Vazyme Covid-19
Antibody rapid test
purpose of use
This product is intended for the in vitro qualitative detection of RBD (SARS-CoV-2 RBD Spike Receptor-Binding Domain) IgG antibodies in serum, plasma and whole blood samples.
It can be used to clinically determine levels of SARS-CoV-2 RBD IgG antibodies in humans.
assay principle
The capture method used for this product is solid phase immunochromatography. Upon passing the labeling pad, the RBD IgG antibody in the sample is combined with the recombinant SARS-CoV-2 RBD & colloidal gold conjugates to form an immune complex of colloidal gold labeled RBD protein-RBD IgG antibody to be tested. The complex continues to spread and is captured by the T (test) line coated with mouse anti-human IgG antibody. The remaining colloidal gold conjugates continue to rise and combine with the C line (quality control line), indicating the completion of the reaction .
The Covid-19 antibody test from Vazyme is of course on the BfArM list
product details
Test for the qualitative detection of SARS-CoV-2 antibodies
Aid for diagnosing the current antibody count, e.g. after recovery or SARS-CoV-2 vaccination
On the list of the BfArM (Federal Institute for Drugs and Medical Devices)
Sampling by taking blood
The test result is available after 15 minutes
Sensitivity: 99.10% Specificity: 98.00% Storage at room temperature (between 4° and 30°C)
Please note that this rapid test may only be used by medical professionals!
Excluded from the right of return
Packaging unit: 1 / 5 / 20 tests/kit
Precautions
for in vitro diagnostic use only
for healthcare professionals and professionals at locations close to the patient
do not use this product as the sole basis for diagnosing or ruling out SARS-CoV-2 infection or for information about the level of antibodies present in the human body
do not use after the expiry date
please read all the information in this leaflet before performing the test
the detection kit should be kept in a sealed pouch before use
all specimens should be classified as potentially hazardous and treated as if they were an infectious agent
the used detection kit should be disposed of in accordance with federal, state, and local government regulations.
Below you will find further links to documents of the "Vazyme Covid-19 ELISA Antibody Test"
from EUR 1.95/net per quick test
Specificity 99.10%
Specificity describes how rarely a test misclassifies people as infected. This is about the statistically false-positive results. Again, the closer the value is to 100 percent, the better.
Source: Federal Institute for Drugs and Medical Devices
*Status: 12.11.2020
Sensitivity 98.00%
Sensitivity describes how well a test actually recognizes infected people and how many infected people slip through the cracks. In statistics, one speaks of false-negative results. The closer the value is to 100 percent, the more reliably the test detects all infected people.
Source: Federal Institute for Drugs and Medical Devices
*Status: 12.11.2020
Vazyme COVID-19 Rapid Antibody Test Procedure
Current scientific information can be found at
Important NOTE
FPFP International excludes any direct or indirect liability for improper use or interpretation of the antibody test, as this may only be carried out by medical professionals. When you order the product, you will receive a letter from us by e-mail in which you declare that you exclude any liability when purchasing the test.
Please note that as with other commercially available diagnostic tests, the results must be compared to other clinical information that is also available to any physician.