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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

In vitro test for the quantitative determination of amikacin in serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Kinetic interaction of microparticles in solution (KIMS) as measured by changes in light transmission.

The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with amikacin and rapidly aggregate in the presence of an amikacin antibody solution. When a sample containing amikacin is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formation is inhibited. Thus, a classic inhibition curve with respect to amikacin concentration is obtained, with the maximum rate of aggregation at the lowest amikacin concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained.

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

Limits and ranges

Measuring range

0.8‑40 µg/mL (1.4‑68.4 µmol/L)

Manually dilute samples above the measuring range 1 + 1 with the Preciset TDM II Diluent (0 µg/mL) and reassay. Multiply the result by 2 to obtain the specimen value.

Lower limits of measurement

Lower detection limit of the test:

0.8 µg/mL (1.4 µmol/L)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 2 standard deviations above that of the 0 μg/mL calibrator (standard 1 + 2 SD, repeatability, n = 21).

Values below the lower detection limit (< 0.8 µg/mL) will not be flagged by the instrument.

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

Expected values

Although optimum values may vary, peak serum values of amikacin in the range of 20 to 25 µg/mL (34.2 to 42.8 µmol/L) and trough values in the range of 5 to 10 µg/mL (8.6 to 17.1 µmol/L) are generally accepted for therapeutic effectiveness. Toxicity is associated with peak levels greater than 35 µg/mL (59.9 µmol/L) and trough values greater than 10 µg/mL (17.1 µmol/L).

LREFJacobs DS, Kaster BL Jr, Demott WR, et al. Laboratory Test Handbook. Stowe, 2nd ed. OH. Lexi-Compl. Mosby 1990;771.
The most serious toxic effect is permanent damage to the vestibular division of the eighth cranial nerve, which has been reported to occur most frequently in patients with renal failure. Since amikacin is inherently stable, is not metabolized, and is excreted primarily by glomerular filtration, the presence of renal impairment drastically alters its pharmacokinetics. If dosage regimens are not adjusted, excess accumulation leading to ototoxicity and further renal impairment could be encountered.
LREFLevy J, Klastersky J. Correlation of serum creatinine concentration and amikacin halflife. J Clin Pharmac 1975;705-707.
,
LREFCabana BE, Taggert BE, Taggert JG. Comparative pharmacokinetics of BB-K8 and kanamycin in dogs and humans. Antimicrob Ag Chemother 1973; 3:478.
,
LREFClarke JT, Libke, RD, Regamey C, et al. Comparative pharmacokinetics of amikacin and kanamycin. Clin Pharm Ther 1974;15:610.
,
LREFMarik PE, Havlik I, Monteagudo FSE, et al. The pharmacokinetic of amikacin in critically ill adult and pediatric patients: comparison of amikacin in critically ill adult and pediatric patients: comparisonof once-versus twice-daily dosing regimens. J Antimicrob Chemother 1991;27(No. C Suppl):81-89."
While serum levels can be toxic, indiscriminately low dosages of amikacin will result in ineffective treatment for many strains of gram-negative bacteria. Organisms which are resistant to amikacin will often show increased resistance to all other available aminoglycosides. This observation
LREFOverturf G,Zawacki BE, Wilkins J et al. Emergence of resistance to amikacin during treatment of burn wounds: the role of antimicrobial susceptibility testing. Surgery 1976;79:224-228.
points out the possibility that the indiscriminate use of low dosages of amikacin could engender the emergence of drug-resistant organisms and possibly render the drug ineffective in treating infectious disease.
LREFPrice KE, et al. Activity of BB-K8 (amikacin) against clinical isolates resistant to one or more aminoglycoside antibiotics. Antimicrob Ag Chemother 1974;5:143-152.
,
LREFBeniviste R, Davies J. Mechanisms of antibiotic resistance in bacteria. J Ann Rev Biochem 1973;42:471.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

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

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at amikacin levels of approximately 5.0 and 30 µg/mL (8.6 and 51.3 µmol/L).

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 50 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 855 µmol/L or 50 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 2000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Triglycerides: No significant interference from triglycerides up to a concentration of 800 mg/dL (9.0 mmol/L).

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 100 IU/mL.

Total protein: No significant interference from total protein in the concentration range of 2‑12 g/dL.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

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.

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

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

05841224 190

ONLINE TDM Amikacin (75 tests)

System‑ID 01 6926 6

Roche/Hitachi cobas c 701/702

Materials required (but not provided):

03375781 190

Preciset TDM II calibrators
1) CAL A‑F (6 x 5 mL)
2) Diluent (1 x 10 mL)

Codes 743‑748

04521536 190

TDM Control Set
1) Level I (2 x 5 mL)
2) Level II (2 x 5 mL)
3) Level III (2 x 5 mL)

Code 310
Code 311
Code 312

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

System information

AMIK2: ACN 8456

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

Reagent handling

Ready for use

Carefully invert reagent container several times prior to use to ensure that the reagent components are mixed.

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

Application for serum and plasma

Deselect Automatic Rerun for this application in the Utility menu, Application screen, Range tab.

cobas c 701/702 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 23‑35

Wavelength (sub/main)

– /700 nm

Reaction direction

Increase

Unit

µg/mL (µmol/L)

Reagent pipetting

Diluent (H2O)

R1

167 µL

R3

50 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

2.0 µL

Decreased

2.0 µL

Increased

2.0 µL

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

Storage and stability

Shelf life at 2 to 8 °C :

See expiration date on cobas c pack label

On‑board in use and refrigerated on the analyzer:

6 weeks

On‑board on the Reagent Manager:

24 hours

Do not freeze.

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

Calibration

Calibrators

S1‑6: Preciset TDM II calibrators

Calibration mode

RCM

Calibration frequency

6‑point calibration
- after cobas c pack change
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against USP reference standards. The calibrators are prepared to contain known quantities of amikacin in normal human serum.

