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FMF First Trimester Screen Test

DNA Labs India | ISO 9001:2015 Certified

FMF First Trimester Screen Test

Short Name: FMF FT Screen

Also known as: Fetal Medicine Foundation First Trimester Screen, FMF Combined Test, First Trimester Combined Screening, First Trimester Maternal Serum Screen, First Trimester Down Syndrome Screen

FMF First Trimester Screen Test test available at DNA Labs India for ₹3,500. Uses ECLIA (Electrochemiluminescence Immunoassay) on Serum samples. Results in Same day report for samples received on Tue / Thu / Sat by 9 AM. Free home collection in 300+ cities across India.

Blood TestFemalePregnant Women (Reproductive Age)🏠 Home Collection

🩺 Medically Reviewed By

Overview

The primary purpose of the FMF First Trimester Screen Test is to identify pregnancies at increased risk of chromosomal abnormalities, particularly Down syndrome (Trisomy 21) and Edwards syndrome (Trisomy 18), during the first trimester. This early screening enables timely clinical decision-making, appropriate genetic counselling, and the option for confirmatory diagnostic testing if required. The test also aids in assessing the overall wellbeing of the pregnancy by evaluating key maternal and fetal markers.

Test Code
626
Price
₹3,500
Sample Type
Serum
Result Time
Same day report for samples received on Tue / Thu / Sat by 9 AM
Fasting Required
No
Method
ECLIA (Electrochemiluminescence Immunoassay)
Step 1

Sample Collection

No fasting is required. Ensure you have a duly filled Maternal Serum Screen Requisition Form (Form 11) with all mandatory details including maternal date of birth, LMP, and ultrasound report (11-13 weeks gestation with CRL, NT, and nasal bone). Inform the healthcare provider about any IVF history, smoking status, diabetic status, body weight, number of fetuses, and previous history of Trisomy 21.

Method: Venipuncture

Step 2

Laboratory Analysis

A trained phlebotomist will collect approximately 2 mL of blood via venipuncture from a vein in the arm. The blood is drawn into a Serum Separator Tube (SST). The procedure typically takes less than 5 minutes and involves minimal discomfort.

Step 3

Report Delivery

Apply gentle pressure on the puncture site with a cotton ball for 2-3 minutes. A small bruise may form at the site, which is normal and resolves within a few days. The sample is shipped refrigerated or frozen to the laboratory. Results are typically available on the same day for samples received on Tuesday, Thursday, or Saturday by 9 AM.

Timeline: Same day report for samples received on Tue / Thu / Sat by 9 AM

Patient Instructions

1
Before the Test:No fasting is required. Ensure that an ultrasound has been performed between 11-13 weeks of gestation with CRL, NT, and nasal bone measurements. Complete the Maternal Serum Screen Requisition Form (Form 11) with all mandatory demographic and clinical details including date of birth, LMP, gestational age, body weight, diabetic status, number of fetuses, IVF history, smoking status, and any previous history of Trisomy 21. Bring the ultrasound report to the sample collection appointment.
2
During the Test:A simple blood draw (venipuncture) is performed from a vein in the arm. Approximately 2 mL of blood is collected into an SST (Serum Separator Tube). The entire procedure takes about 5 minutes. There is minimal discomfort, similar to any routine blood test.
3
After the Test:Apply gentle pressure on the puncture site for 2-3 minutes. A small bruise may develop and resolve on its own. No specific activity restrictions are required after the test. The serum sample is processed and analysed using ECLIA (Electrochemiluminescence Immunoassay) technology, and results are typically available on the same day for samples received on Tuesday, Thursday, or Saturday by 9 AM.

About This Test

Who Should Get This Test

The primary purpose of the FMF First Trimester Screen Test is to identify pregnancies at increased risk of chromosomal abnormalities, particularly Down syndrome (Trisomy 21) and Edwards syndrome (Trisomy 18), during the first trimester. This early screening enables timely clinical decision-making, appropriate genetic counselling, and the option for confirmatory diagnostic testing if required. The test also aids in assessing the overall wellbeing of the pregnancy by evaluating key maternal and fetal markers.

How to Prepare

  • Complete the Maternal Serum Screen Requisition Form (Form 11) accurately with all mandatory fields
  • Provide the ultrasound report between 11-13 weeks gestation including CRL, NT, and nasal bone status
  • Include maternal date of birth (dd/mm/yy), last menstrual period (LMP), and gestational age
  • Mention the number of fetuses (singleton, twins, etc.)
  • Disclose diabetic status, current body weight, IVF history, and smoking status
  • Report any previous history of Trisomy 21 pregnancy
  • The sample (2 mL serum in SST) must be shipped refrigerated or frozen to maintain stability
  • No fasting is required before sample collection
  • Test is valid between 9-13 weeks gestation (ideal 10-13 weeks)

Doctor's Notes

Reviewed by — MBBS, MD (Medical Genetics) · Reg. No. 8532

"The FMF First Trimester Screen is one of the most widely recommended prenatal screening tests globally. It combines maternal serum biochemistry with ultrasound markers to provide an individualised risk assessment for chromosomal anomalies such as Down syndrome (Trisomy 21) and Edwards syndrome (Trisomy 18). I recommend this screening to all pregnant women between 11 and 13 weeks of gestation as part of standard antenatal care. An elevated risk result does not confirm a diagnosis but indicates the need for further confirmatory testing such as CVS or amniocentesis. Early screening allows timely decision-making and appropriate counselling for expectant parents."

