This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 13A2X00197223001**Revised: January, 2017 (3rd edition)*Revised: April,2014( 2nd edition)

This package insert must be read carefully prior to use.
Vancomycin assay kit(Classification No.: 30414000)

treatment of MRSA around the world.
The most important adverse reactions to vancomycin
include renal dysfunction and hearing impairment.
Since these reactions are associated with the bloodconcentration of the drug, they can generally beavoided by monitoring blood levels.1) Monitoring theblood concentration of vancomycin is also importantfor implementing proper use of this antimicrobial
agent based on PK/PD.2)

Nanopia TDM Vancomycin
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. The influence of medications administered to thepatient on assay results is described in the"PRECAUTIONS" section, particularly under"Effects on Laboratory Tests," of the package
insert of each drug. Please also read "2)
Cross-reactivity" under "2. Interfering Substances"in the "Procedural Precautions" section, as well as"2. Precautions for Assessment" in the"Assessment of Assay Results" section, of thispackage 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. VCM Antibody Solution 1 contains materials ofhuman origin that have been shown to be negativefor HBs antigen, HIV (AIDS viruses) antibodies,and HCV antibodies. However, this reagent (aswell as the specimens) should be consideredpotentially infectious and handled with great care.

Assay Principle
1. Assay Principle
When a certain amount of anti-vancomycin
antibody is added to a specimen theanti-vancomycin antibody binds to vancomycin
until it has reacted with all of the available
vancomycin
inthespecimen.
Then
vancomycin-coated latex is added, which reactwith the residual anti-vancomycin antibody,leading to agglutination. Since the extent ofagglutination depends on the concentration ofvancomycin in the specimen, the vancomycin
concentration can be determined by measuring theabsorbance as an indicator of agglutination.
Specimen (vancomycin) + Anti-vancomycin antibody
Antigen-antibody reaction
Residualanti-vancomycin
antibody+
Vancomycin-coated latex
Agglutination via an antigen-antibody
reaction
2. Features
1) A highly specific monoclonal antibody enables
highly sensitive and precise measurement.
2) Liquid reagents, ready-to-use.
3) Applicable to various automated analyzers.
Procedural Precautions ＊＊1. Properties of Samples and Sampling Methods
1) Samples
Serum and plasma (heparin plasma and EDTAplasma) may be used.
2) Storage of samples1)(1) After separation of serum or plasma,
specimens may be stored for up to 7 days ina refrigerator. If secimens cannot bemeasured within 7 days of separation, store
at -20C and measure within 28 days.
Bring samples to room temperature (15–30
C) before use.
(2) Specimens may be frozen and thawed up totwice.
3) The separating agent or other substances in ablood collection tube may influence the assayresults. Attention should be paid to this risk.3)
4) Remove insoluble matter from specimens
before performing the sampling procedure.
Centrifuge heavily turbid specimens before
measurement.
2. Interfering substances
1) Assay results are not affected by free bilirubin

Description (Kit Components)
Component: IngredientsVCM Antibody Solution 1: Mouse anti-vancomycin
monoclonal antibody
VCM Latex Reagent 2: Vancomycin-coated latex
Intended Use
Measurement of the vancomycin in serum orplasma
Vancomycin is a glycopeptide antibiotic isolated
from the species Amycolatopsis orientalis. It shows
potent antimicrobial activity against Gram-positivebacteria
andisalso
effective
againstmethicillin-resistant Staphylococcus aureus (MRSA),
which is a multidrug-resistant organism. Therefore, it
is currently used as the first-line drug for the1(up to 18.7 mg/dL), conjugated bilirubin (up to19.7 mg/dL), hemoglobin (up to 498 mg/dL),
formazin turbidity (up to 1440 FTU), andrheumatoid factor (up to 450 IU/mL).
2) Cross-reactivity
Cross-reactivity with vancomycin analogs andvarious other agents is detailed in the tables
below.
(1) Vancomycin analogs
ConcenCrosstration
Substance
reactivity
tested(%)(g/mL)
Crystalline Degradation
100
3.69
Product-I (CDP-I)
Teicoplanin
100
1.2(2) Drugs
commonlyvancomycin
Substance
Acetaminophen
Amikacin
Amphotericin B
Ampicillin
Bendroflumethiazide
Caffeine
Carbenicillin
Cefamandole nafate
Cefazolin
Cefalexin
Cephalosporin
Cephalothin
Chloramphenicol
Chlorothiazide
Clindamycin
Erythromycin
Etacrynic acid
Ethambutol
5-Fluorocytosine
Furosemide
Fusidic acid
Gentamicin
Hydrochlorothiazide
Ibuprofen
Isoniazid
Kanamycin AKanamycin B
Lincomycin
Methotrexate
Methylprednisolone
Nalidixic acid
Naproxen
Neomycin sulfate
NiacinNitrofurantoinprescribed
Concentration
tested(g/mL)
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500

