In vitro test for the quantitative determination of lithium in human serum and plasma on Roche/Hitachi cobas c systems.
Colorimetric test.
Lithium present in the sample reacts with a substituted porphyrin compound at an alkaline pH, resulting in a change in absorbance which is directly proportional to the concentration of lithium in the sample.
0.05‑3.00 mmol/L (0.03‑2.08 mg/dL)
Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.
Lower limits of measurement
Limit of Blank: | = 0.03 mmol/L (0.02 mg/dL) |
Limit of Detection: | = 0.05 mmol/L (0.03 mg/dL) |
The Limit of Blank and Limit of Detection were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A requirements.
The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.
The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.
The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).
Values below the Limit of Detection (< 0.05 mmol/L) will not be flagged by the instrument.
Lithium LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6). | Therapeutic conc.: | 0.6‑1.2 mmol/L (0.42‑0.83 mg/dL) |
Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.
Criterion: Recovery within ± 10 % of initial values at therapeutic concentrations.
Icterus:
Hemolysis:
Lipemia (Intralipid):
Drugs: No interference was found at therapeutic concentrations using common drug panels.
Key interferences:
Criterion: Recovery within ± 5 % of initial values at therapeutic concentrations.
NH4Cl (19.8 µmol/L), NaCl (140 mmol/L), KCl (4 mmol/L),
CaCl2 (2.4 mmol/L), MgCl2 (0.9 mmol/L), FeCl3 (1.04 mg/L),
Cu(NO3)2 (1.15 mmol/L), ZnCl2 (1.07 mmol/L).
No significant interference was found in the physiological key interference range.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
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 Roche/Hitachi 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 | |
05841941 190 | Lithium (100 tests) | System‑ID 01 6934 7 | Roche/Hitachi cobas c 701/702 |
Materials required (but not provided):
10759350 190 | Calibrator f.a.s. (12 x 3 mL) | Code 401 | |
10759350 360 | Calibrator f.a.s. (12 x 3 mL, for USA) | Code 401 | |
12149435 122 | Precinorm U plus (10 x 3 mL) | Code 300 | |
12149435 160 | Precinorm U plus (10 x 3 mL, for USA) | Code 300 | |
12149443 122 | Precipath U plus (10 x 3 mL) | Code 301 | |
12149443 160 | Precipath U plus (10 x 3 mL, for USA) | Code 301 | |
05117003 190 | PreciControl ClinChem Multi 1 (20 x 5 mL) | Code 391 | |
05947626 190 | PreciControl ClinChem Multi 1 (4 x 5 mL) | Code 391 | |
05947626 160 | PreciControl ClinChem Multi 1 (4 x 5 mL, for USA) | Code 391 | |
05117216 190 | PreciControl ClinChem Multi 2 (20 x 5 mL) | Code 392 | |
05947774 190 | PreciControl ClinChem Multi 2 (4 x 5 mL) | Code 392 | |
05947774 160 | PreciControl ClinChem Multi 2 (4 x 5 mL, for USA) | Code 392 |
LI: ACN 8136
Ready for use
Assay type | 1‑Point | ||
Reaction time / Assay points | 10 / 6 | ||
Wavelength (sub/main) | 480/505 nm | ||
Reaction direction | Decrease | ||
Unit | mmol/L (mg/dL) | ||
Reagent pipetting | Diluent | ||
R1 | 100 µL | - | |
R3 | - | - | |
Sample volumes | Sample | Sample dilution | |
Sample | Diluent (H2O) | ||
Normal | 4 µL | 5 µL | 100 µL |
Decreased | 2 µL | 5 µL | 100 µL |
Increased | 4 µL | 10 µL | 100 µL |
Shelf life at 2‑8 °C: | See expiration date on cobas c pack label. |
On‑board in use and refrigerated on the analyzer: | 12 days |
On‑board on the Reagent Manager: | 24 hours |
Calibrators | S1: H2O |
Calibration mode | Linear |
Calibration frequency | Blank calibration |
Calibration interval may be extended based on acceptable verification of calibration by the laboratory.
Traceability: The lithium calibrator C.f.a.s. is traceable against AAS.
US only: The lithium calibrator C.f.a.s. is traceable against SRM 956b.
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 21 days). The following results were obtained:
Repeatability | Mean | SD | CV |
PreciControl CC Multi 1 | 1.01 (0.701) | 0.01 (0.007) | 0.9 |
PreciControl CC Multi 2 | 2.83 (1.96) | 0.02 (0.01) | 0.6 |
Human serum A | 0.166 (0.115) | 0.006 (0.004) | 3.5 |
Human serum B | 1.20 (0.833) | 0.01 (0.007) | 0.8 |
Human serum C | 2.49 (1.73) | 0.02 (0.01) | 0.7 |
Intermediate precision | Mean | SD | CV |
Precinorm U | 0.79 (0.548) | 0.02 (0.014) | 2.2 |
Precipath U | 2.42 (1.68) | 0.03 (0.02) | 1.3 |
Human serum 1 | 0.64 (0.444) | 0.01 (0.007) | 2.3 |
Human serum 2 | 1.62 (1.12) | 0.03 (0.02) | 1.6 |
Results for intermediate precision were obtained on the master system cobas c 501 analyzer.
