Congenital Hypothyroidism Confirmatory Panel Serum Test
Short Name: CH Confirmatory Panel
Also known as: Congenital Hypothyroidism Serum Panel, Newborn Thyroid Confirmatory Test, CH Confirmatory Blood Test, Neonatal Hypothyroidism Panel Serum
Congenital Hypothyroidism Confirmatory Panel Serum Test test available at DNA Labs India for ₹900. Uses CLIA (Chemiluminescence Immunoassay) on Serum samples. Results in Reports are available within approximately 1 week from the date of sample collection.. Free home collection in 300+ cities across India.
🩺 Medically Reviewed By
Dr Ramarao Paidisetty
Consultant Biochemist · Reg: 21504
Last reviewed: September 7, 2026
Overview
The primary purpose of the Congenital Hypothyroidism Confirmatory Panel Serum Test is to confirm or rule out a diagnosis of congenital hypothyroidism in newborns and infants who have had an abnormal result on initial newborn screening. This test measures the levels of Thyroid Stimulating Hormone (TSH) and Free Thyroxine (Free T4) in serum to assess thyroid function. It is an essential diagnostic step before initiating thyroid hormone replacement therapy and helps pediatric endocrinologists determine the appropriate course of treatment and long-term monitoring plan.
- Test Code
- 12
- CPT Code
- 84436
- ICD Code
- E03.1
- Price
- ₹900
- Sample Type
- Serum
- Result Time
- Reports are available within approximately 1 week from the date of sample collection.
- Fasting Required
- No
- Method
- CLIA (Chemiluminescence Immunoassay)
Sample Collection
No special preparation or fasting is required prior to sample collection. Ensure the infant is comfortable and well-hydrated. Inform the phlebotomist about any medications, supplements, or ongoing treatments the infant may be receiving.
Method: Venipuncture (Heel prick may be used for neonates)
Laboratory Analysis
A small venous blood sample (3 mL, minimum 2 mL) is collected from the infant, typically via venipuncture. In neonates, a heel-prick or scalp vein may be used if venous access is difficult. The blood is transferred into a Serum Separator Tube (SST / Gold top).
Report Delivery
Apply gentle pressure with sterile gauze at the puncture site until bleeding stops. The sample is labeled and processed promptly. Serum is separated by centrifugation and either analyzed immediately or stored under appropriate temperature conditions until testing.
Timeline: Reports are available within approximately 1 week from the date of sample collection.
Patient Instructions
About This Test
Who Should Get This Test
The primary purpose of the Congenital Hypothyroidism Confirmatory Panel Serum Test is to confirm or rule out a diagnosis of congenital hypothyroidism in newborns and infants who have had an abnormal result on initial newborn screening. This test measures the levels of Thyroid Stimulating Hormone (TSH) and Free Thyroxine (Free T4) in serum to assess thyroid function. It is an essential diagnostic step before initiating thyroid hormone replacement therapy and helps pediatric endocrinologists determine the appropriate course of treatment and long-term monitoring plan.
How to Prepare
- No fasting is required for the infant
- Inform the lab about any medications or biotin supplements being given to the infant
- Ensure the SST tube is properly labeled with patient details
- The sample should be transported refrigerated (2–8°C) or frozen if analysis is delayed
- Avoid hemolyzed or lipemic samples as they may interfere with assay results
Doctor's Notes
Reviewed by Dr Ramarao Paidisetty — MBBS, MD (Biochemistry) · Reg. No. 21504
"Congenital hypothyroidism is one of the most common preventable causes of intellectual disability worldwide. When a newborn screening test returns abnormal results, a confirmatory serum panel measuring TSH and Free T4 is essential before initiating thyroid hormone replacement therapy. Early confirmation and treatment within the first two weeks of life can result in normal neurocognitive development. I recommend this panel for every infant with a positive or borderline newborn screening result. Timely follow-up with a pediatric endocrinologist is critical to ensure optimal dosing of levothyroxine and long-term developmental outcomes."
Last medically reviewed: September 7, 2026
Test Parameters & Specifications
Sample Stability
- Hemolyzed or grossly lipemic samples
- Insufficient sample volume (less than 2 mL)
- Unlabeled or mislabeled tubes
- Samples collected in incorrect tube type (non-SST)
- Samples received at room temperature beyond the 2-hour stability window
Understanding Your Results
Consistent with primary congenital hypothyroidism. This pattern indicates that the thyroid gland is underactive or absent, and the pituitary is compensating by producing excess TSH. Thyroid hormone replacement therapy (levothyroxine) is typically initiated.
