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"0008896569190c501", "ProductName": "LFLC", "ProductLongName": "Lambda (λ) Free Light Chains", "Language": "en", "DocumentVersion": "2", "DocumentObjectID": "FF000000049CC60E", "DocumentOriginID": "FF0000000413B10E", "MaterialNumbers": [ "08896569190" ], "InstrumentReferences": [ { "ID": "308", "BrandName": "cobas c 311" }, { "ID": "2324", "BrandName": "cobas c 502" }, { "ID": "309", "BrandName": "cobas c 501" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

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 and monitoring of multiple myeloma in conjunction with other laboratory findings. For in vitro diagnostic use only.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

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.

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Limits and ranges

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 according to CLSI EP17‑A2.

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Limitations - interference

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: High dose hook effect tolerance was measured up to a Lambda FLC concentration of 100000 mg/L.

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. For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other laboratory findings.

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.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

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
Level II: Code 166

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

For cobas c 311/501 analyzers:

LFLC: ACN 629

For cobas c 502 analyzer:

LFLC: ACN 8629

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Reagent handling

Ready for use

Deionized water is needed to dilute high Lambda FLC samples.

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Application for serum

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

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Storage and stability

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.

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: DIH2O
S2: Lambda FLC Calibrator 1
S3: Lambda FLC Calibrator 2
S4: Lambda FLC Calibrator 3
S5: Lambda FLC Calibrator 4
S6: Lambda FLC Calibrator 5

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.

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Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

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Precision

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:

1 lot of reagent on 3 analyzers (n = 240)

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

3 lots of reagents on 1 analyzer (n = 240)

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

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

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.

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

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.

LREFInternational Myeloma Foundation. Understanding Serum Free Light Chain Assay 2011.
,
LREFDrayson M, Tang LX, Drew R, Mead GP, Carr-Smith H, Bradwell AR. Serum free light-chain measurements for identifying and monitoring patients with nonsecretory multiple myeloma. Blood 2001;97(9):2900-2.
,
LREFNelson M, Brown RD, Gibson J, Joshua DE. Measurement of free kappa and lambda chains in serum and the significance of their ratio in patients with multiple myeloma. British Journal of Haematology 1992;81(2):223-30.
,
LREFNakano T, Miyazaki S, Takahashi H, Matsumori A, Maruyama T, Komoda T, Nagata A. Immunochemical quantification of free immunoglobulin light chains from an analytical perspective. Clinical Chemistry Laboratory Medicine 2006;44(5):522-32.
,
LREFBradwell AR, Carr-Cmith HD, Mead GP, Harvey TC, Drayson MT. Serum test for assessment of patients with Bence Jones myeloma. Lancet 2003;361(9356):489-91.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

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 value sheet in mg/L. Calibrator lots are reagent lot specific. The 5 levels of calibrator and DIH2O are to be used for a 6-point calibration.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

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.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

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.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

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.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0008896631190_c503", "ProductName": "LFLC", "ProductLongName": "Lambda (λ) Free Light Chains", "Language": "en", "DocumentVersion": "2", "DocumentObjectID": "FF00000004A3760E", "DocumentOriginID": "FF0000000430F70E", "MaterialNumbers": [ "08896631190" ], "InstrumentReferences": [ { "ID": "8481", "BrandName": "cobas c 503" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

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 and monitoring of multiple myeloma in conjunction with other laboratory findings. For in vitro diagnostic use only.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

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.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

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 according to CLSI EP17‑A2.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

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: High dose hook effect tolerance was measured up to a Lambda FLC concentration of 100000 mg/L.

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. For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other laboratory findings.

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.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

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
Level II: Code 20166

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

LFLC: ACN 21430

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

Deionized water is needed to dilute high Lambda FLC samples.

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum

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

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

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.

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: DIH2O
S2: Lambda FLC Calibrator 1
S3: Lambda FLC Calibrator 2
S4: Lambda FLC Calibrator 3
S5: Lambda FLC Calibrator 4
S6: Lambda FLC Calibrator 5

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.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

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:

1 lot of reagent on 3 analyzers (n = 240)

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

3 lots of reagents on 1 analyzer (n = 240)

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

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

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.

