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"StructureNodeStatus": "Active" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0005841291190c701", "ProductName": "GENT2", "ProductLongName": "ONLINE TDM Gentamicin", "Language": "en", "DocumentVersion": "8", "DocumentObjectID": "FF0000000538A60E", "DocumentOriginID": "FF0000000009A50E", "MaterialNumbers": [ "05841291190" ], "InstrumentReferences": [ { "ID": "2492", "BrandName": "cobas c 702" }, { "ID": "310", "BrandName": "cobas c 701" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

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

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

Test principle

The assay is based on the kinetic interaction of microparticles in a solution (KIMS). Gentamicin antibody is covalently coupled to microparticles and the drug derivative is linked to a macromolecule. The kinetic interaction of microparticles in solutions is induced by binding of drug‑conjugate to the antibody on the microparticles and is inhibited by the presence of gentamicin in the sample. A competitive reaction takes place between the drug conjugate and gentamicin in the serum sample for binding to the gentamicin antibody on the microparticles. The resulting kinetic interaction of microparticles is indirectly proportional to the amount of drug present in the sample.

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

Limits and ranges

Measuring range

Measuring range: 0.6‑10.0 µg/mL (1.25‑20.9 µmol/L)

Manually dilute samples having higher concentrations with Preciset TDM I diluent (0 μg/mL) (1 + 1) and reassay. Multiply the result by 2 to obtain the specimen value.

Lower limits of measurement

Lower detection limit of the test

0.3 µg/mL (0.63 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 (< 0.3  µg/mL) will not be flagged by the instrument.

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

Expected values

Although optimum values may vary, peak serum values in the range of 6 to 10 µg/mL (12.5 to 20.9 µmol/L) and trough values in the range of 0.5 to 2.0 µg/mL (1.0 to 4.2 µmol/L) are generally accepted for therapeutic effectiveness.

LREFTaylor WJ, Diers-Caviness MH (eds.). A Textbook for the Clinical Application of Therapeutic Drug Monitoring. Abbott Laboratories 1986:296.
The achievement of non‑toxic, but therapeutic, serum levels is often difficult, even in patients with normal renal function. Complications encountered with the use of gentamicin are ototoxicity and nephrotoxicity.
LREFCox CE. Gentamicin. Med Clin North Am 1970;54:1305-1315.
,
LREFJackson GG, Arcieri GM. Ototoxicity of gentamicin in man: a survey and controlled analysis of clinical experience in the United States. J Infect Dis 1971;124(Suppl):130-137.
,
LREFArcieri GM, Falco FG, Smith HM, et al. Clinical research experience with gentamicin. Incidence of adverse reactions. Med J Aust 1970;1(Suppl):30-34.
,
LREFFalco FG, Smith HM, Arcieri GM. Nephrotoxicity of aminoglycosides and gentamicin. J Infect Dis 1969;119(4):406-409.
,
LREFGyselynck AM, Forrey A, Cutler R. Pharmacokinetics of gentamicin: distribution and plasma and renal clearance. J Infect Dis 1971;124(Suppl):70-76.
However, these reactions are predictable, and close patient monitoring is essential for the successful use of this agent. The most serious toxic effect of gentamicin 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 gentamicin is inherently unstable, is not metabolized and is excreted primarily by glomerular filtration, toxic concentrations of the drug may accumulate in the body when the dosage is not adjusted for patients with impaired renal function. While high serum levels can be toxic, indiscriminately low dosages of gentamicin will result in ineffective treatment for many strains of gram‑negative bacteria. The indiscriminate use of low dosages of gentamicin may not only engender the emergence of gentamicin‑resistant organisms, but also the emergence of aminoglycoside‑resistant organisms.
LREFRiff LJ, Jackson GG. Pharmacology of gentamicin in man. J Infect Dis 1971;124(Suppl):98-105.
,
LREFWeinstein MJ, Drube CG, Moss EL Jr, et al. Microbiologic studies related to bacterial resistance to gentamicin. J Infect Dis 1971;124(Suppl):11-17.
,
LREFJackson GG, Riff LJ. Pseudomonas bacteremia: pharmacologic and other bases for failure of treatment with gentamicin. J Infect Dis 1971;124(Suppl):185-191.
Current literature reflects increasing interest in once daily dosing versus the conventional administration of drug 2 to 4 times daily. Adoption of once daily dosing may require a revision of target peak and trough concentrations.
LREFBarclay ML, Begg EJ, Hickling KG. What is the evidence for once-daily aminoglycoside therapy? Clin Pharmacokinet 1994;27(1):32-48.
,
LREFHustinx WN, Hoepelman IM. Aminoglycoside dosage regimens. Is once a day enough? Clin Pharmacokinet 1993;25(6):427-432.
,
LREFBertino JS Jr, Rodvold KA, Destache CJ. Cost considerations in therapeutic drug monitoring of aminoglycosides. Clin Pharmacokinet 1994;26(1):71-81.

Expected values reflect the data and information provided in the reference and do not represent therapeutic recommendations and / or dosage instructions. For therapeutic recommendations and dosage instructions refer to the respective national guidelines and the full prescription information of the drug.

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 gentamicin levels of approximately 2 and 6 µg/mL (4.2 and 12.5 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 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 150. 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 1000 mg/dL (11.3 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 up to a concentration of 12 g/dL.

Note

A negative bias of up to approximately 20 % has been observed with this assay for some samples artificially spiked with Gentamicin sulfate. Patient samples have been verified to recover correctly.

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.

In very rare cases, patient samples may contain particle agglutinating proteins (e.g. heterophilic antibodies or antibodies due to abnormal immunoglobulin synthesis, such as gammopathies like MGUSb) or Waldenström‘s macroglobulinemia), which may lead to incorrect low or high results with this assay. Correct results cannot be obtained by sample dilution and these samples should be analyzed by an alternative method.

b) Monoclonal Gammopathy of Unknown Significance

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

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is required in certain cases. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SmpCln1+2/SCCS Method Sheet and for further instructions refer to the operator’s manual.

Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.

