Test Details
Methodology
The immunoglobulin heavy-chain gene variable region (IGHV) somatic hypermutation analysis is performed using extracted patient RNA as starting material. Subsequent amplification of the IgH gene is performed by polymerase chain reaction (PCR). The PCR products are isolated and sequenced. The nucleotide sequence is compared to a consensus germline sequence data base for that VH gene family. The results are reported as percentage of homology between the patient's VH sequence in comparison with the germline VH sequence using the Basic Local Alignment Search Tool (BLAST) for the Immunoglobulin data base at http://www.ncbi.nlm.nih.gov/igblast.
The immunoglobulin heavy-chain gene variable region (I |
The immunoglobulin heavy-chain gene variable region (IGHV) somatic hypermutation analysis is performed using extracted patient RNA as starting material. Subsequent amplification of the IgH gene is performed by polymerase chain reaction (PCR). The PCR products are isolated and sequenced. The nucleotide sequence is compared to a consensus germline sequence data base for that VH gene family. The results are reported as percentage of homology between the patient's VH sequence in comparison with the germline VH sequence using the Basic Local Alignment Search Tool (BLAST) for the Immunoglobulin data base at http://www.ncbi.nlm.nih.gov/igblast. |
Result Turnaround Time
6 - 8 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
This test determines the mutation status of IGHV gene in B lymphocytes, including those of CLL (chronic lymphocytic leukemia). The IGHV gene mutation status is one of the discriminators of clinical outcome in patients with CLL. The mutational status of the immunoglobulin genes expressed by CLL cells can be used to segregate patients into two subsets that have significantly different tendencies for disease progression. Patients with leukemic cells that express unmutated immunoglobulin heavy-chain variable region genes have a greater tendency for disease progression than those who have leukemic cells that express IGHV genes with less than 98% nucleic acid homology with their germ-line counterparts.
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This test determines the mutation status of IGHV gene in B lymphocytes, including those of CLL (chronic lymphocytic leukemia). The IGHV gene mutation status is one of the discriminators of clinical outcome in patients with CLL. The mutational status of the immunoglobulin genes expressed by CLL cells can be used to segregate patients into two subsets that have significantly different tendencies for disease progression. Patients with leukemic cells that express unmutated immunoglobulin heavy-chain variable region genes have a greater tendency for disease progression than those who have leukemic cells that express IGHV genes with less than 98% nucleic acid homology with their germ-line counterparts. |
Limitations
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
Specimen Requirements
Specimen
Peripheral blood or bone marrow
Volume
1 mL
Minimum Volume
0.5 mL
Container
Lavender-top (EDTA) tube, green-top (heparin) tube or yellow-top (ACD) tube
Lavender-top (EDTA) tube, green-top (heparin) tube |
Lavender-top (EDTA) tube, green-top (heparin) tube or yellow-top (ACD) tube |
Storage Instructions
Maintain specimen at room temperature; stable for three to five days.
LOINC® Map
Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
---|---|---|---|---|---|---|
113753 | IGHV Somatic Hypermutation | 111001 | Interpretation: | 62365-2 | ||
113753 | IGHV Somatic Hypermutation | 481541 | 80563-0 | |||
Order Code | 113753 | |||||
Order Code Name | IGHV Somatic Hypermutation | |||||
Order Loinc | ||||||
Result Code | 111001 | |||||
Result Code Name | Interpretation: | |||||
UofM | ||||||
Result LOINC | 62365-2 | |||||
Order Code | 113753 | |||||
Order Code Name | IGHV Somatic Hypermutation | |||||
Order Loinc | ||||||
Result Code | 481541 | |||||
Result Code Name | ||||||
UofM | ||||||
Result LOINC | 80563-0 |