This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Certification No. 224ADAMX00107000**Revised: October 2020 (4th edition)*Revised: January 2017 (3rd edition)

This package insert must be read carefully prior to use.
Arbekacin assay kit(Classification No.: 42929000)

antimicrobial activity against staphylococci,
arbekacin is expected to be useful for MRSA
infection.
Clinically significant adverse reactions to arbekacin
include shock, convulsions, eighth cranial nerve
disorders, and acute renal failure. To avoid theseadverse reactions, monitoring the blood concentrationof arbekacin after administration is recommended.1)
Monitoring is also important to promote theappropriate use of antimicrobial agents based onPK/PD2).

Nanopia TDM Arbekacin
General Precautions
1. This product is for in vitro diagnostic use, andmust not be used for any other purposes.
2. Clinicians should make a comprehensive clinicaldecision based on assay results in conjunction withclinical symptoms and other examination results.
3. Please read carefully the "PRECAUTIONS"
section, particularly under "Effects on Laboratory
Tests" of the package insert of each drug, for
information on the influence to the assay result thatmedications administered to the patient have.
Please also read carefully the "2) Cross-reactivity,"
under "2. Interfering Substances," in the"Procedural Precautions" section, as well as "2.
Precautions for Assessment" in the "Assessment ofAssay Results" section, of this package insert.
4. This product should be used only as directed in thispackage insert. Reliability of results cannot beguaranteed if there are any deviations from theinstructions in this package insert.
5. If the reagent accidentally comes in contact witheyes and/or mouth, rinse immediately with ample
water as first aid, and consult the doctor ifrequired.
6. Carefully read the operating instructions for eachtype of automated analyzers prior to using thisproduct. Parameters for each type of analyzers areavailable, and can be requested from SEKISUIMEDICAL CO., LTD. if required.
7. Perform a quality control test prior to assay toensure accuracy.
8. ABK Antibody Solution 1 contains human-derived
components that have been confirmed to be
negative for HBs antigens, HIV antibodies, andHCV antibodies. However, handle this reagent
with great care in the same manner as the samples,
because it is potentially infectious.

Assay Principle
1. Assay Principle
When a certain amount of anti-arbekacin antibody
is added and reacted with a sample, consumptionof the antibody depends on its content in thesample. When arbekacin-coated latex is added,
residual anti-arbekacin antibody reacts with thelatex and forms aggregates.
Since the extent of aggregation depends on thearbekacin concentration in the sample, thearbekacin concentration can be determined bymeasuring aggregation as the absorbance.
Sample (arbekacin) + Anti-arbekacin antibody───▶ Antigen-antibody reaction
Unreacted anti-arbekacin antibody + arbekacincoated latex───▶ Aggregation by antigen-antibody reaction
2. Features
1) Because an anti-arbekacin monoclonal
antibody is used, this product shows excellent
sensitivity and accuracy.
2) Liquid reagents, ready-to-use.
3) It can be measured using the automatedanalyzers commonly used.
＊＊

Procedural Precautions ＊1. Properties of Samples and Sampling Methods
1) Samples
Serum and plasma (EDTA plasma) may beused.
2) Storage of samples(1) After separation of serum (plasma),samples may be stored for up to 7 days in arefrigerator. If samples cannot be measured
within 7 days of serum (plasma)separation, store them at −30C or lowerand measure them within 14 days. Storedsamples should be brought to room
temperature (15–30C) before use.
(2) Arbekacin may undergo degradation if
there is a high concentration of a β-lactam
antibiotic in the sample. Perform assay
immediately after collection of blood orstore the sample frozen.3)(3) Samples may be frozen and thawed up totwice.

Description (Kit Components)
Component: Ingredients
ABK Antibody Solution 1:
Anti-arbekacin mouse monoclonal
antibody
ABK Latex Reagent 2:
Arbekacin-coated latex
Intended Use
Measurement of arbekacin in serum or plasma
Arbekacin is an aminoglycoside antimicrobial agent.
It is resistant to various aminoglycoside-inactivating
enzymes and exhibits strong antimicrobial activity
against staphylococci, including methicillin-resistant
Staphylococcus aureus (MRSA), as well as against
Pseudomonas aeruginosa. Because of its strong13) Caution must be exercised, because aseparating agent, etc. in the blood collection
tube may affect assay values.4)4) Sampling should be performed after removing
insoluble matter from the sample. Very cloudy
specimens should be centrifuged before assay.
2. Interfering substances
1) Assay results are not affected by unconjugatedbilirubin (up to 19.4 mg/dL), conjugatedbilirubin (up to 20.3 mg/dL), hemoglobin (upto 491 mg/dL), formazin turbidity (up to 1410FTU), or rheumatoid factors (up to 500
IU/mL).
2) Cross-reactivity
The following table summarizes the crossreactivity between arbekacin and other drugs.
ConcentCrossSubstanceration testedreactivity(µg/mL)(%)
Amikacin15> 70
Gentamicin
11ND
Kanamycin A
61
1
Kanamycin B
61
ND
Neomycin
60
ND
Netilmicin
20–3
Sisomicin
60–1
Streptomycin
150
ND
Teicoplanin
1500
Tobramycin
252
Vancomycin
1000Isepamicin
3300
ND: Not Detectable
3. Others1) Always use Arbekacin Calibrator for Nanopia
for calibration.
2) Precautions for assay range
If the arbekacin concentration in the sample
exceeds the measurement range, dilute thesample with arbekacin-free serum, andperform re-measurement.

