Quantum Materials Corp. (fka QTMM)

[TedJ]

INNOVA SARS-CoV-2 Antigen Rapid Qualitative Test Instructions for Use

SARS-CoV-2 Antigen Rapid Qualitative Test

Instructions for Use

For prescription only

For in vitro diagnostic use only

Please read these instructions completely before beginning testing of
specimens.

INTENDED USE

The SARS-CoV-2 Antigen Rapid Qualitative Test is a colloidal gold
immunochromatography intended for the qualitative detection of nucleocapsid antigens
from SARS-CoV-2 in human nasal swabs or throat swabs from individuals who are
suspected of COVID-19 by their healthcare provider. within the first five days of the onset
of symptoms.

Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is
generally detectable in upper respiratory samples or lower respiratory samples during the
acute phase of infection. Positive results indicate the presence of viral antigens, but clinical
correlation with patient history and other diagnostic information is necessary to determine
infection status. Positive results do not rule out bacterial infection or co-infection with
other viruses. The agent detected may not be the definite cause of disease.

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, and
confirmed with a molecular assay, if necessary for patient management.

The SARS-CoV-2 Antigen Rapid Qualitative Test is intended for use by trained clinical
laboratory personnel specifically instructed and trained in the techniques of in vitro
diagnostic procedures, and proper infection control procedures and individuals similarly
trained in point of care settings.