Lithium values for human serum samples obtained with the lithium reagent on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).
Sample size (n) = 238 | |
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. | Linear regression |
y = 1.007x + 0.010 | y = 1.009x + 0.005 |
τ = 0.959 | r = 0.998 |
The sample concentrations were between 0.05 and 2.79 mmol/L (0.035 and 1.94 mg/dL). |
Lithium is widely used in the treatment of manic depressive psychosis. Administered as lithium carbonate, it is completely absorbed by the gastro-intestinal tract; peak serum levels occur 2 to 4 hours after an oral dose. The half life in serum is 48 to 72 hours and it is cleared through the kidneys (excretion parallels that of sodium). Reduced renal function can prolong clearance time. Lithium acts by enhancing the uptake of neurotransmitters, which produces a sedative effect on the central nervous system. Serum lithium concentrations are measured essentially to ensure compliance and to avoid toxicity. Early symptoms of intoxication include apathy, sluggishness, drowsiness, lethargy, speech difficulties, irregular tremors, myoclonic twitchings, muscle weakness and ataxia.
Levels higher than 1.5 mmol/L (12 hours after a dose) indicate a significant risk of intoxication. In the diagnostic laboratory, lithium has traditionally been measured using either flame emission photometry, atomic absorption spectrometry, or ion selective electrodes. These methods require specific and often dedicated instrumentation. This lithium test is a colorimetric method.
R1 | Sodium hydroxide: 0.5 mol/L; EDTA: 50 µmol/L; substituted porphyrin: 15 µmol/L; preservative; detergent |
R1 is in position C and position B is empty.
For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.
Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.
Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.
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:
|
Danger
H290 | May be corrosive to metals. |
H314 | Causes severe skin burns and eye damage. |
Prevention:
P280 | Wear protective gloves/ protective clothing/ eye protection/ face protection. |
Response:
P301 + P330 + P331 | IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. |
P303 + P361 + P353 | IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water. |
P304 + P340 | IF INHALED: Remove person to fresh air and keep comfortable for breathing. |
P305 + P351 + P338 | IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. |
P310 | Immediately call a POISON CENTER /doctor. |
P390 | Absorb spillage to prevent material damage. |
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.
For specimen collection and preparation only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: K2‑EDTA and Na‑heparin plasma.
Do not use lithium heparinized plasma.
The specimen should be separated from cells if storage for more than 4 hours is anticipated.
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 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.
Invert thawed specimens several times prior to testing.
Stability: LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002. | 1 day at 15‑25 °C |
In vitro test for the quantitative determination of lithium in human serum and plasma on Roche/Hitachi cobas c systems.
Colorimetric test.
Lithium present in the sample reacts with a substituted porphyrin compound at an alkaline pH, resulting in a change in absorbance which is directly proportional to the concentration of lithium in the sample.
Measuring range
0.10‑3.00 mmol/L (0.07‑2.08 mg/dL)
Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.
Lower limits of measurement
Limit of Blank, Limit of Detection and Limit of Quantitation
Limit of Blank | = 0.03 mmol/L (0.02 mg/dL) |
Limit of Detection | = 0.05 mmol/L (0.03 mg/dL) |
Limit of Quantitation | = 0.10 mmol/L (0.07 mg/dL) |
The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.
The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.
The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.
The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).
The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 20 %. It has been determined using low concentration lithium samples.
mmol/L
Lithium LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6). | Therapeutic conc.: | 0.6‑1.2 mmol/L |
Toxic range: | > 2.0 mmol/L |
mg/dL*
Lithium LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6). | Therapeutic conc.: | 0.42‑0.83 mg/dL |
Toxic range: | > 1.39 mg/dL |
* calculated by unit conversion factor
Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.
Criterion: Recovery within ± 10 % of initial value at a lithium concentration of 1.0 mmol/L.
Icterus:
Hemolysis:
Lipemia (Intralipid):
Drugs: No interference was found at therapeutic concentrations using common drug panels.
Key interferences:
Criterion: Recovery within ± 5 % of initial values at therapeutic concentrations.
NH4Cl (19.8 µmol/L), NaCl (140 mmol/L), KCl (4 mmol/L),
CaCl2 (2.4 mmol/L), MgCl2 (0.9 mmol/L), FeCl3 (1.04 mg/L),
Cu(NO3)2 (1.15 mmol/L), ZnCl2 (1.07 mmol/L).
No significant interference was found in the physiological key interference range.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
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. The latest version of the carry-over evasion list can be found with the
|
| Analyzer(s) on which cobas c pack(s) can be used | |
08057974190 | Lithium (500 tests) | System‑ID 2084 001 | |
10759350360 | Calibrator f.a.s. (12 x 3 mL) | Code 20401 | |
05947626160 | PreciControl ClinChem Multi 1 (4 x 5 mL) | Code 20391 | |
05947774160 | PreciControl ClinChem Multi 2 (4 x 5 mL) | Code 20392 |
LIX: ACN 20841
Ready for use
Test definition | |||
Reporting time | 10 min | ||
Wavelength (sub/main) | 480/505 nm | ||
Reagent pipetting | Diluent | ||
R1 | 80 µL | - | |
R2 | - | - | |
Sample volumes | Sample | Sample dilution | |
Sample | Diluent (H2O) | ||
Normal | 3.2 µL | 5 µL | 100 µL |
Decreased | 1.6 µL | 5 µL | 100 µL |
Increased | 3.2 µL | 5 µL | 100 µL |
For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.
