
For in vitro diagnostic use only
Please read this package insert carefully prior to use and strictly follow the instructions. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.
INTENDED USE
Diagnostic Kit(Colloidal Gold)for IgM Antibody to Human Enterovirus 71 is acolloidal gold immunochromatographic assay for the qualitative determination of IgM Antibody to
Human Enterovirus 71(EV71-IgM) in human whole blood,serum or plasma.Thistest is a screening reagent. All positive sample must be confirmed by other methodologies.This test is intended for healthcare professional use only.
PACKAGE SIZE
1 kit /box, 10 kits /box, 25 kits,/box, 50 kits /box
Summary
EV71 is one of the main pathogens of hand, foot and mouth disease(HFMD), which can cause myocarditis, encephalitis,acute respiratory disease and other diseases exceptHFMD. The Kit is a simple, visual qualitative test that detects EV71-IgMin human whole blood, serum or plasma.The Diagnostic Kit is based on immunochromatography and can give a result within 15minutes.
Applicable instrument
Exceptvisual inspection, the kit can be matched with Continuous immune analyzer WIZ-A202 of Xiamen Wiz Biotech Co., Ltd
ASSAY PROCEDURE
TheWIZ-A202 test procedure see the instruction ofContinuous immune analyzer. Visual test procedureisas follows
1. Take out the test card from the foil bag, put it on the level table and mark it.
2. Add10μlserum or plasma sample or 20ulwhole blood sample to sample well of the card with provided dispette, then add 100μl (about2-3 drop) sample diluent; start timing
3. Wait for a minimum 10-15 minutes and read the result, the result is invalid after 15 minutes.