The Diazyme Human Lambda (λ) Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis
Lambda (λ) Free Light Chains is based on a latex enhanced immunoturbidimetric assay. Lambda FLC in the sample binds to specific anti-Lambda FLC antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of Lambda FLC in the sample. The instrument calculates the Lambda FLC concentration by interpolation of obtained signals of a 6‑point calibration curve prepared from calibrators of known concentrations.
Measuring range
3.5‑200 mg/L (standard mode)
70‑4000 mg/L (extended mode)
Determine samples having higher concentrations than the standard mode via the rerun function. Dilution of samples via the rerun function is a 1:20 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 20.
The linearity of the Lambda (λ) Free Light Chains assay was evaluated according to CLSI EP6-A guideline.
Reference range
The reference interval of Lambda (λ) Free Light Chains was evaluated according to CLSI C28-A3 protocol with serum samples from 120 apparently healthy individuals. The central 95 % reference interval of 4.23‑27.69 mg/L was established.
The ratio of the Kappa (κ) FLC to Lambda (λ) FLC was evaluated. Serum samples from 315 apparently healthy individuals were tested with the Kappa (κ) Free Light Chains assay and Lambda (λ) Free Light Chains assay. The ratio was calculated as Kappa FLC / Lambda FLC. The total range of the ratio was from 0.22 to 1.74, mean ratio was 0.84, and median ratio was 0.81.
Each laboratory, however, is recommended to establish a range of normal values for the population in their region.
Lower limits of measurement
Limit of Blank | = 1.1 mg/L |
Limit of Detection | = 2.3 mg/L |
Limit of Quantitation | = 3.5 mg/L |
The Limit of Blank, Limit of Detection and Limit of Quantitation were determined
There are no known international standards for Lambda FLC, however, this assay is predicated to a legally marketed device.
The Diazyme Human Lambda (λ) Free Light Chain Assay should be used only with validated instruments using Diazyme provided applications.
To determine the level of interferences from the substances normally present in serum, the Lambda (λ) Free Light Chains assay is tested with normal Lambda FLC and abnormal Lambda FLC (high) serum samples spiked with various concentrations of substances following CLSI EP7‑A2 \"Interference Testing in Clinical Chemistry\" Approved guideline‑Second Edition.
The following substances normally present in serum produced less than 10 % deviation when tested at levels equal to the concentrations listed below.
Triglycerides: No significant interference from triglycerides up to a concentration of 1000 mg/dL.
Bilirubin: No significant interference from conjugated and unconjugated bilirubin up to a concentration of 40 mg/dL.
Ascorbic acid: No significant interference from ascorbic acid up to a concentration of 10 mM.
Hemoglobin: No significant interference from hemoglobin up to a concentration of 1000 mg/dL.
Rheumatoid factor: No significant interference from rheumatoid factor up to a concentration of 100 IU/mL.
Due to the inherent nature of Kappa and Lambda FLC monoclonal proteins, some samples may be non-linear at different dilutions. If the results do not match patient’s medical history, clinical examination and other laboratory findings, the sample should be re‑assayed with dilution.
High‑dose hook effect:
All immunoassays have the potential for antigen excess and a small percentage of samples may exhibit prozone behavior due to antigen excess or presence of unknown intrinsic interferents. If the results do not match patient’s medical history, clinical examination, other laboratory findings and if the sample is from a patient that has previously demonstrated antigen excess, the sample should be re‑assayed with dilution.
Altrough verification and validation studies have examined the effect of likely interferents in this assay, there is a potential for interference from unknown substances.
ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. The latest version of the carry‑over evasion list can be found with the NaOHD-SMS-SmpCln1+2-SCCS Method Sheets. For further instructions refer to the operator’s manual. cobas c 502 analyzer: All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is required in certain cases.
Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.
|
| Analyzer(s) on which cobas c pack(s) can be used | |
08896569 190 | Lambda (λ) Free Light Chains (100 tests) | System-ID 07 7625 4 | cobas c 311, cobas c 501/502 |
Calibrator Set included in 08896569 190 | Codes 775-780 | ||
08896577 190 | Kappa ‑ Lambda FLC Control Set | Level I: Code 165 |
For cobas c 311/501 analyzers:
LFLC: ACN 629
For cobas c 502 analyzer:
LFLC: ACN 8629
Ready for use
Deionized water is needed to dilute high Lambda FLC samples.
cobas c 311 test definition | |||
Assay type | 2‑Point End | ||
Reaction time / Assay points | 10 / 28‑57 | ||
Wavelength (sub/main) | -/570 nm | ||
Reaction direction | Increase | ||
Units | mg/L | ||
Reagent pipetting | Diluent (H2O) | ||
R1 | 80 µL | – | |
R3 | 27 µL | – | |
Sample volumes | Sample | Sample dilution | |
Sample | Diluent (H2O) | ||
Normal | 13 µL | – | – |
Decreased | 13 µL | 8 µL | 152 µL |
Increased | 13 µL | – | – |
cobas c 501/502 test definition | |||
Assay type | 2‑Point End | ||
Reaction time / Assay points | 10 / 38‑70 | ||
Wavelength (sub/main) | -/570 nm | ||
Reaction direction | Increase | ||
Units | mg/L | ||
Reagent pipetting | Diluent (H2O) | ||
R1 | 80 µL | – | |
R3 | 27 µL | – | |
Sample volumes | Sample | Sample dilution | |
Sample | Diluent (H2O) | ||
Normal | 13 µL | – | – |
Decreased | 13 µL | 8 µL | 152 µL |
Increased | 13 µL | – | – |
The Lambda (λ) Free Light Chains reagent and calibrators must be stored at 2‑8 °C. Do not freeze.
Shelf life at 2‑8 °C: See expiration date on cobas c pack label.
On‑board stability for the reagent in use and refrigerated on the analyzer is 4 weeks.
The opened calibrators are stable at least for 1 month when stored at 2‑8 °C and capped tightly to minimize exposure to air and evaporation. Unopened calibrators are stable until expiration date printed on the vial.
Do not use the reagents and calibrators after the expiration date labeled on the outer box.
Calibrators | S1: DIH2O | |
Calibration mode | Spline | |
Calibration frequency | Full calibration - after cobas c pack change - as required following quality control procedures |
Traceability: The Lambda (λ) Free Light Chains assay is traceable to an internally assigned master standard.
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
The Lambda (λ) Free Light Chains assay performance was established on a Roche/Hitachi 917 analyzer with a 6‑point calibration using deionized water and separately provided calibrator levels 1‑5. Results obtained from individual laboratories may vary.
The precision of the Lambda (λ) Free Light Chains Assay was determined in accordance with the CLSI EP5-A requirements. In the study, 8 levels of serum specimens containing Lambda FLC spanning Analytical Measuring Range (AMR) and 2 levels of serum based Lambda FLC controls were tested with 2 runs per day with duplicates over 20 working days using multiple lots of reagents on multiple analyzers. The precision data was analyzed according to 3-way nested ANOVA and the results of mean (mg/L) and CV (%) are summarized below:
ID | Mean | Within-run CV | Between-run CV | Between-day CV | Between-instrument CV | Total |
S1 | 11.89 | 6.3 | 4.5 | 6.1 | N/A | 9.9 |
S2 | 48.65 | 2.1 | 0.7 | 1.3 | 0.8 | 2.7 |
S3 | 144.55 | 1.6 | 1.0 | 1.3 | 0.6 | 2.4 |
S4 | 8.31 | 6.5 | 0.4 | 3.1 | 0.8 | 7.3 |
S5 | 22.27 | 3.0 | 1.4 | 2.6 | 1.1 | 4.3 |
S6 | 35.09 | 2.1 | 1.2 | 1.4 | 1.0 | 2.9 |
S7 | 181.13 | 0.8 | 0.7 | 1.3 | 1.1 | 2.0 |
S8 | 3472.59 | 3.6 | N/A | 2.1 | 0.6 | 4.2 |
Control 1 | 27.62 | 3.9 | N/A | 0.9 | 0.1 | 4.0 |
Control 2 | 62.58 | 1.3 | 0.7 | N/A | 2.9 | 3.2 |
ID | Mean | Within-run CV | Between-run CV | Between-day CV | Between lot CV | Total |
S1 | 11.78 | 5.9 | 4.0 | 7.4 | 4.9 | 11.4 |
S2 | 48.95 | 1.3 | N/A | 1.7 | 0.3 | 2.2 |
S3 | 142.63 | 1.1 | 0.8 | 0.5 | 0.8 | 1.6 |
S4 | 8.16 | 6.3 | 2.3 | N/A | 3.1 | 7.4 |
S5 | 21.90 | 2.9 | 1.3 | N/A | 0.6 | 3.2 |
S6 | 34.79 | 2.0 | 0.4 | 0.3 | N/A | 2.1 |
S7 | 183.02 | 0.6 | 0.3 | 0.8 | 0.3 | 1.1 |
S8 | 3442.60 | 3.2 | N/A | 2.0 | N/A | 3.8 |
Control 1 | 28.13 | 4.5 | N/A | 0.2 | 3.8 | 5.9 |
Control 2 | 65.31 | 1.9 | 0.6 | N/A | 1.2 | 2.3 |
The method comparison studies of the Lambda (λ) Free Light Chains assay was evaluated following CLSI EP9‑A2 protocol. A total of 126 serum samples were tested in comparison with a predicate assay. Among the 126 samples, 39 were Multiple Myeloma (MM), 12 were Monoclonal Gammopathy of Undetermined Significance (MGUS), 34 were Abnormal (due to other disease states) and 41 were Normal (no disease). The concordance between the subject and predicate Lambda FLC is 95 %.
