SARS-CoV-2 Human Influenza Virus A&B(Flu A&B)Antigen Test
Kit ( Colloidal Gold )
Application
The SARS-CoV-2/Human Influenza Virus A&B(Flu A&B)Antigen
Test Kit ( Colloidal Gold ) is a lateral flow chromatography
immunoassay intended for the qualitative detection and
differentiation of nucleocapsid protein antigens from SARS-CoV-2,
influenza type A and influenza type B in the same time directly
from nasal/nasopharyngeal (NS/NP) swab, oropharyngeal (OP) swab and
saliva specimens from patients with signs and symptoms of
respiratory viral infection. The SARS-CoV-2/Human Influenza Virus
A&B(Flu A&B)Antigen Test Kit(Colloidal Gold) is an aid in
the diagnosis of patients with suspected SARS-CoV-2 or influenza
infection in conjunction with clinical presentation and the results
of other laboratory tests. Results from the SARS-CoV-2/Human
Influenza Virus A&B(Flu A&B)Antigen Test Kit(Colloidal
Gold) should not be used as the sole basis for diagnosis. The
SARS-CoV-2/Human Influenza Virus A&B(Flu A&B)Antigen Test
Kit(Colloidal Gold) is intended to aid in the rapid differential
diagnosis of influenza type A and type B and SARS-CoV-2 viral
infections, but does not differentiate between SARS-CoV and
SARS-CoV-2, and is not intend for detection of influenza type C
virus. 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 should be treated as presumptive and confirmed by viral
culture or a molecular assay. Negative results do not rule out
COVID-19 and influenza virus 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. The SARS-CoV-2/Human Influenza Virus A&B(Flu
A&B)Antigen Test Kit(Colloidal Gold) is intended for use by
trained clinical
laboratory personnel and individuals trained in point of care
settings. For prescription use only. For in vitro diagnostic use
only.
Product information
| Advantage | Easy to use with fast, accurate results |
| Specimen | Nasal swab, Nasopharyngeal swab, Oropharyngeal swab |
| Storage Condition | Out of direct sunlight |
| Test time | 15 minutes |
| Main Composition | Test Cassette, Sample Tube, Nasal or Nasopharyngeal Swabs,
Instructions for use |
| Intended Use | Qualitative detection and differentiation of nucleocapsid protein
antigens from SARS-CoV-2, influenza type A and influenza type B |