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

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.

LREFInternational Myeloma Foundation. Understanding Serum Free Light Chain Assay 2011.
,
LREFDrayson M, Tang LX, Drew R, Mead GP, Carr-Smith H, Bradwell AR. Serum free light-chain measurements for identifying and monitoring patients with nonsecretory multiple myeloma. Blood 2001;97(9):2900-2.
,
LREFNelson M, Brown RD, Gibson J, Joshua DE. Measurement of free kappa and lambda chains in serum and the significance of their ratio in patients with multiple myeloma. British Journal of Haematology 1992;81(2):223-30.
,
LREFNakano T, Miyazaki S, Takahashi H, Matsumori A, Maruyama T, Komoda T, Nagata A. Immunochemical quantification of free immunoglobulin light chains from an analytical perspective. Clinical Chemistry Laboratory Medicine 2006;44(5):522-32.
,
LREFBradwell AR, Carr-Cmith HD, Mead GP, Harvey TC, Drayson MT. Serum test for assessment of patients with Bence Jones myeloma. Lancet 2003;361(9356):489-91.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

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 value sheet in mg/L. Calibrator lots are reagent lot specific. The 5 levels of calibrator and DIH2O are to be used for a 6-point calibration.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

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.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

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.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

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.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0608896631190c503", "ProductName": "LFLC", "ProductLongName": "Lambda (λ) Free Light Chains", "Language": "en", "DocumentVersion": "2", "DocumentObjectID": "FF00000004C35B0E", "DocumentOriginID": "FF00000004C35B0E", "MaterialNumbers": [ "08896631190" ], "InstrumentReferences": [ { "ID": "8481", "BrandName": "cobas c 503" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

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.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

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.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

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 according to CLSI EP17‑A2.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

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: High dose hook effect tolerance was measured up to a Lambda FLC concentration of 100000 mg/L.

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. For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other laboratory findings.

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 further instructions, refer to the operator’s manual.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

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
Level II: Code 20166

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

LFLC: ACN 21430

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

Deionized water is needed to dilute high Lambda FLC samples.

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum

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

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

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.

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: DIH2O
S2: Lambda FLC Calibrator 1
S3: Lambda FLC Calibrator 2
S4: Lambda FLC Calibrator 3
S5: Lambda FLC Calibrator 4
S6: Lambda FLC Calibrator 5

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.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

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:

1 lot of reagent on 3 analyzers (n = 240)

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

3 lots of reagents on 1 analyzer (n = 240)

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

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

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.

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

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.

LREFInternational Myeloma Foundation. Understanding Serum Free Light Chain Assay 2011.
,
LREFDrayson M, Tang LX, Drew R, Mead GP, Carr-Smith H, Bradwell AR. Serum free light-chain measurements for identifying and monitoring patients with nonsecretory multiple myeloma. Blood 2001;97(9):2900-2.
,
LREFNelson M, Brown RD, Gibson J, Joshua DE. Measurement of free kappa and lambda chains in serum and the significance of their ratio in patients with multiple myeloma. British Journal of Haematology 1992;81(2):223-30.
,
LREFNakano T, Miyazaki S, Takahashi H, Matsumori A, Maruyama T, Komoda T, Nagata A. Immunochemical quantification of free immunoglobulin light chains from an analytical perspective. Clinical Chemistry Laboratory Medicine 2006;44(5):522-32.
,
LREFBradwell AR, Carr-Cmith HD, Mead GP, Harvey TC, Drayson MT. Serum test for assessment of patients with Bence Jones myeloma. Lancet 2003;361(9356):489-91.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

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 value sheet in mg/L. Calibrator lots are reagent lot specific. The 5 levels of calibrator and DIH2O are to be used for a 6-point calibration.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

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.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

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.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