Method | Linear regression | Deming regression |
Slope | 1.054 | 1.070 |
95 % CI | 1.021‑1.086 | 1.038‑1.102 |
Intercept | 0.636 | ‑3.160 |
95 % CI | ‑20.746‑22.018 | ‑24.630‑18.310 |
Correlation coefficient | 0.972 | 0.972 |
The sample concentrations were between 6.19 and 3917.80 mg/L.
Normal immunoglobulins are composed of smaller units called heavy chains and light chains. There are 5 types of heavy chains (alpha, delta, epsilon, gamma, and mu), and 2 types of light chains (kappa and lambda). The heavy and light chains are produced separately within plasma cells and are assembled to form a whole (\"intact\") immunoglobulin. When the light chains are attached to the heavy chains they are called bound, and when they are not attached they are called free. Kappa Free Light Chain (FLC) is a 22 kDa protein while Lambda FLC is usually a dimer of 44 kDa as present in the serum. Elevated levels of Kappa or Lambda FLC are associated with plasma cell disorders such as multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus.
R1 | TRIS buffer solution |
R3 | Latex particles coated with polyclonal rabbit anti-Lambda FLC antibodies |
R1 is in position B and R3 is in position C.
Calibrator
Reactive components: Human serum and additives. |
Non-reactive components: Sodium azide (NaN3) < 0.1 %. |
The Lambda (λ) Free Light Chains Calibrator Set is a 5-level set that is supplied in liquid form (5 x 1.5 mL). The calibrator levels are manufactured from human serum. The concentrations of the calibrators are lot specific and Lambda FLC concentrations are stated in the
For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.
Avoid ingestion and contact with skin and eyes. See the Safety Data Sheet (SDS).
Additional safety information concerning storage or handling of this product is provided within the SDS for this product.
Specimens containing human sourced material should be handled as if potentially infectious using safe laboratory procedures, such as those outlined in Biosafety in Microbiological and Biomedical Laboratories (HHS Publication Number [CDC] 93‑8395).
The reagent contains < 0.1 % sodium azide (NaN3) as preservative. Sodium azide may react with lead and copper to form highly explosive metal azide. On disposal, flush with a large volume of water to prevent azide buildup.
Caution: Federal law restricts this device to sale by or on the order of a physician or other practitioner licensed by laws of the State in which he/she practices, to use or order the use of the device.
For quality control, use control materials as listed in the \"Order information\" section.
In addition, other validated control material can be used.
The range of acceptable control limits should be established by individual laboratories. Follow federal, state and local guidelines for testing QC materials.
For specimen collection and preparation only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Serum.
See the limitations and interferences section for details about possible sample interferences.
Stability: | 21 days at 2‑8 °C For longer storage, keep samples at ‑20 °C Repeated freeze/thaw cycles must be avoided to minimize potential protein degradation. Severely turbid samples must not be used. |
The Diazyme Human Lambda (λ) Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis
Lambda (λ) Free Light Chains is based on a latex enhanced immunoturbidimetric assay. Lambda FLC in the sample binds to specific anti-Lambda FLC antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of Lambda FLC in the sample. The instrument calculates the Lambda FLC concentration by interpolation of obtained signals of a 6‑point calibration curve prepared from calibrators of known concentrations.
Measuring range
3.5‑200 mg/L (standard mode)
70‑4000 mg/L (extended mode)
Determine samples having higher concentrations than the standard mode via the rerun function. Dilution of samples via the rerun function is a 1:20 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 20.
The linearity of the Lambda (λ) Free Light Chains assay was evaluated according to CLSI EP6-A guideline.
Reference range
The reference interval of Lambda (λ) Free Light Chains was evaluated according to CLSI C28-A3 protocol with serum samples from 120 apparently healthy individuals. The central 95 % reference interval of 4.23‑27.69 mg/L was established.
The ratio of the Kappa (κ) FLC to Lambda (λ) FLC was evaluated. Serum samples from 315 apparently healthy individuals were tested with the Kappa (κ) Free Light Chains assay and Lambda (λ) Free Light Chains assay. The ratio was calculated as Kappa FLC / Lambda FLC. The total range of the ratio was from 0.22 to 1.74, mean ratio was 0.84, and median ratio was 0.81.
Each laboratory, however, is recommended to establish a range of normal values for the population in their region.
Lower limits of measurement
Limit of Blank | = 1.1 mg/L |
Limit of Detection | = 2.3 mg/L |
Limit of Quantitation | = 3.5 mg/L |
The Limit of Blank, Limit of Detection and Limit of Quantitation were determined
There are no known international standards for Lambda FLC, however, this assay is predicated to a legally marketed device.
The Diazyme Human Lambda (λ) Free Light Chain Assay should be used only with validated instruments using Diazyme provided applications.
To determine the level of interferences from the substances normally present in serum, the Lambda (λ) Free Light Chains assay is tested with normal Lambda FLC and abnormal Lambda FLC (high) serum samples spiked with various concentrations of substances following CLSI EP7‑A2 \"Interference Testing in Clinical Chemistry\" Approved guideline‑Second Edition.
The following substances normally present in serum produced less than 10 % deviation when tested at levels equal to the concentrations listed below.
Triglycerides: No significant interference from triglycerides up to a concentration of 1000 mg/dL.
Bilirubin: No significant interference from conjugated and unconjugated bilirubin up to a concentration of 40 mg/dL.
Ascorbic acid: No significant interference from ascorbic acid up to a concentration of 10 mM.
Hemoglobin: No significant interference from hemoglobin up to a concentration of 1000 mg/dL.
Rheumatoid factor: No significant interference from rheumatoid factor up to a concentration of 100 IU/mL.
Due to the inherent nature of Kappa and Lambda FLC monoclonal proteins, some samples may be non-linear at different dilutions. If the results do not match patient’s medical history, clinical examination and other laboratory findings, the sample should be re‑assayed with dilution.
High‑dose hook effect:
All immunoassays have the potential for antigen excess and a small percentage of samples may exhibit prozone behavior due to antigen excess or presence of unknown intrinsic interferents. If the results do not match patient’s medical history, clinical examination, other laboratory findings and if the sample is from a patient that has previously demonstrated antigen excess, the sample should be re‑assayed with dilution.
Although verification and validation studies have examined the effect of likely interferents in this assay, there is a potential for interference from unknown substances.
ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry-over is available via the cobas link. The latest version of the carry-over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet for information. For further instructions refer to the operator’s manual.
|
| Analyzer(s) on which cobas c pack(s) can be used | |
08896631 190 | Lambda (λ) Free Light Chains (150 tests) | System-ID 2143 001 | cobas c 503 |
Calibrator Set included in 08896631 190 | Codes 20775‑20780 | ||
08896577 190 | Kappa ‑ Lambda FLC Control Set | Level I: Code 20165 |
LFLC: ACN 21430
Ready for use
Deionized water is needed to dilute high Lambda FLC samples.
cobas c 503 test definition | |||
Assay type | 2‑Point End | ||
Reaction time / Assay points | 10 / 21‑34 | ||
Wavelength (sub/main) | -/570 nm | ||
Reaction direction | Increase | ||
Units | mg/L | ||
Reagent pipetting | Diluent (H2O) | ||
R1 | 56 µL | – | |
R3 | 19 µL | – | |
Sample volumes | Sample | Sample dilution | |
Sample | Diluent (H2O) | ||
Normal | 9.1 µL | – | – |
Decreased | 9.1 µL | 4 µL | 76 µL |
Increased | 9.1 µL | – | – |
The Lambda (λ) Free Light Chains reagent and calibrators must be stored at 2‑8 °C. Do not freeze.
Shelf life at 2‑8 °C: See expiration date on cobas c pack label.
On‑board stability for the reagent in use and refrigerated on the analyzer is 4 weeks.
The opened calibrators are stable at least for 1 month when stored at 2‑8 °C and capped tightly to minimize exposure to air and evaporation. Unopened calibrators are stable until expiration date printed on the vial.
Do not use the reagents and calibrators after the expiration date labeled on the outer box.
