Place of Origin:
ISO 13485, CE
Diagnostic Kit for Neutrophil gelatinase-associtated lipocalin(Immunochromatographic assay)
The kit is used for quantitative determination of Neutrophil gelatinase-associtated lipocalin (NGAL) in human urine. Clinically, it is mainly used to assist in the diagnosis of renal function injury.
The kit is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of NGAL. The NGAL antigen in the sample was first bound with the conjugated compound of fluorescent labeled NGAL monoclonal antibody, then moved and combined with another NGAL monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.
|It is composed of fluorescent pad (coated with fluorescently-labeled NGAL monoclonal antibody), nitrocellulose membrane (coated with NGAL monoclonal antibody and Goat anti mouse IgG antibody), absorbent paper and backing.
|25 (0.3mL/ tube)
|With specific stand curve file
The components in different batches of kits cannot be used interchangeably.
【Storage conditions and validity】
The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months. The test card should be used within 15 minutes after unsealing under the environment of 15℃~30℃ and 20% ~ 90% relative humidity.
The production date, batch number and expiration date are shown in the outer package of the product.
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.
The normal reference value is less than 132ng/mL in this assay. It is strongly recommended that each laboratory should determine its own normal and abnormal values.
【Interpretation of test results】
【Limitation of method】
4. When the concentration of NGAL in the sample is less than 2000ng/mL, there is no hook effect.
1. Limits of detection
No higher than 10.00 ng/mL.
The relative deviation from the target value is limited to ±15.0%.
The within and between assay coefficient of variations are within 15.0%.
4. Linearity range
Within the linear range (10.00~ 1500.00)ng/mL, the linear correlation coefficient R≥0.990.
1. The kit can be used for in vitro diagnosis only.
2. Test card and buffer solution are single-use and they cannot be reused.
3. Please check the integrity and validity of the kit package before use, and then open the package. When it is stored at low temperature, it should be restored to room temperature (15℃ ~ 30℃) before opening the package for use. The reagents with damaged inner package and beyond the validity period cannot be used.
4. Take the test card out of the aluminum foil bag and carry out experiment in 15min. Do not place it in the air for a long time to avoid dampness.
5. It is required to strictly comply with the requirements for sample collection and storage. If the sample is turbid, please centrifuge and precipitate it before use.
6. The kit used should be disposed of as latent infective material, and all samples, reagents and latent contaminants should be disinfected and disposed of according to relevant local regulations.
|WWHS Assay list
|acute kidney injury.
Interpretation of Test Results
1. The kit can be used for auxiliary test only. If test result is abnormal, retest timely and judge combined with clinical symptoms.
2. For samples whose cTnI concentration is lower than 0.1ng/mL and higher than 40ng/mL, test result is “＜0.1ng/mL” and “＞40ng/mL” respectively.
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1. What is fluorescent immunoassay analyzer?
The Biopanda Fluorescence Immunoassay Analyser is used by small labs for the detection of a range of biomarkers to assist with the diagnosis and monitoring of several medical conditions including cardiovascular disease, inflammation, kidney disease, thyroid conditions, and fertility.
2. Do you have CE certificate for immunoassay analyzer?
WBC analyzer belongs to IVD other/general, no need CE, Ec declaration is enough.
3. How does fluorescence immunoassay work?
Fluorescent Immunoassays are simply a different type of immunoassay. ... A modern fluorescent based immunoassay uses as the detection reagent a fluorescent compound which absorbs light or energy (excitation energy) at a specific wavelength and then emits light or energy at a different wavelength.
4. What is indirect immunofluorescence assay?
Indirect immunofluorescence, or secondary immunofluorescence, is a technique used in laboratories to detect circulating
autoantibodies in patient serum. It is used to diagnose autoimmune blistering diseases.
5. Is immunofluorescence an immunoassay?
Immunofluorescence assay (IFA) is a standard virologic technique to identify the presence of antibodies by their specific ability to react with viral antigens expressed in infected cells; bound antibodies are visualized by incubation with fluorescently labeled antihuman antibody.
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