In vitro test for the quantitative determination of small dense LDL cholesterol in human serum and plasma.
The small dense LDL Seiken test is used in conjunction with other lipid measurements and clinical evaluations to aid in the risk management of lipoprotein disorders associated with cardiovascular disease.
The SDLDL test system is a multi‑step method. sdLDL‑C is measured on automated chemistry analyzers. The assay consists of two steps and is based on the technique of using well‑characterized surfactants and enzymes that selectively react with certain groups of lipoproteins.
In the first step, non-sdLDL lipoproteins, that is, chylomicrons, VLDL, IDL, Large LDL and HDL are decomposed by a surfactant and sphingomyelinase in reagent R1 that is reactive to those non‑sdLDL lipoproteins. The cholesterol released from such non‑sdLDL lipoproteins is then degraded to water and oxygen by the action of enzymes. Cholesterol ester is hydrolyzed by the cholesterol esterase (CHE) and then oxidized by the cholesterol oxidase (CO). Produced hydrogen peroxides are finally decomposed to water and oxygen by the catalase.
In the second step, another surfactant in reagent R3 releases cholesterol only from sdLDL particles and cholesterol released from sdLDL is then subject to the enzymatic reactions. As catalase in the reaction mixture is inhibited by sodium azide in reagent R3, hydrogen peroxides, produced from the reaction with the cholesterol esterase and cholesterol oxidase, then develop a purple‑red color with the coupler in the presence of peroxidase (POD).
Step 1: Chylomicrons‑C, VLDL‑C, IDL‑C, L LDL‑C and HDL‑C | CHE & CO | |
Cholestenone + fatty acid + H2O2 |
2 H2O2 | Catalase | 2 H2O + O2 |
Step 2: sdLDL-C | CHE & CO | Cholestenone + fatty acid + H2O2 |
2 H2O2 + 4-aminoantipyrine + TOOS FREFN-Ethyl-N-(2-hydroxy-3-sulfopropyl)-3-methylaniline | POD | purple-red color + 4 H2O |
0.103‑2.587 mmol/L (4.0‑100 mg/dL)
Limit of Blank | = 0.008 mmol/L (0.3 mg/dL) |
Limit of Detection | = 0.016 mmol/L (0.6 mg/dL) |
Limit of Quantitation | = 0.041 mmol/L (1.6 mg/dL) |
These data were generated on cobas c 501 at Denka, based on the Clinical and Laboratory Standards Institute (CLSI) Protocol EP17‑A2. LoQ was lower than the lower measurement limit of the s LDL-EX “SEIKEN” kit (0.103 mmol/L (4.0 mg/dL)). The precision goal for the Limit of Quantitation was a CV % of less than 10 %.
The data shown below has been obtained by the assay using s LDL-EX “SEIKEN”. All studies (analytical and clinical) were performed on a Roche/Hitachi 917 analyzer. Similar performance has been demonstrated on other instruments.
A reference interval study was performed in accordance with Clinical Laboratory Standard Institute (CLSI) protocol EP28‑A3c. Eligible subjects were enrolled at two US regions and consented to a single blood draw after an overnight fast. Subjects were partitioned by age and gender, according to the following four parameters: (1) males 21‑44 years, (2) males 45‑75 years, (3) women 21‑54 years (presumed pre-menopausal/peri-menopausal), and (4) women 55‑75 years (presumed post-menopausal). The inclusion criteria for the reference populations were ambulatory status and presumptively healthy, HDL‑C ≥ 1.035 mmol/L (40 mg/dL), LDL‑C < 4.139 mmol/L (160 mg/dL), triglyceride < 2.258 mmol/L (200 mg/dL), fasting glucose <6.993 mmol/L (126 mg/dL).
Age differences associated with the sdLDL‑C level were significant in both genders (p = 0.0030 in males and p < 0.0001 in females). No significant difference was observed in the sd LDL‑C level between males and females (p = 0.7564).