", "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

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (n = 63). The following results were obtained:

Repeatability

Mean
µg/mL (µmol/L)

SD
µg/mL (µmol/L)

CV
%

Control 1

5.2 (8.9)

0.1 (0.2)

1.9

Control 2

15.1 (25.8)

0.1 (0.2)

1.0

Human serum A

3.4 (5.8)

0.1 (0.2)

3.8

Human serum B

9.2 (15.7)

0.2 (0.3)

2.1

Human serum C

35.7 (61.0)

0.3 (0.5)

0.8

Intermediate precision

Mean
µg/mL (µmol/L)

SD
µg/mL (µmol/L)

CV
%

Control 1

5.1 (8.7)

0.2 (0.3)

3.8

Control 2

14.4 (24.6)

0.2 (0.3)

1.3

Control 3

28.2 (48.2)

0.4 (0.7)

1.3

Human serum 1

5.0 (8.6)

0.2 (0.3)

3.5

Human serum 2

32.6 (55.7)

0.4 (0.7)

1.3

Results for intermediate precision were obtained on the master system cobas c 501 analyzer.

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

Method comparison

Amikacin values for human serum and plasma samples obtained 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) = 62

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 + 0.161 µg/mL

y = 1.027x + 0.181 µg/mL

τ = 0.970

r = 0.999

The sample concentrations were between 1.10 and 37.6 µg/mL (1.88 and 64.3 µmol/L).

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

Summary

Amikacin is a semi-synthetic aminoglycoside that exhibits bactericidal activity against a wide range of pathogens, including many organisms resistant to other aminoglycosides.

LREFPrice KE,Chisholm DR, Misiek M et al. Microbiological evaluation of BB-K8, a new semi-synthetic aminoglycoside. J Antibiot 1972;25:709.
,
LREFBodey GP, Steward D. In vitro studies of BB-K8, a new aminoglycoside antibiotic. Antimicrob Ag Chemother 1973;4:186.
,
LREFYoung LS, Hewitt WL. Activity of five aminoglycoside antibiotics in vitro against gram-negative bacilli and staphylococcus aureus. Antimicrob Ag Chemother 1973;4:617-625.
,
LREFYourassowsky E, Schoutens E, Vanderlinden MD et al. Comparison of the in vitro activity of BB-K8 and three other aminoglycosides against 215 strains of pseudomonas and enterobacteriaceae with variable sensitivity tokanamycin and gentamicin. Chemother 1975;21:45.
Amikacin is active in vitro against gram-negative organisms, penicillinase and non-penicillinase producing staphylococci. The strength of this drug is due primarily to its high degree of resistance to aminoglycoside-inactivating enzymes.
LREFPrice KE, Pursiano TA, DeFuria MD et al. Activity of BB-K8 (amikacin) against clinical isolates resistant to one or more aminoglycoside antibiotics. Antimicrob Ag Chemother 1974;5:143-152.
Determination of serum or plasma drug levels is required to achieve optimum therapeutic efficacy and minimize toxicity.
LREFJacobs DS, Kaster BL Jr, Demott WR, et al. Laboratory Test Handbook. Stowe, 2nd ed. OH. Lexi-Compl. Mosby 1990;771.

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

Reagents - working solutions

R1

Anti‑amikacin antibody (mouse monoclonal) and human-sourced material in buffer with preservative

R3

Conjugated amikacin derivative microparticles, human-sourced material, and preservative

R1 is in position B and R3 is in position C.

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

Precautions and warnings

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

H318

Causes serious eye damage.

Prevention:

P280

Wear eye protection/ face protection.

Response:

P305 + P351 + P338
+ P310

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.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336

All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods use assays that have been approved by the FDA or that are in compliance with the legal rules applicable to placing in vitro diagnostic medical devices for human use on the market in the European Union.
However, as no testing method can rule out the potential risk of infection with absolute certainty, the material should be handled with the same level of care as a patient specimen. In the event of exposure, the directives of the responsible health authorities should be followed.

LREFOccupational Safety and Health Standards: Bloodborne pathogens. (29 CFR Part 1910.1030). Fed. Register.
,
LREFDirective 2000/54/EC of the European Parliament and Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work.

", "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 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.

", "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: Collect serum using standard sampling tubes.

Plasma: K2- or K3-EDTA or Na or Li heparin plasma.

Stability:

8 hours capped at 15‑25 °C
48 hours capped at 2‑8 °C
4 weeks capped at -20 °C

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.

Do not induce foaming of specimens. Specimens should not be repeatedly frozen and thawed.

Invert thawed specimens several times prior to testing.

Usual sampling time varies dependent upon desired measurement of peak or trough values.

LREFRiff LJ, Jackson GG. Pharmacology of gentamicin in man. J Infect Dis 1971;124(Suppl):98-105.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0208105383190c503", "ProductName": "AMIK2", "ProductLongName": "ONLINE TDM Amikacin", "Language": "en", "DocumentVersion": "4", "DocumentObjectID": "FF0000000598F00E", "DocumentOriginID": "FF0000000595600E", "MaterialNumbers": [ "08105383190" ], "InstrumentReferences": [ { "ID": "9493", "BrandName": "cobas c 303" }, { "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

In vitro test for the quantitative determination of amikacin in serum and plasma on cobas c systems.

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

Test principle

Kinetic interaction of microparticles in solution (KIMS) as measured by changes in light transmission.

The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with amikacin and rapidly aggregate in the presence of an amikacin antibody solution. When a sample containing amikacin is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formation is inhibited. Thus, a classic inhibition curve with respect to amikacin concentration is obtained, with the maximum rate of aggregation at the lowest amikacin concentration. By monitoring the change in scattered light or absorbance, a concentration‑dependent curve is obtained.