Calibrators | S1: DIH2O | |
Calibration mode | Spline | |
Calibration frequency | Full calibration - after cobas c pack change - as required following quality control procedures |
Traceability: The Lambda (λ) Free Light Chains assay is traceable to an internally assigned master standard.
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
The Lambda (λ) Free Light Chains assay performance was established on a Roche/Hitachi 917 analyzer with a 6‑point calibration using deionized water and separately provided calibrator levels 1‑5. Results obtained from individual laboratories may vary.
The precision of the Lambda (λ) Free Light Chains Assay was determined in accordance with the CLSI EP5-A requirements. In the study, 8 levels of serum specimens containing Lambda FLC spanning Analytical Measuring Range (AMR) and 2 levels of serum based Lambda FLC controls were tested with 2 runs per day with duplicates over 20 working days using multiple lots of reagents on multiple analyzers. The precision data was analyzed according to 3-way nested ANOVA and the results of mean (mg/L) and CV (%) are summarized below:
ID | Mean | Within-run CV | Between-run CV | Between-day CV | Between-instrument CV | Total |
S1 | 11.89 | 6.3 | 4.5 | 6.1 | N/A | 9.9 |
S2 | 48.65 | 2.1 | 0.7 | 1.3 | 0.8 | 2.7 |
S3 | 144.55 | 1.6 | 1.0 | 1.3 | 0.6 | 2.4 |
S4 | 8.31 | 6.5 | 0.4 | 3.1 | 0.8 | 7.3 |
S5 | 22.27 | 3.0 | 1.4 | 2.6 | 1.1 | 4.3 |
S6 | 35.09 | 2.1 | 1.2 | 1.4 | 1.0 | 2.9 |
S7 | 181.13 | 0.8 | 0.7 | 1.3 | 1.1 | 2.0 |
S8 | 3472.59 | 3.6 | N/A | 2.1 | 0.6 | 4.2 |
Control 1 | 27.62 | 3.9 | N/A | 0.9 | 0.1 | 4.0 |
Control 2 | 62.58 | 1.3 | 0.7 | N/A | 2.9 | 3.2 |
ID | Mean | Within-run CV | Between-run CV | Between-day CV | Between lot CV | Total |
S1 | 11.78 | 5.9 | 4.0 | 7.4 | 4.9 | 11.4 |
S2 | 48.95 | 1.3 | N/A | 1.7 | 0.3 | 2.2 |
S3 | 142.63 | 1.1 | 0.8 | 0.5 | 0.8 | 1.6 |
S4 | 8.16 | 6.3 | 2.3 | N/A | 3.1 | 7.4 |
S5 | 21.90 | 2.9 | 1.3 | N/A | 0.6 | 3.2 |
S6 | 34.79 | 2.0 | 0.4 | 0.3 | N/A | 2.1 |
S7 | 183.02 | 0.6 | 0.3 | 0.8 | 0.3 | 1.1 |
S8 | 3442.60 | 3.2 | N/A | 2.0 | N/A | 3.8 |
Control 1 | 28.13 | 4.5 | N/A | 0.2 | 3.8 | 5.9 |
Control 2 | 65.31 | 1.9 | 0.6 | N/A | 1.2 | 2.3 |
The method comparison studies of the Lambda (λ) Free Light Chains assay was evaluated following CLSI EP9‑A2 protocol. A total of 126 serum samples were tested in comparison with a predicate assay. Among the 126 samples, 39 were Multiple Myeloma (MM), 12 were Monoclonal Gammopathy of Undetermined Significance (MGUS), 34 were Abnormal (due to other disease states) and 41 were Normal (no disease). The concordance between the subject and predicate Lambda FLC is 95 %.
Method | Linear regression | Deming regression |
Slope | 1.054 | 1.070 |
95 % CI | 1.021‑1.086 | 1.038‑1.102 |
Intercept | 0.636 | ‑3.160 |
95 % CI | ‑20.746‑22.018 | ‑24.630‑18.310 |
Correlation coefficient | 0.972 | 0.972 |
The sample concentrations were between 6.19 and 3917.80 mg/L.
Normal immunoglobulins are composed of smaller units called heavy chains and light chains. There are 5 types of heavy chains (alpha, delta, epsilon, gamma, and mu), and 2 types of light chains (kappa and lambda). The heavy and light chains are produced separately within plasma cells and are assembled to form a whole (\"intact\") immunoglobulin. When the light chains are attached to the heavy chains they are called bound, and when they are not attached they are called free. Kappa Free Light Chain (FLC) is a 22 kDa protein while Lambda FLC is usually a dimer of 44 kDa as present in the serum. Elevated levels of Kappa or Lambda FLC are associated with plasma cell disorders such as multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus.
R1 | TRIS buffer solution |
R3 | Latex particles coated with polyclonal rabbit anti-Lambda FLC antibodies |
R1 is in position B and R3 is in position C.
Calibrator
Reactive components: Human serum and additives. |
Non-reactive components: Sodium azide (NaN3) < 0.1 %. |
The Lambda (λ) Free Light Chains Calibrator Set is a 5-level set that is supplied in liquid form (5 x 1.5 mL). The calibrator levels are manufactured from human serum. The concentrations of the calibrators are lot specific and Lambda FLC concentrations are stated in the
For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.
Avoid ingestion and contact with skin and eyes. See the Safety Data Sheet (SDS).
Additional safety information concerning storage or handling of this product is provided within the SDS for this product.
Specimens containing human sourced material should be handled as if potentially infectious using safe laboratory procedures, such as those outlined in Biosafety in Microbiological and Biomedical Laboratories (HHS Publication Number [CDC] 93‑8395).
The reagent contains < 0.1 % sodium azide (NaN3) as preservative. Sodium azide may react with lead and copper to form highly explosive metal azide. On disposal, flush with a large volume of water to prevent azide buildup.
Caution: Federal law restricts this device to sale by or on the order of a physician or other practitioner licensed by laws of the State in which he/she practices, to use or order the use of the device.
For quality control, use control materials as listed in the \"Order information\" section.
In addition, other validated control material can be used.
The range of acceptable control limits should be established by individual laboratories. Follow federal, state and local guidelines for testing QC materials.
For specimen collection and preparation only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Serum.
See the limitations and interferences section for details about possible sample interferences.
Stability: | 21 days at 2‑8 °C For longer storage, keep samples at ‑20 °C Repeated freeze/thaw cycles must be avoided to minimize potential protein degradation. Severely turbid samples must not be used. |
The Diazyme Human Lambda (λ) Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis of multiple myeloma in conjunction with other laboratory findings. For in vitro diagnostic use only.
Lambda (λ) Free Light Chains is based on a latex enhanced immunoturbidimetric assay. Lambda FLC in the sample binds to specific anti-Lambda FLC antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of Lambda FLC in the sample. The instrument calculates the Lambda FLC concentration by interpolation of obtained signals of a 6‑point calibration curve prepared from calibrators of known concentrations.
Measuring range
6.1‑200 mg/L (standard mode)
122‑4000 mg/L (extended mode)
Determine samples having higher concentrations than the standard mode via the rerun function. Dilution of samples via the rerun function is a 1:20 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 20.
The linearity of the Lambda (λ) Free Light Chains assay was evaluated according to CLSI EP6-A guideline.
Reference range
The reference interval of Lambda (λ) Free Light Chains was evaluated according to CLSI C28-A3 protocol with serum samples from 120 apparently healthy individuals. The central 95 % reference interval of 4.23‑27.69 mg/L was established.
The ratio of the Kappa (κ) FLC to Lambda (λ) FLC was evaluated. Serum samples from 315 apparently healthy individuals were tested with the Kappa (κ) Free Light Chains assay and Lambda (λ) Free Light Chains assay. The ratio was calculated as Kappa FLC / Lambda FLC. The total range of the ratio was from 0.22 to 1.74, mean ratio was 0.84, and median ratio was 0.81.
Each laboratory, however, is recommended to establish a range of normal values for the population in their region.
Lower limits of measurement
Limit of Blank | = 1.7 mg/L |
Limit of Detection | = 2.9 mg/L |
Limit of Quantitation | = 6.1 mg/L |
The Limit of Blank, Limit of Detection and Limit of Quantitation were determined
There are no known international standards for Lambda FLC, however, this assay is predicated to a legally marketed device.
The Diazyme Human Lambda (λ) Free Light Chain Assay should be used only with validated instruments using Diazyme provided applications.
To determine the level of interferences from the substances normally present in serum, the Lambda (λ) Free Light Chains assay is tested with normal Lambda FLC and abnormal Lambda FLC (high) serum samples spiked with various concentrations of substances following CLSI EP7‑A2 \"Interference Testing in Clinical Chemistry\" Approved guideline‑Second Edition.
The following substances normally present in serum produced less than 10 % deviation when tested at levels equal to the concentrations listed below.
Triglycerides: No significant interference from triglycerides up to a concentration of 1000 mg/dL.