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

OrderInformation (CC Reagents - cobas + Integra)

Order information

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

05841291190

ONLINE TDM Gentamicin (100 tests)

System‑ID 01 6922 3

cobas c 701/702

Materials required (but not provided):

03375790190

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

Codes 691-696

04521536190

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

Code 310
Code 311
Code 312

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

System information

GENT2: ACN 8416

", "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 701/702 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 12‑29

Wavelength (sub/main)

800/600 nm

Reaction direction

Increase

Unit

µg/mL (µmol/L)

Reagent pipetting

Diluent (H2O)

R1

100 µL

R2

95 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 2‑8 °C:

See expiration date on cobas c pack label

On‑board in use and refrigerated on the analyzer:

4 weeks

On‑board on the Reagent Manager:

24 hours

Do not freeze.

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

Calibration

Calibrators

S1‑6: Preciset TDM I calibrators

Calibration mode

RCM

Calibration frequency

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

ACTION REQUIRED

After any calibration with Preciset TDM I Calibrators, the TDM Control Set have to be run in the order Level 3 to Level 1. Prior to running samples run a blank serum sample. The blank serum sample can be sheduled for any R1/R2 assay which is assigned to the same reagent rotor as the GENT2 reagent.

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 gentamicin 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 (repeatability n = 21, intermediate precision n = 63). The following results were obtained:

Serum/Plasma

Repeatability

Mean

SD

CV

µg/mL

µmol/L

µg/mL

µmol/L

%

Control 1

2.07

4.33

0.05

0.10

2.3

Control 2

5.24

11.0

0.06

0.1

1.2

Control 3

7.79

16.3

0.08

0.2

1.0

Human Serum A

0.741

1.55

0.029

0.06

3.9

Human Serum B

9.36

19.6

0.09

0.2

0.9

Human Serum C

2.84

5.94

0.05

0.10

1.9

Intermediate precision

Mean

SD

CV

µg/mL

µmol/L

µg/mL

µmol/L

%

Control 1

1.87

3.91

0.09

0.19

5.1

Control 2

4.37

9.13

0.09

0.19

2.0

Control 3

6.48

13.5

0.15

0.31

2.3

Human Serum 1

1.90

3.97

0.08

0.17

4.1

Human Serum 2

6.04

12.6

0.17

0.36

2.8

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

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

Method comparison

Serum/Plasma

Gentamicin values for human serum and plasma samples obtained on a cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 (x).

Sample size (n) = 60

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 = 0.993x + 0.079 µg/mL
τ = 0.945

y = 0.976x + 0.141 µg/mL
r = 0.998

The sample concentrations were between 0.80 and 9.94 µg/mL (1.67 and 20.8 µmol/L).

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

Summary

Gentamicin is an aminoglycoside antibiotic that displays broad spectrum, high potency, anti‑bacterial action for most susceptible organisms.

LREFBlack J, Calesnick B, Williams D, et al. Pharmacology of gentamicin, a new broad-spectrum antibiotic. Antimicrob Agents Chemother 1963;161:138-147.
,
LREFOden EM, Stander H, Weinstein MJ. Microbiological assay of gentamicin. Antimicrob Agents Chemother 1963;161:8-13.
,
LREFWaitz JA, Weinstein M. Recent laboratory studies with gentamicin with reference to structure and resistance. Med J Aust 1970;1(Suppl):19-25.
,
LREFMacMillan BG. Ecology of bacteria colonizing the burned patient given topical and systemic gentamicin therapy: a five-year study. J Infect Dis 1971;124(Suppl):278-286.
,
LREFNunnery AW, Riley HD Jr. Gentamicin: clinical and laboratory studies in infants and children. J Infect Dis 1969;119(4):460-464.
,
LREFYoung LS, Louria DB, Armstrong D. Gentamicin in the treatment of severe, hospital-acquired gram-negative infections. Trans NY Acad Sci 1967;29(5):579-588.
,
LREFHolloway WJ, Taylor WA. Gentamicin and kanamycin in the treatment of gram-negative sepsis: a comparative study. J Infect Dis 1971;124(Suppl):180-184.
,
LREFBodey GP, Middleman E, Umsawasdi T, et al. Intravenous gentamicin therapy for infections in patients with cancer. J Infect Dis 1971;124(Suppl):174-179.
,
LREFKlein JO, Herschel M, Therakan RM, et al. Gentamicin in serious neonatal infections: absorption, excretion, and clinical results in 25 cases. J Infect Dis 1971;124(Suppl):224-231.
At therapeutic serum concentrations ranging from 4 to 10 µg/mL (8.4 to 20.9 µmol/L), gentamicin is capable of inhibiting the growth of many gram positive cocci, especially penicillinase-producing staphylococci. At concentrations of 10 µg/mL (20.9 µmol/L), most strains of E. coli, Proteus spp., Klebsiella, Aerobacter, Clostridium, Brucella spp., Salmonella, Serratia, and Shigella are inhibited. At concentrations ranging from 4 to 10 µg/mL (8.4 to 20.9 µmol/L), gentamicin displays activity against most strains of Pseudomonas aeruginosa . Because of these characteristics, gentamicin has been most successfully used in the treatment of serious infections, especially those caused by gram‑negative bacilli.
LREFCox CE. Gentamicin. Med Clin North Am 1970;54:1305-1315.
,
LREFRiff LJ, Jackson GG. Pharmacology of gentamicin in man. J Infect Dis 1971;124(Suppl):98-105.

The therapeutic range of gentamicin should be measured at peak as well as trough concentrations. In patients with pre‑existing renal damage or those to whom gentamicin has been administered for prolonged periods or in doses above the therapeutic range, hearing impairment and/or nephrotoxicity may develop. Therefore, monitoring of peak and trough gentamicin levels is critical in the prevention of these serious complications with the adjustment of dosage administration as indicated.

LREFKahlmeter G. Gentamicin and tobramycin. Clinical pharmacokinetics and nephrotoxicity. Aspects on assay techniques. Scand J Infect Dis 1979;132(Suppl 18):1-40.
,
LREFBarza M, Lauermann M. Why monitor serum levels of gentamicin? Clin Pharm 1978;3:202-215.

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

Reagents - working solutions

R1

Gentamicin conjugate; piperazine‑N,N'‑bis (ethanesulfonic acid) (PIPES) buffer, pH 7.2; preservative

R2

Anti‑gentamicin antibody (mouse monoclonal); latex microparticle; 3‑(N‑morpholino) propane sulfonic acid (MOPS) buffer, pH 7.5; stabilizer; preservative

R1 is in position B and R2 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.

", "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, sodium citrate, or sodium, lithium, or ammonium heparin plasma.

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.