According to the CLSI guideline, the normal range was defined as the 2.5th percentile value to the 97.5th percentile value, as described below.
Group | Subjects of the study | Reference intervals |
|---|---|---|
Younger group | Males 21‑44 yrs and Females 21‑54 yrs (n = 240) | 0.329‑1.249 mmol/L 12.7‑48.3 mg/dL |
Older group | Males 45‑75 yrs and Females 55‑75 yrs (n = 202) | 0.326‑1.337 mmol/L 12.6‑51.7 mg/dL |
Establishment with Multi-Ethnic Study of Atherosclerosis (MESA)
The Adult Treatment Panel of the National Cholesterol Education Program has generally selected the 75th percentile value for LDL cholesterol as being associated with high risk of CHD.
Concentrations of the potential interferents and the testing protocol were largely based on guidance CLSI Protocol EP07‑A2.
Criterion: Recovery within ± 0.078 mmol/L (± 3 mg/dL) of initial values of samples < 0.776 mmol/L (30 mg/dL) and within ± 10 % for samples ≥ 0.776 mmol/L (30 mg/dL).
Icterus:
Hemolysis:
Lipemia:
Triglycerides: No significant interference from native triglycerides up to a concentration of 16.9 mmol/L (1500 mg/dL). This result was established and confirmed with a high triglyceride chylomicron fraction spiking test on a Roche/Hitachi 917 analyzer at Denka (formerly Denka‑Seiken). The upper limit of the triglyceride tolerance may be lower depending on the individual sample.
Drugs: No interference was found at therapeutic concentrations using common drug panels.
Sodium L‑ascorbate: No significant interference from Sodium L‑ascorbate up to a concentration of 5.048 mmol/L (100 mg/dL).
Uric acid: No significant interference from uric acid up to a concentration of 0.892 mmol/L (15 mg/dL).
Chyle: No significant interference from Chyle up to a concentration of 1420 FTU.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
The assessment of coronary heart disease (CHD) risk should include the patient’s history, clinical information, and other clinical laboratory test results in addition to the results from this assay.
The sdLDL Seiken test is not a replacement for LDL-C measurement. It should not be used in risk assessment calculators.
For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other 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.
|
| Analyzer(s) on which cobas c pack(s) can be used | |
08834075190 | small dense LDL Seiken (200 tests) | System‑ID 03 7623 8 | cobas c 701/702 |
08834091190 | small dense LDL Calibrator (5 × 1 mL) | Code 749 | |
08834105190 | small dense LDL Control Set small dense LDL Control Level 1 (5 × 1 mL) |
|
For cobas c 701/702 analyzer:
SDLDL: ACN 8769
Ready for use
Assay type | 2‑Point End | ||
Reaction time / Assay points | 10 / 18‑38 | ||
Wavelength (sub/main) | 700/600 nm | ||
Reaction direction | Increase | ||
Units | mmol/L (mg/dL) | ||
Reagent pipetting | Diluent (H2O) | ||
R1 | 120 µL | – | |
R3 | 40 µL | – | |
Sample volumes | Sample | Sample dilution | |
Sample | Diluent (H2O) | ||
Normal | 2.4 µL | – | – |
Decreased | 2.4 µL | – | – |
Increased | 2.4 µL | – | – |
Shelf life at 2‑8 °C: | See expiration date on cobas c pack label. |
On‑board in use and refrigerated on the analyzer: | 4 weeks |
0 hours |
Calibrators | S1: H2O S2: small dense LDL Calibrator |
Linear | |
Calibration frequency | Full calibration |
Calibration interval may be extended based on acceptable verification of calibration by the laboratory.
Traceability: This method has been standardized against an in-house ultracentrifugation method.
