TEST PARAMETERS INCLUDED ON THE FINAL REPORT:
Every formal Second Trimester Quadruple Marker report is structured across core analytical, sonographic, and statistical parameters:

• Alpha-Fetoprotein (AFP): Raw serum concentration reported in IU/mL or ng/mL.
• AFP MoM (Multiple of the Median): Normalized value adjusted for exact gestational age, weight, ethnicity, and maternal factors.
• Total Human Chorionic Gonadotropin (Total hCG): Raw serum concentration reported in IU/mL or mIU/mL.
• Total hCG MoM (Multiple of the Median): Normalized value adjusted for gestational age and maternal demographics.
• Unconjugated Estriol (uE3): Raw serum concentration reported in ng/mL or nmol/L.
• uE3 MoM (Multiple of the Median): Normalized value reflecting feto-placental steroid unit activity.
• Dimeric Inhibin-A: Raw serum concentration reported in pg/mL.
• Inhibin-A MoM (Multiple of the Median): Normalized value reflecting placental trophoblastic activity.
• Ultrasound Dating Parameters: Biparietal Diameter (BPD) or Femur Length (FL) in millimeters (mm) confirming exact gestational weeks and days.
• Age-Only Background Risk: Base statistical risk calculated solely from maternal age at estimated date of delivery (EDD).
• Calculated Risk for Trisomy 21 (Down Syndrome): Overall personalized risk ratio synthesizing 4-marker biochemistry and age inputs (e.g., 1:3800).
• Calculated Risk for Trisomy 18 (Edwards Syndrome): Overall personalized combined risk ratio.
• Neural Tube Defect (ONTD) Risk Status: Risk assessment based on maternal serum AFP MoM (typically elevated if AFP ≥ 2.0 to 2.5 MoM).
• Pathologist & Genetic Screening Specialist Remarks: Clinical summary explaining risk categorization (Screen Negative vs. Screen Positive) and recommending next diagnostic steps.

Why does the Quadruple Marker Advance AutoDELFIA test report require a 24 to 36-hour turnaround window?

Delivering precise quantitative results for prenatal risk calculation involves multi-stage processing. This includes serum separation, running automated time-resolved immunofluorometric assays for AFP, Total hCG, uE3, and Inhibin-A on the AutoDELFIA analyzer, calibrating fluorescence standard curves, converting raw concentrations into Multiples of the Median (MoMs), entering patient and ultrasound variables into LifeCycle 7.0 software, computing statistical risks, and final review by our pathology and genetic screening team.

What is the key advantage of the Quadruple Marker test over the Triple Marker test?

The Quadruple Marker test adds Dimeric Inhibin-A to the standard three markers (AFP, hCG, and uE3). Adding Inhibin-A raises the Down Syndrome detection rate from ~65–70% (Triple Screen) to ~80–85%, while substantially lowering the false-positive rate, making it a significantly more accurate second-trimester screen.

Why is this test strictly performed between 15.0 and 20.6 weeks of gestation?

The biochemical separation of all four markers between normal pregnancies and those affected by chromosomal or neural tube defects is established and reliable during this gestational window (ideally between 16 and 18 weeks). Testing outside this window invalidates the standardized population medians used for risk calculation.

What is "AutoDELFIA," and why is it considered the gold standard for prenatal screening?

AutoDELFIA (Automated Dissociation-Enhanced Lanthanide Fluorescent Immunoassay) utilizes time-delayed fluorescence with Europium tracers. Because it measures light emission only after natural background fluorescence has decayed, it provides higher analytical sensitivity, precision, and reproducibility compared to standard ELISA or basic chemiluminescence assays.

What does "MoM" (Multiple of the Median) mean on my report?

Because hormone concentrations naturally change with each day of pregnancy and vary with maternal weight, raw values cannot be compared directly. The raw laboratory value is divided by the median value for a healthy pregnancy at that exact gestational day and weight, yielding a standardized Multiple of the Median (MoM). A MoM of 1.0 represents the exact population average.

What is an Open Neural Tube Defect (ONTD), and how does the test detect it?

Neural tube defects occur when the fetal spine or skull does not close completely during early development (e.g., Spina Bifida or Anencephaly). When an opening exists, fetal Alpha-Fetoprotein (AFP) leaks into the amniotic fluid and crosses into maternal blood, resulting in significantly elevated maternal serum AFP levels (≥ 2.0 to 2.5 MoM).

