This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Certification No. 226ADAMX00212000**Revised: January 2018 (6th edition)* Revised: January 2017 (5th edition)

This package insert must be read carefully prior to use.
Human L-type fatty acid-binding protein (L-FABP)
assay kit(Classification No.: 84051000)

concentration in the sample is determined bymeasuring the aggregation as the change ofabsorbance.
2. Features
1) Liquid reagents, ready-to-use.
2) Applicable to various automated analyzers.

NORUDIA L-FABP
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. For the effects of an administered drug on themeasured value, carefully read the Precautions for
Use in the package insert of the drug, especiallythe section about the effects on laboratory test
results.
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.

Procedural Precautions
1. Properties of Samples and Sampling Methods
1) Samples
Use spot or pooled urine as the sample.
However, do not use acidic urine or pooledurine containing toluene as the sample,
because the measurement system will beaffected.
Measure spot and pooled urine samples
immediately after collection.
If suspended matter is seen in the sample,
centrifuge the sample (500g for 5 minutes5))
and use the supernatant.
2) Storage of samples
If the sample cannot be measured immediately
after collection (after completion of collection
if the sample is pooled urine), store it in arefrigerator or freezer as soon as possible.
Measure refrigerated samples within 1 day ofcollection.
Measurefrozensamples
immediately after thawing and mixing thesample at room temperature or in a water bath.
It has been confirmed that samples are stablefor 1 year when stored at -80oC and for 2
weeks when stored at -30oC. Avoid freezing
and thawing the sample more than once.
2. Interfering substances7)
Assay results are not affected by free bilirubin (upto 20 mg/dL), conjugated bilirubin (up to 20mg/dL), hemoglobin (up to 500 mg/dL), orglucose (4000 mg/dL). Depending on the sample,
ascorbic acid may affect the assay results whenpresent at a concentration of approximately 100
mg/dL.
3. Others
1) Always use L-FABP Calibrator for multipointcalibration.
2) Precautions for assay range
If the concentration of sample exceeds assay
range, dilute the sample with saline and repeat
the measurement.
3) It is known that urinary L-FABP may increase
after administration of an angiography contrast
medium.4)

Description (Kit Components)
Component: Ingredients
L-FABP Buffer Solution 1
L-FABP Latex Reagent 2:
Anti-human L-FABP mousemonoclonal antibody-coated latex※※
Anti-human L-type fatty acid-binding protein
mouse monoclonal antibody-coated latex
Intended Use
Measurement of L-type fatty acid-binding protein(L-FABP) in urine
Urinary L-FABP levels are considered to reflect theseverity of renal tubular dysfunction, thus being
useful for evaluation of peritubular microcirculatory
disturbance (ischemia),1) staging of diabetic
nephropathy and evaluating of the treatment effects, 2)
assessment of the risk of severe acute kidney injury(AKI) 3), and prediction of contrast nephropathy .4)＊＊

Dosage/Administration (Assay Procedure) ＊1. Preparation of reagents
Reagent (1): L-FABP Buffer Solution 1 is readyto use.
Reagent (2): L-FABP Latex Reagent 2 is readyto use.
Before using this product, gently invert theL-FABP Latex Solution 2 bottle to mix it

Assay Principle
1. Assay Principle
In samples, an antigen-antibody reaction occurs
between L-FABP and anti-human L-FABP mousemonoclonal antibody-coated latex , resulting inaggregation of the latex. The L-FABP

1

thoroughly, and check 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.
Sample4 μL+ Reagent (1)150 μL

37C
5 min

Measurement 37C Measurement(Absorbance II※)
(Absorbance I※)
5 minduring the test.
2) Proclin 300, which possesses skin-irritative
potential, is added as an antiseptic agent in theL-FABP Buffer Solution 1 and L-FABP Latex
Reagent 2. Therefore, if the reagent comes incontact with skin or clothes, rinse immediatelywith ample water, and consult the doctor if skinirritation develops.
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) Do not combine L-FABP Buffer Solution 1 andL-FABP Latex Reagent 2 with different lot
numbers on the outer box.
5) 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 121 ºC 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.
4. Other precautions
Do not use the containers for other purposes.

Reagent (2)50 μL
Calculation ofconcentration※

Absorbance I and II: The difference in absorbance

between the dominant wavelength (570 nm) andthe complementary wavelength (800 nm).
Calibrationmaterial:L-FABP
Calibrator(manufacture's assigned value)
Reagent blank: Saline
Assessment of Assay Results
1. Correction of assay results
Correct the assay results for the urinary creatininelevel, and calculate the amount of L-FABP(µg/gCr) per g of urinary creatinine.
2. Reference standard range
The reference range was calculated from theurinary L-FABP levels in 412 healthy volunteers,
and was been reported to be ≤ 8.4 µg/gCr.6
3. 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.
Performance ＊＊1. Sensitivitya) The absorbance of physiological saline is0.0459 or less.
b) The absorbance per 5 ng/mL of L-FABP is ≥0.0048 (L-FABP 4–6 ng/mL).
2. Accuracy: 85–115 % of the expected assay value
3. Within-run Reproducibility:
Coefficient of variation ≤ 15 %(Test methods used for 1.–3. are in-housemethods.)
4. Measurement Range7): (On Hitachi 7180
automated analyzer)
1.0–200 ng /mL
5. Correlation7)
Sample: Spot and pooled urineControl method: Approved in vitro diagnostic
Control method (1): Enzyme immunoassay
N=87
r=0.979
y=1.04x–2.32
Control method (2): Enzyme immunoassay
N=67
r=0.984y=1.02x–1.32
6. Standard Material
Recombinant Human L-FABP Protein (in-housereference standard)

Storage and Shelf Life ＊1. Storage temperature: 2–10 C
2. Shelf life: 1 year from the date of manufacture(The expiration date is printed on the outerpackage.)
Packaging
Name
Package
L-FABP Buffer
1 × 18 mL
NORUDIA Solution 1L-FABP
L-FABP Latex
1 × 7 mLReagent 2
Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
References
1) Sugaya K. et al.: Modern Physician, 28(8), 1159,2008.
2) Ikemori A. et al.: J Jpn Soc Clin Chem, 43(1), 20,2014.
3) Matsui K. et al.: Circ J, 76(1), 213, 2012.
4) Nakamura T. et al.: Am J Kidney Dis, 47(3), 439,

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 pipetting22006.
5) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 33th ed. 130, 2010.
6) Kamijo A. et al.: Diabetes care, 34(3), 691, 2011.
7) 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