renal tubular injury

biomarker
lipid peroxidation
hypoxic tissue injury

sepsisnephrotoxins
cardiac surgery
acute tubular necrosis
apheresis

renal transplantation

microcirculation

predicting dialysis-free survival

ischemiaradiocontrast agents

hypertension

diabetes nephropathy

FOR EARLY DETECTION OF ISCHEMIC EVENTS ON ACUTE KIDNEY INJURYRENISCHEM
L-FABP POC Kit
3

RENISCHEM L-FABP POC Kit

Check box 8

Reference Card

Control Line 6

Patient name

L-FABP concentration
after 15min9 [ng/mL]

2Date 3

L-FABP

100

Lot :CT4:Memo12.5

Test Line 7

Start of test

10012.5＜ 12.55

Negative

X

This reference card is type X. Please makesure “X” is printed on the Test cassette 10.

LOT

REF KZ-002

Assay specifications
Size:
Intended User:Store Temperature:
Method:Sample:Assay time:
Shelf life:
Reference range:

10 test kits
Lab professional
1-30°C
Immunochromatographic test for
detection and semi-quantitative
determination
Human urine
15min.
18 months
L-FABP < 12.5ng/mL
L-FABP ≥ 12.5ng/mL- and < 100 ng/mL
L-FABP ≥ 100 ng/mL

Kit componentsAluminum Pouch
Reference Card
Instruction For Use
In Aluminum Pouch
L-FABP Test Cassette
Pre-treatment Micro TubeDropper
Dry Sheetx 10x1x1x1
x1
L-FABP BIOMARKER WEBSITE OPENED!

fabp websearch®

L-FABP excretion of mechanism

To urinelumen
Free Fatty Acids (FFAs) are bound to serum albumin filtered through glomeruli and reabsorbed intoRenal
thetubuleproximal
tubule along with albumin. FFAs up-regulate the expression of L-FABP gene. L-FABP, a carrier protein or 14kDa
expressed in the proximal tubule plays a role in theTo urine
Cytoplasm ofReactive
oxygenproximal tubule
intracellular transport of FFAs to mitochondria and/or
Renal tubule lumen
peroxisomes for metabolism.
Oxidative
Mitochondria
Lysosome
Lipoperoxides are accumulated in proximal tubules during
stressrenal ischemia/re-perfusion. L-FABP is excreted from the
Tubulointerstitualside of
Cytoplasm
Reactive
oxygenproximal tubuleproximal tubules into urine by binding these cytotoxic lipids.
Ischemia-reperfusion injury
Oxidative
stress

Mitochondria

L-FABPAlbumin

Lipoperoxide

Free fatty acid

Reactive oxygen generated due to peritubularAlbumin
L-FABPischemia/reperfusion
injury change free fatty
acids to fatty acid peroxides(lipoperoxides),which are highly toxic to cells.
Lipoperoxide
Free fatty acid
L-FABPbinds withthese lipoperoxides, and is
excreted outside of cells. Thus, it is thoughtthat L-FABP is “renoprotective”—it works toprotect the kidneys.

Lysosome
Tubulointerstitual side

Ischemia-reperfusion injury

PRINCIPLE

Urinary L-FABP level displayed on testline

RENISCHEM® L-FABP POC Kit is an immunochromatographic test for detection and semi-quantitative determinationof L-FABP. Urinary L-FABP levels can be visualized within 15 minutes after the specimen is added to the sample pad.
L-FABP in the urine samples reacts to a gold colloid anti-human L-FABP mouse monoclonal antibody (CloneL), forms
an antigen-antibody complex, move through the membrane by a capillarity action, and reacts to the anti-humanL-FABP mouse monoclonal antibody on the Test Line (Clone2), visualizing a burgundy color. RENISCHEM® L-FABP
POC Kit allows semi-quantitative measurement by comparing the color density of Test Line with that on reference
card.
Urine
Additionally, the gold colloid anti-human L-FABP
Assay bed
mouse monoclonal antibody (CloneL) moves
further on the membrane and binds with the antimouse IgG polyclonal antibody on the Control Line,visualizing a burgundy color. This line is an index for
Sample pad
Test line
Control line
checking that the test is performed properly.
T

400

100

12.50 (ng/mL)

L-FABPGold colloid anti-human L-FABP mousemonoclonal antibody
Anti-human L-FABP mouse monoclonal
antibody
Anti-mouse IgG polyclonal antibody

CAccuracy of test

Table 1 Results of correlation test

As shown in Table 1, this product shows strong correlation with L-FABP ELISA (CE-marked). Theconcordance rate is 92.6% (125/135).