Last medically reviewed: September 7, 2026

Test Parameters & Specifications

Sample TypeSerum
Sample Volume2 mL (1 mL min.)
ContainerSST (Serum Separator Tube)
Collection MethodVenipuncture

Sample Stability

Room Temperature
Refrigerated (2-8°C)
Frozen (-20°C)
Sample Rejection Criteria:
  • Sample received without the mandatory Maternal Serum Screen Requisition Form (Form 11)
  • Incomplete demographic or clinical details on the requisition form (missing LMP, DOB, or ultrasound data)
  • Sample collected outside the valid gestational window of 9-13 weeks
  • Haemolysed, lipaemic, or insufficient sample volume (less than 1 mL serum)
  • Sample not shipped at the required temperature (refrigerated or frozen)
  • Absence of ultrasound report with NT, CRL, and nasal bone assessment
  • Duplicate sample received without prior communication

Understanding Your Results

The FMF First Trimester Screen Test provides an individualised risk estimate for chromosomal abnormalities, primarily Down syndrome (Trisomy 21) and Edwards syndrome (Trisomy 18). The result is expressed as a risk ratio (e.g., 1 in 1000 or 1 in 50). A high-risk result does not confirm that the fetus has a chromosomal abnormality; it indicates an increased likelihood that warrants further confirmatory diagnostic testing. A low-risk result significantly reduces the probability but does not eliminate it entirely.
📊

The calculated risk is below the cut-off threshold. This suggests a low probability of Down syndrome. Routine antenatal care is recommended. No further testing is typically required for this indication unless other clinical concerns arise.

📊

The calculated risk exceeds the screening cut-off. This does not confirm Down syndrome but indicates increased probability. Confirmatory diagnostic testing such as Chorionic Villus Sampling (CVS) or amniocentesis is recommended. Genetic counselling should be offered.

📊

The risk for Edwards syndrome is below the threshold. Routine antenatal care is recommended with standard follow-up.

📊

The risk for Edwards syndrome is elevated. Confirmatory CVS or amniocentesis with fetal karyotyping is recommended. Genetic counselling should be arranged.

📊

An increased nuchal translucency measurement (≥ 3.5 mm) even with normal serum markers warrants specialist fetal medicine review. Additional structural assessment and fetal echocardiography may be recommended.

📊

Very low PAPP-A may indicate risk for adverse pregnancy outcomes such as pre-eclampsia, fetal growth restriction, or preterm delivery, even when the chromosomal risk is low. Close monitoring of fetal growth in the second and third trimesters is recommended.

⚠️ When to Consult a Doctor:

Consult your obstetrician or fetal medicine specialist if your FMF First Trimester Screen result indicates high risk for any chromosomal abnormality. Additionally, consult your doctor if you experience unexplained vaginal bleeding, severe abdominal pain, or have concerns about your pregnancy at any stage. If your NT measurement is significantly elevated (≥ 3.5 mm), a specialist fetal medicine consultation is recommended regardless of overall screening risk. Always discuss your screening results with a qualified healthcare provider to understand what they mean for your specific pregnancy and to plan any necessary follow-up testing.

Limitations

  • This is a screening test, not a diagnostic test — it estimates risk and cannot confirm or rule out chromosomal abnormalities with certainty
  • The detection rate is approximately 85-90%, meaning 10-15% of affected pregnancies may screen as low risk (false negatives)
  • A false positive rate of approximately 5% means some unaffected pregnancies may be flagged as high risk
  • The test is only valid between 9-13 weeks gestation (ideal window 11-13 weeks) and cannot be performed outside this timeframe
  • The test primarily screens for Trisomy 21 and Trisomy 18; it does not detect all genetic or chromosomal conditions
  • Screening accuracy depends heavily on the quality of ultrasound measurements (NT, CRL, nasal bone)
  • A high-risk result requires confirmatory diagnostic testing such as CVS or amniocentesis for definitive diagnosis
  • Results may be affected by incomplete or inaccurate patient demographic information

Risks & Considerations

  • Minimal risk associated with blood draw — slight bruising or discomfort at the puncture site
  • False positive results may cause unnecessary anxiety and lead to additional invasive testing
  • False negative results (10-15% miss rate) may provide false reassurance
  • Psychological stress associated with a high-risk screening result pending confirmatory testing

Interfering Factors

  • Incorrect gestational age dating may affect the accuracy of risk calculations
  • Multiple pregnancies (twins or higher-order multiples) alter biochemical marker levels and require adjusted interpretation
  • Maternal weight can influence serum marker concentrations, requiring weight-adjusted MoM values
  • IVF pregnancies may have different baseline marker levels requiring specific correction factors
  • Maternal smoking status affects PAPP-A and free β-hCG levels and must be accurately recorded
  • Insulin-dependent diabetes mellitus (pre-gestational) can lower marker levels
  • Vaginal bleeding prior to sample collection may affect serum biochemistry
  • Incorrect or incomplete demographic details on the requisition form may compromise risk calculation accuracy