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

Limits and ranges

Measuring range

0.8‑40 µg/mL (1.4‑68.4 µmol/L)

Manually dilute samples above the measuring range 1 + 1 with the Preciset TDM II Diluent (0 µg/mL) and reassay. Multiply the result by 2 to obtain the specimen value.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 0.8 µg/mL (1.4 µmol/L)

Limit of Detection

= 0.8 µg/mL (1.4 µmol/L)

Limit of Quantitation

= 1.2 µg/mL (2.05 µmol/L)

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 amikacin samples.

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

Expected values

Although optimum values may vary, peak serum values of amikacin in the range of 20 to 25 µg/mL (34.2 to 42.8 µmol/L) and trough values in the range of 5 to 10 µg/mL (8.6 to 17.1 µmol/L) are generally accepted for therapeutic effectiveness. Toxicity is associated with peak levels greater than 35 µg/mL (59.9 µmol/L) and trough values greater than 10 µg/mL (17.1 µmol/L).

LREFJacobs DS, Kaster BL Jr, Demott WR, et al. Laboratory Test Handbook. Stowe, 2nd ed. OH. Lexi-Compl. Mosby 1990;771.
The most serious toxic effect is permanent damage to the vestibular division of the eighth cranial nerve, which has been reported to occur most frequently in patients with renal failure. Since amikacin is inherently stable, is not metabolized, and is excreted primarily by glomerular filtration, the presence of renal impairment drastically alters its pharmacokinetics. If dosage regimens are not adjusted, excess accumulation leading to ototoxicity and further renal impairment could be encountered.
LREFLevy J, Klastersky J. Correlation of serum creatinine concentration and amikacin halflife. J Clin Pharmac 1975;705-707.
,
LREFCabana BE, Taggert BE, Taggert JG. Comparative pharmacokinetics of BB-K8 and kanamycin in dogs and humans. Antimicrob Ag Chemother 1973; 3:478.
,
LREFClarke JT, Libke, RD, Regamey C, et al. Comparative pharmacokinetics of amikacin and kanamycin. Clin Pharm Ther 1974;15:610.
,
LREFMarik PE, Havlik I, Monteagudo FSE, et al. The pharmacokinetic of amikacin in critically ill adult and pediatric patients: comparison of amikacin in critically ill adult and pediatric patients: comparisonof once-versus twice-daily dosing regimens. J Antimicrob Chemother 1991;27(No. C Suppl):81-89."
While serum levels can be toxic, indiscriminately low dosages of amikacin will result in ineffective treatment for many strains of gram‑negative bacteria. Organisms which are resistant to amikacin will often show increased resistance to all other available aminoglycosides. This observation
LREFOverturf G,Zawacki BE, Wilkins J et al. Emergence of resistance to amikacin during treatment of burn wounds: the role of antimicrobial susceptibility testing. Surgery 1976;79:224-228.
points out the possibility that the indiscriminate use of low dosages of amikacin could engender the emergence of drug‑resistant organisms and possibly render the drug ineffective in treating infectious disease.
LREFPrice KE, Pursiano TA, DeFuria MD et al. Activity of BB-K8 (amikacin) against clinical isolates resistant to one or more aminoglycoside antibiotics. Antimicrob Ag Chemother 1974;5:143-152.
,
LREFBeniviste R, Davies J. Mechanisms of antibiotic resistance in bacteria. J Ann Rev Biochem 1973;42:471.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

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

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at amikacin levels of approximately 5.0 and 30 µg/mL (8.6 and 51.3 µmol/L).

Serum/plasma

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 50 for conjugated bilirubin and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 50 mg/dL or 855 µmol/L).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 1000 mg/dL or 621 µmol/L).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 2000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Triglycerides: No significant interference from triglycerides up to a concentration of 800 mg/dL (9.0 mmol/L).

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 100 IU/mL.

Total protein: No significant interference from total protein in the concentration range of 2‑12 g/dL.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

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 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

08105383190

ONLINE TDM Amikacin (200 tests)

System‑ID 2015 001

cobas c 303, cobas c 503

Materials required (but not provided):

03375781190

Preciset TDM II
CAL A-F (1 x 5 mL)
Diluent (1 x 10 mL)

Codes 20743‑20748

04521536190

TDM Control Set
Level I (2 x 5 mL)
Level II (2 x 5 mL)
Level III (2 x 5 mL)


Code 20310
Code 20311
Code 20312

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

System information

AMIK2X: ACN 20151

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

Reagent handling

Ready for use

Carefully invert reagent container several times prior to use to ensure that the reagent components are mixed.

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

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

– /700 nm

Reagent pipetting

Diluent (H2O)

R1

84 µL

R3

25 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

1.0 µL

Decreased

1.0 µL

Increased

1.0 µL

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

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

Storage and stability

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

Do not freeze.

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

Calibration

Calibrator

S1‑6: Preciset TDM II calibrators

Calibration mode

Non‑linear

Calibration frequency

cobas c 303 analyzer

Full calibration
- after reagent lot change
- every 4 days on-board
- every 6 weeks during shelf life
- as required following quality control procedures

cobas c 503 analyzer

Full calibration
- after reagent lot change
- every 14 days on-board
- every 6 weeks during shelf life
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against USP reference standards. The calibrators are prepared to contain known quantities of amikacin in normal human serum.

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

Specific performance data

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.

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

Precision

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). Results for repeatability and intermediate precision were obtained on the cobas c 503 analyzer.

