Vazyme Covid-19
ELISA - antibody test
purpose of use
Neutralizing antibodies are a type of antibodies that protect the host cell from viral infection by neutralizing viral activity. The Anti-SARS-CoV-2 Neutralizing Antibodies ELISA Kit can be used for the qualitative detection of the neutralizing antibodies in serum/plasma, providing a reference for the assessment of immune protection against the virus.
assay principle
The interaction between HRP-RBD and human ACE2 (hACE2) coated on the microplate can be blocked by neutralizing antibodies bound to HRP-RBD. The amount of HRP-RBD-hACE2 on the microtiter plate can be indicated by reading at the wavelength of 450 nm and the absorbance of the samples is inversely related to the degree of inhibition of the active neutralizing antibodies.
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 60 minutes (in the laboratory)
Sensitivity: 98.50% [95%CI: 92.01%, 99.74%], Specificity: 99.30% [95%CI: 98.75%, 99.61%]
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 quantity: 96 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 6.35/net per quick test
Specificity 99.30%
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 98.50%
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 Antibody Test 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 any other diagnostic test commonly found on the market, the results must be compared to other clinical information that is also available to any physician.