Stability:

1 week capped at 2‑8 °C

4 weeks capped at ‑20 °C

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.

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 through values.

LREFO'Bey KA, Jim LK, Gee JP, et al. Temperature dependence of the stability of tobramycin mixed with penicillins in human serum. Am J Hosp Pharm 1982;39(6):1005-1008.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0004490843190c501", "ProductName": "GENT2", "ProductLongName": "ONLINE TDM Gentamicin", "Language": "en", "DocumentVersion": "14", "DocumentObjectID": "FF000000054DE30E", "DocumentOriginID": "FF0000000009A60E", "MaterialNumbers": [ "04490843190" ], "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 gentamicin in serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

The assay is based on the kinetic interaction of microparticles in a solution (KIMS). Gentamicin antibody is covalently coupled to microparticles and the drug derivative is linked to a macromolecule. The kinetic interaction of microparticles in solutions is induced by binding of drug‑conjugate to the antibody on the microparticles and is inhibited by the presence of gentamicin in the sample. A competitive reaction takes place between the drug conjugate and gentamicin in the serum sample for binding to the gentamicin antibody on the microparticles. The resulting kinetic interaction of microparticles is indirectly proportional to the amount of drug present in the sample.

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

Limits and ranges

Measuring range

Measuring range: 0.4‑10.0 µg/mL (0.84‑20.9 µmol/L)

Manually dilute samples having higher concentrations with Preciset TDM I diluent (0 μg/mL) (1 + 1) and reassay. Multiply the result by 2 to obtain the specimen value.

Lower limits of measurement

Lower detection limit of the test

0.3 µg/mL (0.63 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 in the range of 6 to 10 µg/mL (12.5 to 20.9 µmol/L) and trough values in the range of 0.5 to 2.0 µg/mL (1.0 to 4.2 µmol/L) are generally accepted for therapeutic effectiveness.

LREFTaylor WJ, Diers-Caviness MH (eds.). A Textbook for the Clinical Application of Therapeutic Drug Monitoring. Abbott Laboratories 1986:296.
The achievement of non-toxic, but therapeutic, serum levels is often difficult, even in patients with normal renal function. Complications encountered with the use of gentamicin are ototoxicity and nephrotoxicity.
LREFCox CE. Gentamicin. Med Clin North Am 1970;54:1305-1315.
,
LREFJackson GG, Arcieri GM. Ototoxicity of gentamicin in man: a survey and controlled analysis of clinical experience in the United States. J Infect Dis 1971;124(Suppl):130-137.
,
LREFArcieri GM, Falco FG, Smith HM, et al. Clinical research experience with gentamicin. Incidence of adverse reactions. Med J Aust 1970;1(Suppl):30-34.
,
LREFFalco FG, Smith HM, Arcieri GM. Nephrotoxicity of aminoglycosides and gentamicin. J Infect Dis 1969;119(4):406-409.
,
LREFGyselynck AM, Forrey A, Cutler R. Pharmacokinetics of gentamicin: distribution and plasma and renal clearance. J Infect Dis 1971;124(Suppl):70-76.
However, these reactions are predictable, and close patient monitoring is essential for the successful use of this agent. The most serious toxic effect of gentamicin 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 gentamicin is inherently unstable, is not metabolized and is excreted primarily by glomerular filtration, toxic concentrations of the drug may accumulate in the body when the dosage is not adjusted for patients with impaired renal function. While high serum levels can be toxic, indiscriminately low dosages of gentamicin will result in ineffective treatment for many strains of gram‑negative bacteria. The indiscriminate use of low dosages of gentamicin may not only engender the emergence of gentamicin‑resistant organisms, but also the emergence of aminoglycoside‑resistant organisms.
LREFRiff LJ, Jackson GG. Pharmacology of gentamicin in man. J Infect Dis 1971;124(Suppl):98-105.
,
LREFWeinstein MJ, Drube CG, Moss EL Jr, et al. Microbiologic studies related to bacterial resistance to gentamicin. J Infect Dis 1971;124(Suppl):11-17.
,
LREFJackson GG, Riff LJ. Pseudomonas bacteremia: pharmacologic and other bases for failure of treatment with gentamicin. J Infect Dis 1971;124(Suppl):185-191.
Current literature reflects increasing interest in once daily dosing versus the conventional administration of drug 2 to 4 times daily. Adoption of once daily dosing may require a revision of target peak and trough concentrations.
LREFBarclay ML, Begg EJ, Hickling KG. What is the evidence for once-daily aminoglycoside therapy? Clin Pharmacokinet 1994;27(1):32-48.
,
LREFHustinx WN, Hoepelman IM. Aminoglycoside dosage regimens. Is once a day enough? Clin Pharmacokinet 1993;25(6):427-432.
,
LREFBertino JS Jr, Rodvold KA, Destache CJ. Cost considerations in therapeutic drug monitoring of aminoglycosides. Clin Pharmacokinet 1994;26(1):71-81.

Expected values reflect the data and information provided in the reference and do not represent therapeutic recommendations and / or dosage instructions. For therapeutic recommendations and dosage instructions refer to the respective national guidelines and the full prescription information of the drug.

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 gentamicin levels of approximately 2 and 6 µg/mL (4.2 and 12.5 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 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 150. 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 1000 mg/dL (11.3 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 up to a concentration of 12 g/dL.

Note

A negative bias of up to approximately 20 % has been observed with this assay for some samples artificially spiked with Gentamicin sulfate. Patient samples have been verified to recover correctly.

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.

In very rare cases, patient samples may contain particle agglutinating proteins (e.g. heterophilic antibodies or antibodies due to abnormal immunoglobulin synthesis, such as gammopathies like MGUSb) or Waldenström‘s macroglobulinemia), which may lead to incorrect low or high results with this assay. Correct results cannot be obtained by sample dilution and these samples should be analyzed by an alternative method.

b) Monoclonal Gammopathy of Unknown Significance

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

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. The latest version of the carry‑over evasion list can be found with the NaOHD-SMS-SmpCln1+2-SCCS Method Sheets. For further instructions refer to the operator’s manual. cobas c 502 analyzer: All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is required in certain cases.

Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.