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
Precision testing was performed in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP5‑A3 requirements using 2 controls and 5 samples (2 aliquots per run, 2 runs per day, 22 days, for a total of 88 results per sample). The following results were obtained:
Repeatability | Mean | SD | CV |
Lipid control I | 0.482 (18.6) | 0.006 (0.24) | 1.3 |
Lipid control II | 1.37 (52.8) | 0.017 (0.67) | 1.3 |
Pool serum 1 | 0.003 (0.13) | 1.9 | |
Pool serum 2 | 0.711 (27.5) | 0.017 (0.65) | 2.3 |
Pool serum 3 | 1.20 (46.4) | 0.019 (0.73) | 1.6 |
Pool serum 4 | 2.03 (78.5) | 0.023 (0.88) | 1.1 |
Pool serum 5 | 2.25 (86.9) | 0.026 (1.00) | 1.1 |
sdLDL cholesterol values for human serum samples obtained on a cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).
Sample size (n) = 56
Passing/Bablok LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790. y = 1.045x – 0.015 mmol/L τ = 0.980 | Linear regression y = 1.036x – 0.010 mmol/L r = 0.998 |
The sample concentrations were between 0.111 and 2.38 mmol/L (4.30 and 92.1 mg/dL).
Elevated low-density lipoprotein cholesterol (LDL-C) in blood has long been regarded as a risk factor for coronary heart disease (CHD). Recently, LDL‑C sub-fractions (subclasses) have emerged to further elucidate the association between lipid levels and development of CHD.
R1 | Good's buffer, pH 7; cholesterol esterase (microorganism): < 58.33 µkat/L (3500 U/L); cholesterol oxidase (microorganism): < 33.33 µkat/L (2000 U/L); sphingomyelinase (microorganism): < 116.7 µkat/L (7000 U/L); catalase (microorganism): < 41.7 kµkat/L (2500 KU/L); N-ethyl-N-(2‑hydroxy-3‑sulfopropyl)‑3‑methylaniline (TOOS): < 5.0 mmol/L; detergents; preservatives |
R3 | Good's buffer, pH 7; peroxidase (horseradish): < 200 µkat/L (12000 U/L); 4‑aminoantipyrine: < 10.0 mmol/L; sodium azide: 0.05 %; detergents; preservatives |
R1 is in position B and R3 is in position C.
For professional 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.
For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.
This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:
![](\"http://pim-media.roche.com/Images/GHS_exclam_922241547_All.jpg\"/)
Warning
H317 | May cause an allergic skin reaction. |
H412 | Harmful to aquatic life with long lasting effects. |
Prevention:
P261 | Avoid breathing dust/fume/gas/mist/vapours/spray. |
P273 | Avoid release to the environment. |
P280 | Wear protective gloves. |
Response:
P333 + P313 | If skin irritation or rash occurs: Get medical advice/attention. |
P362 + P364 | Take off contaminated clothing and wash it before reuse. |
Disposal:
P501 | Dispose of contents/container to an approved waste disposal plant. |
Product safety labeling follows EU GHS guidance.
Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336
For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.
The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.
Follow the applicable government regulations and local guidelines for quality control.
• Due to the circadian rhythm of sdLDL‑C serum concentrations, it is recommended that specimens be collected in the morning.
• Refrigerate the samples after the separation.
• It is recommended that blood samples be processed to serum/plasma within 4 hours after collection; otherwise, samples should be refrigerated for up to 8 hours.
For specimen collection and preparation only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Serum: Fresh clear serum and serum from gel separation tubes.
Plasma: Fresh clear Li‑heparin and K2‑EDTA plasma from gel separation tubes.
The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.
Centrifuge samples containing precipitates before performing the assay.
See the limitations and interferences section for details about possible sample interferences.
Sample stability (serum/plasma)
It is recommended that samples be stored at refrigerated temperatures (2‑8 °C) after the separation process. They may remain refrigerated for up to 3 days at 4 °C. For longer storage, samples should be stored frozen at −80 °C or below. At −80 °C samples are stable for 3 months.
If samples need to be shipped, they should be shipped at refrigerated conditions. For frozen samples, they should be shipped on dry ice.
Avoid subjecting samples to more than three freeze‑thaw cycles.
Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.