Shelf life at 2‑8 °C: | See expiration date on cobas c pack label. |
On‑board in use and refrigerated on the analyzer: | 26 weeks |
Calibrators | S1: H2O S2: C.f.a.s. |
Calibration mode | Linear |
Calibration frequency | Full calibration |
Calibration interval may be extended based on acceptable verification of calibration by the laboratory.
Traceability: The lithium calibrator C.f.a.s. is traceable against SRM 956b.
Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.
Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.
Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days).
Repeatability | Mean mmol/L (mg/dL) | SD mmol/L (mg/dL) | CV % |
PCCC1a) | 0.904 (0.627) | 0.00825 (0.00573) | 0.9 |
PCCC2b) | 1.72 (1.19) | 0.00748 (0.00519) | 0.4 |
Human serum 1 | 0.149 (0.103) | 0.00755 (0.00524) | 5.1 |
Human serum 2 | 0.628 (0.436) | 0.00694 (0.00482) | 1.1 |
Human serum 3 | 1.25 (0.868) | 0.00824 (0.00572) | 0.7 |
Human serum 4 | 1.54 (1.07) | 0.00859 (0.00596) | 0.6 |
Human serum 5 | 2.64 (1.83) | 0.0127 (0.00882) | 0.5 |
Intermediate precision | Mean mmol/L (mg/dL) | SD mmol/L (mg/dL) | CV % |
PCCC1 FREFPreciControl ClinChem Multi 1 | 0.904 (0.627) | 0.0103 (0.00715) | 1.1 |
PCCC2 FREFPreciControl ClinChem Multi 2 | 1.72 (1.19) | 0.0129 (0.00895) | 0.8 |
Human serum 1 | 0.149 (0.103) | 0.00883 (0.00613) | 5.9 |
Human serum 2 | 0.621 (0.431) | 0.00851 (0.00591) | 1.4 |
Human serum 3 | 1.25 (0.868) | 0.00992 (0.00689) | 0.8 |
Human serum 4 | 1.54 (1.07) | 0.0114 (0.00791) | 0.7 |
Human serum 5 | 2.64 (1.83) | 0.0160 (0.0111) | 0.6 |
Lithium values for human serum samples obtained with the lithium reagent on a cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).
Sample size (n) = 105 | |
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. | Linear regression |
y = 1.022x - 0.00332 mmol/L | y = 1.019x - 0.00146 mmol/L |
τ = 0.983 | r = 1.000 |
The sample concentrations were between 0.156 and 2.99 mmol/L (0.108 and 2.08 mg/dL). |
Sample size (n) = 104 | |
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. | Linear regression |
y = 1.027x - 0.0148 mmol/L | y = 1.025x - 0.0128 mmol/L |
τ = 0.986 | r = 1.000 |
The sample concentrations were between 0.140 and 2.80 mmol/L (0.097 and 1.94 mg/dL). |
Lithium is widely used in the treatment of manic depressive psychosis. Administered as lithium carbonate, it is completely absorbed by the gastro‑intestinal tract; peak serum levels occur 2 to 4 hours after an oral dose. The half life in serum is 48 to 72 hours and it is cleared through the kidneys (excretion parallels that of sodium). Reduced renal function can prolong clearance time. Lithium acts by enhancing the uptake of neurotransmitters, which produces a sedative effect on the central nervous system. Serum lithium concentrations are measured essentially to ensure compliance and to avoid toxicity. Early symptoms of intoxication include apathy, sluggishness, drowsiness, lethargy, speech difficulties, irregular tremors, myoclonic twitchings, muscle weakness and ataxia.
Levels higher than 1.5 mmol/L (12 hours after a dose) indicate a significant risk of intoxication. In the diagnostic laboratory, lithium has traditionally been measured using either flame emission photometry, atomic absorption spectrometry, or ion selective electrodes. These methods require specific and often dedicated instrumentation. This lithium test is a colorimetric method.
R1 | Sodium hydroxide: 0.5 mol/L; EDTA: 50 µmol/L; substituted porphyrin: 15 µmol/L; preservative; detergent |
R1 is in position B.
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.
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:
|
Danger
H290 | May be corrosive to metals. |
H314 | Causes severe skin burns and eye damage. |
Prevention:
P280 | Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection. |
Response:
P301 + P330 + P331 | IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. |
P303 + P361 + P353 | IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water. |
P304 + P340 + P310 | IF INHALED: Remove person to fresh air and keep comfortable for breathing. |
P305 + P351 + P338 | IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor. |
P390 | Absorb spillage to prevent material damage. |
Product safety labeling follows EU GHS guidance.
Contact phone: 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. It is recommended to perform quality control always after lot calibration and subsequently at least every 26 weeks. 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.
For specimen collection and preparation only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: K2‑EDTA and Na‑heparin plasma.
Do not use lithium heparinized plasma.
