NGAL Test Cassette (Urine)
REF FI-NGAL-102
English
Concentrations
Clinical Reference
10ng/mL
Health
100ng/mL
Low risk for AKI
＞100ng/mL
High risk for AKI
Index of Symbols
Consult instructions for
use or consult electronic
instructions for use
Contains
<n> tests
In vitro diagnostic
medical device
Catalogue
number
Authorized
European Community
Do not use if package is
instructions for use
Hangzhou AllTest Biotech Co., Ltd.
MedNet EC-REP GmbH
Borkstrasse 10
48163 Muenster
Germany
Package Insert
A test for measuring NGAL in urine with the use of Fluorescence Immunoassay Analyzer.
For professional in vitro diagnostic use only.
【INTENDED USE】
The NGAL Test Cassette (Urine) is based on Fluorescence Immunoassay to measure NGAL in
Urine.
【
SUMMARY】
Neutrophil gelatinase-associated lipocalin (NGAL), also known as Lipocalin-2 (LCN2) or
oncogene 24p3,is a protein that in humans is encoded by the LCN2 gene.
in innate immunity by sequestrating iron that in turn limits bacterial growth.
neutrophils and in low levels in the kidney, prostate, and epithelia of the respiratory and
alimentary tracts.
In the case of acute kidney injury (AKI), NGAL is secreted in high levels into the blood and
urine within 2 hours of injury.
easily excreted and detected in the urine.
associated with the severity of their prognosis and can be used as a biomarker for AKI
can also be used as an early diagnosis for procedures such as chronic kidney disease,
contrast induced nephropathy, and kidney transplant.
【
PRINCIPLE】
The NGAL Test Cassette (Urine) detects NGAL based on Fluorescence Immunoassay. The
sample moves through the strip from sample pad to absorbent pad. NGAL in the urine will be
captured by anti-NGAL antibody that conjugated with fluorescent microspheres. Then the
compound will be captured by another anti-NGAL antibody coated on the membrane (Test line).
The concentration of NGAL in the sample is inversely related to the intensity of the fluorescent
signal captured on the T line. According to the fluorescence intensity and the standard curve,
the concentration of NGAL in the sample can be calculated by Analyzer to show NGAL
concentration in specimen.
REAGENTS】
【
The test includes anti-NGAL antibody coated fluorescent microspheres and anti-NGAL
antibody coated on the membrane.
【
PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Do not use after the expiration date indicated on the package. Do not use the test if the foil
pouch is damaged. Do not reuse.
3. Avoid cross-contamination of specimens by using a new specimen collection container for
each specimen obtained.
4. Do not eat, drink or smoke in the area where the specimens and tests are handled. Handle
all specimens as if they contain infectious agents. Observe established precautions against
microbiological hazards throughout the procedure and follow standard procedures for proper
disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves
and eye protection when specimens are assayed.
5. Do not interchange or mix reagents from different lots.
6. Humidity and temperature can adversely affect results.
7. Used testing materials should be discarded in accordance with local regulations.
8. Read the entire procedure carefully prior to any testing.
9. The NGAL Test Cassette (Urine) should only be used with the Analyzer by approved
medical professionals.
【
STORAGE AND STABILITY】
1. The kit should be stored at 4-30 °C before the expiry date printed on the sealed pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect the components of the kit from contamination. Do not use if
there is evidence of microbial contamination or precipitation. Biological contamination of
dispensing equipment, containers or reagents can lead to false results.
【
SPECIMEN COLLECTION AND PREPARATION】
Use preferably only fresh morning urine for testing since physical effort can lead to an increase
in albumin expulsion. Urine sample should be stored at 2-8 °C if the test is to be run within 2
days of collection. For long term storage, specimens should be kept below -20 °C. Samples
that have been refrigerated must be equilibrated to room temperature before testing. Avoid
repeated freezing and thawing of urine samples.
MATERIALS】
【
• Test Cassettes • Package Insert • Droppers
• ID Card • Specimen Collection Tubes with Buffer
• Timer • Centrifuge • Specimen Collection Containers
• Fluorescence Immunoassay Analyzer • Pipette
【
DIRECTIONS FOR USE】
Refer to Fluorescence Immunoassay Analyzer Operation Manual for the complete instructions
on use of the analyzer. The test should be conducted in room temperature.
