The COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette is a lateral flow immunoassay intended for the qualitative detection of SARSCoV-2, influenza A and influenza B viral nucleoprotein antigens in nasopharyngeal swab from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. Symptoms of Respiratory viral infection due to SARS-CoV-2 and influenza can be similar. The COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette is intended for the detection and differentiation of SARS-CoV-2, influenza A and influenza B viral nucleoprotein antigens. Antigens are generally detectable in nasopharyngeal specimens 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. Negative results do not rule out SARS-CoV-2, influenza A or influenza Infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results must be combined with clinical observations, patient history and epidemiological information, and confirmed with a molecular assay, if necessary for patient management. The COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro diagnostic procedures.
The novel corona viruses (SARS-CoV-2) belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel corona virus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, Fatigue and dry cough. Nasal congestion, runny nose, sore throat, malignant diarrhea are found in a few cases. Influenza (flu) is a contagious respiratory illness caused by influenza Viruses. It can cause mild to severe illness. Serious outcomes of flu infection Can result in hospitalization or death. Some people, such as older people, young children, and people with certain health conditions, are at high risk of serious flu complications. There are two main types of influenza (flu) virus: Types A and B. The influenza A and viruses that routinely spread in people (human influenza viruses) are responsible for seasonal flu epidemics each year.
The COVID-19 Antigen Rapid Test is a lateral flow immunoassay based on the principle of the double-antibody sandwich technique. SARS-CoV-2nucleocapsid protein monoclonal antibody conjugated with color microparticlesis used as detector and sprayed on conjugation pad. During the test, SARS-CoV-2 antigen in the specimen interacts with SARS-CoV-2antibody conjugated with color micro particles making antigen-antibody labeled complex. This complex migrates on the membrane via capillary action until the test line, where it will be captured by the pre-coated SARSCoV-2 nucleocapsid protein monoclonal antibody. A colored test line (T)
Materials Provided Test Cassette: a test cassette includes the COVID-19 Antigen Test Strip and the Influenza A+B Test Strip, which are fixed inside a plastic device
· Extraction Reagent: Ampoule containing 0.4 mL of extraction reagent
· Sterilized Swab
· Extraction Tube
· Dropper Tip
· Work Station
· Package Insert
The quantity of tests was printed on the labeling. Materials required but not provided
[STORAGE AND STABILITY]
· Store as packaged in the sealed pouch at the temperature (4-30℃ or 40-86℉). The kit is stable within the expiration date printed on the labeling.
· Once open the pouch, the test should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration. The LOT and the expiration date were printed on the labeling.
Specimens obtained early during symptom onset will contain the highest viral titers; specimens obtained after five days of symptoms are more likely to produce negative results when compared to an RT-PCR assay. Inadequate specimen collection, improper specimen handling and/or transport may yield a falsely negative result; therefore, training in specimen collection is highly recommended due to the importance of specimen quality for generating accurate test results.