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IRT Analysis (Not valid after 90 days of age)

Omics test Model
Test Code B0005
Test Summary

This biochemical test analyzes the levels of immunoreactive trypsinogen (IRT) in newborns
Turn Around Time 3 days
Acceptable Sample Types Dried Blood Spots
Acceptable Billing Types Institutional Billing , Self (patient) Payment
NY Approved Yes
Self (patient) Price $165.00
Institutional Price $165.00
*TAT starts after the sample and all required sample information is received at the processing laboratory.

**The CPT codes listed are in accordance with Current Procedural Terminology, a publication of the American Medical Association, and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party.

This testing service has not been cleared or approved by the U.S. Food and Drug Administration. Testing services may not be licensed in accordance with the laws in all countries. The availability of specific test offerings is dependent upon laboratory location.
Test Inquiry
Test Code: B0005
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General Biochemical and Molecular Requisition Form

Test Description

Immunoreactive trypsinogen (IRT) analysis is used to screen for cystic fibrosis.

Indications for Testing

  • Infants with a clinical suspicion of cystic fibrosis

Condition Description

Cystic fibrosis is a condition characterized by the buildup of thick, sticky mucus that can damage many of the body's organs. Common signs and symptoms include progressive damage of the respiratory system and chronic digestive system problems. Cystic fibrosis is a common genetic condition that occurs in 1 in 2500-3500 caucasian newborns and is less common among other ethnic groups. Cystic fibrosis is a ressive condition caused by mutations in the gene CFTR. (NIH, genetics home reference)

Test Methods and Limitations

Fluoroimmunometric assay based on the direct sandwich technique in which two antibodies are directed against a given analyte. Calibrators and serum samples, containing the analyte are reacted with immobilized monoclonal antibodies directed against the analyte. Europium-labeled monoclonal antibodies directed against an antigenic site on the analyte are reacted with the analyte bound to the solid-phase antibody.  The Inducer dissociates europium ions from the labeled antibodies into the solution where they form highly fluorescent chelates with components of the Inducer. The fluorescence in each cup is then measured. The europium fluorescence from each sample is proportional to the concentration of analyte in the sample.

Detailed Sample Requirements

Dried Blood Spots
Test Details Page
Collection Container(s) Dried blood spot card
Collection

Follow kit instructions. Briefly, allow blood to saturate the card until indicated areas are filled and blood has soaked through the card. Air dry the card at ambient temperature for at least 3 hours.

  • NBS: Please contact Revvity Omics to request the StepOne® kit.
  • Gene Sequencing: Please contact Revvity Omics to request the DBS collection kit.
  • For pre-punched DBS: The required minimum is 6 punches
Sample Condition Follow the instructions provided with the collection set. Store the dried blood at ambient temperature for up to two days. If the specimen cannot be sent as soon as it is dry, the filter paper should be placed in a sealable plastic bag and stored in a refrigerator (≤ 8°C) or preferably in a freezer.
Shipping Follow kit instructions. Double bag and ship overnight at ambient temperature.

Resources

General Biochemical and Molecular Requisition Form