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

OrderInformation (CC Reagents - cobas + Integra)

Order information

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

04490843190

ONLINE TDM Gentamicin (100 tests)

System‑ID 07 6922 3

cobas c 311, cobas c 501/502

Materials required (but not provided):

03375790190

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

Codes 691-696

04521536190

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

Code 310
Code 311
Code 312

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

System information

For cobas c 311/501 analyzer:

GENT2: ACN 416

For cobas c 502 analyzer:

GENT2: ACN 8416

", "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 / 11‑32

Wavelength (sub/main)

800/600 nm

Reaction direction

Increase

Unit

µg/mL (µmol/L)

Reagent pipetting

Diluent (H2O)

R1

100 µL

R2

95 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H20)

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 / 18‑49

Wavelength (sub/main)

800/600 nm

Reaction direction

Increase

Unit

µg/mL (µmol/L)

Reagent pipetting

Diluent (H2O)

R1

100 µL

R2

95 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H20)

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

Calibrators

S1‑6: Preciset TDM I calibrators

Calibration mode

RCM

Calibration frequency

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

ACTION REQUIRED

After any calibration with Preciset TDM I Calibrators, the TDM Control Set have to be run in the order Level 3 to Level 1. Prior to running samples run a blank serum sample. The blank serum sample can be sheduled for any R1/R2 assay.

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 gentamicin 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‑T2 protocol (repeatability n = 63, intermediate precision n = 63). The following results were obtained on a cobas c 501 analyzer.

Serum/Plasma

Repeatability

Mean

SD

CV

µg/mL

µmol/L

µg/mL

µmol/L

%

Control 1

1.87

3.91

0.08

0.17

4.2

Control 2

4.37

9.13

0.08

0.17

1.8

Control 3

6.48

13.5

0.12

0.3

1.8

HS 1

1.90

3.97

0.07

0.15

3.6

HS 2

6.04

12.6

0.13

0.3

2.2

Intermediate precision

Mean

SD

CV

µg/mL

µmol/L

µg/mL

µmol/L

%

Control 1

1.87

3.91

0.09

0.19

5.1

Control 2

4.37

9.13

0.09

0.19

2.0

Control 3

6.48

13.5

0.15

0.31

2.3

HS 1

1.90

3.97

0.08

0.17

4.1

HS 2

6.04

12.6

0.17

0.36

2.8

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

Gentamicin values for human serum and plasma samples obtained on a 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 800 analyzer (x).

Roche/Hitachi 917 analyzer

Sample size (n) = 64

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 = 0.976x - 0.014 µg/mL
τ = 0.962

y = 0.976x - 0.016 µg/mL
r = 0.999

The sample concentrations were between 0.540 and 9.65 µg/mL (1.13 and 20.2 µmol/L).

COBAS INTEGRA 800 analyzer

Sample size (n) = 63

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 = 0.983x - 0.214 µg/mL
τ = 0.965

y = 0.988x - 0.219 µg/mL
r = 0.997

The sample concentrations were between 0.530 and 9.14 µg/mL (1.11 and 19.1 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

Gentamicin is an aminoglycoside antibiotic that displays broad spectrum, high potency, anti‑bacterial action for most susceptible organisms.

LREFBlack J, Calesnick B, Williams D, et al. Pharmacology of gentamicin, a new broad-spectrum antibiotic. Antimicrob Agents Chemother 1963;161:138-147.
,
LREFOden EM, Stander H, Weinstein MJ. Microbiological assay of gentamicin. Antimicrob Agents Chemother 1963;161:8-13.
,
LREFWaitz JA, Weinstein M. Recent laboratory studies with gentamicin with reference to structure and resistance. Med J Aust 1970;1(Suppl):19-25.
,
LREFMacMillan BG. Ecology of bacteria colonizing the burned patient given topical and systemic gentamicin therapy: a five-year study. J Infect Dis 1971;124(Suppl):278-286.
,
LREFNunnery AW, Riley HD Jr. Gentamicin: clinical and laboratory studies in infants and children. J Infect Dis 1969;119(4):460-464.
,
LREFYoung LS, Louria DB, Armstrong D. Gentamicin in the treatment of severe, hospital-acquired gram-negative infections. Trans NY Acad Sci 1967;29(5):579-588.
,
LREFHolloway WJ, Taylor WA. Gentamicin and kanamycin in the treatment of gram-negative sepsis: a comparative study. J Infect Dis 1971;124(Suppl):180-184.
,
LREFBodey GP, Middleman E, Umsawasdi T, et al. Intravenous gentamicin therapy for infections in patients with cancer. J Infect Dis 1971;124(Suppl):174-179.
,
LREFKlein JO, Herschel M, Therakan RM, et al. Gentamicin in serious neonatal infections: absorption, excretion, and clinical results in 25 cases. J Infect Dis 1971;124(Suppl):224-231.
At therapeutic serum concentrations ranging from 4 to 10 µg/mL (8.4 to 20.9 µmol/L), gentamicin is capable of inhibiting the growth of many gram positive cocci, especially penicillinase-producing staphylococci. At concentrations of 10 µg/mL (20.9 µmol/L), most strains of E. coli, Proteus spp., Klebsiella, Aerobacter, Clostridium, Brucella spp., Salmonella, Serratia, and Shigella are inhibited. At concentrations ranging from 4 to 10 µg/mL (8.4 to 20.9 µmol/L), gentamicin displays activity against most strains of Pseudomonas aeruginosa . Because of these characteristics, gentamicin has been most successfully used in the treatment of serious infections, especially those caused by gram‑negative bacilli.
LREFCox CE. Gentamicin. Med Clin North Am 1970;54:1305-1315.
,
LREFRiff LJ, Jackson GG. Pharmacology of gentamicin in man. J Infect Dis 1971;124(Suppl):98-105.

The therapeutic range of gentamicin should be measured at peak as well as trough concentrations. In patients with pre‑existing renal damage or those to whom gentamicin has been administered for prolonged periods or in doses above the therapeutic range, hearing impairment and/or nephrotoxicity may develop. Therefore, monitoring of peak and trough gentamicin levels is critical in the prevention of these serious complications with the adjustment of dosage administration as indicated.

LREFKahlmeter G. Gentamicin and tobramycin. Clinical pharmacokinetics and nephrotoxicity. Aspects on assay techniques. Scand J Infect Dis 1979;132(Suppl 18):1-40.
,
LREFBarza M, Lauermann M. Why monitor serum levels of gentamicin? Clin Pharm 1978;3:202-215.