The specimen should be separated from cells if storage for more than 4 hours is anticipated.
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 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.
Stability: LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002. | 1 day at 15‑25 °C |
7 days at 2‑8 °C | |
6 months at (-15)‑(-25) °C |
In vitro test for the quantitative determination of lithium in human serum and plasma on Roche/Hitachi cobas c systems.
Colorimetric test.
Lithium present in the sample reacts with a substituted porphyrin compound at an alkaline pH, resulting in a change in absorbance which is directly proportional to the concentration of lithium in the sample.
Measuring range
0.05‑3.00 mmol/L (0.03‑2.08 mg/dL)
Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.
Lower limits of measurement
Limit of Blank, Limit of Detection and Limit of Quantitation
Limit of Blank | = 0.03 mmol/L (0.02 mg/dL) |
Limit of Detection | = 0.05 mmol/L (0.03 mg/dL) |
Limit of Quantitation | = 0.10 mmol/L (0.07 mg/dL) |
The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.
The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.
The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.
The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).
The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 20 %. It has been determined using low concentration lithium samples.
mmol/L
Lithium LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6). | Therapeutic conc.: | 0.6‑1.2 mmol/L |
Toxic range: | > 2.0 mmol/L |
mg/dL*
Lithium LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6). | Therapeutic conc.: | 0.42‑0.83 mg/dL |
Toxic range: | > 1.39 mg/dL |
* calculated by unit conversion factor
Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.
Criterion: Recovery within ± 10 % of initial value at a lithium concentration of 1.0 mmol/L.
Icterus:
Hemolysis:
Lipemia (Intralipid):
Drugs: No interference was found at therapeutic concentrations using common drug panels.
Key interferences:
Criterion: Recovery within ± 5 % of initial values at therapeutic concentrations.
NH4Cl (19.8 µmol/L), NaCl (140 mmol/L), KCl (4 mmol/L),
CaCl2 (2.4 mmol/L), MgCl2 (0.9 mmol/L), FeCl3 (1.04 mg/L),
Cu(NO3)2 (1.15 mmol/L), ZnCl2 (1.07 mmol/L).
No significant interference was found in the physiological key interference range.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
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
|
| Analyzer(s) on which cobas c pack(s) can be used | |
08057974190 | Lithium (500 tests) | System‑ID 2084 001 | cobas c 303, cobas c 503 |
Materials required (but not provided):
10759350190 | Calibrator f.a.s. (12 x 3 mL) | Code 20401 | |
05117003190 | PreciControl ClinChem Multi 1 (20 x 5 mL) | Code 20391 | |
05947626190 | PreciControl ClinChem Multi 1 (4 x 5 mL) | Code 20391 | |
05117216190 | PreciControl ClinChem Multi 2 (20 x 5 mL) | Code 20392 | |
05947774190 | PreciControl ClinChem Multi 2 (4 x 5 mL) | Code 20392 |
LI: ACN 20840
Ready for use
Test definition | |||
Reporting time | 10 min | ||
Wavelength (sub/main) | 480/505 nm | ||
Reagent pipetting | Diluent | ||
R1 | 80 µL | - | |
R2 | - | - | |
Sample volumes | Sample | Sample dilution | |
Sample | Diluent (H2O) | ||
Normal | 3.2 µL | 5 µL | 100 µL |
Decreased | 1.6 µL | 5 µL | 100 µL |
Increased | 3.2 µL | 5 µL | 100 µL |
For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.
Shelf life at 2‑8 °C: | See expiration date on cobas c pack label. |
On‑board in use and refrigerated on the analyzer: | 26 weeks |
Calibrators | S1: H2O S2: C.f.a.s. |
Calibration mode | Linear |
Calibration frequency | Full calibration |
Calibration interval may be extended based on acceptable verification of calibration by the laboratory.
Traceability: The lithium calibrator C.f.a.s. is traceable against
Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.
Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.
Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days).
Repeatability | Mean mmol/L | SD mmol/L | CV % |
PCCC1a) | 0.904 | 0.00825 | 0.9 |
PCCC2b) | 1.72 | 0.00748 | 0.4 |
Human serum 1 | 0.149 | 0.00755 | 5.1 |
Human serum 2 | 0.628 | 0.00694 | 1.1 |
Human serum 3 | 1.25 | 0.00824 | 0.7 |
Human serum 4 | 1.54 | 0.00859 | 0.6 |
Human serum 5 | 2.64 | 0.0127 | 0.5 |
Intermediate precision | Mean mmol/L | SD mmol/L | CV % |
PCCC1 FREFPreciControl ClinChem Multi 1 | 0.904 | 0.0103 | 1.1 |
PCCC2 FREFPreciControl ClinChem Multi 2 | 1.72 | 0.0129 | 0.8 |
Human serum 1 | 0.149 | 0.00883 | 5.9 |
Human serum 2 | 0.621 | 0.00851 | 1.4 |
Human serum 3 | 1.25 | 0.00992 | 0.8 |
Human serum 4 | 1.54 | 0.0114 | 0.7 |
Human serum 5 | 2.64 | 0.0160 | 0.6 |
Lithium values for human serum samples obtained with the lithium reagent on a
Sample size (n) = 108 | |
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. | Linear regression |
y = 1.022x - 0.00392 | y = 1.019x - 0.00186 |
τ = 0.983 | r = 1.000 |
The sample concentrations were between 0.0500 and 2.99 mmol/L. |
Sample size (n) = 104 | |
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. | Linear regression |
y = 1.031x - 0.0139 | y = 1.028x - 0.0113 |
τ = 0.986 | r = 1.000 |
The sample concentrations were between 0.140 and 2.80 mmol/L. |
Lithium is widely used in the treatment of manic depressive psychosis. Administered as lithium carbonate, it is completely absorbed by the gastro‑intestinal tract; peak serum levels occur 2 to 4 hours after an oral dose. The half life in serum is 48 to 72 hours and it is cleared through the kidneys (excretion parallels that of sodium). Reduced renal function can prolong clearance time. Lithium acts by enhancing the uptake of neurotransmitters, which produces a sedative effect on the central nervous system. Serum lithium concentrations are measured essentially to ensure compliance and to avoid toxicity. Early symptoms of intoxication include apathy, sluggishness, drowsiness, lethargy, speech difficulties, irregular tremors, myoclonic twitchings, muscle weakness and ataxia.
