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Test Code USCSSO Unity Screen Carrier Screen with Reflex sgNIPT

Important Note

For internal ordering only. Not available to outreach clients.

Useful For

UNITY uses next-generation DNA sequencing and deletion analysis of HBA1, HBA2, HBB, CFTR, and SMN1 to diagnose carrier status for cystic fibrosis, spinal muscular atrophy, and hemoglobinopathies (alpha-thalassemia, beta-thalassemia, and sickle cell disease). Single nucleotide variants in the gene panel are identified by next-generation sequencing (NGS) of exons. Deletion analysis is performed by NGS and proprietary Quantitative Counting Template (QCT) technology. UNITY offers fetal risk assessment non-invasive prenatal testing (NIPT) of these single-gene disorders when a carrier is identified from pregnant, maternal blood. Single-gene NIPT is offered as an auto-reflex test that analyzes cell-free DNA (cfDNA) in blood plasma.

Specimen Requirements

Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
 
Whole Blood 3- Streck 10 mL N/A 30 mL total: 10 mL in each of 3 DNA Streck tubes (30 mL total) 10 mL N/A

Specimen Stability Information

Store and transport specimen tubes at ambient temperature (43-98 F or 6-37 C).

Specimen Type Temperature Time
Whole Blood Ambient 7days

Rejection Criteria

Refrigerated or Frozen Specimens

Performing Laboratory Name

BillionToOne

Referral Laboratory Information

Address Telephone Website Link Marshfield Lab Account #
 
3200 Whipple Rd.
Union City, CA 94587		 650-460-2551 www.unityscreen.com 6542

Performing Information

Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
 
BillionToOne Monday - Friday (samples processed Sun-Sat) 14 -21 days Next Generation Sequencing: Counting and SNP-based methodologies, QCT technology

CPT Codes

CPT Modifier
(if needed)		 Quantity Description Comments
 
81220   1 Cystic Fibrosis
 
81329   1 Spinal Muscle Atrophy
 
81361   1 -Thalassemia (HBB)
 
81257   1 Alpha Thalassemia (HBA)
 
81243   Optional Fragile X  

Ordering Applications

Ordering Application Description
Cerner Unity Screen Carrier Screen with Reflex sgNIPT