SARS-CoV-2 Neutralizing Antibody Rapid Test
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SARS-CoV-2 Neutralizing Antibody Rapid Test Within 2-4 weeks of infection, >90% of individuals vaccinated or infected with SARS-CoV-2 virus develop detectable levels of polyclonal antibodies. Among these are neutralizing antibo- dies (NAb), which impede the virus from entering host cells, thus reducing the infectivity of the virus. While neutralizing antibodies are primarily directed against the spike protein of the virus, the cellular immunity triggered by the infection is mainly directed directly against cells infected with the virus. 1 The presence of neutralizing antibodies to SARS-CoV-2 is the best current indication of immunoprotection against infection in previously infected or vaccinated individuals. The S1 domain of the SARS-CoV-2 spike protein comprises the receptor-binding domain (RBD) which binds to ACE2, an enzyme on the outer surface of host cells. The binding of RBD to ACE2 is the first step of cell infection. Antibodies targeting the RBD critically interfere with virus entry into the cells. Several studies have shown that the neutralizing ability of polyclonal antibo- dies in serum positively correlates with anti-spike IgG or anti-RBD IgG. 2 The SARS-CoV-2 Neutralizing Antibody Rapid Test detects these RBD-specific antibodies. > > Add 10 μl of specimen into the sample window. Immediately add 3 drops of diluent buffer into the sample window. Read the results after 15 minutes. neg pos Test procedure Spike Protein ACE2 Receptor Human Cell Neutralizing Antibody
Transcript of SARS-CoV-2 Neutralizing Antibody Rapid Test
SARS-CoV-2 Neutralizing Antibody Rapid TestWithin 2-4 weeks of infection, >90% of individuals vaccinated
or infected with SARS-CoV-2 virus develop detectable levels of
polyclonal antibodies. Among these are neutralizing antibo-
dies (NAb), which impede the virus from entering host cells,
thus reducing the infectivity of the virus. While neutralizing
antibodies are primarily directed against the spike protein of
the virus, the cellular immunity triggered by the infection is
mainly directed directly against cells infected with the virus.1
The presence of neutralizing antibodies to SARS-CoV-2 is the
best current indication of immunoprotection against infection
in previously infected or vaccinated individuals.
The S1 domain of the SARS-CoV-2 spike protein comprises the
receptor-binding domain (RBD) which binds to ACE2, an enzyme
on the outer surface of host cells. The binding of RBD to ACE2
is the first step of cell infection. Antibodies targeting the RBD
critically interfere with virus entry into the cells. Several studies
have shown that the neutralizing ability of polyclonal antibo-
dies in serum positively correlates with anti-spike IgG or
anti-RBD IgG.2
The SARS-CoV-2 Neutralizing Antibody Rapid Test detects
these RBD-specific antibodies.
> >
Add 10 μl of specimen into the
sample window.
Immediately add 3 drops of diluent
buffer into the sample window.
Read the results
after 15 minutes.
neg pos
Test procedure
Spike Protein
ACE2 Receptor
Human Cell
NeutralizingAntibody
SARS-CoV-2 NAb Rapid Test REF: LFA0407-25NSARS-CoV-2 Neutralizing Antibody Rapid Test is a serological test
to detect neutralizing antibodies to SARS-CoV-2.
> Kit size: 25 tests
> Sample material: serum, plasma, whole blood and finger prick samples
> Storage: 2…30°C
> Shelf life: 18 months
> CE marked in accordance with Directive 98/79/EC
More information about COVID-19 at
www.human.de/covid-19/
1 WHO COVID-19 natural immunity (2021), WHO-2019-nCoV-Sci-Brief-Natural-immunity-2021.1-eng.pdf2 ECDCImmune responses and immunity to SARS-CoV-2 https://www.ecdc.europa.eu/en/covid-19/latest-evidence/immune-responses. State: May 20213 SARS-CoV-2 Neutralizing Antibody Test kit (Immunochromatography). Package insert; article number LFA0407-25N
HUMAN Gesellschaft für Biochemica und Diagnostica mbH Max-Planck-Ring 21 · 65205 Wiesbaden · GermanyTel. +49 6122-9988-0 · Fax +49 6122-9988-100 · e-mail: [email protected] · www.human.de
Clinical performance3 A total of 404 clinical samples, including 153 positive samples confirmed by RT-PCR and 251 negative samples
were obtained for the study. To verify that the test can detect the neutralizing antibodies in the vaccinated individuals,
460 serum samples were collected from volunteers who had received two vaccinations and the time of sampling
was at least 10 days after the second vaccination - comparison method was a Neutralizing Test.3
For professional use only
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Your advantages at a glance > High sensitivity and specificity
> No instrument and laboratory required, storage at room temperature
> Result within 15 minutes
> Complete accessories per test kit
SARS-CoV-2 Neutralizing Antibody Rapid Test results compared to Neutralizing Test
Sensitivity 151/153 = 98.69% (95%CI: 95.36% - 99.64%)
Specificity 246/251 = 98.01% (95%CI: 95.42% - 99.15%)
Accuracy 397/404 = 98.27% (95%CI: 96.47% - 99.16%)
SARS-CoV-2 Neutralizing Antibody Rapid Test results compared to Neutralizing Test
Sensitivity 412/416 = 99.04% (95%CI: 97.55% - 99.63%)
Specificity 42/44 = 95.45% (95%CI: 84.86% - 98.74%)
Accuracy 454/460 = 98.70% (95%CI: 97.18% - 99.40%)
Samples of double vaccinated individuals
Clinical samples of previously SARS-CoV-2 infected individuals