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

Reagents - working solutions

R1

Gentamicin conjugate; piperazine‑N,N'‑bis (ethanesulfonic acid) (PIPES) buffer, pH 7.2; preservative

R2

Anti‑gentamicin antibody (mouse monoclonal); latex microparticle; 3‑(N‑morpholino) propane sulfonic acid (MOPS) buffer, pH 7.5; stabilizer; preservative

R1 is in position B and R2 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.

", "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, sodium citrate, or sodium, lithium, or ammonium heparin plasma.

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.

Stability:

1 week capped at 2‑8 °C

4 weeks capped at ‑20 °C

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.

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 through values.

LREFO'Bey KA, Jim LK, Gee JP, et al. Temperature dependence of the stability of tobramycin mixed with penicillins in human serum. Am J Hosp Pharm 1982;39(6):1005-1008.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0108057770190c503", "ProductName": "GENT2", "ProductLongName": "ONLINE TDM Gentamicin", "Language": "en", "DocumentVersion": "7", "DocumentObjectID": "FF000000058F320E", "DocumentOriginID": "FF00000004D92F0E", "MaterialNumbers": [ "08057770190" ], "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 gentamicin in serum and plasma on cobas c systems.

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

Test principle

The assay is based on the kinetic interaction of microparticles in a solution (KIMS). Gentamicin antibody is covalently coupled to microparticles and the drug derivative is linked to a macromolecule. The kinetic interaction of microparticles in solutions is induced by binding of drug‑conjugate to the antibody on the microparticles and is inhibited by the presence of gentamicin in the sample. A competitive reaction takes place between the drug conjugate and gentamicin in the serum sample for binding to the gentamicin antibody on the microparticles. The resulting kinetic interaction of microparticles is indirectly proportional to the amount of drug present in the sample.

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

Limits and ranges

Measuring range

Measuring range: 0.4‑10.0 µg/mL (0.84‑20.9 µmol/L)

Manually dilute samples having higher concentrations with Preciset TDM I diluent (0 μg/mL) (1 + 1) 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

= 0.3 µg/mL (0.63 µmol/L)

Limit of Detection

= 0.4 µg/mL (0.84 µmol/L)

Limit of Quantitation

= 0.8 µg/mL (1.67 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 gentamicin samples.

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

Expected values

Although optimum values may vary, peak serum values in the range of
6 to 10 µg/mL
(12.5 to 20.9 µmol/L)*
and trough values in the range of
0.5 to 2.0 µg/mL
(1.0 to 4.2 µmol/L)* are generally accepted for therapeutic effectiveness.

LREFTaylor WJ, Diers-Caviness MH (eds.). A Textbook for the Clinical Application of Therapeutic Drug Monitoring. Abbott Laboratories 1986:296.

*calculated by unit conversion factor

The achievement of non-toxic, but therapeutic, serum levels is often difficult, even in patients with normal renal function. Complications encountered with the use of gentamicin are ototoxicity and nephrotoxicity.

LREFCox CE. Gentamicin. Med Clin North Am 1970;54:1305-1315.
,
LREFJackson GG, Arcieri GM. Ototoxicity of gentamicin in man: a survey and controlled analysis of clinical experience in the United States. J Infect Dis 1971;124(Suppl):130-137.
,
LREFArcieri GM, Falco FG, Smith HM, et al. Clinical research experience with gentamicin. Incidence of adverse reactions. Med J Aust 1970;1(Suppl):30-34.
,
LREFFalco FG, Smith HM, Arcieri GM. Nephrotoxicity of aminoglycosides and gentamicin. J Infect Dis 1969;119(4):406-409.
,
LREFGyselynck AM, Forrey A, Cutler R. Pharmacokinetics of gentamicin: distribution and plasma and renal clearance. J Infect Dis 1971;124(Suppl):70-76.
However, these reactions are predictable, and close patient monitoring is essential for the successful use of this agent. The most serious toxic effect of gentamicin 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 gentamicin is inherently unstable, is not metabolized and is excreted primarily by glomerular filtration, toxic concentrations of the drug may accumulate in the body when the dosage is not adjusted for patients with impaired renal function. While high serum levels can be toxic, indiscriminately low dosages of gentamicin will result in ineffective treatment for many strains of gram‑negative bacteria. The indiscriminate use of low dosages of gentamicin may not only engender the emergence of gentamicin‑resistant organisms, but also the emergence of aminoglycoside‑resistant organisms.
LREFRiff LJ, Jackson GG. Pharmacology of gentamicin in man. J Infect Dis 1971;124(Suppl):98-105.
,
LREFWeinstein MJ, Drube CG, Moss EL Jr, et al. Microbiologic studies related to bacterial resistance to gentamicin. J Infect Dis 1971;124(Suppl):11-17.
,
LREFJackson GG, Riff LJ. Pseudomonas bacteremia: pharmacologic and other bases for failure of treatment with gentamicin. J Infect Dis 1971;124(Suppl):185-191.
Current literature reflects increasing interest in once daily dosing versus the conventional administration of drug 2 to 4 times daily. Adoption of once daily dosing may require a revision of target peak and trough concentrations.
LREFBarclay ML, Begg EJ, Hickling KG. What is the evidence for once-daily aminoglycoside therapy? Clin Pharmacokinet 1994;27(1):32-48.
,
LREFHustinx WN, Hoepelman IM. Aminoglycoside dosage regimens. Is once a day enough? Clin Pharmacokinet 1993;25(6):427-432.
,
LREFBertino JS Jr, Rodvold KA, Destache CJ. Cost considerations in therapeutic drug monitoring of aminoglycosides. Clin Pharmacokinet 1994;26(1):71-81.

Expected values reflect the data and information provided in the reference and do not represent therapeutic recommendations and / or dosage instructions. For therapeutic recommendations and dosage instructions refer to the respective national guidelines and the full prescription information of the drug.

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 gentamicin levels of approximately 2 and 6 µg/mL.

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 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 150. 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 1000 mg/dL (11.3 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 up to a concentration of 12 g/dL.

Note

A negative bias of up to approximately 20 % has been observed with this assay for some samples artificially spiked with gentamicin sulfate. Patient samples have been verified to recover correctly.

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.

