page above, here area a few translated notes. As far as I can tell
its like a home pregnancy test.
● A Negative result does not rule out present or future SARS-CoV-2
infection. In the case of a symptomatic case or a suspicion of recent
infection, the only method recommended by the World Health Organization
is through the RT-PCR (Polymerase Chain Reaction) methodology .
Warnings on the Use of Antibody Tests for COVID-19
This test is for In Vitro Diagnostic Use (IVD) only in Cabinet or
Its sale is exclusively aimed at Health Professionals.
● The results obtained by antibody tests should not be used as
a sole basis to diagnose or discriminate the presence of
infection present with the SARS-CoV-2 virus (COVID-19 disease).
● In the case of a symptomatic case or a suspicion of recent infection,
the only method recommended by the World Health Organization is
through the RT-PCR (Polymerase Chain Reaction) methodology.
● The Positive Predictive Value of Any diagnostic test for antibody
detection it is correlated to the specificity of the test and the
prevalence of the infectious agent in the population.
● The analytical sensitivity of the test is 100% in samples taken
from patients with at least 14 days of having obtained positive
results in PCR.
It is still unknown whether people with antibodies to SARS-CoV-2 are
not infectious, may re-infect, or may have COVID-19 in the future.
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