Bilirubin: No significant interference from conjugated and unconjugated bilirubin up to a concentration of 40 mg/dL.
Ascorbic acid: No significant interference from ascorbic acid up to a concentration of 10 mM.
Hemoglobin: No significant interference from hemoglobin up to a concentration of 1000 mg/dL.
Rheumatoid factor: No significant interference from rheumatoid factor up to a concentration of 100 IU/mL.
Due to the inherent nature of Kappa and Lambda FLC monoclonal proteins, some samples may be non-linear at different dilutions. If the results do not match patient’s medical history, clinical examination and other laboratory findings, the sample should be re‑assayed with dilution.
High‑dose hook effect:
All immunoassays have the potential for antigen excess and a small percentage of samples may exhibit prozone behavior due to antigen excess or presence of unknown intrinsic interferents. If the results do not match patient’s medical history, clinical examination, other laboratory findings and if the sample is from a patient that has previously demonstrated antigen excess, the sample should be re‑assayed with dilution.
Although verification and validation studies have examined the effect of likely interferents in this assay, there is a potential for interference from unknown substances.
ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry-over is available via the cobas link. The latest version of the carry-over evasion list can be found with the NaOHD/SMS/SCCS Method
|
| Analyzer(s) on which cobas c pack(s) can be used | |
08896631190 | Lambda (λ) Free Light Chains (150 tests) | System-ID 2143 001 | cobas c 503 |
Calibrator Set included in 08896631190 | Codes 20775‑20780 | ||
08896577190 | Kappa ‑ Lambda FLC Control Set | Level I: Code 20165 |
LFLC: ACN 21430
Ready for use
Deionized water is needed to dilute high Lambda FLC samples.
cobas c 503 test definition | |||
Assay type | 2‑Point End | ||
Reaction time / Assay points | 10 / 21‑34 | ||
Wavelength (sub/main) | -/570 nm | ||
Reaction direction | Increase | ||
Units | mg/L | ||
Reagent pipetting | Diluent (H2O) | ||
R1 | 56 µL | – | |
R3 | 19 µL | – | |
Sample volumes | Sample | Sample dilution | |
Sample | Diluent (H2O) | ||
Normal | 9.1 µL | – | – |
Decreased | 9.1 µL | 4 µL | 76 µL |
Increased | 9.1 µL | – | – |
The Lambda (λ) Free Light Chains reagent and calibrators must be stored at 2‑8 °C. Do not freeze.
Shelf life at 2‑8 °C: See expiration date on cobas c pack label.
On‑board stability for the reagent in use and refrigerated on the analyzer is 4 weeks.
The opened calibrators are stable at least for 1 month when stored at 2‑8 °C and capped tightly to minimize exposure to air and evaporation. Unopened calibrators are stable until expiration date printed on the vial.
Do not use the reagents and calibrators after the expiration date labeled on the outer box.
Calibrators | S1: DIH2O | |
Calibration mode | Spline | |
Calibration frequency | Full calibration - after cobas c pack change - as required following quality control procedures |
Traceability: The Lambda (λ) Free Light Chains assay is traceable to an internally assigned master standard.
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
The Lambda (λ) Free Light Chains assay performance was established on a Roche/Hitachi 917 analyzer with a 6‑point calibration using deionized water and separately provided calibrator levels 1‑5. Results obtained from individual laboratories may vary.
The precision of the Lambda (λ) Free Light Chains Assay was determined in accordance with the CLSI EP5-A requirements. In the study, 8 levels of serum specimens containing Lambda FLC spanning Analytical Measuring Range (AMR) and 2 levels of serum based Lambda FLC controls were tested with 2 runs per day with duplicates over 20 working days using multiple lots of reagents on multiple analyzers. The precision data was analyzed according to 3-way nested ANOVA and the results of mean (mg/L) and CV (%) are summarized below:
ID | Mean | Within-run CV | Between-run CV | Between-day CV | Between-instrument CV | Total |
S1 | 11.89 | 6.3 | 4.5 | 6.1 | N/A | 9.9 |
S2 | 48.65 | 2.1 | 0.7 | 1.3 | 0.8 | 2.7 |
S3 | 144.55 | 1.6 | 1.0 | 1.3 | 0.6 | 2.4 |
S4 | 8.31 | 6.5 | 0.4 | 3.1 | 0.8 | 7.3 |
S5 | 22.27 | 3.0 | 1.4 | 2.6 | 1.1 | 4.3 |
S6 | 35.09 | 2.1 | 1.2 | 1.4 | 1.0 | 2.9 |
S7 | 181.13 | 0.8 | 0.7 | 1.3 | 1.1 | 2.0 |
S8 | 3472.59 | 3.6 | N/A | 2.1 | 0.6 | 4.2 |
Control 1 | 27.62 | 3.9 | N/A | 0.9 | 0.1 | 4.0 |
Control 2 | 62.58 | 1.3 | 0.7 | N/A | 2.9 | 3.2 |
ID | Mean | Within-run CV | Between-run CV | Between-day CV | Between lot CV | Total |
S1 | 11.78 | 5.9 | 4.0 | 7.4 | 4.9 | 11.4 |
S2 | 48.95 | 1.3 | N/A | 1.7 | 0.3 | 2.2 |
S3 | 142.63 | 1.1 | 0.8 | 0.5 | 0.8 | 1.6 |
S4 | 8.16 | 6.3 | 2.3 | N/A | 3.1 | 7.4 |
S5 | 21.90 | 2.9 | 1.3 | N/A | 0.6 | 3.2 |
S6 | 34.79 | 2.0 | 0.4 | 0.3 | N/A | 2.1 |
S7 | 183.02 | 0.6 | 0.3 | 0.8 | 0.3 | 1.1 |
S8 | 3442.60 | 3.2 | N/A | 2.0 | N/A | 3.8 |
Control 1 | 28.13 | 4.5 | N/A | 0.2 | 3.8 | 5.9 |
Control 2 | 65.31 | 1.9 | 0.6 | N/A | 1.2 | 2.3 |
The method comparison studies of the Lambda (λ) Free Light Chains assay was evaluated following CLSI EP9‑A2 protocol. A total of 126 serum samples were tested in comparison with a predicate assay. Among the 126 samples, 39 were Multiple Myeloma (MM), 12 were Monoclonal Gammopathy of Undetermined Significance (MGUS), 34 were Abnormal (due to other disease states) and 41 were Normal (no disease). The concordance between the subject and predicate Lambda FLC is 95 %.
Method | Linear regression | Deming regression |
Slope | 1.054 | 1.070 |
95 % CI | 1.021‑1.086 | 1.038‑1.102 |
Intercept | 0.636 | ‑3.160 |
95 % CI | ‑20.746‑22.018 | ‑24.630‑18.310 |
Correlation coefficient | 0.972 | 0.972 |
The sample concentrations were between 6.19 and 3917.80 mg/L.
Normal immunoglobulins are composed of smaller units called heavy chains and light chains. There are 5 types of heavy chains (alpha, delta, epsilon, gamma, and mu), and 2 types of light chains (kappa and lambda). The heavy and light chains are produced separately within plasma cells and are assembled to form a whole (\"intact\") immunoglobulin. When the light chains are attached to the heavy chains they are called bound, and when they are not attached they are called free. Kappa Free Light Chain (FLC) is a 22 kDa protein while Lambda FLC is usually a dimer of 44 kDa as present in the serum. Elevated levels of Kappa or Lambda FLC are associated with plasma cell disorders such as multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus.
R1 | TRIS buffer solution |
R3 | Latex particles coated with polyclonal rabbit anti-Lambda FLC antibodies |
R1 is in position B and R3 is in position C.
Calibrator
Reactive components: Human serum and additives. |
Non-reactive components: Sodium azide (NaN3) < 0.1 %. |
The Lambda (λ) Free Light Chains Calibrator Set is a 5-level set that is supplied in liquid form (5 x 1.5 mL). The calibrator levels are manufactured from human serum. The concentrations of the calibrators are lot specific and Lambda FLC concentrations are stated in the
For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.
Avoid ingestion and contact with skin and eyes. See the Safety Data Sheet (SDS).
Additional safety information concerning storage or handling of this product is provided within the SDS for this product.
Specimens containing human sourced material should be handled as if potentially infectious using safe laboratory procedures, such as those outlined in Biosafety in Microbiological and Biomedical Laboratories (HHS Publication Number [CDC] 93‑8395).
The reagent contains < 0.1 % sodium azide (NaN3) as preservative. Sodium azide may react with lead and copper to form highly explosive metal azide. On disposal, flush with a large volume of water to prevent azide buildup.
Caution: Federal law restricts this device to sale by or on the order of a physician or other practitioner licensed by laws of the State in which he/she practices, to use or order the use of the device.
For quality control, use control materials as listed in the \"Order information\" section.
In addition, other validated control material can be used.
The range of acceptable control limits should be established by individual laboratories. Follow federal, state and local guidelines for testing QC materials.