Urine※The reference range, which are determined by the distribution of urinary L-FABP corrected by urinary creatinine levels
in 431 healthy adults is 8.4ug/gCr or below. The quantitative assay kit for L-FABP, RENISCHEM®L-FABP ELISA kit wasused for the trial. The reference range of urinary L-FABP concentration, which is not corrected by urinary creatininelevels, is 10.1ng/mL or below.

<12.5≥12.5,<100≥100Total

RENISCHEM®

RENISCHEM®
L-FABP POC Kit<12.5 ≥12.5,<100 ≥10062
1063200331683631Total
633834135

Clinical evaluation[Contact][Manufacturer]

ndstndFigure 1 Correlation between the ratio ofurinary L-FABP to urinary creatinine, POC kit
results and lactate levels in RRT treated patients.
Urine samples from 3 patients who wereadmitted to the ICU were measured with theELISA test and POC kit. The test lines obtainedwith the POC kit were scored using threescore method. Lactate levels measured by theblood gas analyzer. 2 patients discharged fromthe hospital (a, b). Another patient died after 3
days of RRT. (c).

6000

50

Lactate (mg/dL)

10Lactate

7060

5000

50

4000

40

3000

30

2000

201000Urinary L-FABP

10

Lactate (mg/dL)

c
15
Urinary L-FABP (µg/gCr)

Lactate (mg/dL)

st

Urinary L-FABP((µg/gCr)

Urinary L-FABP (µg/gCr)

Clinical evaluation of L-FABP POC kit was performed in renal replacement therapy (RRT) setting. The POC kit and
ELISA were performed on urine samples from 3 patients who were admitted to the ICU at Shinmatsudo Central
General Hospital (Chiba, Japan) as critically ill patient with sepsis. The lactate level which was described as the newcriteria of sepsis in third international consensus definition for sepsis and septic shock (Sepsis-3) was also evaluatedat pre- and post-RRT by the blood gas analyzer. As a result, lactate (mg/dL) and urinary L-FABP/creatinine (μg/gCr)
were decreased in 2 patients after RRT. The results of POC kit were assessed as score 3: 100 ng/mL at Pre-1st RRT,
and as score 1: < 12.5 ng/mL at Post-2nd RRT (Figure 1a, b). These 2 patients discharged from the hospital. In
another patient, the lactate level was decreased slightly, whereas the urinary L-FABP was increased in a patient after
RRT. Also, the result of POC kit was assessed as score 2: ≧12.5 ng/mL and <100 ng/mL at Pre-RRT, and as score 3: ≧100 ng/mL at Post-RRT (Figure 1c). The patient died after 3 days of RRT. Thus, when the score of POC kit for urinary
L-FABP and lactate level were decreasedabin the patients after RRT, the patient
150
250
25tends to improve the condition. On theLactate
Lactate200
20100
other hand, when the score of POC kit
150
15and lactate were sustained high level in100
10
Urinary L-FABP
50
the patient even after RRT, the patient
Urinary L-FABP
50
5tends to deteriorate the condition.
000
Therefore, these results suggested thatControl Line
Control LinePOC kit for urinary L-FABP can be useful
Test Line
Test Lineto evaluate therapeutic efficacy of RRT in
Pre PostPre PostPre PostPre Postsepsis patient.
1 RRT
1 RRT
2 RRT
2 RRT

0Control Line
Test LinePre -Post1st RRT

Address: Hamamatsucho Bldg., 1-1-1 Shibaura, Minato-ku, Tokyo 105-0023, JAPANURL: https://www.cmicgroup.com/e/E-mail: l-fabp@cmic.co.jp

R-16-022018-9