which this information is used to guide patient care is
the responsibility of the healthcare provider, including advising for the need for genetic counselling or additional diagnostic testing like
amniocentesis or Chorionic Villus Sampling. Any diagnostic test should be interpreted in the context of all available clinical findings.
As with any medical test, there is always a chance of failure or error in sample analysis though extensive measures are taken to avoid these
errors.
PRENATAL SCREENING TESTS ARE NOT CONFIRMATORY TESTS AND THEY PROVIDE RISK ASSESSMENT RESULT AS
High risk or screen positive report- which does not mean that the pregnancy is affected with these conditions. It means
that you have a higher chance of having a baby with one of these conditions as compared to the chances of miscarriage
that you have, if you opt for an invasive procedure.
High Risk
Low Risk
Low risk or screen negative report- which does not mean that the pregnancy is not affected with these conditions. It
means that you have a lower chance of having a baby with one of these conditions as compared to the chances of
miscarriage that you have, if you opt for an invasive procedure.
Based on a comparison of two risks (i.e. risk reported by screening test vs. risk of miscarriage associated with invasive procedure), the patient,
guided by her clinician can decide on opting or rejecting definitive invasive testing.
SIGNIFICANCE OF MULTIPLE OF MEDIAN (MOM) VALUES OF HORMONES
Prenatal screening tests analyze the levels of fetoplacental hormones (hormones released by placenta or fetus) found in mother's blood
sample. Their raised or grossly reduced levels not only provides indication for common chromosomal abnormalities like Down syndrome,
Edwards' syndrome or Patau syndrome but also provide indication for placental insufficiency that can in some cases lead to late pregnancy
complications such as Pre-eclampsia or Fetal Growth Restriction. This necessitates observation of the levels of hormones (MoMs) reported in
the prenatal screening report besides looking at the reported risk estimates for holistic interpretation and clinical decision making.