This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Certification No. 224ADAMX00034000**Revised: November 2020 (6th edition)*Revised: January 2017 (5th edition)

This package insert must be read carefully prior to use.
Teicoplanin assay kit(Classification No.: 30415000)

include shock, anaphylactic reaction, eighth nerve
disorder, toxic epidermal necrolysis, agranulocytosis,
leukopenia, thrombopenia, acute renal failure, hepaticfunction disorder, and jaundice. To avoid theseadverse reactions, monitoring the blood concentrationof teicoplanin after administration is recommended.1)
Monitoring is also important to promote theappropriate use of antimicrobial agents based onPK/PD.2)

Nanopia TDM Teicoplanin
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 LaboratoryTests" of the package insert of each drug, forinformation 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 of
Assay 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. TEIC Antibody Solution 1 contains human-derived
components that have been confirmed to benegative 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-teicoplaninantibody is added and reacted with a sample,
consumption of the antibody depends on its
content in the sample. When teicoplanin-coatedlatex is added, residual anti-teicoplanin antibody
reacts with the latex and forms aggregates. Since
the extent of aggregation depends on theteicoplanin concentration in the sample, theteicoplanin concentration can be determined bymeasuring aggregation as the absorbance.
Sample (teicoplanin) + Anti-teicoplanin antibody───▶ Antigen-antibody reaction
Unreacted anti-teicoplanin antibody +Teicoplanin-coated latex───▶ Aggregation by antigen-antibody reaction
2. Features
1) Liquid reagents, ready-to-use.
2) It can be measured using the automatedanalyzers commonly used.
＊＊

Procedural Precautions ＊1. Properties of Samples and Sampling Methods
1) Samples
Serum and plasma (heparin plasma and EDTAplasma) may be used.
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 -20C or lower and measurethem within 28 days. Stored samples should
be brought to room temperature (15–30C)
before use.
(2) Samples may be frozen and thawed up totwice.
3) Caution must be exercised, because aseparating agent, etc. in the blood collection
tube may affect assay values.3)
4) Sampling should be performed after removing
insoluble matter from the sample. Highlyturbid specimens should be centrifuged before
assay.
2. Interfering substances
1) Assay results are not affected by free bilirubin(up to 18.7 mg/dL), conjugated bilirubin (up toDescription (Kit Components)
Component: IngredientsTEIC Antibody Solution 1:
Anti-teicoplanin sheep polyclonal
antibody
TEIC Latex Reagent 2:
Teicoplanin-coated latex
Intended Use
Measurement of teicoplanin in serum or plasma
Teicoplanin is a glycopeptide antibiotic produced byActinoplanes teichomyceticus. It shows antimicrobialactivity against aerobic and anaerobic gram-positivebacteria, including methicillin-resistant
Staphylococcus aureus (MRSA).
Clinically significant adverse reactions to teicoplanin119.7 mg/dL), hemoglobin (up to 498 mg/dL),
formazin turbidity (up to 1440 FTU), or
rheumatoid factors (up to 450 IU/mL).
2) Cross-reactivity
The following table summarizes the crossreactivity between teicoplanin and other drugs.
Substance
Acetylsalicylic acidAcetaminophen
Amikacin
Amphotericin B
Ampicillin
Arbekacin
Bendroflumethiazide
CaffeineCarbenicillin
Cefamandole nafate
Cefazolin
Cephalexin
Cephalosporin C
Cephalothin
Chloramphenicol
Chlorothiazide
Clindamycin
EDTA-2K
Erythromycin
Ethacrynic acid
Ethambutol
5-Fluorocytosine
Furosemide
Fusidic acid
Gentamicin
Hydrochlorothiazide
Ibuprofen
Isoniazid
Kanamycin A
Kanamycin B
Lincomycin
Methotrexate
6α-Methylprednisolone

Nalidixic acid
Naproxen
Neomycin
NiacinNitrofurantoin
Oxytetracycline
Penicillin G
Penicillin V
Phenacetin
Phenytoin
Prednisolone
Prednisone
Rifampicin
Salicylic acid
Sisomicin
Sodium fluoride
Spectinomycin