For specimen collection and preparation only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Serum.
See the limitations and interferences section for details about possible sample interferences.
Stability: | 21 days at 2‑8 °C For longer storage, keep samples at ‑20 °C Repeated freeze/thaw cycles must be avoided to minimize potential protein degradation. Severely turbid samples must not be used. |
The Diazyme Human Lambda (λ) Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis
Lambda (λ) Free Light Chains is based on a latex enhanced immunoturbidimetric assay. Lambda FLC in the sample binds to specific anti-Lambda FLC antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of Lambda FLC in the sample. The instrument calculates the Lambda FLC concentration by interpolation of obtained signals of a 6‑point calibration curve prepared from calibrators of known concentrations.
Measuring range
Determine samples having higher concentrations than the standard mode via the rerun function. Dilution of samples via the rerun function is a 1:20 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 20.
The linearity of the Lambda (λ) Free Light Chains assay was evaluated according to CLSI EP6-A guideline.
Reference range
The reference interval of Lambda (λ) Free Light Chains was evaluated according to CLSI C28-A3 protocol with serum samples from 120 apparently healthy individuals. The central 95 % reference interval of 4.23‑27.69 mg/L was established.
The ratio of the Kappa (κ) FLC to Lambda (λ) FLC was evaluated. Serum samples from 315 apparently healthy individuals were tested with the Kappa (κ) Free Light Chains assay and Lambda (λ) Free Light Chains assay. The ratio was calculated as Kappa FLC / Lambda FLC. The total range of the ratio was from 0.22 to 1.74, mean ratio was 0.84, and median ratio was 0.81.
Each laboratory, however, is recommended to establish a range of normal values for the population in their region.
Lower limits of measurement
Limit of Blank | = |
Limit of Detection | = 2.8 mg/L |
Limit of Quantitation | = 3.5 |
The Limit of Blank, Limit of Detection and Limit of Quantitation were determined according to CLSI EP17‑A2.
There are no known international standards for Lambda FLC, however, this assay is predicated to a legally marketed device.
The Diazyme Human Lambda (λ) Free Light Chain Assay should be used only with validated instruments using Diazyme provided applications.
To determine the level of interferences from the substances normally present in serum, the Lambda (λ) Free Light Chains assay is tested with normal Lambda FLC and abnormal Lambda FLC (high) serum samples spiked with various concentrations of substances following CLSI EP7‑A2 \"Interference Testing in Clinical Chemistry\" Approved guideline‑Second Edition.
The following substances normally present in serum produced less than 10 % deviation when tested at levels equal to the concentrations listed below.
Triglycerides: No significant interference from triglycerides up to a concentration of 1000 mg/dL.
Bilirubin: No significant interference from conjugated and unconjugated bilirubin up to a concentration of 40 mg/dL.
Ascorbic acid: No significant interference from ascorbic acid up to a concentration of 10 mM.
Hemoglobin: No significant interference from hemoglobin up to a concentration of 1000 mg/dL.
Rheumatoid factor: No significant interference from rheumatoid factor up to a concentration of 100 IU/mL.
Due to the inherent nature of Kappa and Lambda FLC monoclonal proteins, some samples may be non-linear at different dilutions. If the results do not match patient’s medical history, clinical examination and other laboratory findings, the sample should be re‑assayed with dilution.
High‑dose hook effect:
All immunoassays have the potential for antigen excess and a small percentage of samples may exhibit prozone behavior due to antigen excess or presence of unknown intrinsic interferents. If the results do not match patient’s medical history, clinical examination, other laboratory findings and if the sample is from a patient that has previously demonstrated antigen excess, the sample should be re‑assayed with dilution.
Although verification and validation studies have examined the effect of likely interferents in this assay, there is a potential for interference from unknown substances.
ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is required in certain cases. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SmpCln1+2/SCCS Method Sheet and for further instructions refer to the operator’s manual.
Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.
|
| Analyzer(s) on which cobas c pack(s) can be used | |
08896658190 | Lambda (λ) Free Light Chains (150 tests) | System-ID 03 7625 4 | cobas c 701/702 |
Calibrator Set included in 08896658190 | Codes 775-780 | ||
08896577190 | Kappa ‑ Lambda FLC Control Set |
|
LFLC: ACN 8629
Ready for use
Deionized water is needed to dilute high Lambda FLC samples.
cobas c 701/702 test definition | |||
Assay type | 2‑Point End | ||
Reaction time / Assay points | 10 / 23‑38 | ||
Wavelength (sub/main) | -/570 nm | ||
Reaction direction | Increase | ||
Units | mg/L | ||
Reagent pipetting | Diluent (H2O) | ||
R1 | 80 µL | – | |
R3 | 27 µL | – | |
Sample volumes | Sample | Sample dilution | |
Sample | Diluent (H2O) | ||
Normal | 13 µL | – | – |
Decreased | 13 µL | 8 µL | 152 µL |
Increased | 13 µL | – | – |
The Lambda (λ) Free Light Chains reagent and calibrators must be stored at 2‑8 °C. Do not freeze.
Shelf life at 2‑8 °C: See expiration date on cobas c pack label.
On‑board stability for the reagent in use and refrigerated on the analyzer is 4 weeks.
On‑board stability for the reagent on the Reagent Manager is 24 hours.
The opened calibrators are stable at least for 1 month when stored at 2‑8 °C and capped tightly to minimize exposure to air and evaporation. Unopened calibrators are stable until expiration date printed on the vial.
Do not use the reagents and calibrators after the expiration date labeled on the outer box.
Calibrators | S1: DIH2O | |
Calibration mode | Spline | |
Calibration frequency | Full calibration - after cobas c pack change - as required following quality control procedures |
Traceability: The Lambda (λ) Free Light Chains assay is traceable to an internally assigned master standard.
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
The Lambda (λ) Free Light Chains assay performance was established on a Roche/Hitachi 917 analyzer with a 6‑point calibration using deionized water and separately provided calibrator levels 1‑5. Results obtained from individual laboratories may vary.
The precision of the Lambda (λ) Free Light Chains assay was determined in accordance with the CLSI EP5-A requirements. In the study, 8 levels of serum specimens containing Lambda FLC spanning Analytical Measuring Range (AMR) and 2 levels of serum based Lambda FLC controls were tested with 2 runs per day with duplicates over 20 working days using multiple lots of reagents on multiple analyzers. The precision data was analyzed according to 3-way nested ANOVA and the results of mean (mg/L) and CV (%) are summarized below:
ID | Mean | Within-run CV | Between-run CV | Between-day CV | Between-instrument CV | Total |
S1 | 11.89 | 6.3 | 4.5 | 6.1 | N/A | 9.9 |
S2 | 48.65 | 2.1 | 0.7 | 1.3 | 0.8 | 2.7 |
S3 | 144.55 | 1.6 | 1.0 | 1.3 | 0.6 | 2.4 |
S4 | 8.31 | 6.5 | 0.4 | 3.1 | 0.8 | 7.3 |
S5 | 22.27 | 3.0 | 1.4 | 2.6 | 1.1 | 4.3 |
S6 | 35.09 | 2.1 | 1.2 | 1.4 | 1.0 | 2.9 |
S7 | 181.13 | 0.8 | 0.7 | 1.3 | 1.1 | 2.0 |
S8 | 3472.59 | 3.6 | N/A | 2.1 | 0.6 | 4.2 |
Control 1 | 27.62 | 3.9 | N/A | 0.9 | 0.1 | 4.0 |
Control 2 | 62.58 | 1.3 | 0.7 | N/A | 2.9 | 3.2 |
ID | Mean | Within-run CV | Between-run CV | Between-day CV | Between lot CV | Total |
S1 | 11.78 | 5.9 | 4.0 | 7.4 | 4.9 | 11.4 |
S2 | 48.95 | 1.3 | N/A | 1.7 | 0.3 | 2.2 |
S3 | 142.63 | 1.1 | 0.8 | 0.5 | 0.8 | 1.6 |
S4 | 8.16 | 6.3 | 2.3 | N/A | 3.1 | 7.4 |
S5 | 21.90 | 2.9 | 1.3 | N/A | 0.6 | 3.2 |
S6 | 34.79 | 2.0 | 0.4 | 0.3 | N/A | 2.1 |
S7 | 183.02 | 0.6 | 0.3 | 0.8 | 0.3 | 1.1 |
S8 | 3442.60 | 3.2 | N/A | 2.0 | N/A | 3.8 |
Control 1 | 28.13 | 4.5 | N/A | 0.2 | 3.8 | 5.9 |
Control 2 | 65.31 | 1.9 | 0.6 | N/A | 1.2 | 2.3 |
The method comparison studies of the Lambda (λ) Free Light Chains assay was evaluated following CLSI EP9‑A2 protocol. A total of 126 serum samples were tested in comparison with a predicate assay. Among the 126 samples, 39 were Multiple Myeloma (MM), 12 were Monoclonal Gammopathy of Undetermined Significance (MGUS), 34 were Abnormal (due to other disease states) and 41 were Normal (no disease). The concordance between the subject and predicate Lambda FLC is 95 %.