※Calibration material: Arbekacin Calibrator forNanopia (Manufacture's assigned value)
Assessment of Assay Results *1. Reference standard range
It has been reported that the maximum bloodconcentration of arbekacin is related to its
efficacy and the recommended therapeutic range
is 15–20 μg/mL, but there is no clear evidence forthe upper limit.3 It has also been reported that therisk of adverse reactions increases with anincrease in the frequency of abnormally highmaximum and minimum blood concentrations,and that the trough value should be < 1–2 μg/mL
from the standpoint of protecting renal function.3
Since the therapeutic concentrations and toxic
concentrations may overlap, interpretation of
assay results should also be based on the patient's
clinical findings and other examination results.
It is recommended that the blood concentration ofarbekacin should be measured in a sufficientnumber of samples for statistical analysis and thatits therapeutic range should be determined byeach medical institution.
2. Precautions for Assessment
1) There may be reactions or interfering reactions
with non-target substances. If assay resultsappear to be unreliable, repeat the measurement(if necessary, after dilution) or try anotheranalytical methods.
2) This product shows cross-reactivity withamikacin. Accurate assay values cannot beobtained with samples from patients receiving
amikacin.
Performance
1. Sensitivity
1) Absorbance of standard solution (0.0 µg/mL) is3200 (Abs. × 10000).
2) The ratio between the absorbance with thestandard solution (0.0 µg/mL) and that withanother standard solution (2.0 µg/mL) is 55–85%.
2. Accuracy: 80–120 % of the expected assay value
3. Within-run Reproducibility:
Coefficient of variation ≤ 10 %(Test methods used for 1.–3. are in-housemethods.)
4. Measurement Range5): (On Hitachi 7170
automated analyzer)
Minimum detection sensitivity was 0.6μg/mL.
Upper measurement limit is 30.0μg/mL.
5. Correlation5)
Serum N=70 r=0.997 y=0.98x–0.25
Control method: Approved in vitro diagnostic(fluorescence polarization immuno assay)
6. Standard Material
Arbekacin (in-house standard material)

Dosage/Administration (Assay Procedure) *1. Preparation of reagents
Reagent (1): ABK Antibody Solution 1 is ready touse.
Reagent (2): ABK Latex Reagent 2 is ready touse.
Before using this product, gently invert the ABK
Latex Reagent 2 bottle to mix it thoroughly, andcheck that there are no bubbles.
2. Assay Procedure
This product is compatible with various types ofautomated analyzer. An example of the assay
procedure is indicated below.

Sample +3.0 μL

Absorbance I and II: Absorbance at 700 nm

37C Reagent 37C Measurement
Reagent(2)(1) Approx. 120 μL Approx.(Absorbance※
105 μL 5 min
1 min I )Precautions for Use or Handling
1. Precautions for Handling (to Ensure Safety)
1) All samples used in the test should be handled
as a material possibly infected with HIV, HBV,HCV, or other viruses. To prevent infection, use
disposable gloves and avoid mouth pipetting

37C Measurement(AbsorbanceApprox. ※II )4 min
Calculation ofconcentration

2during the test.
2) Sodium azide is added as an antiseptic agent inthis product. Therefore, if the reagent comesin accidentally contact with eyes, mouth or skin,rinse immediately with ample water as first aid,
and consult the doctor if required.
2. Precautions for use
1) This product should be stored as directed,
without freezing. Freezing can deteriorate thereagents, which can produce inaccurate results.
Therefore, avoid using the reagents which havebeen previously frozen.
2) Do not use expired reagents. Use of suchreagents cannot guarantee the reliability ofmeasurement values.
3) Do not replenish the reagents.
4) After completion of measurement, this productshould be tightly stoppered and stored in arefrigerator.
5) Do not mix materials from different kit lotnumbers.
6) Do not perform the assay under direct sunlight
3. Precautions for Disposal
1) Before disposal, used samples and theircontainers must be immersed in sodium
hypochlorite solution at a concentration ofgreater than 0.1% for longer than 1 hour orautoclaved at 121ºC for 20 minutes.
2）To prevent infections from spilled samples orsolutions containing samples, wipe the spilledarea thoroughly with disinfectants such as
sodium hypochlorite solution at a concentrationof greater than 0.1%.
3) The reagents and treated samples should bediscarded as medical waste or industrial waste
according to the waste disposal regulations.
4) The reagents should be disposed of inaccordance with the Water Pollution Control act
or related regulations.
5) Sodium azide has been added as an antiseptic
agent in this product. It can react with lead orcopper pipes to produce the highly explosive
metal azide. Therefore, the reagent should beflushed with large amounts of water during
disposal.
4. Other precautions
Do not use the containers for other purposes.

2) Kizu J. et al.: Jpn J Chemother, 58(4), 2010.
Japanese.
3) Japanese Society of Chemotherapy, JapaneseSociety of Therapeutic Drug Monitoring: A revised
edition of guidelines for therapeutic drug
monitoring of antimicrobials, 2016. Japanese.
4) Dasgupta A., Dean R., et al.：Am J Clin Pathol.
101(4).1994.
5) SEKISUI MEDICAL CO., LTD. In house data.
Japanese.
Contact
SEKISUI MEDICAL CO., LTD.
international@sekisui.com

Storage and Shelf Life *1. Storage temperature: 2–8C
2. Shelf life: 1 year from the date of manufacture(The expiration date is printed on the outerpackage.)
PackagingName
ABK Antibody
Nanopia TDM Solution 1
Arbekacin
ABK Latex
Reagent 2

Manufacturer *SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan

Package1 × 11 mL"Nanopia" is trademark or registered trademarks ofSEKISUI MEDICAL CO., LTD. in Japan and/or othercountries.
All other brands, product names and service names aretrademarks or registered trademarks of their respective
companies.

1 × 12.5 mL

References *1) Package insert of Habekacin Injection 25mg,75mg, 100mg, and 200mg. Japanese.

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