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CD16A (FCGR3A) F158V Polymorphism Analysis
Test Code34493
CPT Codes
81479
Preferred Specimen
5 mL whole blood collected in an EDTA (lavender-top) tube, or an acid citrate dextrose ACD solution A or B (yellow-top) tube
Minimum Volume
3 mL whole blood • 20 uL extracted DNA
Other Acceptable Specimens
Whole blood collected in a sodium heparin (green-top) tube • 100 uL genomic DNA sample (extracted at CLIA approved lab) collected in a microcentrifuge tube
Instructions
Do not reject extracted DNA sample. Submitted extracted DNA must be extracted from a CLIA approved lab. Normal phlebotomy procedure. Specimen stability is crucial. Store and ship ambient immediately. Do not freeze.
Acceptable: Whole blood collected in a sodium heparin (green-top) tube is acceptable but not recommended.
Acceptable: Whole blood collected in a sodium heparin (green-top) tube is acceptable but not recommended.
Transport Temperature
Room temperature
Specimen Stability
Whole blood
Room temperature: 8 days
Refrigerated: 30 days
Frozen: Unacceptable
Extracted DNA
Room temperature: 30 days
Refrigerated: 1 year
Frozen: 2 years
Room temperature: 8 days
Refrigerated: 30 days
Frozen: Unacceptable
Extracted DNA
Room temperature: 30 days
Refrigerated: 1 year
Frozen: 2 years
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Samples received frozen • Clotted specimen
Methodology
Polymerase Chain Reaction (PCR) • SNaPshot
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. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Wednesday, Saturday Morning
Report available: 6 Days
Report available: 6 Days
Reference Range
| CD16A (FCGR3A) F158V | Not detected |
| F158 | Not detected |
| V158 | Not detected |
Clinical Significance
CD16A (FCGR3A) F158V Polymorphism Analysis - The CD16A (FCGR3A) gene encodes for an Fc-gamma receptor on human white blood cells which plays an important role in antibody dependent cell-mediated cytotoxicity (ADCC). In cancer patients, differential clinical response to therapeutic monoclonal antibodies has been reported to correlate with the genotype of the CD16A (FCGR3A) gene (PMID: 23286345, PMID: 30374078, PMID 33480963). The different genotypes (V/V, F/V, or F/F) result from a single nucleotide polymorphism, dbSNP rs396991, where a T>G substitution changes phenylalanine (F) to valine (V) at position 158 (P08637 VAR 003960).
