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Test Code B0005
Test Summary

This biochemical test analyzes the levels of immunoreactive trypsinogen (IRT) in newborns

Turn-Around-Time (TAT)* 3  days
Acceptable Sample Types
Dried Blood Spots
Acceptable Billing Types
Self (patient) Payment
Institutional Billing
*TAT starts after the sample and all required sample information is received at PerkinElmer Genomics, or after the benefits investigation is complete if requested for commercial insurance billing.

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

Infants with a clinical suspicion of cystic fibrosis

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)

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.

Dried Blood Spots
Collection Container(s):

Dried blood spot card

Collection:

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

  • NBS: Please contact PKIG to request the StepOne® kit.
  • Gene Sequencing: Please contact PKIG to request the DBS collection kit.
  • For pre-punched DBS: The required minimum 6 punches with 3.2 mm or 4 punches 4.75 mm.
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.

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