Serum/plasma

Repeatability

Mean
µg/mL

SD
µg/mL

CV
%

TDMC1a)

5.14

0.152

2.9

TDMC2b)

14.5

0.203

1.4

TDMC3c)

27.4

0.694

2.5

Human serum 1

2.18

0.147

6.8

Human serum 2

10.7

0.159

1.5

Human serum 3

20.1

0.231

1.1

Human serum 4

24.2

0.283

1.2

Human serum 5

35.4

0.549

1.6

Intermediate precision

Mean
µg/mL

SD
µg/mL

CV
%

TDMC1

FREFTDM Control Set Level I

5.14

0.215

4.2

TDMC2

FREFTDM Control Set Level II

14.4

0.252

1.7

TDMC3

FREFTDM Control Set Level III

27.4

0.694

2.5

Human serum 1

1.96

0.223

11.4

Human serum 2

10.7

0.220

2.0

Human serum 3

20.2

0.289

1.4

Human serum 4

24.2

0.331

1.4

Human serum 5

35.4

0.589

1.7

The data obtained on cobas c 503 analyzer(s) are representative for cobas c 303 analyzer(s).

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

Method comparison

Serum/plasma

Amikacin values for human serum and plasma samples obtained 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) = 75

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 = 0.975x + 0.209 µg/mL

y = 0.991x + 0.0137 µg/mL

τ = 0.965

r = 0.997

The sample concentrations were between 1.20 and 37.5 µg/mL.

Amikacin values for human serum and plasma samples obtained on a cobas c 303 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 75

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 = 0.967x + 0.110 µg/mL

y = 0.978x - 0.0391 µg/mL

τ = 0.981

r = 0.998

The sample concentrations were between 1.30 and 37.2 µg/mL.

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

Summary

Amikacin is a semi‑synthetic aminoglycoside that exhibits bactericidal activity against a wide range of pathogens, including many organisms resistant to other aminoglycosides.

LREFPrice KE,Chisholm DR, Misiek M et al. Microbiological evaluation of BB-K8, a new semi-synthetic aminoglycoside. J Antibiot 1972;25:709.
,
LREFBodey GP, Steward D. In vitro studies of BB-K8, a new aminoglycoside antibiotic. Antimicrob Ag Chemother 1973;4:186.
,
LREFYoung LS, Hewitt WL. Activity of five aminoglycoside antibiotics in vitro against gram-negative bacilli and staphylococcus aureus. Antimicrob Ag Chemother 1973;4:617-625.
,
LREFYourassowsky E, Schoutens E, Vanderlinden MD et al. Comparison of the in vitro activity of BB-K8 and three other aminoglycosides against 215 strains of pseudomonas and enterobacteriaceae with variable sensitivity tokanamycin and gentamicin. Chemother 1975;21:45.
Amikacin is active in vitro against gram‑negative organisms, penicillinase and non‑penicillinase producing staphylococci. The strength of this drug is due primarily to its high degree of resistance to aminoglycoside‑inactivating enzymes.
LREFPrice KE, Pursiano TA, DeFuria MD et al. Activity of BB-K8 (amikacin) against clinical isolates resistant to one or more aminoglycoside antibiotics. Antimicrob Ag Chemother 1974;5:143-152.
Determination of serum or plasma drug levels is required to achieve optimum therapeutic efficacy and minimize toxicity.
LREFJacobs DS, Kaster BL Jr, Demott WR, et al. Laboratory Test Handbook. Stowe, 2nd ed. OH. Lexi-Compl. Mosby 1990;771.

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

Reagents - working solutions

R1

Anti‑amikacin antibody (mouse monoclonal) and human‑sourced material in buffer with preservative

R3

Conjugated amikacin derivative microparticles, human‑sourced material, and preservative

R1 is in position B and R3 is in position C.

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

Precautions and warnings

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.

All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods use assays that have been approved by the FDA or that are in compliance with the legal rules applicable to placing in vitro diagnostic medical devices for human use on the market in the European Union.
However, as no testing method can rule out the potential risk of infection with absolute certainty, the material should be handled with the same level of care as a patient specimen. In the event of exposure, the directives of the responsible health authorities should be followed.

LREFOccupational Safety and Health Standards: Bloodborne pathogens. (29 CFR Part 1910.1030). Fed. Register.
,
LREFDirective 2000/54/EC of the European Parliament and Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Danger

H318

Causes serious eye damage.

Prevention:

P280

Wear eye protection/ face protection.

Response:

P305 + P351 + P338
+ P310

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.

Product safety labeling follows EU GHS guidance.

Contact phone: 1-800-428-2336

", "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 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.

", "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: Collect serum using standard sampling tubes.
Plasma: K2‑ or K3‑EDTA or Na or Li heparin plasma.

Stability:

8 hours capped at 15‑25 °C

48 hours capped at 2‑8 °C

4 weeks capped at -20 °C

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.

Do not induce foaming of specimens. Specimens should not be repeatedly frozen and thawed.

Invert thawed specimens several times prior to testing.

Usual sampling time varies dependent upon desired measurement of peak or trough values.

LREFRiff LJ, Jackson GG. Pharmacology of gentamicin in man. J Infect Dis 1971;124(Suppl):98-105.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0108105383190c503", "ProductName": "AMIK2", "ProductLongName": "ONLINE TDM Amikacin", "Language": "en", "DocumentVersion": "6", "DocumentObjectID": "FF00000005A4D80E", "DocumentOriginID": "FF00000004D4F00E", "MaterialNumbers": [ "08105383190" ], "InstrumentReferences": [ { "ID": "9493", "BrandName": "cobas c 303" }, { "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

In vitro test for the quantitative determination of amikacin in serum and plasma on cobas c systems.

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

Test principle

Kinetic interaction of microparticles in solution (KIMS) as measured by changes in light transmission.

The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with amikacin and rapidly aggregate in the presence of an amikacin antibody solution. When a sample containing amikacin is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formation is inhibited. Thus, a classic inhibition curve with respect to amikacin concentration is obtained, with the maximum rate of aggregation at the lowest amikacin concentration. By monitoring the change in scattered light or absorbance, a concentration‑dependent curve is obtained.