Levels higher than 1.5 mmol/L (12 hours after a dose) indicate a significant risk of intoxication. In the diagnostic laboratory, lithium has traditionally been measured using either flame emission photometry, atomic absorption spectrometry, or ion selective electrodes. These methods require specific and often dedicated instrumentation. This lithium test is a colorimetric method.
R1 | Sodium hydroxide: 0.5 mol/L; EDTA: 50 µmol/L; substituted porphyrin: 15 µmol/L; preservative; detergent |
R1 is in position B.
For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.
Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.
Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.
Safety data sheet available for professional user on request.
This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:
|
Danger
H290 | May be corrosive to metals. |
H314 | Causes severe skin burns and eye damage. |
Prevention:
P280 | Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection. |
Response:
P301 + P330 + P331 | IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. |
P303 + P361 + P353 | IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water. |
P304 + P340 + P310 | IF INHALED: Remove person to fresh air and keep comfortable for breathing. |
P305 + P351 + P338 | IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor. |
P390 | Absorb spillage to prevent material damage. |
Product safety labeling follows EU GHS guidance.
Contact phone: all countries: +49-621-7590
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. It is recommended to perform quality control always after lot calibration and subsequently at least every 26 weeks. 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.
For specimen collection and preparation only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: K2‑EDTA and Na‑heparin plasma.
Do not use lithium heparinized plasma.
The specimen should be separated from cells if storage for more than 4 hours is anticipated.
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 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.
Stability: LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002. | 1 day at 15‑25 °C |
7 days at 2‑8 °C | |
6 months at (-15)‑(-25) °C |
In vitro test for the quantitative determination of lithium in human serum and plasma on Roche/Hitachi cobas c systems.
Colorimetric test.
Lithium present in the sample reacts with a substituted porphyrin compound at an alkaline pH, resulting in a change in absorbance which is directly proportional to the concentration of lithium in the sample.
Measuring range
0.05‑3.00 mmol/L (0.03‑2.08 mg/dL)
Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.
Lower limits of measurement
Limit of Blank, Limit of Detection and Limit of Quantitation
Limit of Blank | = 0.03 mmol/L (0.02 mg/dL) |
Limit of Detection | = 0.05 mmol/L (0.03 mg/dL) |
Limit of Quantitation | = 0.10 mmol/L (0.07 mg/dL) |
The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.
The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.
The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.
The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).
The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 20 %. It has been determined using low concentration lithium samples.
mmol/L
Lithium LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6). | Therapeutic conc.: | 0.6‑1.2 mmol/L |
Toxic range: | > 2.0 mmol/L |
mg/dL*
Lithium LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6). | Therapeutic conc.: | 0.42‑0.83 mg/dL |
Toxic range: | > 1.39 mg/dL |
* calculated by unit conversion factor
Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.
Criterion: Recovery within ± 10 % of initial value at a lithium concentration of 1.0 mmol/L.
Icterus:
Hemolysis:
Lipemia (Intralipid):
Drugs: No interference was found at therapeutic concentrations using common drug panels.
Key interferences:
Criterion: Recovery within ± 5 % of initial values at therapeutic concentrations.
NH4Cl (19.8 µmol/L), NaCl (140 mmol/L), KCl (4 mmol/L),
CaCl2 (2.4 mmol/L), MgCl2 (0.9 mmol/L), FeCl3 (1.04 mg/L),
Cu(NO3)2 (1.15 mmol/L), ZnCl2 (1.07 mmol/L).