In vitro test for the quantitative determination of small dense LDL cholesterol in human serum and plasma.
The small dense LDL Seiken test is used in conjunction with other lipid measurements and clinical evaluations to aid in the risk management of lipoprotein disorders associated with cardiovascular disease.
The SDLDL test system is a multi‑step method. sdLDL‑C is measured on automated chemistry analyzers. The assay consists of two steps and is based on the technique of using well‑characterized surfactants and enzymes that selectively react with certain groups of lipoproteins.
In the first step, non‑sdLDL lipoproteins, that is, chylomicrons, VLDL, IDL, Large LDL and HDL are decomposed by a surfactant and sphingomyelinase in reagent R1 that is reactive to those non‑sdLDL lipoproteins. The cholesterol released from such non‑sdLDL lipoproteins is then degraded to water and oxygen by the action of enzymes. Cholesterol ester is hydrolyzed by the cholesterol esterase (CHE) and then oxidized by the cholesterol oxidase (CO). Produced hydrogen peroxides are finally decomposed to water and oxygen by the catalase.
In the second step, another surfactant in reagent R3 releases cholesterol only from sdLDL particles and cholesterol released from sdLDL is then subject to the enzymatic reactions. As catalase in the reaction mixture is inhibited by sodium azide in reagent R3, hydrogen peroxides, produced from the reaction with the cholesterol esterase and cholesterol oxidase, then develop a purple‑red color with the coupler in the presence of peroxidase (POD).
Step 1: Chylomicrons‑C, VLDL‑C, IDL‑C, L LDL‑C and HDL‑C | CHE & CO | |
Cholestenone + fatty acid + H2O2 |
2 H2O2 | Catalase | 2 H2O + O2 |
Step 2: sdLDL-C | CHE & CO | Cholestenone + fatty acid + H2O2 |
2 H2O2 + 4-aminoantipyrine + TOOS FREFN-Ethyl-N-(2-hydroxy-3-sulfopropyl)-3-methylaniline | POD | purple-red color + 4 H2O |
0.103‑2.587 mmol/L (4.0‑100 mg/dL)
Limit of Blank | = 0.008 mmol/L (0.3 mg/dL) |
Limit of Detection | = 0.016 mmol/L (0.6 mg/dL) |
Limit of Quantitation | = 0.041 mmol/L (1.6 mg/dL) |
These data were generated on cobas c 501 at Denka, based on the Clinical and Laboratory Standards Institute (CLSI) Protocol EP17‑A2. LoQ was lower than the lower measurement limit of the s LDL-EX “SEIKEN” kit (0.103 mmol/L (4.0 mg/dL)). The precision goal for the Limit of Quantitation was a CV % of less than 10 %.
The data shown below has been obtained by the assay using s LDL-EX “SEIKEN”. All studies (analytical and clinical) were performed on a Roche/Hitachi 917 analyzer. Similar performance has been demonstrated on other instruments.
A reference interval study was performed in accordance with Clinical Laboratory Standard Institute (CLSI) protocol EP28‑A3c. Eligible subjects were enrolled at two US regions and consented to a single blood draw after an overnight fast. Subjects were partitioned by age and gender, according to the following four parameters: (1) males 21‑44 years, (2) males 45‑75 years, (3) women 21‑54 years (presumed pre-menopausal/peri-menopausal), and (4) women 55‑75 years (presumed post-menopausal). The inclusion criteria for the reference populations were ambulatory status and presumptively healthy, HDL‑C ≥ 1.035 mmol/L (40 mg/dL), LDL‑C < 4.139 mmol/L (160 mg/dL), triglyceride < 2.258 mmol/L (200 mg/dL), fasting glucose < 6.993 mmol/L (126 mg/dL).
Age differences associated with the sdLDL‑C level were significant in both genders (p = 0.0030 in males and p < 0.0001 in females). No significant difference was observed in the sd LDL‑C level between males and females (p = 0.7564).
