M&D 2019-nCoV Antigen Home Test Kit is a rapid and convenient
lateral flow immunochromatographic assay for the qualitative
detection of SARS-CoV-2 nucleocapsid protein from SARS-CoV-2. This
test is for research use only with self-collected observed direct
anterior nasal (nares) swab specimens from individuals aged 14 years
or older and who are suspected of COVID-19 within seven days of
symptom onset and/or epidemiological criteria or adult collected nasal
swab specimens from individuals aged 4 years or older who are
suspected of COVID-19 within the first seven days of symptom onset
and/or epidemiological criteria. The rapid test device is for research
use only.
Positive results indicate the presence of viral antigens, but the clinical
correlation with patient history and other diagnostic information is
necessary to determine infection status. Positive results do not rule out
a bacterial infection or co-infection with other viruses. The agent
detected may not be the definite cause of the disease. Negative results
from patients with symptom onset beyond seven days should be treated
as presumptive and confirmation with a molecular assay, if necessary,
for patient management, may be performed. Negative results do not
rule out SARS-CoV-2 infection and should not be used as the sole basis
for treatment or patient management decisions, including infection
control decisions. Negative results should be considered in the context
of a patient’s recent exposures, history, and the presence of clinical
signs and symptoms consistent with COVID-19.
Individuals who test negative and continue to experience COVID-like
symptoms should seek follow-up care from their healthcare provider.
Individuals who test positive should report the test results to relevant
public health authorities.
The result of this test should not be the sole basis for the diagnosis
and the test results should be confirmed by a local
government-approved Real-Time Reverse Transcriptase (RT)-PCR
Diagnostic kit