No significant interference was found in the physiological key interference range.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
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 Roche/Hitachi cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet for information. For further instructions refer to the operator’s manual.
|
| Analyzer(s) on which cobas c pack(s) can be used | |
08057974 190 | Lithium (500 tests) | System‑ID 2084 001 | Roche/Hitachi cobas c 503 |
Materials required (but not provided):
10759350 190 | Calibrator f.a.s. (12 x 3 mL) | Code 20401 | |
10759350 360 | Calibrator f.a.s. (12 x 3 mL, for USA) | Code 20401 | |
05117003 190 | PreciControl ClinChem Multi 1 (20 x 5 mL) | Code 20391 | |
05947626 190 | PreciControl ClinChem Multi 1 (4 x 5 mL) | Code 20391 | |
05947626 160 | PreciControl ClinChem Multi 1 (4 x 5 mL, for USA) | Code 20391 | |
05117216 190 | PreciControl ClinChem Multi 2 (20 x 5 mL) | Code 20392 | |
05947774 190 | PreciControl ClinChem Multi 2 (4 x 5 mL) | Code 20392 | |
05947774 160 | PreciControl ClinChem Multi 2 (4 x 5 mL, for USA) | Code 20392 |
LI: ACN 20840
Ready for use
Test definition | |||
Reporting time | 10 min | ||
Wavelength (sub/main) | 480/505 nm | ||
Reagent pipetting | Diluent | ||
R1 | 80 µL | - | |
R2 | - | - | |
Sample volumes | Sample | Sample dilution | |
Sample | Diluent (H2O) | ||
Normal | 3.2 µL | 5 µL | 100 µL |
Decreased | 1.6 µL | 5 µL | 100 µL |
Increased | 3.2 µL | 5 µL | 100 µL |
For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.
Shelf life at 2‑8 °C: | See expiration date on cobas c pack label. |
On‑board in use and refrigerated on the analyzer: | 26 weeks |
Calibrators | S1: H2O S2: C.f.a.s. |
Calibration mode | Linear |
Calibration frequency | Full calibration |
Calibration interval may be extended based on acceptable verification of calibration by the laboratory.
Traceability: The lithium calibrator C.f.a.s. is traceable against AAS.
US only: The lithium calibrator C.f.a.s. is traceable against SRM 956b.
Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.
Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.
Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). The following results were obtained:
Repeatability | Mean mmol/L | SD mmol/L | CV % |
PCCC1a) | 0.904 | 0.00825 | 0.9 |
PCCC2b) | 1.72 | 0.00748 | 0.4 |
Human serum 1 | 0.149 | 0.00755 | 5.1 |
Human serum 2 | 0.628 | 0.00694 | 1.1 |
Human serum 3 | 1.25 | 0.00824 | 0.7 |
Human serum 4 | 1.54 | 0.00859 | 0.6 |
Human serum 5 | 2.64 | 0.0127 | 0.5 |
Intermediate precision | Mean mmol/L | SD mmol/L | CV % |
PCCC1 FREFPreciControl ClinChem Multi 1 | 0.904 | 0.0103 | 1.1 |
PCCC2 FREFPreciControl ClinChem Multi 2 | 1.72 | 0.0129 | 0.8 |
Human serum 1 | 0.149 | 0.00883 | 5.9 |
Human serum 2 | 0.621 | 0.00851 | 1.4 |
Human serum 3 | 1.25 | 0.00992 | 0.8 |
Human serum 4 | 1.54 | 0.0114 | 0.7 |
Human serum 5 | 2.64 | 0.0160 | 0.6 |
Lithium values for human serum samples obtained with the lithium reagent on a Roche/Hitachi cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).
Sample size (n) = 108 | |
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. | Linear regression |
y = 1.022x - 0.00392 | y = 1.019x - 0.00186 |
τ = 0.983 | r = 1.000 |
The sample concentrations were between 0.0500 and 2.99 mmol/L. |
Lithium is widely used in the treatment of manic depressive psychosis. Administered as lithium carbonate, it is completely absorbed by the gastro‑intestinal tract; peak serum levels occur 2 to 4 hours after an oral dose. The half life in serum is 48 to 72 hours and it is cleared through the kidneys (excretion parallels that of sodium). Reduced renal function can prolong clearance time. Lithium acts by enhancing the uptake of neurotransmitters, which produces a sedative effect on the central nervous system. Serum lithium concentrations are measured essentially to ensure compliance and to avoid toxicity. Early symptoms of intoxication include apathy, sluggishness, drowsiness, lethargy, speech difficulties, irregular tremors, myoclonic twitchings, muscle weakness and ataxia.
Levels higher than 1.5 mmol/L (12 hours after a dose) indicate a significant risk of intoxication. In the diagnostic laboratory, lithium has traditionally been measured using either flame emission photometry, atomic absorption spectrometry, or ion selective electrodes. These methods require specific and often dedicated instrumentation. This lithium test is a colorimetric method.
R1 | Sodium hydroxide: 0.5 mol/L; EDTA: 50 µmol/L; substituted porphyrin: 15 µmol/L; preservative; detergent |
R1 is in position B.
For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.
Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.
Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.
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:
|
Danger
H290 | May be corrosive to metals. |
H314 | Causes severe skin burns and eye damage. |
Prevention:
P280 | Wear protective gloves/ protective clothing/ eye protection/ face protection. |
Response:
P301 + P330 + P331 | IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. |
P303 + P361 + P353 | IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water. |
P304 + P340 | IF INHALED: Remove person to fresh air and keep comfortable for breathing. |
P305 + P351 + P338 | IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. |
P310 | Immediately call a POISON CENTER /doctor. |
P390 | Absorb spillage to prevent material damage. |
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. It is recommended to perform quality control always after lot calibration and subsequently at least every 26 weeks. 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.
