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Test Directory

Beta-Globin Complete

Test Summary

1) To identify disease-causing mutations in individuals affected with beta-thalassemia.
2) To identify carriers in high-risk ethnic group or people with positive family history.
3) Prenatal diagnosis of beta-thalassemia.

Aliases

  • N/A

Specimen Collection

Special Instructions

N/A

Preferred Specimen

5 mL whole blood collected in a EDTA (lavender-top) tube, or ACD solution A or B (yellow-top) tube

Minimum Volume

3 mL

Instructions

Whole blood: Normal phlebotomy procedure. Specimen stability is crucial. Store and ship ambient immediately. Glass tubes should not be shipped frozen.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Room temperature

Specimen Stability

  • Room temperature: 30 days
  • Refrigerated: 30 days
  • Frozen: 30 days

Limitations

If these mutations are not found by the testing procedure, it does not mean that the risk of carrying or developing beta thalassemia is not present. It simply means that these specific mutations have not seen found with this assay, although other mutations may be present.

Other Acceptable Specimens

Whole blood collected in: sodium heparin (green-top) tube

Unacceptable Specimens

N/A

Order Code

BGLOBC

EPIC (Premier) Code

LAB5980

Includes

N/A

CPT Code

  • 81364 for New York State patient testing
  • use Test Code 14979 Beta-Globin Complete (NY)

Billing Code

  • 670585

CPT Statement

Methodology

DNA Sequencing • Polymerase Chain Reaction (PCR)

FDA Status

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Physician Attestation of Informed Consent

This germline genetic test requires physician attestation that patient consent has been received if ordering medical facility is located in AK, DE, FL, GA, IA, MA, MN, NV, NJ, NY, OR, SD or VT or test is performed in MA.

Testing Laboratory

Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675

Department

Reference Testing

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Monday, Thursday; Report available: 15 days

Specimen Collection

Special Instructions

N/A

Preferred Specimen

5 mL whole blood collected in a EDTA (lavender-top) tube, or ACD solution A or B (yellow-top) tube

Minimum Volume

3 mL

Instructions

Whole blood: Normal phlebotomy procedure. Specimen stability is crucial. Store and ship ambient immediately. Glass tubes should not be shipped frozen.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Room temperature

Specimen Stability

  • Room temperature: 30 days
  • Refrigerated: 30 days
  • Frozen: 30 days

Limitations

If these mutations are not found by the testing procedure, it does not mean that the risk of carrying or developing beta thalassemia is not present. It simply means that these specific mutations have not seen found with this assay, although other mutations may be present.

Other Acceptable Specimens

Whole blood collected in: sodium heparin (green-top) tube

Unacceptable Specimens

N/A

Billing

CPT Code

  • 81364 for New York State patient testing
  • use Test Code 14979 Beta-Globin Complete (NY)

Billing Code

  • 670585

CPT Statement

Result Information

Methodology

DNA Sequencing • Polymerase Chain Reaction (PCR)

Testing Laboratory

N/A

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Monday, Thursday; Report available: 15 days