Method | Linear regression | Deming regression |
Slope | 1.054 | 1.070 |
95 % CI | 1.021‑1.086 | 1.038‑1.102 |
Intercept | 0.636 | ‑3.160 |
95 % CI | ‑20.746‑22.018 | ‑24.630‑18.310 |
Correlation coefficient | 0.972 | 0.972 |
The sample concentrations were between 6.19 and 3917.80 mg/L.
Normal immunoglobulins are composed of smaller units called heavy chains and light chains. There are 5 types of heavy chains (alpha, delta, epsilon, gamma, and mu), and 2 types of light chains (kappa and lambda). The heavy and light chains are produced separately within plasma cells and are assembled to form a whole (\"intact\") immunoglobulin. When the light chains are attached to the heavy chains they are called bound, and when they are not attached they are called free. Kappa Free Light Chain (FLC) is a 22 kDa protein while Lambda FLC is usually a dimer of 44 kDa as present in the serum. Elevated levels of Kappa or Lambda FLC are associated with plasma cell disorders such as multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus.
R1 | TRIS buffer solution |
R3 | Latex particles coated with polyclonal rabbit anti-Lambda FLC antibodies |
R1 is in position B and R3 is in position C.
Calibrator
Reactive components: Human serum and additives. |
Non-reactive components: Sodium azide (NaN3) < 0.1 %. |
The Lambda (λ) Free Light Chains Calibrator Set is a 5-level set that is supplied in liquid form (5 x 1.5 mL). The calibrator levels are manufactured from human serum. The concentrations of the calibrators are lot specific and Lambda FLC concentrations are stated in the
For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.
Avoid ingestion and contact with skin and eyes. See the Safety Data Sheet (SDS).
Additional safety information concerning storage or handling of this product is provided within the SDS for this product.
Specimens containing human sourced material should be handled as if potentially infectious using safe laboratory procedures, such as those outlined in Biosafety in Microbiological and Biomedical Laboratories (HHS Publication Number [CDC] 93‑8395).
The reagent contains < 0.1 % sodium azide (NaN3) as preservative. Sodium azide may react with lead and copper to form highly explosive metal azide. On disposal, flush with a large volume of water to prevent azide buildup.
Caution: Federal law restricts this device to sale by or on the order of a physician or other practitioner licensed by laws of the State in which he/she practices, to use or order the use of the device.
For quality control, use control materials as listed in the \"Order information\" section.
In addition, other validated control material can be used.
The range of acceptable control limits should be established by individual laboratories. Follow federal, state and local guidelines for testing QC materials.
For specimen collection and preparation only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Serum.
See the limitations and interferences section for details about possible sample interferences.
Stability: | 21 days at 2‑8 °C For longer storage, keep samples at ‑20 °C. Repeated freeze/thaw cycles must be avoided to minimize potential protein degradation. Severely turbid samples must not be used. |
The Diazyme Human Lambda (λ) Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis
Lambda (λ) Free Light Chains is based on a latex enhanced immunoturbidimetric assay. Lambda FLC in the sample binds to specific anti-Lambda FLC antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of Lambda FLC in the sample. The instrument calculates the Lambda FLC concentration by interpolation of obtained signals of a 6‑point calibration curve prepared from calibrators of known concentrations.
Measuring range
3.5‑200 mg/L (standard mode)
70‑4000 mg/L (extended mode)
Determine samples having higher concentrations than the standard mode via the rerun function. Dilution of samples via the rerun function is a 1:20 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 20.
The linearity of the Lambda (λ) Free Light Chains assay was evaluated according to CLSI EP6-A guideline.
Reference range
The reference interval of Lambda (λ) Free Light Chains was evaluated according to CLSI C28-A3 protocol with serum samples from 120 apparently healthy individuals. The central 95 % reference interval of 4.23‑27.69 mg/L was established.
The ratio of the Kappa (κ) FLC to Lambda (λ) FLC was evaluated. Serum samples from 315 apparently healthy individuals were tested with the Kappa (κ) Free Light Chains assay and Lambda (λ) Free Light Chains assay. The ratio was calculated as Kappa FLC / Lambda FLC. The total range of the ratio was from 0.22 to 1.74, mean ratio was 0.84, and median ratio was 0.81.
Each laboratory, however, is recommended to establish a range of normal values for the population in their region.
Lower limits of measurement
Limit of Blank | = 1.1 mg/L |
Limit of Detection | = 2.3 mg/L |
Limit of Quantitation | = 3.5 mg/L |
The Limit of Blank, Limit of Detection and Limit of Quantitation were determined
There are no known international standards for Lambda FLC, however, this assay is predicated to a legally marketed device.
The Diazyme Human Lambda (λ) Free Light Chain Assay should be used only with validated instruments using Diazyme provided applications.
To determine the level of interferences from the substances normally present in serum, the Lambda (λ) Free Light Chains assay is tested with normal Lambda FLC and abnormal Lambda FLC (high) serum samples spiked with various concentrations of substances following CLSI EP7‑A2 \"Interference Testing in Clinical Chemistry\" Approved guideline‑Second Edition.
The following substances normally present in serum produced less than 10 % deviation when tested at levels equal to the concentrations listed below.
Triglycerides: No significant interference from triglycerides up to a concentration of 1000 mg/dL.
Bilirubin: No significant interference from conjugated and unconjugated bilirubin up to a concentration of 40 mg/dL.
Ascorbic acid: No significant interference from ascorbic acid up to a concentration of 10 mM.
Hemoglobin: No significant interference from hemoglobin up to a concentration of 1000 mg/dL.
Rheumatoid factor: No significant interference from rheumatoid factor up to a concentration of 100 IU/mL.
Due to the inherent nature of Kappa and Lambda FLC monoclonal proteins, some samples may be non-linear at different dilutions. If the results do not match patient’s medical history, clinical examination and other laboratory findings, the sample should be re‑assayed with dilution.
High‑dose hook effect:
All immunoassays have the potential for antigen excess and a small percentage of samples may exhibit prozone behavior due to antigen excess or presence of unknown intrinsic interferents. If the results do not match patient’s medical history, clinical examination, other laboratory findings and if the sample is from a patient that has previously demonstrated antigen excess, the sample should be re‑assayed with dilution.
Altrough verification and validation studies have examined the effect of likely interferents in this assay, there is a potential for interference from unknown substances.
ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is required in certain cases. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SmpCln1+2/SCCS Method Sheet and for further instructions refer to the operator’s manual.
Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.
|
| Analyzer(s) on which cobas c pack(s) can be used | |
08896658 190 | Lambda (λ) Free Light Chains (150 tests) | System-ID 03 7625 4 | cobas c 701/702 |
Calibrator Set included in 08896658 190 | Codes 775-780 | ||
08896577 190 | Kappa ‑ Lambda FLC Control Set | Level I: Code 165 |
LFLC: ACN 8629
Ready for use
Deionized water is needed to dilute high Lambda FLC samples.
cobas c 701/702 test definition | |||
Assay type | 2‑Point End | ||
Reaction time / Assay points | 10 / 23‑38 | ||
Wavelength (sub/main) | -/570 nm | ||
Reaction direction | Increase | ||
Units | mg/L | ||
Reagent pipetting | Diluent (H2O) | ||
R1 | 80 µL | – | |
R3 | 27 µL | – | |
Sample volumes | Sample | Sample dilution | |
Sample | Diluent (H2O) | ||
Normal | 13 µL | – | – |
Decreased | 13 µL | 8 µL | 152 µL |
Increased | 13 µL | – | – |
The Lambda (λ) Free Light Chains reagent and calibrators must be stored at 2‑8 °C. Do not freeze.
Shelf life at 2‑8 °C: See expiration date on cobas c pack label.
On‑board stability for the reagent in use and refrigerated on the analyzer is 4 weeks.
On‑board stability for the reagent on the Reagent Manager is 24 hours.
The opened calibrators are stable at least for 1 month when stored at 2‑8 °C and capped tightly to minimize exposure to air and evaporation. Unopened calibrators are stable until expiration date printed on the vial.
Do not use the reagents and calibrators after the expiration date labeled on the outer box.
Calibrators | S1: DIH2O | |
Calibration mode | Spline | |
Calibration frequency | Full calibration - after cobas c pack change - as required following quality control procedures |
Traceability: The Lambda (λ) Free Light Chains assay is traceable to an internally assigned master standard.
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
The Lambda (λ) Free Light Chains assay performance was established on a Roche/Hitachi 917 analyzer with a 6‑point calibration using deionized water and separately provided calibrator levels 1‑5. Results obtained from individual laboratories may vary.