In very rare cases, patient samples may contain particle agglutinating proteins (e.g. heterophilic antibodies or antibodies due to abnormal immunoglobulin synthesis, such as gammopathies like MGUSb) or Waldenström‘s macroglobulinemia), which may lead to incorrect low or high results with this assay. Correct results cannot be obtained by sample dilution and these samples should be analyzed by an alternative method.

b) Monoclonal Gammopathy of Unknown Significance

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

08057770190

ONLINE TDM Gentamicin (100 tests)

System‑ID 2059 001

cobas c 303, cobas c 503

08057770190

ONLINE TDM Gentamicin (100 tests)

System‑ID 2059 002

cobas c 303, cobas c 503

Materials required (but not provided):

03375790190

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

Codes 20691-20696

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

GENT2: ACN 20590 (100 tests; System ID 2059 001)

GENT2O: ACN 20591 (100 tests; System ID 2059 002)

", "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)

800/600 nm

Reagent pipetting

Diluent (H2O)

R1

65 µL

R3

62 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

1.3 µL

Decreased

1.3 µL

Increased

1.3 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:

12 weeks

Do not freeze.

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

Calibration

Calibrators

S1‑6: Preciset TDM I calibrators

Calibration mode

Non‑linear

Calibration frequency
System ID 2059 001

Full calibration
- after cobas c pack change
- after reagent lot change
- as required following quality control procedures

Calibration frequency
System ID 2059 002

Full calibration
- after cobas c pack change
- after reagent lot change
- every 4 weeks on‑board
- 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 gentamicin 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)

1.81

0.0375

2.1

TDMC2b)

4.49

0.0558

1.2

TDMC3c)

6.48

0.0786

1.2

Human serum 1

0.663

0.0392

5.9

Human serum 2

1.94

0.0353

1.8

Human serum 3

4.60

0.0518

1.1

Human serum 4

7.76

0.108

1.4

Human serum 5

7.90

0.129

1.6

Intermediate precision

Mean
µg/mL

SD
µg/mL

CV
%

TDMC1

FREFTDM Control Set Level I

1.81

0.0544

3.0

TDMC2

FREFTDM Control Set Level II

4.45

0.0720

1.6

TDMC3

FREFTDM Control Set Level III

6.48

0.106

1.6

Human serum 1

0.663

0.0525

7.9

Human serum 2

1.89

0.0581

3.1

Human serum 3

4.63

0.0876

1.9

Human serum 4

7.76

0.149

1.9

Human serum 5

7.90

0.167

2.1

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

Gentamicin 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) = 82

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 = 1.000x - 0.0200 µg/mL
τ = 0.970

y = 1.002x - 0.0312 µg/mL
r = 0.999

The sample concentrations were between 0.41 and 9.81 µg/mL.

Serum/plasma

Gentamicin 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) = 77

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 = 1.079x - 0.205 µg/mL
τ = 0.954

y = 1.091x - 0.231 µg/mL
r = 0.996

The sample concentrations were between 0.470 and 9.68 µg/mL.

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

Summary

Gentamicin is an aminoglycoside antibiotic that displays broad spectrum, high potency, anti‑bacterial action for most susceptible organisms.

LREFBlack J, Calesnick B, Williams D, et al. Pharmacology of gentamicin, a new broad-spectrum antibiotic. Antimicrob Agents Chemother 1963;161:138-147.
,
LREFOden EM, Stander H, Weinstein MJ. Microbiological assay of gentamicin. Antimicrob Agents Chemother 1963;161:8-13.
,
LREFWaitz JA, Weinstein M. Recent laboratory studies with gentamicin with reference to structure and resistance. Med J Aust 1970;1(Suppl):19-25.
,
LREFMacMillan BG. Ecology of bacteria colonizing the burned patient given topical and systemic gentamicin therapy: a five-year study. J Infect Dis 1971;124(Suppl):278-286.
,
LREFNunnery AW, Riley HD Jr. Gentamicin: clinical and laboratory studies in infants and children. J Infect Dis 1969;119(4):460-464.
,
LREFYoung LS, Louria DB, Armstrong D. Gentamicin in the treatment of severe, hospital-acquired gram-negative infections. Trans NY Acad Sci 1967;29(5):579-588.
,
LREFHolloway WJ, Taylor WA. Gentamicin and kanamycin in the treatment of gram-negative sepsis: a comparative study. J Infect Dis 1971;124(Suppl):180-184.
,
LREFBodey GP, Middleman E, Umsawasdi T, et al. Intravenous gentamicin therapy for infections in patients with cancer. J Infect Dis 1971;124(Suppl):174-179.
,
LREFKlein JO, Herschel M, Therakan RM, et al. Gentamicin in serious neonatal infections: absorption, excretion, and clinical results in 25 cases. J Infect Dis 1971;124(Suppl):224-231.
At therapeutic serum concentrations ranging from 4 to 10 µg/mL (8.4 to 20.9 µmol/L), gentamicin is capable of inhibiting the growth of many gram positive cocci, especially penicillinase-producing staphylococci. At concentrations of 10 µg/mL (20.9 µmol/L), most strains of E. coli, Proteus spp., Klebsiella, Aerobacter, Clostridium, Brucella spp., Salmonella, Serratia, and Shigella are inhibited. At concentrations ranging from 4 to 10 µg/mL (8.4 to 20.9 µmol/L), gentamicin displays activity against most strains of Pseudomonas aeruginosa . Because of these characteristics, gentamicin has been most successfully used in the treatment of serious infections, especially those caused by gram‑negative bacilli.
LREFCox CE. Gentamicin. Med Clin North Am 1970;54:1305-1315.
,
LREFRiff LJ, Jackson GG. Pharmacology of gentamicin in man. J Infect Dis 1971;124(Suppl):98-105.

The therapeutic range of gentamicin should be measured at peak as well as trough concentrations. In patients with pre‑existing renal damage or those to whom gentamicin has been administered for prolonged periods or in doses above the therapeutic range, hearing impairment and/or nephrotoxicity may develop. Therefore, monitoring of peak and trough gentamicin levels is critical in the prevention of these serious complications with the adjustment of dosage administration as indicated.

LREFKahlmeter G. Gentamicin and tobramycin. Clinical pharmacokinetics and nephrotoxicity. Aspects on assay techniques. Scand J Infect Dis 1979;132(Suppl 18):1-40.
,
LREFBarza M, Lauermann M. Why monitor serum levels of gentamicin? Clin Pharm 1978;3:202-215.