Allow the test, specimens and/or controls to reach room temperature (15-30 °C) prior to
testing.
1. Turn on the Analyzer power. Then according to the need, select “Standard test” or “Quick
test” mode.
2. Take out the ID card and insert it into the Analyzer port.
3,5
NGAL is used as a biomarker of kidney injury.6
7
Because NGAL is protease resistant and small, the protein is
8
NGAL levels in patients with AKI have been
9
Materials Provided
Materials Required But Not Provided
1,2,3
NGAL is involved
4
It is expressed in
7
NGAL
3. To use a pipette: Pipette 10 μL of sample into the buffer tube; mix the specimen and the
buffer well.
To use a dropper: Without squeezing the dropper, put the glass capillary tube end in
contact with the liquid sample surface tilted. Liquid sample will migrate into the capillary
tube automatically. Note: Make sure do not take the plastic part of the dropper in contact
with the sample.
Then release the sample into the buffer tube by squeezing the bulb at the top end of the
dropper vertically. Wash the tube 2-3 times by squeezing the top bulb. Mix the sample and
the buffer well.
4. To use a pipette: Pipette 75 μL of diluted specimen into the sample well of the cassette.
Start the timer at the same time.
To use a dropper: Immerse the tube end (plastic tube) into the diluted sample; squeeze
the top bulb to absorb the solution into the lower bulb (no more than the lower bulb).
Squeeze the top bulb vertically to release the diluted solution into the sample well of the
test cassette and start the timer.
5. There are two test modes for Fluorescence Immunoassay Analyzer, Standard Test mode
and Quick Test mode. Please refer to the user manual of Fluorescence Immunoassay
Analyzer for details.
“Quick test” mode: After 10 minutes of adding sample，Insert the test cassette into the
Analyzer, click “QUICK TEST”, fill the test information and click "NEW T EST" immediately. The
Analyzer will automatically give the test result after a few seconds.
“Standard test” mode: Insert the test cassette into the Analyzer immediately after adding
specimen, click “STANDARD TEST ”, fill the test information and click "NEWTEST" at the
same time, The Analyzer will automatically countdown 10 minutes. After the countdown, the
Analyzer will give the result at once.
【
INTERPRETATION OF RESULTS】
Results read by Fluorescence Immunoassay Analyzer.
The result of tests for NGAL is calculated by Fluorescence Immunoassay Analyzer and display
the result on the screen. For additional information, please refer to the user manual of
Fluorescence Immunoassay Analyzer.
Linearity range of NGAL Test is 10~1500 ng/mL.
Reference value: 0.7~9.6ng/mL
【QUALITY CONTROL】
Each NGAL Test Cassette (Urine) contains internal control that satisfies routine quality control
requirements. This internal control is performed each time a sample is tested. This control
indicates that the test cassette was inserted and read properly by Fluorescence Immunoassay
Analyzer. An invalid result from the internal control causes an error message on Fluorescence
Immunoassay Analyzer indicating that the test should be repeated. An invalid result from the
internal control causes an “N/A” message on Fluorescence Immunoassay Analyzer. Insufficient
specimen volume or incorrect procedural techniques are the most likely reasons for control
failure. Review the procedure and repeat the test with a new test. If the problem persists,
discontinue using the test kit immediately and contact your local distributor.
LIMITATIONS】
【
1. The NGAL Test Cassette (Urine) is for professional in vitro diagnostic use, and should only
be used for the quantitative detection of NGAL.
2. The NGAL Test Cassette (Urine) will only indicate the presence of NGAL in the specimen.
3. Like with all diagnostic tests, a confirmed diagnosis should only be made by a physician
after all clinical and laboratory findings have been evaluated.
4. The results of NGAL Tests are based on measuring the levels of NGAL in the specimen. It
should not be used as the sole criterion for treatment decisions. If the result is positive, other
clinical findings and alternative test methods are recommended to reach proper medical
treatments.