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.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0608896658190c701", "ProductName": "LFLC", "ProductLongName": "Lambda (λ) Free Light Chains", "Language": "en", "DocumentVersion": "3", "DocumentObjectID": "FF00000005F8D10E", "DocumentOriginID": "FF00000004C3CF0E", "MaterialNumbers": [ "08896658190" ], "InstrumentReferences": [ { "ID": "2492", "BrandName": "cobas c 702" }, { "ID": "310", "BrandName": "cobas c 701" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

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 and monitoring of multiple myeloma in conjunction with other laboratory and clinical findings. For in vitro diagnostic use only.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

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.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

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

1.6 mg/L

Limit of Detection

= 2.8 mg/L

Limit of Quantitation

= 3.5 mg/L

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined according to CLSI EP17‑A2.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

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: High dose hook effect tolerance was measured up to a Lambda FLC concentration of 100000 mg/L.

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. For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other laboratory findings.

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.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

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
Level II

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

LFLC: ACN 8629

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

Deionized water is needed to dilute high Lambda FLC samples.

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum

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

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

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.

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: DIH2O
S2: Lambda FLC Calibrator 1
S3: Lambda FLC Calibrator 2
S4: Lambda FLC Calibrator 3
S5: Lambda FLC Calibrator 4
S6: Lambda FLC Calibrator 5

Manually configure calibrators using the codes listed in the \"Order information\" section.

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.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

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:

1 lot of reagent on 3 analyzers (n = 240)

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

3 lots of reagents on 1 analyzer (n = 240)

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

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

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.

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

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.

LREFInternational Myeloma Foundation. Understanding Serum Free Light Chain Assay 2011.
,
LREFDrayson M, Tang LX, Drew R, Mead GP, Carr-Smith H, Bradwell AR. Serum free light-chain measurements for identifying and monitoring patients with nonsecretory multiple myeloma. Blood 2001;97(9):2900-2.
,
LREFNelson M, Brown RD, Gibson J, Joshua DE. Measurement of free kappa and lambda chains in serum and the significance of their ratio in patients with multiple myeloma. British Journal of Haematology 1992;81(2):223-30.
,
LREFNakano T, Miyazaki S, Takahashi H, Matsumori A, Maruyama T, Komoda T, Nagata A. Immunochemical quantification of free immunoglobulin light chains from an analytical perspective. Clinical Chemistry Laboratory Medicine 2006;44(5):522-32.
,
LREFBradwell AR, Carr-Cmith HD, Mead GP, Harvey TC, Drayson MT. Serum test for assessment of patients with Bence Jones myeloma. Lancet 2003;361(9356):489-91.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

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 value sheet in mg/L. Calibrator lots are reagent lot specific. The 5 levels of calibrator and DIH2O are to be used for a 6-point calibration.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

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.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the \"Order information\" section.

Manually configure QC material using non-Roche QC material codes.

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.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

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.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0008896658190c701", "ProductName": "LFLC", "ProductLongName": "Lambda (λ) Free Light Chains", "Language": "en", "DocumentVersion": "2", "DocumentObjectID": "FF000000049CCF0E", "DocumentOriginID": "FF0000000413B80E", "MaterialNumbers": [ "08896658190" ], "InstrumentReferences": [ { "ID": "2492", "BrandName": "cobas c 702" }, { "ID": "310", "BrandName": "cobas c 701" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

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 and monitoring of multiple myeloma in conjunction with other laboratory findings. For in vitro diagnostic use only.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

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.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

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 according to CLSI EP17‑A2.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

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: High dose hook effect tolerance was measured up to a Lambda FLC concentration of 100000 mg/L.

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. For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other laboratory findings.

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.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

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
Level II: Code 166

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

LFLC: ACN 8629

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

Deionized water is needed to dilute high Lambda FLC samples.

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum

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

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

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.

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: DIH2O
S2: Lambda FLC Calibrator 1
S3: Lambda FLC Calibrator 2
S4: Lambda FLC Calibrator 3
S5: Lambda FLC Calibrator 4
S6: Lambda FLC Calibrator 5

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.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

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:

1 lot of reagent on 3 analyzers (n = 240)

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

3 lots of reagents on 1 analyzer (n = 240)

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

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

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.

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

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.