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

Reagents - working solutions

R1

Gentamicin conjugate; piperazine‑N,N'‑bis (ethanesulfonic acid) (PIPES) buffer, pH 7.2; preservative

R3

Anti‑gentamicin antibody (mouse monoclonal); latex microparticle; 3‑(N‑morpholino) propane sulfonic acid (MOPS) buffer, pH 7.5; stabilizer; 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.

", "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 12 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, sodium citrate, or sodium, lithium, or ammonium heparin plasma.

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.

Stability:

1 week capped at 2‑8 °C

4 weeks capped at ‑20 °C

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

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.

LREFO'Bey KA, Jim LK, Gee JP, et al. Temperature dependence of the stability of tobramycin mixed with penicillins in human serum. Am J Hosp Pharm 1982;39(6):1005-1008.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0008057770190c503", "ProductName": "GENT2", "ProductLongName": "ONLINE TDM Gentamicin", "Language": "en", "DocumentVersion": "1", "DocumentObjectID": "FF000000037DE20E", "DocumentOriginID": "FF000000037DE20E", "MaterialNumbers": [ "08057770190" ], "InstrumentReferences": [ { "ID": "8481", "BrandName": "cobas c 503" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

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

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

Test principle

The assay is based on the kinetic interaction of microparticles in a solution (KIMS). Gentamicin antibody is covalently coupled to microparticles and the drug derivative is linked to a macromolecule. The kinetic interaction of microparticles in solutions is induced by binding of drug‑conjugate to the antibody on the microparticles and is inhibited by the presence of gentamicin in the sample. A competitive reaction takes place between the drug conjugate and gentamicin in the serum sample for binding to the gentamicin antibody on the microparticles. The resulting kinetic interaction of microparticles is indirectly proportional to the amount of drug present in the sample.

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

Limits and ranges

Measuring range

Measuring range: 0.4‑10.0 µg/mL (0.84‑20.9 µmol/L)

Manually dilute samples having higher concentrations with Preciset TDM I diluent (0 μg/mL) (1 + 1) 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

= 0.3 µg/mL (0.63 µmol/L)

Limit of Detection

= 0.4 µg/mL (0.84 µmol/L)

Limit of Quantitation

= 0.8 µg/mL (1.67 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 gentamicin samples.

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

Expected values

Although optimum values may vary, peak serum values in the range of
6 to 10 µg/mL
(12.5 to 20.9 µmol/L)*
and trough values in the range of
0.5 to 2.0 µg/mL
(1.0 to 4.2 µmol/L)* are generally accepted for therapeutic effectiveness.

LREFTaylor WJ, Diers-Caviness MH (eds.). A Textbook for the Clinical Application of Therapeutic Drug Monitoring. Abbott Laboratories 1986:296.

*calculated by unit conversion factor

The achievement of non-toxic, but therapeutic, serum levels is often difficult, even in patients with normal renal function. Complications encountered with the use of gentamicin are ototoxicity and nephrotoxicity.

LREFCox CE. Gentamicin. Med Clin North Am 1970;54:1305-1315.
,
LREFJackson GG, Arcieri GM. Ototoxicity of gentamicin in man: a survey and controlled analysis of clinical experience in the United States. J Infect Dis 1971;124(Suppl):130-137.
,
LREFArcieri GM, Falco FG, Smith HM, et al. Clinical research experience with gentamicin. Incidence of adverse reactions. Med J Aust 1970;1(Suppl):30-34.
,
LREFFalco FG, Smith HM, Arcieri GM. Nephrotoxicity of aminoglycosides and gentamicin. J Infect Dis 1969;119(4):406-409.
,
LREFGyselynck AM, Forrey A, Cutler R. Pharmacokinetics of gentamicin: distribution and plasma and renal clearance. J Infect Dis 1971;124(Suppl):70-76.
However, these reactions are predictable, and close patient monitoring is essential for the successful use of this agent. The most serious toxic effect of gentamicin 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 gentamicin is inherently unstable, is not metabolized and is excreted primarily by glomerular filtration, toxic concentrations of the drug may accumulate in the body when the dosage is not adjusted for patients with impaired renal function. While high serum levels can be toxic, indiscriminately low dosages of gentamicin will result in ineffective treatment for many strains of gram‑negative bacteria. The indiscriminate use of low dosages of gentamicin may not only engender the emergence of gentamicin‑resistant organisms, but also the emergence of aminoglycoside‑resistant organisms.
LREFRiff LJ, Jackson GG. Pharmacology of gentamicin in man. J Infect Dis 1971;124(Suppl):98-105.
,
LREFWeinstein MJ, Drube CG, Moss EL Jr, et al. Microbiologic studies related to bacterial resistance to gentamicin. J Infect Dis 1971;124(Suppl):11-17.
,
LREFJackson GG, Riff LJ. Pseudomonas bacteremia: pharmacologic and other bases for failure of treatment with gentamicin. J Infect Dis 1971;124(Suppl):185-191.
Current literature reflects increasing interest in once daily dosing versus the conventional administration of drug 2 to 4 times daily. Adoption of once daily dosing may require a revision of target peak and trough concentrations.
LREFBarclay ML, Begg EJ, Hickling KG. What is the evidence for once-daily aminoglycoside therapy? Clin Pharmacokinet 1994;27(1):32-48.
,
LREFHustinx WN, Hoepelman IM. Aminoglycoside dosage regimens. Is once a day enough? Clin Pharmacokinet 1993;25(6):427-432.
,
LREFBertino JS Jr, Rodvold KA, Destache CJ. Cost considerations in therapeutic drug monitoring of aminoglycosides. Clin Pharmacokinet 1994;26(1):71-81.

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 gentamicin levels of approximately 2 and 6 µg/mL.

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 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 150. 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 1000 mg/dL (11.3 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 up to a concentration of 12 g/dL.

Note

A negative bias of up to approximately 20 % has been observed with this assay for some samples artificially spiked with gentamicin sulfate. Patient samples have been verified to recover correctly.

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.

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

OrderInformation (CC Reagents - cobas + Integra)

Order information

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

08057770 190

ONLINE TDM Gentamicin (100 tests)

System‑ID 2059 001

Roche/Hitachi cobas c 503

03375790 190

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

Codes 20691-20696

04521536 190

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

Code 20310
Code 20311
Code 20312

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

System information

GENT2: ACN 20590

", "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)

800/600 nm

Reagent pipetting

Diluent (H2O)

R1

65 µL

R3

62 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

1.3 µL

Decreased

1.3 µL

Increased

1.3 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:

12 weeks

Do not freeze.