Oxytetracycline
Penicillin G
Penicillin V
Phenacetin
Prednisolone
Prednisone
Rifampicin
Salicylic acid
Sisomicin
Spectinomycin
Sulfadiazine
Sulfamethoxazole
Sulfisoxazole
fuTetracycline
Tobramycin
Trimethoprimwith

Crossreactivity(%)

500500
500
500
500
500
500
500
500
500
500
500
500500500500

-0.07
-0.01
0.01
-0.04
0.02
0.03
0.07
0.10
0.07
-0.05
-0.03
0.00
-0.02
0.04
-0.16
-0.04

3. Others
1) Always use Vancomycin Calibrator for
Nanopia for calibration.
2) Precautions for assay range
If the concentration of sample exceeds assay
range, dilute the sample with saline and repeat
the measurement.

0.05
-0.02
-0.07
0.08
0.05
0.04
0.06
-0.17
-0.04
-0.11
-0.05
-0.14
0.03
0.16
0.09
-0.11
-0.01
0.06
-0.14
0.05
0.05
0.01
0.06
-0.07
-0.05
0.05
0.07
0.01
-0.11
-0.04
-0.17
-0.03
0.12
0.03
0.03

Dosage/Administration (Assay Procedure) ＊＊1. Preparation of reagents
Reagent (1): VCM Antibody Solution 1 is readyto use.
Reagent (2): VCM Latex Reagent 2 is ready touse.
Before using this product, gently invert the VCM
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 L37C37C5 min

1 min

Reagent
Reagent
Measurement(1)(2)(Absorbance I※)
Approx.
Approx.
125 L125 L

37C
Measurement

Approx.
(Absorbance II※)
2 min
Calculation ofconcentration※

Absorbance I and II: Absorbance at 700 nm
Calibration materials: Vancomycin Calibrator for
Nanopia (Manufacture's assigned value)＊＊

Assessment of Assay Results ＊1. Reference standard range
According to guidelines, vancomycin should beadministered at doses that obtain trough levels of
10 to 15 μg/mL in order to achieve a therapeutic
concentration, while trough levels of 15 to 20
μg/mL are recommended to obtain a good clinicalresponse in patients with bacteremia, endocarditis,

2

osteomyelitis,
meningitis,
pneumonia(nosocomial pneumonia and nursing andhealthcare-associated pneumonia), or severe skinor soft tissue infections.4 However, therapeutic
and toxic concentrations of this agent may
overlap. Therefore, interpretation of assay results
should also be based on the patient's clinicalfindings and other examination results.
It is recommended that the therapeutic
concentration range of vancomycin be
determined at each institution by measuring theblood concentration in a statistically adequate
number of specimens.
2. There may be reactions or interfering reactions
with non-target substances. If assay results appear
to be unreliable, repeat the measurement (ifnecessary, after dilution) or try another analyticalmethods.

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 puroduct. 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.

Performance
1. Sensitivity
1) Absorbance of standard solution (0.0 g/mL) is 1900 (Abs.  10000)
2) The difference of absorbance between standard
solution (0.0 g/mL) and another standard
solution (5.0 g/mL) is  600 (Abs.  10000)
2. Accuracy: 80–120 % of the expected assay value
3. Within-run Reproducibility:
Coefficient of variation ≤ 15 %(Test methods used for 1.–3. are in-housemethods.)
4. Measurement Range5): (On Hitachi 7180
automated analyzer)
2.5–100 g/mL
5. Correlation5)
Serum N=51
r=0.985y=0.95x+1.8
Control method: Approved in vitro diagnostic(enzyme immunoassay)
6. Standard Material
Vancomycin (United States Pharmacopeia)

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 outer package.)
Packaging
NamePackage
VCM Antibody
1 × 15 mL
Nanopia
Solution 1
TDM
VCM Latex
Vancomycin
1 × 15 mL
Reagent 2
Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.

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
during the test.
2) Sodium azide is added as an antiseptic agent inthis product. Therefore, if the reagent comes in
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.

＊＊References ＊1) Iga T., Inui K., eds.-auths.: Practical Manual ofTDM for Pharmacists and Pharmacy Students.
Tokyo, Japan: Jiho, Inc.;172(2004)
2) Sohara Y. et al: Mebio 28(7), 47(2011)
3) Dasgupta A., Dean R., et al.:Am J Clin
Pathol.101(4) 456-461(1994)
4) Japanese Society of Chemotherapy and JapaneseSociety of Therapeutic Drug Monitoring: Practice
Guidelines for Therapeutic drug monitoring ofAntibiotics, p35-58 (2016)
5) In house data, SEKISUI MEDICAL CO., LTD.
Contact
SEKISUI MEDICAL CO., LTD.
international@sekisui.com
Manufacturer ＊＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan3