Heme samples : one 5 mL blood in EDTA (lav top), OR one 3 mL bone marrow in EDTA (min 0.5mL or >100K nucleated cells) Formalin-Fixed, paraffin-embedded tissue (FFPE) in microtainer: 3-5 10uM slices or >100K cells Formalin-Fixed, paraffin-embedded tissue (FFPE) slides: 10 unstained slides with slices of 10uM. Fresh tissue: min 0.1mL Frozen tissue: min 100mg or 0.5cc / 0.5 cm3 Body Fluids (CSF, Pleural): >200K cells Fine needle aspirate slides: Minimum volume is dependent on the tumor size and cellularity. Unfixed, ethanol fixed, or H&E stained – Soak slide in xylene to remove coverslip and dry before transporting to the lab.
Storage/Transport Temperature
20-25°C for several hours acceptable Protect FFPE samples from heat exposure, especially in summer months. Fresh tissue should be sent in saline soaked gauze, a tube with saline, or tissue culture medium. Frozen samples should be sent on dry ice.
A positive result indicates the presence of monoclonal B-cell population within the sample. A negative result does not entirely exclude the presence of monoclonal B-cell population in the sample.
Reference Interval
Negative: A monoclonal B-cell population is not detected. Positive: A monoclonal B-cell population is detected.
Interpretive Data
Patient DNA is isolated, purified and subjected to PCR amplification using two primer sets specific for the immunoglobulin kappa light chain (IGK) gene. An additional PCR amplification directed at a beta-globin gene segment is performed as a control for sample DNA quality as needed. Each assay includes a positive control reaction using DNA from a B-cell lymphoma with a clonal IGK gene rearrangement and a negative control reaction using DNA from a sample with no evidence of a clonal IGK gene rearrangement. PCR products are analyzed by gel electrophoresis. Positive and negative control reactions give appropriate results. The limit of detection for this assay is 10% in a polyclonal B-cell background. Results of this test must always be interpreted in the context of morphologic and other relevant data, and should not be used alone for a diagnosis of malignancy.
CPT Codes
81264
LOINC Mapping
21748-9
Order Type (Individual or Group)
G
Group Test Information
Result Test ID
Reportable
Result Test Name
Result Type
Type (Alpha or Numeric)
TYP11
Y
SPECIMEN TYPE,IGK
I
A
CAS#6
Y
PATH CASE #,IGK
I
A
IGKR
Y
IGK GENE
I
A
IGINT
Y
INTERPRETATION,IGK
I
N
IGREV
Y
REVIEWED BY,IGK
I
A
RRIGK
Y
IGKG REVIEW
I
A
CPT Codes
81264
LOINC Mapping
21748-9
Pricing
Refer to Lab Account Manager. email: labservicesoutreach@urmc.rochester.edu
Specimen Requirements
Collect
Heme samples : one 5 mL blood in EDTA (lav top), OR one 3 mL bone marrow in EDTA (min 0.5mL or >100K nucleated cells) Formalin-Fixed, paraffin-embedded tissue (FFPE) in microtainer: 3-5 10uM slices or >100K cells Formalin-Fixed, paraffin-embedded tissue (FFPE) slides: 10 unstained slides with slices of 10uM. Fresh tissue: min 0.1mL Frozen tissue: min 100mg or 0.5cc / 0.5 cm3 Body Fluids (CSF, Pleural): >200K cells Fine needle aspirate slides: Minimum volume is dependent on the tumor size and cellularity. Unfixed, ethanol fixed, or H&E stained – Soak slide in xylene to remove coverslip and dry before transporting to the lab.
Storage/Transport Temperature
20-25°C for several hours acceptable Protect FFPE samples from heat exposure, especially in summer months. Fresh tissue should be sent in saline soaked gauze, a tube with saline, or tissue culture medium. Frozen samples should be sent on dry ice.
A positive result indicates the presence of monoclonal B-cell population within the sample. A negative result does not entirely exclude the presence of monoclonal B-cell population in the sample.
Result Interpretation
Reference Interval
Negative: A monoclonal B-cell population is not detected. Positive: A monoclonal B-cell population is detected.
Interpretive Data
Patient DNA is isolated, purified and subjected to PCR amplification using two primer sets specific for the immunoglobulin kappa light chain (IGK) gene. An additional PCR amplification directed at a beta-globin gene segment is performed as a control for sample DNA quality as needed. Each assay includes a positive control reaction using DNA from a B-cell lymphoma with a clonal IGK gene rearrangement and a negative control reaction using DNA from a sample with no evidence of a clonal IGK gene rearrangement. PCR products are analyzed by gel electrophoresis. Positive and negative control reactions give appropriate results. The limit of detection for this assay is 10% in a polyclonal B-cell background. Results of this test must always be interpreted in the context of morphologic and other relevant data, and should not be used alone for a diagnosis of malignancy.
Coding
CPT Codes
81264
LOINC Mapping
21748-9
URM Labs Internal
Test Build
Order Type (Individual or Group)
G
Group Test Information
Result Test ID
Reportable
Result Test Name
Result Type
Type (Alpha or Numeric)
TYP11
Y
SPECIMEN TYPE,IGK
I
A
CAS#6
Y
PATH CASE #,IGK
I
A
IGKR
Y
IGK GENE
I
A
IGINT
Y
INTERPRETATION,IGK
I
N
IGREV
Y
REVIEWED BY,IGK
I
A
RRIGK
Y
IGKG REVIEW
I
A
CPT Codes
81264
LOINC Mapping
21748-9
Pricing
Refer to Lab Account Manager. email: labservicesoutreach@urmc.rochester.edu
