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Test ID: Thyroid Stimulating Hormone-DBS
Thyroid Stimulating Hormone-DBS
Screening test to Detect Congenital Hypothyroidism (CH) in newborns.
Useful For

Screening test to Detect Congenital Hypothyroidism (CH) in newborns.

Method name and description

Solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique.                 

Reporting name

Thyroid Stimulating Hormone-DBS

Clinical information

Early fetal development of the thyroid gland seems to be independent of the pituitary. hTSH-secretion from the pituitary does not start until the end of the first trimester of pregnancy after which the secretion of hTSH increases rapidly and reaches a level higher  than the maternal level. hTSH and thyroid hormones are not transported through the placenta. Consequently the pituitary-thyroid functions of the fetus are independent of those  of the mother . 

Immediately after birth a rapid increase in hTSH concentration - known as the hTSH  surge - is seen in neonatal blood. The concentration stabilizes to a lower level some days  after birth if the baby’s thyroid is functioning normally . 

An elevated hTSH concentration in infant blood is the earliest available laboratory  manifestation of primary hypothyroidism. Due to its high specificity and sensitivity, hTSH testing is the screening method of choice for the detection of neonatal hypothyroidism. 
 Early identification and appropriate treatment of infants with congenital hypothyroidism has been highly successful in reducing the severity of impairment from this disorder. 

Reference: GSP Neonatal Neonatal hTSH package insert

Aliases

Congenital Hypothyroidism (CH)

Neonatal screening Test

Neonatal screening Testing

Specimen type / Specimen volume / Specimen container

Specimen type: Whole blood collected from heel prick with direct application onto special Whatman 903 filter paper.

Specimen Volume: 5 Circles(spot) if ordered with the whole screening panel. Minimum 2 spot if requested alone i.e., successive collection.                                  

Specimen container: Newborn screening Blood Spot Collection Card. 

Collection instructions / Special Precautions / Timing of collection

Collection instructions:

1.Collect blood for newborn screening at 24 hours of age.

2.Complete the required patient information on the collection card and ensure that the expiration date of the collection card has not passed.

3.Collect blood from the most medial or lateral portion of the plantar surface of the heel; allow blood to soak through to completely fill each of the preprinted circles; do not apply layers of successive blood drops to the same printed circle; inspect both sides of the collection card to be sure blood is soaked through to the back of the card.

4.Allow blood specimen to air dry for a minimum of three hours on a horizontally level, nonabsorbent, open surface at an ambient temperature of 18 to 25 °C.

5. Fold-over cover provides protection from contamination before blood collection, during specimen transportation and during specimen storage after analysis. Blood spots must be thoroughly dry before the flap is closed over spots.

6.The collection card/dried blood specimen should be transported to the laboratory with the appropriate tracking documentation and within 24 hours of collection.

Special Precautions

1.Premature infants who are less than 32 weeks of gestational age, screening must be repeated after the infant completes 32 weeks.  

2.In case of immediate blood transfusion, exchange transfusion, treatment with corticosteroids or dopamine initial specimen must be collected even if the newborn less than 24 hrs.  age and repeated after 5 days of discontinuation of drug or last transfusion.  

3.3.Timing of blood spot collection is important for accurately interpreting test results. Collecting specimen after 24  hours of age is particularly important to minimize  false positive results that occur due to the physiological surge in TSH during the first hours after birth.

Relevant clinical information to be provided

Complete the required demographic information on the blood spot collection card.

Storage and transport instructions

Transport the specimen at ambient temperature. Newborn screening laboratory specimens have limitations with temperature and humidity conditions between collection and analysis and if the specimens could be subjected to extreme temperature during transit place a cold pack in the specimen transport insulated box.

The specimen must be sent immediately after drying to the laboratory (do not accumulate or batch the specimens). If the blood specimen is taken after midday, or during weekends, the sample should be sent to the laboratory the next working day.

Delays in specimen transportation from the collection facility may compromise the integrity of the specimen and could critically impact the newborn.      

Specimen Rejection Criteria

Specimen collected in expired Guthrie card. 

Specimen collected before 24 hours of newborn age.

Insufficient quantity of blood. 

Errors in patient identifiers.

Damaged or delayed Specimen

Specimen appears scratched or abraded.

Specimen appears supersaturated.

Specimen appears diluted, discolored, or contaminated.

Specimen exhibits serum rings.

Specimen appears clotted or layered.

Applying blood using capillary tubes or using Anticoagulants (EDTA, citrate).

Specimens accompanied by improper or incomplete paperwork.

Using white ink on the blood specimen filter paper.

Biological reference intervals and clinical decision values

0 -  15.0 µU/mL blood (age at collection <72 hrs after birth)

0 -  10.0 μU/mL blood (age at collection ≥ 72 hrs after birth)

Factors affecting test performance and result interpretation

Gestational age 

Timing of specimen collection

Maternal Conditions/ Treatments: Hyperthyroidism, treated with PTU or methimazole (thiamazole), Hypothyroidism (untreated or poorly controlled)/ Glucocorticoids, Dopamine

Newborn Conditions: Acute illness , Significant hypoxia , Immature HPT axis , Iodine deficiency, Preterm and/or LBW

Newborn Treatments: Dopamine , Iodine exposure with povidone-iodine preps at birth or postnatally and Steroids 

Turnaround time / Days and times test performed / Specimen retention time

Turnaround time :3 working days.

Days and times test performed: Saturday -Thursday 7:00am-3:00PM

Specimen retention time: Indefinite