StepOne® Comprehensive Biochemical Profile

Omics test Model
Test Code B0200
Test Summary

The StepOne® Comprehensive Biochemical Profile is a newborn screening test that can detect more than 70 disorders in newborns from just a few drops of blood.
Turn Around Time 3 - 5 days
Acceptable Sample Types Dried Blood Spots
Acceptable Billing Types Institutional Billing , Self (patient) Payment
NY Approved Yes
*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.
This test is not available in your region Japan, please select your nearest laboratory to request more information.
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Test Inquiry
Test Code: B0200
Download PDF Version
General Biochemical and Molecular Requisition Form

Test Description

A comprehensive biochemical profile is performed to identify the presence of more than 70 inherited disorders. This test screens for Recommended Universal Newborn Screening Panel (RUSP) disorders, which includes the full core and secondary panel recommended by the American College of Medical Genetics and Genomics (ACMG) along with other conditions that may not be found in state-mandated programs.

Indications for Testing

This test may be appropriate for individuals with a clinical suspicion of an inherited metabolic disorder.

Condition Description

StepOne Comprehensive Biochemical Profile includes fatty acid oxidation disorders, organic acid disorders, amino acid disorders, and other conditions. 

Test Methods and Limitations

The StepOne Comprehensive Biochemical Profile is performed by tandem mass spectrometry and other technologies.

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