For specimen collection and preparation only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: K2‑EDTA and Na‑heparin plasma.
Do not use lithium heparinized plasma.
The specimen should be separated from cells if storage for more than 4 hours is anticipated.
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 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.
Stability: LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002. | 1 day at 15‑25 °C |
7 days at 2‑8 °C | |
6 months at (-15)‑(-25) °C |
In vitro test for the quantitative determination of lithium in human serum and plasma on Roche/Hitachi cobas c systems.
Colorimetric test.
Lithium present in the sample reacts with a substituted porphyrin compound at an alkaline pH, resulting in a change in absorbance which is directly proportional to the concentration of lithium in the sample.
Measuring range
0.05‑3.00 mmol/L (0.03‑2.08 mg/dL)
Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.
Lower limits of measurement
Limit of Blank: | = 0.03 mmol/L (0.02 mg/dL) |
Limit of Detection: | = 0.05 mmol/L (0.03 mg/dL) |
The Limit of Blank and Limit of Detection were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A requirements.
The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.
The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.
The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).
Values below the Limit of Detection (< 0.05 mmol/L or 0.03 mg/dL) will not be flagged by the instrument.
Lithium LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6). | Therapeutic conc.: | 0.6‑1.2 mmol/L (0.42‑0.83 mg/dL) |
Toxic range: | > 2.0 mmol/L (> 1.39 mg/dL) |
Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.
Criterion: Recovery within ± 10 % of initial values at therapeutic concentrations.
Icterus:
Hemolysis:
Lipemia (Intralipid):
Drugs: No interference was found at therapeutic concentrations using common drug panels.
Key interferences:
Criterion: Recovery within ± 5 % of initial values at therapeutic concentrations.
NH4Cl (19.8 µmol/L), NaCl (140 mmol/L), KCl (4 mmol/L),
CaCl2 (2.4 mmol/L), MgCl2 (0.9 mmol/L), FeCl3 (1.04 mg/L),
Cu(NO3)2 (1.15 mmol/L), ZnCl2 (1.07 mmol/L).
No significant interference was found in the physiological key interference range.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
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 Roche/Hitachi 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 | |
04679598 190 | Lithium (100 tests) | System‑ID 07 6934 7 | Roche/Hitachi cobas c 311, cobas c 501/502 |
Materials required (but not provided):
10759350 190 | Calibrator f.a.s. (12 x 3 mL) | Code 401 | |
10759350 360 | Calibrator f.a.s. (12 x 3 mL, for USA) | Code 401 | |
12149435 122 | Precinorm U plus (10 x 3 mL) | Code 300 | |
12149435 160 | Precinorm U plus (10 x 3 mL, for USA) | Code 300 | |
12149443 122 | Precipath U plus (10 x 3 mL) | Code 301 | |
12149443 160 | Precipath U plus (10 x 3 mL, for USA) | Code 301 | |
05117003 190 | PreciControl ClinChem Multi 1 (20 x 5 mL) | Code 391 | |
05947626 190 | PreciControl ClinChem Multi 1 (4 x 5 mL) | Code 391 | |
05947626 160 | PreciControl ClinChem Multi 1 (4 x 5 mL, for USA) | Code 391 | |
05117216 190 | PreciControl ClinChem Multi 2 (20 x 5 mL) | Code 392 | |
05947774 190 | PreciControl ClinChem Multi 2 (4 x 5 mL) | Code 392 | |
05947774 160 | PreciControl ClinChem Multi 2 (4 x 5 mL, for USA) | Code 392 |
For cobas c 311/501 analyzers:
LI: ACN 136
For cobas c 502 analyzer:
LI: ACN 8136
Ready for use
cobas c 311 test definition | |||
Assay type | 1‑Point | ||
Reaction time / Assay points | 10 / 7 | ||
Wavelength (sub/main) | 480/505 nm | ||
Reaction direction | Decrease | ||
Unit | mmol/L (mg/dL) | ||
Reagent pipetting | Diluent | ||
R1 | 100 µL | - | |
R2 | - | - | |
Sample volumes | Sample | Sample dilution | |
Sample | Diluent (H2O) | ||
Normal | 4 µL | 5 µL | 100 µL |
Decreased | 2 µL | 5 µL | 100 µL |
Increased | 4 µL | 5 µL | 100 µL |
cobas c 501 test definition | |||
Assay type | 1‑Point | ||
Reaction time / Assay points | 10 / 11 | ||
Wavelength (sub/main) | 480/505 nm | ||
Reaction direction | Decrease | ||
Unit | mmol/L (mg/dL) | ||
Reagent pipetting | Diluent | ||
R1 | 100 µL | - | |
R2 | - | - | |
Sample volumes | Sample | Sample dilution | |
Sample | Diluent (H2O) | ||
Normal | 4 µL | 5 µL | 100 µL |
Decreased | 2 µL | 5 µL | 100 µL |
Increased | 4 µL | 5 µL | 100 µL |
cobas c 502 test definition | |||
Assay type | 1‑Point | ||
Reaction time / Assay points | 10 / 11 | ||
Wavelength (sub/main) | 480/505 nm | ||
Reaction direction | Decrease | ||
Unit | mmol/L (mg/dL) | ||
Reagent pipetting | Diluent | ||
R1 | 100 µL | - | |
R2 | - | - | |
Sample volumes | Sample | Sample dilution | |
Sample | Diluent (H2O) | ||
Normal | 4 µL | 5 µL | 100 µL |
Decreased | 2 µL | 5 µL | 100 µL |
Increased | 4 µL | 10 µL | 100 µL |
LI | |
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: C.f.a.s. |
Calibration mode | Linear |
Calibration frequency | 2‑point calibration |
Calibration interval may be extended based on acceptable verification of calibration by the laboratory.