According to the CLSI guideline, the normal range was defined as the 2.5th percentile value to the 97.5th percentile value, as described below.
Group | Subjects of the study | Reference intervals |
|---|---|---|
Younger group | Males 21‑44 yrs and Females 21‑54 yrs (n = 240) | 0.329‑1.249 mmol/L 12.7‑48.3 mg/dL |
Older group | Males 45‑75 yrs and Females 55‑75 yrs (n = 202) | 0.326‑1.337 mmol/L 12.6‑51.7 mg/dL |
Establishment with Multi-Ethnic Study of Atherosclerosis (MESA)
The Adult Treatment Panel of the National Cholesterol Education Program has generally selected the 75th percentile value for LDL cholesterol as being associated with high risk of CHD.
Concentrations of the potential interferents and the testing protocol were largely based on guidance CLSI Protocol EP07‑A2.
Criterion: Recovery within ± 0.078 mmol/L (± 3 mg/dL) of initial values of samples < 0.776 mmol/L (30 mg/dL) and within ± 10 % for samples ≥ 0.776 mmol/L (30 mg/dL).
Icterus:
Hemolysis:
Lipemia:
Triglycerides: No significant interference from native triglycerides up to a concentration of 16.9 mmol/L (1500 mg/dL). This result was established and confirmed with a high triglyceride chylomicron fraction spiking test on a Roche/Hitachi 917 analyzer at Denka (formerly Denka‑Seiken). The upper limit of the triglyceride tolerance may be lower depending on the individual sample.
Drugs: No interference was found at therapeutic concentrations using common drug panels.
Sodium L‑ascorbate: No significant interference from Sodium L‑ascorbate up to a concentration of 5.048 mmol/L (100 mg/dL).
Uric acid: No significant interference from uric acid up to a concentration of 0.892 mmol/L (15 mg/dL).
Chyle: No significant interference from Chyle up to a concentration of 1420 FTU.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
The assessment of coronary heart disease (CHD) risk should include the patient’s history, clinical information, and other clinical laboratory test results in addition to the results from this assay.
The sdLDL Seiken test is not a replacement for LDL-C measurement. It should not be used in risk assessment calculators.
For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other 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.
Analyzer(s) on which cobas c pack(s) can be used | |||
08834059190 | small dense LDL Seiken (100 tests) | System‑ID 07 7623 8 | cobas c 501/502 |
08834091190 | small dense LDL Calibrator (5 × 1 mL) | Code 749 | |
08834105190 | small dense LDL Control Set small dense LDL Control Level 1 (5 × 1 mL) |
|
For cobas c 501 analyzer:
SDLDL: ACN 769
For cobas c 502 analyzer:
SDLDL: ACN 8769
Ready for use
Assay type | 2‑Point End | ||
Reaction time / Assay points | 10 / 34‑70 | ||
Wavelength (sub/main) | 700/600 nm | ||
Reaction direction | Increase | ||
Units | mmol/L (mg/dL) | ||
Reagent pipetting | Diluent (H2O) | ||
R1 | 120 µL | – | |
R3 | 40 µL | – | |
Sample volumes | Sample | Sample dilution | |
Sample | Diluent (H2O) | ||
Normal | 2.4 µL | – | – |
Decreased | 2.4 µL | – | – |
Increased | 2.4 µL | – | – |
Shelf life at 2‑8 °C: | See expiration date on cobas c pack label. |
On‑board in use and refrigerated on the analyzer: | 4 weeks |
Calibrators | S1: H2O S2: small dense LDL Calibrator |
Linear | |
Calibration frequency | Full calibration |
Calibration interval may be extended based on acceptable verification of calibration by the laboratory.
Traceability: This method has been standardized against an in-house ultracentrifugation method.
