As a leading lateral flow test kits manufacturer in China, JOYSBIO has developed and launched one of the world’s first point-of-care lateral flow rapid test cassettes for the diagnosis of 2019 novel coronavirus disease. The COVID-19 Antibody Rapid Test Kit (Colloidal Gold) is for in vitro qualitative determination of both IgG and IgM antibodies in human serum, plasma, and fingertip blood. Clinical laboratories or healthcare workers can use this product for laboratory or point-of-care testing. The COVID-19 antibody lateral flow test is a fast and effective method for the SARS-CoV-2 antibody screening of a large population. For rapid detection of active infection, learn more about the new COVID-19 rapid antigen test kit.
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Not all the antibodies are neutralizing. Non-neutralizing antibodies, or binding antibodies, are able to bind to viral antigens but do not block viral infection. Binding antibodies can flag the viral antigen to trigger immune responses but the presence of binding antibodies does not reflect the level of immunity. Neutralizing antibodies (NAbs) are antibodies that not only bind to viral antigens, but also block viral infection. The presence of NAb can be used to evaluate immunity status after infection or vaccination.
Neutralizing Antibody Rapid Test Intended Use
The 2019 novel coronavirus (SARS-CoV-2) has several structural proteins, including spike (S), envelope (E), membrane (M), and nucleocapsid (N). The S-protein contains a receptor binding domain (RBD), which can recognize the cell surface receptor, angiotensin-converting enzyme-2 (ACE2). In a recent study, neutralizing antibody (NAb) can block the interaction between the receptor-binding domain (RBD) of the novel coronavirus spike protein with the ACE2 cell surface receptor. The level of NAb, therefore, can be used to analyze a patient’s immunity against future SARS-CoV-2 infection. This COVID-19 neutralizing antibody lateral flow assay rapidly detects any antibodies that can neutralize the RBD-ACE2 interaction.
Researchers have been using traditional viral neutralization assay for testing SARS-CoV-2 neutralizing antibodies and there are several ELISA based neutralizing antibody test kits available in the market since May 2020. However, performing COVID-19 neutralization assays or ELISA requires complex laboratory settings, and it is time-consuming, despite a higher sensitivity and specificity. JOYSBIO’s surrogate neutralizing antibody rapid test cassette provides an easy way for the preliminary screening of NAb to estimate patients’ immunity to novel coronavirus infection.
The clinical sensitivity of the kit is determined by specimens collected from 93 participants who received Pfizer-BioNTech COVID-19 mRNA vaccine (Tozinameran or BNT162b2) in Italy between January 2021 and March 2021. The clinical specificity of the kit is determined by specimens from 317 uninfected and unvaccinated participants from Heilongjiang Province Hospital in China. The reference reagent used in the clinical study is cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit manufactured by GenScript USA Inc. The kit showed 92.47% of sensitivity and 99.68% of specificity.
JJOYSBIO’s COVID-19 neutralizing antibody test kit is a lateral flow assay for rapid NAb screening, which can mimics the virus neutralization process. This lateral flow assay contains two key components: the recombinant SARS-CoV-2 RBD fragment and chicken IgY, labeled by colloidal gold are as tracers; and the human ACE2 receptor protein (hACE2) and goat anti-chicken IgY antibody, coated with cellulose nitrate membrane. The protein-protein interaction between RBD and hACE2 can be blocked if the test samples contains a certain level of neutralizing antibody against SARS-CoV-2.
When specimens are added to the sample pad, neutralizing antibodies present in the specimen will bind to the RBD labeled colloidal gold and block the protein-protein interaction between RBD and hACE2. The unbound RBD labeled colloidal gold as well as any RBD labeled colloidal gold bound to non-neutralizing antibody will be captured on the test line. The colloidal gold labeled chicken IgY antibody is bound to the goat anti-chicken IgY antibody coated with a colored band (C line), which acts as a procedural quality control line.
Step 1:
Wipe to clean the puncture site on your finger with the alcohol pad.
Step 2:
Remove the cap from safety lancet, push the lancet firmly against the puncture site.
Step 3:
Use the disposable pipette to draw the blood from puncture site.
Step 4:
Add one (1) drop (20µL) of blood from disposable pipette to sample well on the test cassette.
Step 5:
Add three (3) drops (100µL) of dilution buffer from the buffer bottle to the buffer well on the test cassette.
Step 6:
Start the timer. Read the test results between 25 and 30 minutes. Do not read the results after 30 minutes
WIthout a cassette reading device, test results can be interpreted visually:
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