Traceability: The lithium calibrator C.f.a.s. is traceable against AAS.
US only: The lithium calibrator C.f.a.s. is traceable against SRM 956b.
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 21 days). The following results were obtained:
Repeatability | Mean mmol/L (mg/dL) | SD mmol/L (mg/dL) | CV % |
Precinorm U | 0.77 (0.534) | 0.01 (0.007) | 1.7 |
Precipath U | 2.38 (1.65) | 0.02 (0.01) | 1.0 |
Human serum 1 | 0.46 (0.319) | 0.01 (0.007) | 1.9 |
Human serum 2 | 1.40 (0.972) | 0.02 (0.014) | 1.2 |
Intermediate precision | Mean mmol/L (mg/dL) | SD mmol/L (mg/dL) | CV % |
Precinorm U | 0.79 (0.548) | 0.02 (0.014) | 2.2 |
Precipath U | 2.42 (1.68) | 0.03 (0.02) | 1.3 |
Human serum 1 | 0.64 (0.444) | 0.01 (0.007) | 2.3 |
Human serum 2 | 1.62 (1.12) | 0.03 (0.02) | 1.6 |
Lithium values for human serum samples obtained with the lithium reagent on a Roche/Hitachi cobas c 501 analyzer (y) were compared
x = Roche/Hitachi 917 analyzer, y = cobas c 501 analyzer | |
Sample size (n) = 50 | |
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. | Linear regression |
y = 1.034x - 0.013 | y = 1.032x - 0.016 |
τ = 0.959 | r = 0.996 |
The sample concentrations were between 0.434 and 1.36 mmol/L (0.301 and 0.944 mg/dL). |
x = COBAS INTEGRA 400 analyzer, y = cobas c 501 analyzer | |
Sample size (n) = 78 | |
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. | Linear regression |
y = 0.989x + 0.037 | y = 0.961x + 0.060 |
τ = 0.958 | r = 0.998 |
The sample concentrations were between 0.120 and 3.35 mmol/L (0.083 and 2.323 mg/dL). |
Lithium is widely used in the treatment of manic depressive psychosis. Administered as lithium carbonate, it is completely absorbed by the gastro‑intestinal tract; peak serum levels occur 2 to 4 hours after an oral dose. The half life in serum is 48 to 72 hours and it is cleared through the kidneys (excretion parallels that of sodium). Reduced renal function can prolong clearance time. Lithium acts by enhancing the uptake of neurotransmitters, which produces a sedative effect on the central nervous system. Serum lithium concentrations are measured essentially to ensure compliance and to avoid toxicity. Early symptoms of intoxication include apathy, sluggishness, drowsiness, lethargy, speech difficulties, irregular tremors, myoclonic twitchings, muscle weakness and ataxia.
Levels higher than 1.5 mmol/L (12 hours after a dose) indicate a significant risk of intoxication. In the diagnostic laboratory, lithium has traditionally been measured using either flame emission photometry, atomic absorption spectrometry, or ion selective electrodes. These methods require specific and often dedicated instrumentation. This lithium test is a colorimetric method.
R1 | Sodium hydroxide: 0.5 mol/L; EDTA: 50 µmol/L; substituted porphyrin: 15 µmol/L; preservative; detergent |
R1 is in position B.
For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.
Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.
Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.
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:
|
Danger
H290 | May be corrosive to metals. |
H314 | Causes severe skin burns and eye damage. |
Prevention:
P280 | Wear protective gloves/ protective clothing/ eye protection/ face protection. |
Response:
P301 + P330 + P331 | IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. |
P303 + P361 + P353 | IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water. |
P304 + P340 | IF INHALED: Remove person to fresh air and keep comfortable for breathing. |
P305 + P351 + P338 | IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. |
P310 | Immediately call a POISON CENTER /doctor. |
P390 | Absorb spillage to prevent material damage. |
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.
For specimen collection and preparation only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: K2‑EDTA and Na‑heparin plasma.
Do not use lithium heparinized plasma.
The specimen should be separated from cells if storage for more than 4 hours is anticipated.
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 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.
Stability: LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002. | 1 day at 15‑25 °C |
7 days at 2‑8 °C | |
6 months at (-15)‑(-25) °C |
Lithium
![](\"http://pim-media.roche.com/Images/REF_Frame_1_970150539_All.jpg\"/)
![](\"http://pim-media.roche.com/Images/CONTENT_Frame_1_970070027_All.jpg\"/)
![](\"http://pim-media.roche.com/Images/GHS_acid_922236427_All.jpg\"/)