The precision of the Lambda (λ) Free Light Chains assay was determined in accordance with the CLSI EP5-A requirements. In the study, 8 levels of serum specimens containing Lambda FLC spanning Analytical Measuring Range (AMR) and 2 levels of serum based Lambda FLC controls were tested with 2 runs per day with duplicates over 20 working days using multiple lots of reagents on multiple analyzers. The precision data was analyzed according to 3-way nested ANOVA and the results of mean (mg/L) and CV (%) are summarized below:
ID | Mean | Within-run CV | Between-run CV | Between-day CV | Between-instrument CV | Total |
S1 | 11.89 | 6.3 | 4.5 | 6.1 | N/A | 9.9 |
S2 | 48.65 | 2.1 | 0.7 | 1.3 | 0.8 | 2.7 |
S3 | 144.55 | 1.6 | 1.0 | 1.3 | 0.6 | 2.4 |
S4 | 8.31 | 6.5 | 0.4 | 3.1 | 0.8 | 7.3 |
S5 | 22.27 | 3.0 | 1.4 | 2.6 | 1.1 | 4.3 |
S6 | 35.09 | 2.1 | 1.2 | 1.4 | 1.0 | 2.9 |
S7 | 181.13 | 0.8 | 0.7 | 1.3 | 1.1 | 2.0 |
S8 | 3472.59 | 3.6 | N/A | 2.1 | 0.6 | 4.2 |
Control 1 | 27.62 | 3.9 | N/A | 0.9 | 0.1 | 4.0 |
Control 2 | 62.58 | 1.3 | 0.7 | N/A | 2.9 | 3.2 |
ID | Mean | Within-run CV | Between-run CV | Between-day CV | Between lot CV | Total |
S1 | 11.78 | 5.9 | 4.0 | 7.4 | 4.9 | 11.4 |
S2 | 48.95 | 1.3 | N/A | 1.7 | 0.3 | 2.2 |
S3 | 142.63 | 1.1 | 0.8 | 0.5 | 0.8 | 1.6 |
S4 | 8.16 | 6.3 | 2.3 | N/A | 3.1 | 7.4 |
S5 | 21.90 | 2.9 | 1.3 | N/A | 0.6 | 3.2 |
S6 | 34.79 | 2.0 | 0.4 | 0.3 | N/A | 2.1 |
S7 | 183.02 | 0.6 | 0.3 | 0.8 | 0.3 | 1.1 |
S8 | 3442.60 | 3.2 | N/A | 2.0 | N/A | 3.8 |
Control 1 | 28.13 | 4.5 | N/A | 0.2 | 3.8 | 5.9 |
Control 2 | 65.31 | 1.9 | 0.6 | N/A | 1.2 | 2.3 |
The method comparison studies of the Lambda (λ) Free Light Chains assay was evaluated following CLSI EP9‑A2 protocol. A total of 126 serum samples were tested in comparison with a predicate assay. Among the 126 samples, 39 were Multiple Myeloma (MM), 12 were Monoclonal Gammopathy of Undetermined Significance (MGUS), 34 were Abnormal (due to other disease states) and 41 were Normal (no disease). The concordance between the subject and predicate Lambda FLC is 95 %.
Method | Linear regression | Deming regression |
Slope | 1.054 | 1.070 |
95 % CI | 1.021‑1.086 | 1.038‑1.102 |
Intercept | 0.636 | ‑3.160 |
95 % CI | ‑20.746‑22.018 | ‑24.630‑18.310 |
Correlation coefficient | 0.972 | 0.972 |
The sample concentrations were between 6.19 and 3917.80 mg/L.
Normal immunoglobulins are composed of smaller units called heavy chains and light chains. There are 5 types of heavy chains (alpha, delta, epsilon, gamma, and mu), and 2 types of light chains (kappa and lambda). The heavy and light chains are produced separately within plasma cells and are assembled to form a whole (\"intact\") immunoglobulin. When the light chains are attached to the heavy chains they are called bound, and when they are not attached they are called free. Kappa Free Light Chain (FLC) is a 22 kDa protein while Lambda FLC is usually a dimer of 44 kDa as present in the serum. Elevated levels of Kappa or Lambda FLC are associated with plasma cell disorders such as multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus.
R1 | TRIS buffer solution |
R3 | Latex particles coated with polyclonal rabbit anti-Lambda FLC antibodies |
R1 is in position B and R3 is in position C.
Calibrator
Reactive components: Human serum and additives. |
Non-reactive components: Sodium azide (NaN3) < 0.1 %. |
The Lambda (λ) Free Light Chains Calibrator Set is a 5-level set that is supplied in liquid form (5 x 1.5 mL). The calibrator levels are manufactured from human serum. The concentrations of the calibrators are lot specific and Lambda FLC concentrations are stated in the
For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.
Avoid ingestion and contact with skin and eyes. See the Safety Data Sheet (SDS).
Additional safety information concerning storage or handling of this product is provided within the SDS for this product.
Specimens containing human sourced material should be handled as if potentially infectious using safe laboratory procedures, such as those outlined in Biosafety in Microbiological and Biomedical Laboratories (HHS Publication Number [CDC] 93‑8395).
The reagent contains < 0.1 % sodium azide (NaN3) as preservative. Sodium azide may react with lead and copper to form highly explosive metal azide. On disposal, flush with a large volume of water to prevent azide buildup.
Caution: Federal law restricts this device to sale by or on the order of a physician or other practitioner licensed by laws of the State in which he/she practices, to use or order the use of the device.
For quality control, use control materials as listed in the \"Order information\" section.
In addition, other validated control material can be used.
The range of acceptable control limits should be established by individual laboratories. Follow federal, state and local guidelines for testing QC materials.
For specimen collection and preparation only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Serum.
See the limitations and interferences section for details about possible sample interferences.
Stability: | 21 days at 2‑8 °C For longer storage, keep samples at ‑20 °C. Repeated freeze/thaw cycles must be avoided to minimize potential protein degradation. Severely turbid samples must not be used. |
The Diazyme Human Lambda (λ) Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis of multiple myeloma in conjunction with other laboratory findings. For in vitro diagnostic use only.
Lambda (λ) Free Light Chains is based on a latex enhanced immunoturbidimetric assay. Lambda FLC in the sample binds to specific anti-Lambda FLC antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of Lambda FLC in the sample. The instrument calculates the Lambda FLC concentration by interpolation of obtained signals of a 6‑point calibration curve prepared from calibrators of known concentrations.
Measuring range
6.1‑200 mg/L (standard mode)
122‑4000 mg/L (extended mode)
Determine samples having higher concentrations than the standard mode via the rerun function. Dilution of samples via the rerun function is a 1:20 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 20.
The linearity of the Lambda (λ) Free Light Chains assay was evaluated according to CLSI EP6-A guideline.
Reference range
The reference interval of Lambda (λ) Free Light Chains was evaluated according to CLSI C28-A3 protocol with serum samples from 120 apparently healthy individuals. The central 95 % reference interval of 4.23‑27.69 mg/L was established.
The ratio of the Kappa (κ) FLC to Lambda (λ) FLC was evaluated. Serum samples from 315 apparently healthy individuals were tested with the Kappa (κ) Free Light Chains assay and Lambda (λ) Free Light Chains assay. The ratio was calculated as Kappa FLC / Lambda FLC. The total range of the ratio was from 0.22 to 1.74, mean ratio was 0.84, and median ratio was 0.81.
Each laboratory, however, is recommended to establish a range of normal values for the population in their region.
Lower limits of measurement
Limit of Blank | = 1.7 mg/L |
Limit of Detection | = 2.9 mg/L |
Limit of Quantitation | = 6.1 mg/L |
The Limit of Blank, Limit of Detection and Limit of Quantitation were determined
There are no known international standards for Lambda FLC, however, this assay is predicated to a legally marketed device.
The Diazyme Human Lambda (λ) Free Light Chain Assay should be used only with validated instruments using Diazyme provided applications.
To determine the level of interferences from the substances normally present in serum, the Lambda (λ) Free Light Chains assay is tested with normal Lambda FLC and abnormal Lambda FLC (high) serum samples spiked with various concentrations of substances following CLSI EP7‑A2 \"Interference Testing in Clinical Chemistry\" Approved guideline‑Second Edition.
The following substances normally present in serum produced less than 10 % deviation when tested at levels equal to the concentrations listed below.
Triglycerides: No significant interference from triglycerides up to a concentration of 1000 mg/dL.
Bilirubin: No significant interference from conjugated and unconjugated bilirubin up to a concentration of 40 mg/dL.
Ascorbic acid: No significant interference from ascorbic acid up to a concentration of 10 mM.
Hemoglobin: No significant interference from hemoglobin up to a concentration of 1000 mg/dL.
Rheumatoid factor: No significant interference from rheumatoid factor up to a concentration of 100 IU/mL.