Compare With Similar Tests

TestFMF First Trimester Screen TestDouble Marker TestTriple Marker TestQuadruple Marker TestNIPT (Non-Invasive Prenatal Testing)Integrated Test (First + Second Trimester Combined)
ComparisonFMF First Trimester Screen Test

Frequently Asked Questions

What is the FMF First Trimester Screen Test?
The FMF First Trimester Screen Test is a combined prenatal screening test recommended by the Fetal Medicine Foundation. It uses maternal serum markers (PAPP-A and free ?-hCG) along with ultrasound measurements (Nuchal Translucency, Crown-Rump Length, and nasal bone) and maternal factors to calculate the individualised risk of chromosomal abnormalities such as Down syndrome (Trisomy 21) and Edwards syndrome (Trisomy 18). The test is performed between 9 and 13 weeks of gestation.
When is the best time to do the FMF First Trimester Screen Test?
The test is valid between 9 and 13 weeks of gestation, with the ideal window being 11 to 13 weeks. During this period, the ultrasound markers (NT and CRL) can be measured most accurately, and the serum markers provide the most reliable results when combined with ultrasound data.
What does a high-risk FMF First Trimester Screen result mean?
A high-risk result means that the calculated probability of the fetus having a chromosomal abnormality (such as Down syndrome) exceeds the screening cut-off threshold. It does NOT confirm a diagnosis. Approximately 5% of normal pregnancies may also screen as high risk (false positive). Your doctor will recommend confirmatory diagnostic testing such as Chorionic Villus Sampling (CVS) or amniocentesis for definitive diagnosis.
How accurate is the FMF First Trimester Screen Test?
The FMF First Trimester Screen has a detection rate of approximately 85-90% for Down syndrome (Trisomy 21) with a false positive rate of about 5%. This means it correctly identifies 85-90 out of 100 affected pregnancies while flagging about 5% of unaffected pregnancies as high risk. It is among the most reliable first trimester screening methods available.
Is the FMF First Trimester Screen Test the same as the Double Marker Test?
No, they are not the same. The Double Marker Test measures only serum biochemistry (PAPP-A and free ?-hCG), while the FMF First Trimester Screen is a combined test that integrates serum biochemistry with ultrasound markers (NT, CRL, nasal bone) and maternal factors. The FMF combined test has a higher detection rate (85-90%) compared to the Double Marker Test alone (80-85%).
Do I need to fast before the FMF First Trimester Screen Test?
No, fasting is not required for this test. You can eat and drink normally before your blood sample is collected. However, it is important to complete the Maternal Serum Screen Requisition Form (Form 11) with all mandatory details and bring your ultrasound report.
What documents do I need to bring for the test?
You need to bring a duly filled Maternal Serum Screen Requisition Form (Form 11) with details such as your date of birth, LMP (last menstrual period), body weight, diabetic status, number of fetuses, IVF history, smoking status, and previous history of Trisomy 21. You also need an ultrasound report from 11-13 weeks gestation showing CRL, NT, and nasal bone measurements.
How much does the FMF First Trimester Screen Test cost?
The FMF First Trimester Screen Test costs INR 3500 at DNA Labs India. This price includes free home sample collection across India, lab analysis, and same-day report delivery via online portal, email, or WhatsApp. The cost may vary at other healthcare providers.
What happens if my screening result is high risk?
If your screening result indicates high risk, your obstetrician or fetal medicine specialist will discuss the findings with you and recommend confirmatory diagnostic testing. Options include Chorionic Villus Sampling (CVS), which can be performed between 10-13 weeks, or amniocentesis, typically done between 15-18 weeks. Genetic counselling will be provided to help you understand the results and make informed decisions.
Can the FMF First Trimester Screen Test detect all birth defects?
No. The test primarily screens for chromosomal abnormalities, mainly Down syndrome (Trisomy 21) and Edwards syndrome (Trisomy 18). It does not detect all genetic conditions, structural birth defects, or neural tube defects. Other screening and diagnostic tests may be recommended during pregnancy to assess for additional conditions.
Is the FMF First Trimester Screen Test safe during pregnancy?
Yes, the test is completely safe. It involves only a routine blood draw from the arm, which carries minimal risk such as slight bruising or discomfort at the puncture site. Unlike diagnostic tests such as CVS or amniocentesis, the FMF First Trimester Screen carries no risk of miscarriage or harm to the fetus.
Can I take the FMF First Trimester Screen Test if I am carrying twins?
Yes, the test can be performed in twin pregnancies, though the interpretation is more complex. The screening algorithm accounts for multiple pregnancies, and correction factors are applied. However, the detection rate may differ slightly from singleton pregnancies. Inform your healthcare provider and the laboratory about the number of fetuses on the requisition form.
Worried about the process? Our certified phlebotomists collect thousands of samples every month across India. The process takes under 5 minutes and is virtually painless. Questions? Message us on WhatsApp — we're here 7 days a week.

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