Product Details
COVID-19 Neutralizing AntibodyRapid Test Device
INTENDED USE
The COVID-19Neutralizing Antibody Rapid Test is a lateral flow chromatographic immunoassay for
qualitative detection of neutralizing antibody to SARS-CoV-2 in
human whole blood,serum,or plasma as an aid in the evaluation of human anti- SARS-CoV-2
neutralizing antibody titer.
Product name: | COVID-19 Neutralizing AntibodyRapid Test Device |
Format: | Card |
Specimen: | serum/plasma/whole blood |
Sensitivity: | 95.39% |
Accuracy: | 98.66% |
Specificity: | >99% |
Packing | 25pcs/box; 5pcs/box; 1pcs/box |
shelf life | 24 months |
Certificate: | CE , FSC |
DIRECTIONS FOR USE
Allow the test device,specimen,buffer,and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening.Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface.
3. Add 20μl whole blood or 10μl serum and plasma into the sample well of the test device, then add 80μl buffer into the
sample well.
4. Read the result at 15~20 minutes. The result is invalid after 20 minutes.
Note: 1 drop volume of the disposable plastic pipette provided is about 10μl.
INTERPRETATION OF RESULTS
NEGATIVE:Presence of a single colored band in the control region (C) indicates the absence of COVID-19 neutralizing antibodies or that the concentration of antibodies in sample is below the detection cut-off level.
POSITIVE: Presence of two visible, pink-colored bands, one in the control region (C) and one in test region (T), indicates presence of COVID-19neutralizingantibodies in sample.
INVALID: There is no line appeared in the C region. Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure.Review and repeat the procedure with a new test device. If the problem persists,discontinue using the test kit immediately and contact your local distributor.
Company Profile
Innovation Biotech (Beijing) Co.,Ltd is a biotechnology company
specializing in research, development and manufacturing of advanced
medical in-vitro diagnostic (IVD) rapid test kits, medical and
laboratory disposal products. We provide one step medical
diagnostic rapid test kit based on our INVBIO brand, Product
include Fertility Tests, Infectious diseases, Tumor markers, DOA
drug of abuse test, Drug test cup, Urinalysis reagent strip, ELISA
kit, Digital alcohol tester, urine analyzer, et.
OEM packaging is available, drug of abuse test, troponin I test,
alcohol screening saliva test strips, urine strips, elisa kits,
microscope slides
Our focus is to expand our markets internationally by forming
strategic alliances and entering into partnerships with
distributors worldwide. We have established an international
reputation for excellence in the manufacturing of quality medical
and laboratory products. In addition, we have obtained approval
licenses ISO13485, FSC certificate, and most of our products get CE
mark Our objective is the utmost satisfaction of our clients all
around the world by supplying our quality and economical products
For more details pls contact us at sales@rapid-test-kit.com