What does a "High Risk" or "Screen Positive" result for Down Syndrome mean?

A "Screen Positive" result does not mean the baby has Down Syndrome; it means the statistical probability is higher than the established cut-off (e.g., 1 in 90 instead of 1 in 1000). It indicates that further evaluation—such as a targeted Level-II ultrasound, NIPT, or confirmatory amniocentesis—is recommended.

What does a "Low Risk" or "Screen Negative" result mean?

A "Screen Negative" result means the probability of the baby having Down Syndrome, Edwards Syndrome, or an open neural tube defect is low. While it provides substantial reassurance, no screening test can completely rule out all birth defects.

Why is an accurate ultrasound gestational age required for this test?

Biochemical marker levels change significantly week by week in the second trimester. If the estimated gestational age is off by even one or two weeks (due to irregular periods), the calculated MoM values will be inaccurate, potentially causing a false-positive or false-negative result. Using ultrasound measurements (such as BPD) ensures precise gestational dating.

Do I need to fast before providing a blood sample for the Quadruple Marker test?

No. Fasting is entirely unnecessary. Routine meals and water intake do not alter circulating AFP, hCG, uE3, or Inhibin-A levels, allowing you to have your blood drawn at any convenient time during the 15.0 to 20.6-week window.

Can twin pregnancies be screened using the Quadruple Marker test?

Yes, but interpretation requires specialized adjustment. Twin pregnancies produce higher baseline amounts of AFP, hCG, and Inhibin-A because there are two fetuses and two placentas. The LifeCycle software applies validated correction factors for twin gestations.

What is the difference between the Dual Marker test and the Quadruple Marker test?

The Dual Marker test is performed in the first trimester (11.0–13.6 weeks) using Free β-hCG and PAPP-A combined with an NT ultrasound. The Quadruple Marker test is performed in the second trimester (15.0–20.6 weeks) using AFP, Total hCG, uE3, and Inhibin-A. It is ideal for patients who missed the first-trimester window or who need screening for neural tube defects.

What is the difference between a screening test and a diagnostic test?

A screening test (like the Quadruple Marker test or NIPT) estimates the statistical probability of a condition without posing any physical risk to the pregnancy. A diagnostic test (like Amniocentesis) examines actual fetal cells to provide a definitive, confirmed diagnosis.

What does an elevated Inhibin-A level indicate on the Quad Screen?

Inhibin-A is produced in higher amounts by the placenta in Down Syndrome pregnancies. An elevated Inhibin-A MoM (≥ 1.8–2.0 MoM), especially when paired with low AFP and high hCG, significantly raises the likelihood ratio for Trisomy 21.

How does maternal body weight affect the test results?

Mothers with higher body weight have a larger total blood volume, which naturally dilutes circulating biochemical markers. The LifeCycle software adjusts for maternal weight so that marker concentrations are accurately interpreted.

Is this maternal blood draw safe for the baby?

Yes, completely safe. It requires a routine, non-invasive venous blood collection (3 mL) from the mother's arm, carrying zero physical risk to the pregnancy or the developing baby.

What is Edwards Syndrome (Trisomy 18)?

Edwards Syndrome is a chromosomal condition caused by an extra copy of chromosome 18, leading to multiple structural organ anomalies and developmental delays. On the Quad Screen, it characteristically presents with very low levels across AFP, hCG, and uE3.

What is the standard immediate medical approach if my Quadruple Marker test returns high risk?

A high-risk result indicates a clear next step. Your obstetrician will review the ultrasound dating, perform or refer for a detailed Level-II anomaly scan (TIFFA), and discuss follow-up options, which may include genetic counseling, NIPT, or confirmatory Amniocentesis.

How can our family securely access and download our final digital PDF report file?

As soon as the AutoDELFIA run and LifeCycle risk calculations are verified and signed off by our consultant pathology team, your secure digital report can be downloaded from www.drpatholab.in using your registered credentials.

Are my personal prenatal records, genetic profiles, and laboratory data kept private?

Absolute adherence to medical privacy standards, sample identity logging protocols, and encrypted data channels across our digital infrastructure guarantees that your entire diagnostic and prenatal profile remains strictly confidential and secure.