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

Calibration

Calibrators

S1‑6: Preciset TDM I calibrators

Calibration mode

Non‑linear

Calibration frequency

Full calibration
- after cobas c pack change
- after reagent lot change
- as required following quality control procedures

ACTION REQUIRED

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 gentamicin 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). The following results were obtained:

Serum/plasma

Repeatability

Mean
µg/mL

SD
µg/mL

CV
%

TDMC1a)

1.81

0.0375

2.1

TDMC2b)

4.49

0.0558

1.2

TDMC3c)

6.48

0.0786

1.2

Human serum 1

0.663

0.0392

5.9

Human serum 2

1.94

0.0353

1.8

Human serum 3

4.60

0.0518

1.1

Human serum 4

7.76

0.108

1.4

Human serum 5

7.90

0.129

1.6

Intermediate precision

Mean
µg/mL

SD
µg/mL

CV
%

TDMC1

FREFTDM Control Set Level I

1.81

0.0544

3.0

TDMC2

FREFTDM Control Set Level II

4.45

0.0720

1.6

TDMC3

FREFTDM Control Set Level III

6.48

0.106

1.6

Human serum 1

0.663

0.0525

7.9

Human serum 2

1.89

0.0581

3.1

Human serum 3

4.63

0.0876

1.9

Human serum 4

7.76

0.149

1.9

Human serum 5

7.90

0.167

2.1

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

Method comparison

Serum/plasma

Gentamicin values for human serum and plasma samples obtained 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) = 82

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 = 1.000x - 0.0200 µg/mL
τ = 0.970

y = 1.002x - 0.0312 µg/mL
r = 0.999

The sample concentrations were between 0.41 and 9.81 µg/mL.

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

Summary

Gentamicin is an aminoglycoside antibiotic that displays broad spectrum, high potency, anti‑bacterial action for most susceptible organisms.

LREFBlack J, Calesnick B, Williams D, et al. Pharmacology of gentamicin, a new broad-spectrum antibiotic. Antimicrob Agents Chemother 1963;161:138-147.
,
LREFOden EM, Stander H, Weinstein MJ. Microbiological assay of gentamicin. Antimicrob Agents Chemother 1963;161:8-13.
,
LREFWaitz JA, Weinstein M. Recent laboratory studies with gentamicin with reference to structure and resistance. Med J Aust 1970;1(Suppl):19-25.
,
LREFMacMillan BG. Ecology of bacteria colonizing the burned patient given topical and systemic gentamicin therapy: a five-year study. J Infect Dis 1971;124(Suppl):278-286.
,
LREFNunnery AW, Riley HD Jr. Gentamicin: clinical and laboratory studies in infants and children. J Infect Dis 1969;119(4):460-464.
,
LREFYoung LS, Louria DB, Armstrong D. Gentamicin in the treatment of severe, hospital-acquired gram-negative infections. Trans NY Acad Sci 1967;29(5):579-588.
,
LREFHolloway WJ, Taylor WA. Gentamicin and kanamycin in the treatment of gram-negative sepsis: a comparative study. J Infect Dis 1971;124(Suppl):180-184.
,
LREFBodey GP, Middleman E, Umsawasdi T, et al. Intravenous gentamicin therapy for infections in patients with cancer. J Infect Dis 1971;124(Suppl):174-179.
,
LREFKlein JO, Herschel M, Therakan RM, et al. Gentamicin in serious neonatal infections: absorption, excretion, and clinical results in 25 cases. J Infect Dis 1971;124(Suppl):224-231.
At therapeutic serum concentrations ranging from 4 to 10 µg/mL (8.4 to 20.9 µmol/L), gentamicin is capable of inhibiting the growth of many gram positive cocci, especially penicillinase-producing staphylococci. At concentrations of 10 µg/mL (20.9 µmol/L), most strains of E. coli, Proteus spp., Klebsiella, Aerobacter, Clostridium, Brucella spp., Salmonella, Serratia, and Shigella are inhibited. At concentrations ranging from 4 to 10 µg/mL (8.4 to 20.9 µmol/L), gentamicin displays activity against most strains of Pseudomonas aeruginosa . Because of these characteristics, gentamicin has been most successfully used in the treatment of serious infections, especially those caused by gram‑negative bacilli.
LREFCox CE. Gentamicin. Med Clin North Am 1970;54:1305-1315.
,
LREFRiff LJ, Jackson GG. Pharmacology of gentamicin in man. J Infect Dis 1971;124(Suppl):98-105.

The therapeutic range of gentamicin should be measured at peak as well as trough concentrations. In patients with pre‑existing renal damage or those to whom gentamicin has been administered for prolonged periods or in doses above the therapeutic range, hearing impairment and/or nephrotoxicity may develop. Therefore, monitoring of peak and trough gentamicin levels is critical in the prevention of these serious complications with the adjustment of dosage administration as indicated.

LREFKahlmeter G. Gentamicin and tobramycin. Clinical pharmacokinetics and nephrotoxicity. Aspects on assay techniques. Scand J Infect Dis 1979;132(Suppl 18):1-40.
,
LREFBarza M, Lauermann M. Why monitor serum levels of gentamicin? Clin Pharm 1978;3:202-215.

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

Reagents - working solutions

R1

Gentamicin conjugate; piperazine‑N,N'‑bis (ethanesulfonic acid) (PIPES) buffer, pH 7.2; preservative

R3

Anti‑gentamicin antibody (mouse monoclonal); latex microparticle; 3‑(N‑morpholino) propane sulfonic acid (MOPS) buffer, pH 7.5; stabilizer; 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.
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.

", "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 12 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, sodium citrate, or sodium, lithium, or ammonium heparin plasma.

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.

Stability:

1 week capped at 2‑8 °C

4 weeks capped at ‑20 °C

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.

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.

LREFO'Bey KA, Jim LK, Gee JP, et al. Temperature dependence of the stability of tobramycin mixed with penicillins in human serum. Am J Hosp Pharm 1982;39(6):1005-1008.

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

GENT2

ONLINE TDM Gentamicin

IVD For in vitro diagnostic use.
GENT2

Overview

Detailed Specifications

Ordering Information

Compatible Instruments

...
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    Technical Documents

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