Concentration
tested(µg/mL)
686
201
150
105
57
66
498
101
252
253
508
108
1022
154
251
38
58
5414
200
438
24391
107
922
2242448
73
63
61
2138
910
202
515
1007
1154
831
119
2101
138
104
201
106
131255
505
101
22108

Sulfadiazine
Sulfamethoxazole
Sulfisoxazole
Tetracycline
Tobramycin
Trimethoprim
Trisodium citrate
Vancomycin

Crossreactivity
(%)
ND
ND
ND
ND
ND
ND
ND
ND
ND
–0.31
ND
0.65
–0.14
ND
ND
ND
ND
ND
ND
–0.13
ND
ND
–0.57
ND
ND
–1.920.15
ND
ND
ND
ND
–0.09
ND
ND
ND
ND
0.05
ND
–0.03
ND
ND
–0.31
ND
4.51
6.58
–14.24
–0.29
ND
ND
ND

228405
298
1726
21506
636

ND
–0.19
0.28
3.40
ND
ND
ND
0.22

ND: Not Detectable
3. Others
1) Always use Teicoplanin 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.
Dosage/Administration (Assay Procedure) *1. Preparation of reagents
Reagent (1): TEIC Antibody Solution 1 is ready touse.
Reagent (2): TEIC Latex Reagent 2 is ready to use.
Before using this product, gently invert the TEIC
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.
37C37CSample Reagent
Reagent
Measurement
2.4 μL + (1)(2)
Approx.
Approx. (Absorbance I※)
180 μL
60 μL
5 min
1 min
37C
Measurement
Approx. (Absorbance II※)
2 min
Calculation ofconcentration※

Absorbance I and II: Absorbance at 700 nm

Calibration material: Teicoplanin Calibrator for
Nanopia (manufacture's assigned value)
Assessment of Assay Results *1. Reference standard range
It is recommended to set the target trough level
for the therapeutic range of teicoplanin as 15–30
μg/mL, or as ≥ 20 μg/mL to obtain a better
response in patients with serious diseases orcomplex infections (such as endocarditis andosteoarticular infections).4) Since the therapeutic
concentrations and toxic concentrations may
overlap, interpretation of assay results should also
be based on the patient's clinical findings andother examination results.
It is recommended that the blood concentration ofteicoplanin should be measured in a sufficientnumber of samples for statistical analysis and thatits clinical effective concentration should bedetermined by each medical institution.
2. Precautions for Assessment
There may be reactions or interfering reactions

2with non-target substances. If assay results appear
to be unreliable, repeat the measurement (ifnecessary, after dilution) or try another analyticalmethods.

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.

Performance
1. Sensitivity
1) Absorbance of standard solution (0.0 µg/mL) is≥ 2300 (Abs. × 10000).
2) The difference of absorbance between standard
solution (0.0 µg/mL) and another standard
solution (5.0 µg/mL) is ≥ 550 (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)
3.0–100 μg /mL
5. Correlation5)
Serum N=61 r=0.978 y=0.94x + 0.75
Control method: Approved in vitro diagnostic(fluorescence polarization immuno assay)
6. Standard Material
Teicoplanin(in-house standard material)

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.)
Packaging
NamePackage
TEIC Antibody
1 × 24 mL
Nanopia TDM Solution 1
Teicoplanin
TEIC Latex
1 × 8 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.
5) Do not mix materials from different kit lot
numbers.
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 or
autoclaved 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%.

References *1) Package insert of Targocid 200mg. Japanese.
2) Kizu J. et al.: Jpn J Chemother, 58(4), 464, 2010.
Japanese.
3) Dasgupta A., Dean R., et al.: Am J Clin Pathol,101(4), 1994.
4) Japanese Society of Chemotherapy, JapaneseSociety of Therapeutic Drug Monitoring: A revised
edition of guidelines for therapeutic drug
monitoring of antimicrobials, 2016. Japanese.
5) SEKISUI MEDICAL CO., LTD. In house data.
Japanese.
Contact
SEKISUI MEDICAL CO., LTD.
international@sekisui.com

Manufacturer ＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan"Nanopia" is trademark or registered trademarks ofSEKISUI MEDICAL CO., LTD. in Japan and/or
other countries.
All other brands, product names and service names
are trademarks or registered trademarks of theirrespective companies.

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