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

Limits and ranges

Measuring range

0.8‑40 µg/mL (1.4‑68.4 µmol/L)

Manually dilute samples above the measuring range 1 + 1 with the Preciset TDM II Diluent (0 µg/mL) and reassay. Multiply the result by 2 to obtain the specimen value.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 0.8 µg/mL (1.4 µmol/L)

Limit of Detection

= 0.8 µg/mL (1.4 µmol/L)

Limit of Quantitation

= 1.2 µg/mL (2.05 µmol/L)

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 amikacin samples.

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

Expected values

Although optimum values may vary, peak serum values of amikacin in the range of 20 to 25 µg/mL (34.2 to 42.8 µmol/L) and trough values in the range of 5 to 10 µg/mL (8.6 to 17.1 µmol/L) are generally accepted for therapeutic effectiveness. Toxicity is associated with peak levels greater than 35 µg/mL (59.9 µmol/L) and trough values greater than 10 µg/mL (17.1 µmol/L).

LREFJacobs DS, Kaster BL Jr, Demott WR, et al. Laboratory Test Handbook. Stowe, 2nd ed. OH. Lexi-Compl. Mosby 1990;771.
The most serious toxic effect is permanent damage to the vestibular division of the eighth cranial nerve, which has been reported to occur most frequently in patients with renal failure. Since amikacin is inherently stable, is not metabolized, and is excreted primarily by glomerular filtration, the presence of renal impairment drastically alters its pharmacokinetics. If dosage regimens are not adjusted, excess accumulation leading to ototoxicity and further renal impairment could be encountered.
LREFLevy J, Klastersky J. Correlation of serum creatinine concentration and amikacin halflife. J Clin Pharmac 1975;705-707.
,
LREFCabana BE, Taggert BE, Taggert JG. Comparative pharmacokinetics of BB-K8 and kanamycin in dogs and humans. Antimicrob Ag Chemother 1973; 3:478.
,
LREFClarke JT, Libke, RD, Regamey C, et al. Comparative pharmacokinetics of amikacin and kanamycin. Clin Pharm Ther 1974;15:610.
,
LREFMarik PE, Havlik I, Monteagudo FSE, et al. The pharmacokinetic of amikacin in critically ill adult and pediatric patients: comparison of amikacin in critically ill adult and pediatric patients: comparisonof once-versus twice-daily dosing regimens. J Antimicrob Chemother 1991;27(No. C Suppl):81-89."
While serum levels can be toxic, indiscriminately low dosages of amikacin will result in ineffective treatment for many strains of gram‑negative bacteria. Organisms which are resistant to amikacin will often show increased resistance to all other available aminoglycosides. This observation
LREFOverturf G,Zawacki BE, Wilkins J et al. Emergence of resistance to amikacin during treatment of burn wounds: the role of antimicrobial susceptibility testing. Surgery 1976;79:224-228.
points out the possibility that the indiscriminate use of low dosages of amikacin could engender the emergence of drug‑resistant organisms and possibly render the drug ineffective in treating infectious disease.
LREFPrice KE, Pursiano TA, DeFuria MD et al. Activity of BB-K8 (amikacin) against clinical isolates resistant to one or more aminoglycoside antibiotics. Antimicrob Ag Chemother 1974;5:143-152.
,
LREFBeniviste R, Davies J. Mechanisms of antibiotic resistance in bacteria. J Ann Rev Biochem 1973;42:471.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

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

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at amikacin levels of approximately 5.0 and 30 µg/mL (8.6 and 51.3 µmol/L).

Serum/plasma

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 50 for conjugated bilirubin and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 50 mg/dL or 855 µmol/L).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 1000 mg/dL or 621 µmol/L).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 2000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Triglycerides: No significant interference from triglycerides up to a concentration of 800 mg/dL (9.0 mmol/L).

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 100 IU/mL.

Total protein: No significant interference from total protein in the concentration range of 2‑12 g/dL.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

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 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

08105383190

ONLINE TDM Amikacin (200 tests)

System‑ID 2015 001

cobas c 303, cobas c 503

Materials required (but not provided):

03375781190

Preciset TDM II
CAL A-F (1 x 5 mL)
Diluent (1 x 10 mL)

Codes 20743‑20748

04521536190

TDM Control Set
Level I (2 x 5 mL)
Level II (2 x 5 mL)
Level III (2 x 5 mL)


Code 20310
Code 20311
Code 20312

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

System information

AMIK2: ACN 20150

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

Reagent handling

Ready for use

Carefully invert reagent container several times prior to use to ensure that the reagent components are mixed.

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

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

– /700 nm

Reagent pipetting

Diluent (H2O)

R1

84 µL

R3

25 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

1.0 µL

Decreased

1.0 µL

Increased

1.0 µL

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

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

Storage and stability

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

Do not freeze.

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

Calibration

Calibrators (full calibration)

S1‑6: Preciset TDM II calibrators

Calibrators (2‑point calibration)

S2: Preciset TDM II‑B
S6: Preciset TDM II‑F

Calibration mode

Non‑linear

Calibration frequency
cobas c 303 analyzer

2‑point calibration
- every 4 days on‑board

Full calibration
- after reagent lot change
- every 6 weeks during shelf life
- as required following quality control procedures

Calibration frequency
cobas c 503 analyzer

2‑point calibration
- every 14 days on‑board

Full calibration
- after reagent lot change
- every 6 weeks during shelf life
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against USP reference standards. The calibrators are prepared to contain known quantities of amikacin in normal human serum.

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

Specific performance data

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.

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

Precision

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). Results for repeatability and intermediate precision were obtained on the cobas c 503 analyzer.