【
EXPECTED RESULTS】
＜
＜
【PERFORMANCE CHARACTERISTICS】
1. Accuracy
The test deviation is ≤±15%.
2. Sensitivity
The NGAL Test Cassette (Urine) can detect levels of NGAL as low as 10ng/mL in Urine.
3. Detection range
10~1500ng/mL
4. Linearity range
10~1500ng/mL, R≥0.990
5. Precision
Intra-lot precision
Within-run precision has been determined by using 10 replicates of 2 specimens containing
50ng/mL, 200ng/mL of NGAL. C.V. is ≤ 15%.
Inter-lot precision
Between-run precision has been determined by using 10 replicates for each of three lots using
2 specimens containing 50ng/mL，200ng/mL of NGAL. C.V. is ≤15%.
6. interfering substances
The following substances do not interfere with the test results at the indicated concentration:
50mg/mL creatinine, 100mg/mL carbamide, 20mg/ml albumin.
【
BIBLIOGRAPHY】
1. Kjeldsen L, Johnsen AH, Sengeløv H, Borregaard N (May 1993). "Isolation and primary
structure of NGAL, a novel protein associated with human neutrophil gelatinase". J. Biol.
Chem. 268 (14): 10425–32. PMID 7683678.
2. Chan P, Simon-Chazottes D, Mattei MG, Guenet JL, Salier JP (September 1994).
"Comparative mapping of lipocalin genes in human and mouse: the four genes for
complement C8 gamma chain, prostaglandin-D-synthase, oncogene-24p3, and
progestagen-associated endometrial protein map to HSA9 and MMU2". Genomics. 23 (1):
145–50. doi:10.1006/geno.1994.1470.PMID 7829063.
3. Jump up to:a b Cowland JB, Borregaard N (October 1997). "Molecular characterization and
pattern of tissue expression of the gene for neutrophil gelatinase-associated lipocalin from
humans". Genomics. 45 (1): 17–23. doi:10.1006/geno.1997.4896. PMID 9339356.
4. Yang J, Goetz D, Li JY, Wang W, Mori K, Setlik D, Du T, Erdjument-Bromage H, Tempst P,
Strong R, Barasch J (November 2002). "An iron delivery pathway mediated by a
lipocalin". Mol. Cell. 10 (5): 1045–56. doi:10.1016/ S1097-2765(02) 00710-4.
PMID 12453413.
5. Friedl A, Stoesz SP, Buckley P, Gould MN (July 1999). "Neutrophil gelatinase-associated
lipocalin in normal and neoplastic human tissues. Cell type-specific pattern of expression".
Histochem. J. 31 (7): 433–41. doi:10.1023/A:1003708808934. PMID 10475571.
6. Devarajan P (June 2010). "Review: neutrophil gelatinase-associated lipocalin: a
troponin-like biomarker for human acute kidney injury". Nephrology (Carlton). 15 (4): 419–
28. doi:10.1111/j.1440-1797.2010.01317.x. PMID 20609093.
7. Bennett M, Dent CL, Ma Q, Dastrala S, Grenier F, Workman R, Syed H, Ali S, Barasch J,
Devarajan P (May 2008). "Urine NGAL predicts severity of acute kidney injury after cardiac
surgery: a prospective study". Clin J Am Soc Nephrol. 3 (3): 665–73. doi:10.2215/ CJN.
04010907. PMC 2386703. PMID 18337554.
8. Jump up to:a b Uttenthal LO (April 2007). "NGAL: How Useful Is the New Marker of Kidney
Damage?" (PDF). CLI.
9. Goldstein SL (2011). "Acute kidney injury biomarkers: renal angina and the need for a renal
troponin I". BMC Med. 9: 135. doi:10.1186/1741-7015-9-135. PMC 3287120. PMID
22189039.
representative in the
damaged and consult
Distributed in Italy by PM2 Services Srl, Corso Mazzini 38- Largo Marchi, 36071 Arzignano (VI)
- info@pm2services.it
Number: F145107200
Revision date: 2022-09-26
sufficient for
Batch code
Use-by date
Manufacturer
Temperature limit
Do not re-use
Loading...