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
Precision testing was performed in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP5‑A3 requirements using 2 controls and 5 samples (2 aliquots per run, 2 runs per day, 21 days, for a total of 84 results per sample). The following results were obtained:
Repeatability | Mean | SD | CV |
Lipid control I | 0.458 (17.7) | 0.007 (0.28) | 1.6 |
Lipid control II | 1.48 (57.4) | 0.016 (0.63) | 1.1 |
Pool serum 1 | 0.248 (9.6) | 0.005 (0.18) | 1.9 |
Pool serum 2 | 0.562 (21.7) | 0.008 (0.30) | 1.4 |
Pool serum 3 | 1.43 (55.2) | 0.041 (1.57) | 2.8 |
Pool serum 4 | 2.09 (80.7) | 0.029 (1.14) | 1.4 |
Pool serum 5 | 2.25 (86.8) | 0.025 (0.95) | 1.1 |
sdLDL cholesterol values for human serum samples obtained on a cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).
Sample size (n) = 56
Passing/Bablok LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790. y = 1.045x – 0.015 mmol/L τ = 0.980 | Linear regression y = 1.036x – 0.010 mmol/L r = 0.998 |
The sample concentrations were between 0.111 and 2.38 mmol/L (4.30 and 92.1 mg/dL).
Elevated low-density lipoprotein cholesterol (LDL-C) in blood has long been regarded as a risk factor for coronary heart disease (CHD). Recently, LDL‑C sub-fractions (subclasses) have emerged to further elucidate the association between lipid levels and development of CHD.
R1 | Good's buffer, pH 7; cholesterol esterase (microorganism): < 58.33 µkat/L (3500 U/L); cholesterol oxidase (microorganism): < 33.33 µkat/L (2000 U/L); sphingomyelinase (microorganism): < 116.7 µkat/L (7000 U/L); catalase (microorganism): < 41.7 kµkat/L (2500 KU/L); N-ethyl-N-(2‑hydroxy-3‑sulfopropyl)‑3‑methylaniline (TOOS): < 5.0 mmol/L; detergents; preservatives |
R3 | Good's buffer, pH 7; peroxidase (horseradish): < 200 µkat/L (12000 U/L); 4‑aminoantipyrine: < 10.0 mmol/L; sodium azide: 0.05 %; detergents; preservatives |
R1 is in position B and R3 is in position C.
For professional 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.
For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.
This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:
Warning
H317 | May cause an allergic skin reaction. |
H412 | Harmful to aquatic life with long lasting effects. |
Prevention:
P261 | Avoid breathing dust/fume/gas/mist/vapours/spray. |
P273 | Avoid release to the environment. |
P280 | Wear protective gloves. |
Response:
P333 + P313 | If skin irritation or rash occurs: Get medical advice/attention. |
P362 + P364 | Take off contaminated clothing and wash it before reuse. |
Disposal:
P501 | Dispose of contents/container to an approved waste disposal plant. |
Product safety labeling follows EU GHS guidance.
Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336
For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.
The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.
Follow the applicable government regulations and local guidelines for quality control.
• Due to the circadian rhythm of sdLDL‑C serum concentrations, it is recommended that specimens be collected in the morning.
• Refrigerate the samples after the separation.
• It is recommended that blood samples be processed to serum/plasma within 4 hours after collection; otherwise, samples should be refrigerated for up to 8 hours.
For specimen collection and preparation only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Serum: Fresh clear serum and serum from gel separation tubes.
Plasma: Fresh clear Li‑heparin and K2‑EDTA plasma from gel separation tubes.
The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.
Centrifuge samples containing precipitates before performing the assay.
See the limitations and interferences section for details about possible sample interferences.
Sample stability (serum/plasma)
It is recommended that samples be stored at refrigerated temperatures (2‑8 °C) after the separation process. They may remain refrigerated for up to 3 days at 4 °C. For longer storage, samples should be stored frozen at −80 °C or below. At −80 °C samples are stable for 3 months.
If samples need to be shipped, they should be shipped at refrigerated conditions. For frozen samples, they should be shipped on dry ice.
Avoid subjecting samples to more than three freeze‑thaw cycles.
Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.
small dense LDL Seiken
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