Clinical action: Refer to pediatric endocrinologist. Initiate levothyroxine. Thyroid imaging (ultrasound or scan) may be recommended.
Thyroid function is within the normal range for age. The initial newborn screening abnormality may have been transient or due to a false positive.
Clinical action: Repeat testing may be recommended at follow-up intervals. Continue clinical monitoring.
May indicate central (secondary/tertiary) hypothyroidism due to pituitary or hypothalamic dysfunction. This is less common but requires prompt evaluation.
Clinical action: Urgent referral to pediatric endocrinology. Further evaluation of pituitary function and MRI may be indicated.
May indicate subclinical hypothyroidism or compensated thyroid dysfunction. This can also be a transient finding in premature infants.
Clinical action: Repeat testing in 2–4 weeks. Clinical correlation and endocrine consultation recommended.
Consult a pediatric endocrinologist if the confirmatory panel results show elevated TSH, low Free T4, or any abnormal pattern. Additionally, seek medical attention if your newborn displays any signs of hypothyroidism such as prolonged jaundice, persistent constipation, poor feeding, hoarse cry, excessive sleepiness, or slow growth. Early consultation ensures timely initiation of treatment and optimal developmental outcomes.
Limitations
- ⚠This test is a confirmatory panel and is not intended to replace initial newborn screening performed via heel-prick
- ⚠Results must be interpreted in clinical context by a qualified pediatric endocrinologist
- ⚠A single confirmatory test may not differentiate between permanent and transient congenital hypothyroidism
- ⚠Thyroid hormone reference ranges in neonates are age-dependent and may differ from adult ranges
- ⚠Additional imaging (thyroid ultrasound or scintigraphy) may be required to determine the etiology of CH
Risks & Considerations
- ●Minor bruising or discomfort at the venipuncture site
- ●Very rare risk of infection at the puncture site
- ●Transient mild pain during needle insertion
- ●In rare cases, difficulty in obtaining venous access in neonates may require a repeat attempt
Interfering Factors
- ●Biotin supplementation in the mother or infant may interfere with CLIA-based immunoassays and cause falsely low or high results
- ●Maternal thyroid antibodies crossing the placenta can transiently affect neonatal TSH and T4 levels
- ●Premature birth or critical illness (non-thyroidal illness syndrome) may alter thyroid hormone levels
- ●Recent administration of iodine-containing contrast agents or antiseptics
- ●Heterophilic antibodies in serum can cause analytical interference in immunoassays
Compare With Similar Tests
| Test | Congenital Hypothyroidism Confirmatory Panel Serum Test | Newborn Screening (Heel Prick) | Thyroid Profile Test | Thyroid Antibody Panel |
|---|---|---|---|---|
| Comparison | Congenital Hypothyroidism Confirmatory Panel Serum Test | The newborn screening is a first-line population-level test performed on dried blood spots within 48–72 hours of birth. The confirmatory serum panel is a follow-up diagnostic test performed on venous serum to verify abnormal screening results. | A general thyroid profile (TSH, Total T3, Total T4) is typically ordered for adults and older children. The CH Confirmatory Panel is specifically designed for neonates and infants, using age-appropriate reference ranges and ultrasensitive assay methodology. | The thyroid antibody panel (anti-TPO, anti-thyroglobulin) is used to diagnose autoimmune thyroid disease in older children and adults. It is not typically used in neonatal confirmatory testing unless maternal autoimmune thyroiditis is suspected. |
Frequently Asked Questions
What is the Congenital Hypothyroidism Confirmatory Panel Serum Test?
Why is this confirmatory test necessary after newborn screening?
At what age should this test be performed?
Is fasting required for the infant before the test?
What sample type is required for this test?
What does an elevated TSH and low Free T4 result mean?
What is the cost of the Congenital Hypothyroidism Confirmatory Panel Serum Test at DNA Labs India?
Is home sample collection available for this test?
How long does it take to get the test results?
Can congenital hypothyroidism be treated?
What happens if congenital hypothyroidism is not detected early?
Which cities does DNA Labs India cover for home sample collection?
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