Serum/plasma

Repeatability

Mean
µg/mL

SD
µg/mL

CV
%

TDMC1a)

5.14

0.152

2.9

TDMC2b)

14.5

0.203

1.4

TDMC3c)

27.4

0.694

2.5

Human serum 1

2.18

0.147

6.8

Human serum 2

10.7

0.159

1.5

Human serum 3

20.1

0.231

1.1

Human serum 4

24.2

0.283

1.2

Human serum 5

35.4

0.549

1.6

Intermediate precision

Mean
µg/mL

SD
µg/mL

CV
%

TDMC1

FREFTDM Control Set Level I

5.14

0.215

4.2

TDMC2

FREFTDM Control Set Level II

14.4

0.252

1.7

TDMC3

FREFTDM Control Set Level III

27.4

0.694

2.5

Human serum 1

1.96

0.223

11.4

Human serum 2

10.7

0.220

2.0

Human serum 3

20.2

0.289

1.4

Human serum 4

24.2

0.331

1.4

Human serum 5

35.4

0.589

1.7

The data obtained on cobas c 503 analyzer(s) are representative for cobas c 303 analyzer(s).

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

Method comparison

Serum/plasma

Amikacin values for human serum and plasma samples obtained 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) = 75

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 = 0.975x + 0.209 µg/mL

y = 0.991x + 0.0137 µg/mL

τ = 0.965

r = 0.997

The sample concentrations were between 1.20 and 37.5 µg/mL.

Amikacin values for human serum and plasma samples obtained on a cobas c 303 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 75

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 = 0.967x + 0.110 µg/mL

y = 0.978x - 0.0391 µg/mL

τ = 0.981

r = 0.998

The sample concentrations were between 1.30 and 37.2 µg/mL.

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

Summary

Amikacin is a semi‑synthetic aminoglycoside that exhibits bactericidal activity against a wide range of pathogens, including many organisms resistant to other aminoglycosides.

LREFPrice KE,Chisholm DR, Misiek M et al. Microbiological evaluation of BB-K8, a new semi-synthetic aminoglycoside. J Antibiot 1972;25:709.
,
LREFBodey GP, Steward D. In vitro studies of BB-K8, a new aminoglycoside antibiotic. Antimicrob Ag Chemother 1973;4:186.
,
LREFYoung LS, Hewitt WL. Activity of five aminoglycoside antibiotics in vitro against gram-negative bacilli and staphylococcus aureus. Antimicrob Ag Chemother 1973;4:617-625.
,
LREFYourassowsky E, Schoutens E, Vanderlinden MD et al. Comparison of the in vitro activity of BB-K8 and three other aminoglycosides against 215 strains of pseudomonas and enterobacteriaceae with variable sensitivity tokanamycin and gentamicin. Chemother 1975;21:45.
Amikacin is active in vitro against gram‑negative organisms, penicillinase and non‑penicillinase producing staphylococci. The strength of this drug is due primarily to its high degree of resistance to aminoglycoside‑inactivating enzymes.
LREFPrice KE, Pursiano TA, DeFuria MD et al. Activity of BB-K8 (amikacin) against clinical isolates resistant to one or more aminoglycoside antibiotics. Antimicrob Ag Chemother 1974;5:143-152.
Determination of serum or plasma drug levels is required to achieve optimum therapeutic efficacy and minimize toxicity.
LREFJacobs DS, Kaster BL Jr, Demott WR, et al. Laboratory Test Handbook. Stowe, 2nd ed. OH. Lexi-Compl. Mosby 1990;771.

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

Reagents - working solutions

R1

Anti‑amikacin antibody (mouse monoclonal) and human‑sourced material in buffer with preservative

R3

Conjugated amikacin derivative microparticles, human‑sourced material, and preservative

R1 is in position B and R3 is in position C.

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

Precautions and warnings

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.

All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods use assays that have been approved by the FDA or that are in compliance with the legal rules applicable to placing in vitro diagnostic medical devices for human use on the market in the European Union.
However, as no testing method can rule out the potential risk of infection with absolute certainty, the material should be handled with the same level of care as a patient specimen. In the event of exposure, the directives of the responsible health authorities should be followed.

LREFOccupational Safety and Health Standards: Bloodborne pathogens. (29 CFR Part 1910.1030). Fed. Register.
,
LREFDirective 2000/54/EC of the European Parliament and Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Danger

H318

Causes serious eye damage.

Prevention:

P280

Wear eye protection/ face protection.

Response:

P305 + P351 + P338
+ P310

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.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590

", "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 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.

", "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: Collect serum using standard sampling tubes.
Plasma: K2‑ or K3‑EDTA or Na or Li heparin plasma.

Stability:

8 hours capped at 15‑25 °C

48 hours capped at 2‑8 °C

4 weeks capped at -20 °C

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.

Do not induce foaming of specimens. Specimens should not be repeatedly frozen and thawed.

Invert thawed specimens several times prior to testing.

Usual sampling time varies dependent upon desired measurement of peak or trough values.

LREFRiff LJ, Jackson GG. Pharmacology of gentamicin in man. J Infect Dis 1971;124(Suppl):98-105.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0004791959190c501", "ProductName": "AMIK2", "ProductLongName": "ONLINE TDM Amikacin", "Language": "en", "DocumentVersion": "11", "DocumentObjectID": "FF000000047D360E", "DocumentOriginID": "FF00000000F31B0E", "MaterialNumbers": [ "04791959190" ], "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

In vitro test for the quantitative determination of amikacin in serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Kinetic interaction of microparticles in solution (KIMS) as measured by changes in light transmission.

The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with amikacin and rapidly aggregate in the presence of an amikacin antibody solution. When a sample containing amikacin is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formation is inhibited. Thus, a classic inhibition curve with respect to amikacin concentration is obtained, with the maximum rate of aggregation at the lowest amikacin concentration. By monitoring the change in scattered light or absorbance, a concentration‑dependent curve is obtained.