LREFInternational Myeloma Foundation. Understanding Serum Free Light Chain Assay 2011.
,
LREFDrayson M, Tang LX, Drew R, Mead GP, Carr-Smith H, Bradwell AR. Serum free light-chain measurements for identifying and monitoring patients with nonsecretory multiple myeloma. Blood 2001;97(9):2900-2.
,
LREFNelson M, Brown RD, Gibson J, Joshua DE. Measurement of free kappa and lambda chains in serum and the significance of their ratio in patients with multiple myeloma. British Journal of Haematology 1992;81(2):223-30.
,
LREFNakano T, Miyazaki S, Takahashi H, Matsumori A, Maruyama T, Komoda T, Nagata A. Immunochemical quantification of free immunoglobulin light chains from an analytical perspective. Clinical Chemistry Laboratory Medicine 2006;44(5):522-32.
,
LREFBradwell AR, Carr-Cmith HD, Mead GP, Harvey TC, Drayson MT. Serum test for assessment of patients with Bence Jones myeloma. Lancet 2003;361(9356):489-91.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

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 value sheet in mg/L. Calibrator lots are reagent lot specific. The 5 levels of calibrator and DIH2O are to be used for a 6-point calibration.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

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.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

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.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

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.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0608896658190c701", "ProductName": "LFLC", "ProductLongName": "Lambda (λ) Free Light Chains", "Language": "en", "DocumentVersion": "2", "DocumentObjectID": "FF00000004C3CF0E", "DocumentOriginID": "FF00000004BF250E", "MaterialNumbers": [ "08896658190" ], "InstrumentReferences": [ { "ID": "2492", "BrandName": "cobas c 702" }, { "ID": "310", "BrandName": "cobas c 701" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

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.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

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.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

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 according to CLSI EP17‑A2.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

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: High dose hook effect tolerance was measured up to a Lambda FLC concentration of 100000 mg/L.

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. For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other laboratory findings.

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.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

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
Level II: Code 166

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

LFLC: ACN 8629

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

Deionized water is needed to dilute high Lambda FLC samples.

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum

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

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

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.

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: DIH2O
S2: Lambda FLC Calibrator 1
S3: Lambda FLC Calibrator 2
S4: Lambda FLC Calibrator 3
S5: Lambda FLC Calibrator 4
S6: Lambda FLC Calibrator 5

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.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

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:

1 lot of reagent on 3 analyzers (n = 240)

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

3 lots of reagents on 1 analyzer (n = 240)

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

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

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.

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

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.

LREFInternational Myeloma Foundation. Understanding Serum Free Light Chain Assay 2011.
,
LREFDrayson M, Tang LX, Drew R, Mead GP, Carr-Smith H, Bradwell AR. Serum free light-chain measurements for identifying and monitoring patients with nonsecretory multiple myeloma. Blood 2001;97(9):2900-2.
,
LREFNelson M, Brown RD, Gibson J, Joshua DE. Measurement of free kappa and lambda chains in serum and the significance of their ratio in patients with multiple myeloma. British Journal of Haematology 1992;81(2):223-30.
,
LREFNakano T, Miyazaki S, Takahashi H, Matsumori A, Maruyama T, Komoda T, Nagata A. Immunochemical quantification of free immunoglobulin light chains from an analytical perspective. Clinical Chemistry Laboratory Medicine 2006;44(5):522-32.
,
LREFBradwell AR, Carr-Cmith HD, Mead GP, Harvey TC, Drayson MT. Serum test for assessment of patients with Bence Jones myeloma. Lancet 2003;361(9356):489-91.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

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 value sheet in mg/L. Calibrator lots are reagent lot specific. The 5 levels of calibrator and DIH2O are to be used for a 6-point calibration.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

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.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

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.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

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.

", "Language": "en" } ] } } ] }

LFLC

Lambda (λ) Free Light Chains

IVD For in vitro diagnostic use.
LFLC

Overview

Detailed Specifications

Ordering Information

Compatible Instruments

...
    ...

    Technical Documents

    Access Material Data Sheets, Certificates of Analysis, and other product documentation.

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