Due to the inherent nature of Kappa and Lambda FLC monoclonal proteins, some samples may be non-linear at different dilutions. If the results do not match patient’s medical history, clinical examination and other laboratory findings, the sample should be re‑assayed with dilution.
High‑dose hook effect:
All immunoassays have the potential for antigen excess and a small percentage of samples may exhibit prozone behavior due to antigen excess or presence of unknown intrinsic interferents. If the results do not match patient’s medical history, clinical examination, other laboratory findings and if the sample is from a patient that has previously demonstrated antigen excess, the sample should be re‑assayed with dilution.
Although verification and validation studies have examined the effect of likely interferents in this assay, there is a potential for interference from unknown substances.
ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is required in certain cases. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SmpCln1+2/SCCS Method Sheet and for further instructions refer to the operator’s manual.
Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.
|
| Analyzer(s) on which cobas c pack(s) can be used | |
08896658190 | Lambda (λ) Free Light Chains (150 tests) | System-ID 03 7625 4 | cobas c 701/702 |
Calibrator Set included in 08896658190 | Codes 775-780 | ||
08896577190 | Kappa ‑ Lambda FLC Control Set | Level I: Code 165 |
LFLC: ACN 8629
Ready for use
Deionized water is needed to dilute high Lambda FLC samples.
cobas c 701/702 test definition | |||
Assay type | 2‑Point End | ||
Reaction time / Assay points | 10 / 23‑38 | ||
Wavelength (sub/main) | -/570 nm | ||
Reaction direction | Increase | ||
Units | mg/L | ||
Reagent pipetting | Diluent (H2O) | ||
R1 | 80 µL | – | |
R3 | 27 µL | – | |
Sample volumes | Sample | Sample dilution | |
Sample | Diluent (H2O) | ||
Normal | 13 µL | – | – |
Decreased | 13 µL | 8 µL | 152 µL |
Increased | 13 µL | – | – |
The Lambda (λ) Free Light Chains reagent and calibrators must be stored at 2‑8 °C. Do not freeze.
Shelf life at 2‑8 °C: See expiration date on cobas c pack label.
On‑board stability for the reagent in use and refrigerated on the analyzer is 4 weeks.
On‑board stability for the reagent on the Reagent Manager is 24 hours.
The opened calibrators are stable at least for 1 month when stored at 2‑8 °C and capped tightly to minimize exposure to air and evaporation. Unopened calibrators are stable until expiration date printed on the vial.
Do not use the reagents and calibrators after the expiration date labeled on the outer box.
Calibrators | S1: DIH2O | |
Calibration mode | Spline | |
Calibration frequency | Full calibration - after cobas c pack change - as required following quality control procedures |
Traceability: The Lambda (λ) Free Light Chains assay is traceable to an internally assigned master standard.
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
The Lambda (λ) Free Light Chains assay performance was established on a Roche/Hitachi 917 analyzer with a 6‑point calibration using deionized water and separately provided calibrator levels 1‑5. Results obtained from individual laboratories may vary.
The precision of the Lambda (λ) Free Light Chains assay was determined in accordance with the CLSI EP5-A requirements. In the study, 8 levels of serum specimens containing Lambda FLC spanning Analytical Measuring Range (AMR) and 2 levels of serum based Lambda FLC controls were tested with 2 runs per day with duplicates over 20 working days using multiple lots of reagents on multiple analyzers. The precision data was analyzed according to 3-way nested ANOVA and the results of mean (mg/L) and CV (%) are summarized below:
ID | Mean | Within-run CV | Between-run CV | Between-day CV | Between-instrument CV | Total |
S1 | 11.89 | 6.3 | 4.5 | 6.1 | N/A | 9.9 |
S2 | 48.65 | 2.1 | 0.7 | 1.3 | 0.8 | 2.7 |
S3 | 144.55 | 1.6 | 1.0 | 1.3 | 0.6 | 2.4 |
S4 | 8.31 | 6.5 | 0.4 | 3.1 | 0.8 | 7.3 |
S5 | 22.27 | 3.0 | 1.4 | 2.6 | 1.1 | 4.3 |
S6 | 35.09 | 2.1 | 1.2 | 1.4 | 1.0 | 2.9 |
S7 | 181.13 | 0.8 | 0.7 | 1.3 | 1.1 | 2.0 |
S8 | 3472.59 | 3.6 | N/A | 2.1 | 0.6 | 4.2 |
Control 1 | 27.62 | 3.9 | N/A | 0.9 | 0.1 | 4.0 |
Control 2 | 62.58 | 1.3 | 0.7 | N/A | 2.9 | 3.2 |
ID | Mean | Within-run CV | Between-run CV | Between-day CV | Between lot CV | Total |
S1 | 11.78 | 5.9 | 4.0 | 7.4 | 4.9 | 11.4 |
S2 | 48.95 | 1.3 | N/A | 1.7 | 0.3 | 2.2 |
S3 | 142.63 | 1.1 | 0.8 | 0.5 | 0.8 | 1.6 |
S4 | 8.16 | 6.3 | 2.3 | N/A | 3.1 | 7.4 |
S5 | 21.90 | 2.9 | 1.3 | N/A | 0.6 | 3.2 |
S6 | 34.79 | 2.0 | 0.4 | 0.3 | N/A | 2.1 |
S7 | 183.02 | 0.6 | 0.3 | 0.8 | 0.3 | 1.1 |
S8 | 3442.60 | 3.2 | N/A | 2.0 | N/A | 3.8 |
Control 1 | 28.13 | 4.5 | N/A | 0.2 | 3.8 | 5.9 |
Control 2 | 65.31 | 1.9 | 0.6 | N/A | 1.2 | 2.3 |
The method comparison studies of the Lambda (λ) Free Light Chains assay was evaluated following CLSI EP9‑A2 protocol. A total of 126 serum samples were tested in comparison with a predicate assay. Among the 126 samples, 39 were Multiple Myeloma (MM), 12 were Monoclonal Gammopathy of Undetermined Significance (MGUS), 34 were Abnormal (due to other disease states) and 41 were Normal (no disease). The concordance between the subject and predicate Lambda FLC is 95 %.
Method | Linear regression | Deming regression |
Slope | 1.054 | 1.070 |
95 % CI | 1.021‑1.086 | 1.038‑1.102 |
Intercept | 0.636 | ‑3.160 |
95 % CI | ‑20.746‑22.018 | ‑24.630‑18.310 |
Correlation coefficient | 0.972 | 0.972 |
The sample concentrations were between 6.19 and 3917.80 mg/L.
Normal immunoglobulins are composed of smaller units called heavy chains and light chains. There are 5 types of heavy chains (alpha, delta, epsilon, gamma, and mu), and 2 types of light chains (kappa and lambda). The heavy and light chains are produced separately within plasma cells and are assembled to form a whole (\"intact\") immunoglobulin. When the light chains are attached to the heavy chains they are called bound, and when they are not attached they are called free. Kappa Free Light Chain (FLC) is a 22 kDa protein while Lambda FLC is usually a dimer of 44 kDa as present in the serum. Elevated levels of Kappa or Lambda FLC are associated with plasma cell disorders such as multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus.
R1 | TRIS buffer solution |
R3 | Latex particles coated with polyclonal rabbit anti-Lambda FLC antibodies |
R1 is in position B and R3 is in position C.
Calibrator
Reactive components: Human serum and additives. |
Non-reactive components: Sodium azide (NaN3) < 0.1 %. |
The Lambda (λ) Free Light Chains Calibrator Set is a 5-level set that is supplied in liquid form (5 x 1.5 mL). The calibrator levels are manufactured from human serum. The concentrations of the calibrators are lot specific and Lambda FLC concentrations are stated in the
For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.
Avoid ingestion and contact with skin and eyes. See the Safety Data Sheet (SDS).
Additional safety information concerning storage or handling of this product is provided within the SDS for this product.
Specimens containing human sourced material should be handled as if potentially infectious using safe laboratory procedures, such as those outlined in Biosafety in Microbiological and Biomedical Laboratories (HHS Publication Number [CDC] 93‑8395).
The reagent contains < 0.1 % sodium azide (NaN3) as preservative. Sodium azide may react with lead and copper to form highly explosive metal azide. On disposal, flush with a large volume of water to prevent azide buildup.
Caution: Federal law restricts this device to sale by or on the order of a physician or other practitioner licensed by laws of the State in which he/she practices, to use or order the use of the device.
For quality control, use control materials as listed in the \"Order information\" section.
In addition, other validated control material can be used.
The range of acceptable control limits should be established by individual laboratories. Follow federal, state and local guidelines for testing QC materials.
For specimen collection and preparation only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Serum.
See the limitations and interferences section for details about possible sample interferences.
Stability: | 21 days at 2‑8 °C For longer storage, keep samples at ‑20 °C. Repeated freeze/thaw cycles must be avoided to minimize potential protein degradation. Severely turbid samples must not be used. |
Lambda (λ) Free Light Chains
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