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

Limits and ranges

Measuring range

0.8‑40 µg/mL (1.4‑68.4 µmol/L)

Manually dilute samples above the measuring range 1 + 1 with the Preciset TDM II Diluent (0 µg/mL) and reassay. Multiply the result by 2 to obtain the specimen value.

Lower limits of measurement

Lower detection limit of the test

0.8 µg/mL (1.4 µmol/L)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 2 standard deviations above that of the 0 µg/mL calibrator (standard 1 + 2 SD, repeatability, n = 21).

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

Expected values

Although optimum values may vary, peak serum values of amikacin in the range of 20 to 25 µg/mL (34.2 to 42.8 µmol/L) and trough values in the range of 5 to 10 µg/mL (8.6 to 17.1 µmol/L) are generally accepted for therapeutic effectiveness. Toxicity is associated with peak levels greater than 35 µg/mL (59.9 µmol/L) and trough values greater than 10 µg/mL (17.1 µmol/L).

LREFJacobs DS, Kaster BL Jr, Demott WR, et al. Laboratory Test Handbook. Stowe, 2nd ed. OH. Lexi-Compl. Mosby 1990;771.
The most serious toxic effect is permanent damage to the vestibular division of the eighth cranial nerve, which has been reported to occur most frequently in patients with renal failure. Since amikacin is inherently stable, is not metabolized, and is excreted primarily by glomerular filtration, the presence of renal impairment drastically alters its pharmacokinetics. If dosage regimens are not adjusted, excess accumulation leading to ototoxicity and further renal impairment could be encountered.
LREFLevy J, Klastersky J. Correlation of serum creatinine concentration and amikacin halflife. J Clin Pharmac 1975;705-707.
,
LREFCabana BE, Taggert BE, Taggert JG. Comparative pharmacokinetics of BB-K8 and kanamycin in dogs and humans. Antimicrob Ag Chemother 1973; 3:478.
,
LREFClarke JT, Libke, RD, Regamey C, et al. Comparative pharmacokinetics of amikacin and kanamycin. Clin Pharm Ther 1974;15:610.
,
LREFMarik PE, Havlik I, Monteagudo FSE, et al. The pharmacokinetic of amikacin in critically ill adult and pediatric patients: comparison of amikacin in critically ill adult and pediatric patients: comparisonof once-versus twice-daily dosing regimens. J Antimicrob Chemother 1991;27(No. C Suppl):81-89."
While serum levels can be toxic, indiscriminately low dosages of amikacin will result in ineffective treatment for many strains of gram‑negative bacteria. Organisms which are resistant to amikacin will often show increased resistance to all other available aminoglycosides. This observation
LREFOverturf G,Zawacki BE, Wilkins J et al. Emergence of resistance to amikacin during treatment of burn wounds: the role of antimicrobial susceptibility testing. Surgery 1976;79:224-228.
points out the possibility that the indiscriminate use of low dosages of amikacin could engender the emergence of drug‑resistant organisms and possibly render the drug ineffective in treating infectious disease.
LREFPrice KE, Pursiano TA, DeFuria MD et al. Activity of BB-K8 (amikacin) against clinical isolates resistant to one or more aminoglycoside antibiotics. Antimicrob Ag Chemother 1974;5:143-152.
,
LREFBeniviste R, Davies J. Mechanisms of antibiotic resistance in bacteria. J Ann Rev Biochem 1973;42:471.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

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

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at amikacin levels of approximately 5.0 and 30 µg/mL (8.6 and 51.3 µmol/L).

Serum/Plasma

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 50 for conjugated bilirubin and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 50 mg/dL or 855 µmol/L).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 1000 mg/dL or 621 µmol/L).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 2000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Triglycerides: No significant interference from triglycerides up to a concentration of 800 mg/dL (9.0 mmol/L).

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 100 IU/mL.

Total protein: No significant interference from total protein in the concentration range of 2‑12 g/dL.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

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.

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

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

04791959 190

ONLINE TDM Amikacin (75 tests)

System‑ID 07 6926 6

Roche/Hitachi cobas c 311, cobas c 501/502

Materials required (but not provided):

03375781 190

Preciset TDM II Calibrators
CAL A-F (6 x 5 mL)
Diluent (1 x 10 mL)

Codes 743‑748

04521536 190

TDM Control Set
Level I (2 x 5 mL)
Level II (2 x 5 mL)
Level III (2 x 5 mL)


Code 310
Code 311
Code 312

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

System information

For cobas c 311/501 analyzers:

AMIK2: ACN 456

For cobas c 502 analyzers:

AMIK2: ACN 8456

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

Reagent handling

Ready for use

Carefully invert reagent container several times prior to use to ensure that the reagent components are mixed.

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

Application for serum and plasma

Deselect Automatic Rerun for these applications in the Utility menu, Application screen, Range tab.

cobas c 311 test definition

Assay type

2‑Point End

Reaction time /Assay points:

10 / 10‑26

Wavelength (sub/main)

– /700 nm

Reaction direction

Increase

Unit

µg/mL

Reagent pipetting

Diluent (H2O)

R1

167 µL

R2

50 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2.0 µL

Decreased

2.0 µL

Increased

2.0 µL

cobas c 501/502 test definition

Assay type

2‑Point End

Reaction time /Assay points:

10 / 16‑38

Wavelength (sub/main)

– /700 nm

Reaction direction

Increase

Unit

µg/mL

Reagent pipetting

Diluent (H2O)

R1

167 µL

R2

50 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2.0 µL

Decreased

2.0 µL

Increased

2.0 µL

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

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label

On‑board in use and refrigerated on the analyzer :

12 weeks

Do not freeze.

