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Test Directory » CFvantage® Cystic Fibrosis Expanded Screen

CFvantage® Cystic Fibrosis Expanded Screen

Order Code: CFVATG

Test Summary

The CFvantage® Cystic Fibrosis Expanded Screen analyzes an expanded number of variants that have been proven to cause Cystic Fibrosis (CF). This panel includes the 23 variants recommended by the American College of Obstetricians and Gynecologists (ACOG) for screening of all women of childbearing age. ACOG also recommends that patients with a personal or family history of CF be offered screening.

Aliases

  • N/A

Specimen Collection

Special Instructions

N/A

Preferred Specimen

5 mL Whole blood collected in an EDTA (lavender-top), ACD (yellow-top), or sodium heparin (green-top) tube

Minimum Volume

3 mL whole blood • 10 mL amniotic fluid • 10 mg chorionic villi

Instructions

Do not hold specimen; forward to laboratory when specimen arrives.

Whole blood: Normal phlebotomy procedure. Specimen stability is crucial. Store and ship room temperature immediately. Do not freeze.

Note: Please indicate the ethnicity of the patient.

For fetal testing:
1) Please call 1-866-GENE-INFO (1-866-436-3463) prior to submission; 2) Documentation of parental carrier status must be provided;3) It is required that Maternal Cell Contamination Study, STR Analysis be ordered in conjunction with fetal testing. A separate tube of maternal blood (EDTA) is required for this test.

Amniotic fluid (acceptable): Normal collection procedure. Specimen stability is crucial. Store and ship at room temperature immediately. Do not refrigerate or freeze; forward to laboratory when sample arrives.
Amniocyte or Chorionic Villus (CVS) culture (acceptable): Two sterile T25 flasks, 75% confluent, filled with culture medium. Specimen stability is crucial. Store and ship at room temperature immediately. Do not refrigerate or freeze; forward to laboratory when cells arrive.
Dissected Chorionic Villus (CVS) biopsy (acceptable): 10-20 mg dissected chorionic villi collected in sterile tube, filled with sterile culture medium. Specimen stability is crucial. Store and ship at room temperature immediately. Do not refrigerate or freeze; forward to laboratory when sample arrives.


Patient Preparation

N/A

Storage

N/A

Transport Temperature

Room temperature

Specimen Stability

  • Whole blood
  • Room temperature: 7 days
  • Refrigerated: 14 days
  • Frozen: UnacceptableAll other specimens
  • Room temperature: 48 hours
  • Refrigerated: Unacceptable
  • Frozen: Unacceptable

Limitations

N/A

Other Acceptable Specimens

10 mL amniotic fluid collected in a sterile plastic leak-proof container • 10 mg chorionic villi collected in a sterile tube filled with sterile culture media • Cultured cells collected in each of two sterile T-25 flasks

Unacceptable Specimens

Do not reject

Order Code

CFVATG

EPIC (Premier) Code

LAB156

Includes

N/A

CPT Code

  • 81220

Billing Code

  • 670978

CPT Statement

CPT Statement

Methodology

Multiplex PCR • Next Generation Sequencing

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

Mornings

Specimen Collection

Special Instructions

N/A

Preferred Specimen

5 mL Whole blood collected in an EDTA (lavender-top), ACD (yellow-top), or sodium heparin (green-top) tube

Minimum Volume

3 mL whole blood • 10 mL amniotic fluid • 10 mg chorionic villi

Instructions

Do not hold specimen; forward to laboratory when specimen arrives.

Whole blood: Normal phlebotomy procedure. Specimen stability is crucial. Store and ship room temperature immediately. Do not freeze.

Note: Please indicate the ethnicity of the patient.

For fetal testing:
1) Please call 1-866-GENE-INFO (1-866-436-3463) prior to submission; 2) Documentation of parental carrier status must be provided;3) It is required that Maternal Cell Contamination Study, STR Analysis be ordered in conjunction with fetal testing. A separate tube of maternal blood (EDTA) is required for this test.

Amniotic fluid (acceptable): Normal collection procedure. Specimen stability is crucial. Store and ship at room temperature immediately. Do not refrigerate or freeze; forward to laboratory when sample arrives.
Amniocyte or Chorionic Villus (CVS) culture (acceptable): Two sterile T25 flasks, 75% confluent, filled with culture medium. Specimen stability is crucial. Store and ship at room temperature immediately. Do not refrigerate or freeze; forward to laboratory when cells arrive.
Dissected Chorionic Villus (CVS) biopsy (acceptable): 10-20 mg dissected chorionic villi collected in sterile tube, filled with sterile culture medium. Specimen stability is crucial. Store and ship at room temperature immediately. Do not refrigerate or freeze; forward to laboratory when sample arrives.


Patient Preparation

N/A

Storage

N/A

Transport Temperature

Room temperature

Specimen Stability

  • Whole blood
  • Room temperature: 7 days
  • Refrigerated: 14 days
  • Frozen: UnacceptableAll other specimens
  • Room temperature: 48 hours
  • Refrigerated: Unacceptable
  • Frozen: Unacceptable

Limitations

N/A

Other Acceptable Specimens

10 mL amniotic fluid collected in a sterile plastic leak-proof container • 10 mg chorionic villi collected in a sterile tube filled with sterile culture media • Cultured cells collected in each of two sterile T-25 flasks

Unacceptable Specimens

Do not reject

Billing

CPT Code

  • 81220

Billing Code

  • 670978

CPT Statement

CPT Statement

Result Information

Methodology

Multiplex PCR • Next Generation Sequencing

Testing Laboratory

N/A

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Mornings