Test principle
The assay is a double-antibody sandwich immunoassay for quantitative determination of Fer concentration based on immunofluorescence technology. The sample droplets to be measured were added to the sample well of the detection card. Through chromatography, the sample reacts with the fluorescent latex coated with ferritin monoclonal antibody I on the conjugated pad. The complex spread forward along the nitrocellulose membrane captured by the ferritin monoclonal Antibody II, which was fixed on the test line. The more ferritin there is in the sample, the more complexes are accumulated on the test line. The intensity of the fluorescent antibody signal reflects the amount of ferritin captured. The concentration of ferritin in the sample can be determined by the Immunofluorescence quantitative analysis instrument produced by the company.
Package
25 Tests /Box
Sample Type
Serum
Materials provided
Contents
Accessories required but not provided
Immunofluorescence quantitative analyzer（NRM-FI-1000）Fer Control
Warnings and precautions
For in vitro diagnostic use.
Safety precautions
CAUTION: This product requires the handling of human samples. It is recommended that all human sourced materials are considered potentially infectious and be handled in accordance with the OSHA Standard on Bloodborne Pathogens. Biosafety Level 211 or other appropriate biosafety practices should be used for materials that contain or are suspected of containing infectious agents.
Handling precautions
Do not use the kit beyond the expiration date. The production date and expiration date are on the label.
Specimen collection and preparation
The serum must be collected by standard tubes or pro-coagulation tube filled inside with separation gel. The sample is advised to be tested immediately. Serum should be stored at 2-8℃; If testing is delayed more than 24 hours, then store the sample at -20℃ or below.
Procedure
Preparation
Calibration Card installation
Each box contains a lot-specific Calibration Card to correct for lot-to-lot deviation.
Cartridge
Cartridge needs to reach room temperature before opened.
Test procedure
Remove the cartridge (after reaching room temperature), draw in 30μL of the sample to sample diluent. After gently mixing the sample, add 90μL into the well and incubate it for 15 minutes in the reagent strip incubator.
Caution
Please check the direction of the cartridge before insertion and assure the insertion is correct.
Dilution
If a sample with Fer higher than the limit of the kit of 1000μg/L and a definitive result is required, the sample should be manually diluted with normal saline and then re-assayed according to the test procedure. The maximum valid dilution ratio is 2 times, the detection limit is 2000μg/L.
Result analysis
The analyzer automatically calculates the Fer concentration in each sample by means of a calibration curve. The results are expressed inμg/L. For further information please refer to the operator’s manual of Immunofluorescence quantitative analyzers (NRM-FI-1000).
Explanation of results
The test result is only for reference and it should be considered comprehensively in conjunction with clinical symptoms, health history and other laboratory test, etc. The result cannot serve as a sole factor of clinical diagnostic.All operation must be in strict accordance with operating procedures to get the correct result. The accuracy of test results may be affected by any changes to operational procedures.
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