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

Calibration

Calibrator

S1‑6: Preciset TDM II Calibrators

Calibration mode

RCM

Calibration frequency

6‑point calibration
• after reagent lot change
• every 6 weeks
• as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against USP reference standards. The calibrators are prepared to contain known quantities of amikacin in normal human serum.

", "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

Precision was determined using human samples and controls in a modified NCCLS EP5‑A protocol (repeatability n = 63, intermediate precision n = 63). The following results were obtained on a Roche/Hitachi cobas c 501 analyzer.

Serum/Plasma

Repeatability

Mean

SD

CV

µg/mL

µmol/L

µg/mL

µmol/L

%

Control 1

5.07

8.67

0.14

0.24

2.7

Control 2

14.4

24.6

0.16

0.27

1.1

Control 3

28.2

48.2

0.27

0.46

1.0

HS 1

4.98

8.52

0.13

0.22

2.6

HS 2

32.6

55.7

0.31

0.53

0.9

Intermediate precision

Mean

SD

CV

µg/mL

µmol/L

µg/mL

µmol/L

%

Control 1

5.07

8.67

0.19

0.32

3.8

Control 2

14.4

24.6

0.19

0.32

1.3

Control 3

28.2

48.2

0.36

0.62

1.3

HS 1

4.98

8.52

0.17

0.29

3.5

HS 2

32.6

55.7

0.41

0.70

1.3

The data obtained on cobas c 501 analyzer(s) are representative for cobas c 311 analyzer(s).

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

Method comparison

Serum/plasma

Amikacin values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 501 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 analyzer (x) and on a COBAS INTEGRA 700 analyzer (x).

Roche/Hitachi 917 analyzer

Sample size (n) = 57

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 = 0.988x - 0.078 µg/mL

y = 0.986x - 0.033 µg/mL

τ = 0.981

r = 1.000

The sample concentrations were between 1.1 and 37.4 µg/mL (1.88 and 64.0 µmol/L).

COBAS INTEGRA 700 analyzer

Sample size (n) = 53

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 = 0.950x - 0.195 µg/mL

y = 0.949x - 0.327 µg/mL

τ = 0.934

r = 0.993

The sample concentrations were between 1.4 and 39.8 µg/mL (2.39 and 68.1 µmol/L).

The data obtained on cobas c 501 analyzer(s) are representative for cobas c 311 analyzer(s).

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

Summary

Amikacin is a semi‑synthetic aminoglycoside that exhibits bactericidal activity against a wide range of pathogens, including many organisms resistant to other aminoglycosides.

LREFPrice KE,Chisholm DR, Misiek M et al. Microbiological evaluation of BB-K8, a new semi-synthetic aminoglycoside. J Antibiot 1972;25:709.
,
LREFBodey GP, Steward D. In vitro studies of BB-K8, a new aminoglycoside antibiotic. Antimicrob Ag Chemother 1973;4:186.
,
LREFYoung LS, Hewitt WL. Activity of five aminoglycoside antibiotics in vitro against gram-negative bacilli and staphylococcus aureus. Antimicrob Ag Chemother 1973;4:617-625.
,
LREFYourassowsky E, Schoutens E, Vanderlinden MD et al. Comparison of the in vitro activity of BB-K8 and three other aminoglycosides against 215 strains of pseudomonas and enterobacteriaceae with variable sensitivity tokanamycin and gentamicin. Chemother 1975;21:45.
Amikacin is active in vitro against gram‑negative organisms, penicillinase and non‑penicillinase producing staphylococci. The strength of this drug is due primarily to its high degree of resistance to aminoglycoside‑inactivating enzymes.
LREFPrice KE, Pursiano TA, DeFuria MD et al. Activity of BB-K8 (amikacin) against clinical isolates resistant to one or more aminoglycoside antibiotics. Antimicrob Ag Chemother 1974;5:143-152.
Determination of serum or plasma drug levels is required to achieve optimum therapeutic efficacy and minimize toxicity.
LREFJacobs DS, Kaster BL Jr, Demott WR, et al. Laboratory Test Handbook. Stowe, 2nd ed. OH. Lexi-Compl. Mosby 1990;771.

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

Reagents - working solutions

R1

Anti‑amikacin antibody (mouse monoclonal) and human‑sourced material in buffer with preservative

R2

Conjugated amikacin derivative microparticles, human‑sourced material, and preservative

R1 is in position A and R2 is in position B.

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

Precautions and warnings

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

H318

Causes serious eye damage.

Prevention:

P280

Wear eye protection/ face protection.

Response:

P305 + P351 + P338
+ P310

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.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336

All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods use assays that have been approved by the FDA or that are in compliance with the legal rules applicable to placing in vitro diagnostic medical devices for human use on the market in the European Union.
However, as no testing method can rule out the potential risk of infection with absolute certainty, the material should be handled with the same level of care as a patient specimen. In the event of exposure, the directives of the responsible health authorities should be followed.

LREFOccupational Safety and Health Standards: Bloodborne pathogens. (29 CFR Part 1910.1030). Fed. Register.
,
LREFDirective 2000/54/EC of the European Parliament and Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work.

", "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 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.

", "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: Collect serum using standard sampling tubes.
Plasma: K2‑ or K3‑EDTA or Na or Li heparin plasma.

Stability:

8 hours capped at 15‑25 °C

48 hours capped at 2‑8 °C

4 weeks capped at -20 °C

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.

Do not induce foaming of specimens. Specimens should not be repeatedly frozen and thawed.

Invert thawed specimens several times prior to testing.

Usual sampling time varies dependent upon desired measurement of peak or trough values.

LREFRiff LJ, Jackson GG. Pharmacology of gentamicin in man. J Infect Dis 1971;124(Suppl):98-105.

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

AMIK 2

ONLINE TDM Amikacin

IVD For in vitro diagnostic use.
AMIK 2

Overview

Detailed Specifications

Ordering Information

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