SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)
SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein, Influenza A and Influenza B virus antigens present in human nasopharynx.
For professional in vitro diagnostic use only.
The SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein, Influenza A and Influenza B virus antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/Influenza infection in conjunction with clinical presentation and the results of other laboratory tests.
Results are for the detection of SARS-CoV-2 Nucleocapsid protein and Influenza A+B Antigens. An antigen is generally detectable in upper respiratory 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. The agent detected may not be the definite cause of disease.
Negative results do not preclude SARS-CoV-2/ Influenza A+B infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. 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 SARS-CoV-2/ Influenza A+B.
SPECIMEN COLLECTION, TRANSPORT AND STORAGE
1. Insert a sterile swab into the nostril of the patient, reaching the surface of the posterior nasopharynx.
2. Swab over the surface of the posterior nasopharynx 5-10 times.
3. Withdraw the sterile swab from the nasal cavity and avoid excess volume and highly-viscous nasopharyngeal discharge.
Only the extraction buffer and tubes provided in the kit is to be used for swab specimen preparation.
Please refer to the Procedure card for detailed information of Specimen Extraction.
1. Place the swab specimen in the Extraction tube with Extraction Buffer. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab.
2. Remove the swab while squeezing the swab head against the inside of the Extraction tube as you remove it to expel as much liquid as possible from the swab. Discard the swab in accordance with your biohazard waste disposal protocol.
*NOTE: The storage of the specimen after extraction is stable for
Allow the test, extracted specimen and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Remove the test cassette from the sealed foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Invert the specimen extraction tube and add 3 drops of extracted specimen (approx.75-100μl) to each of the specimen well(S) respectively and then start the timer.
3. Wait for the colored line(s) to appear. Read the result at 15 minutes. Do not interpret the result after 20 minutes.
The novel coronaviruses belong to the β genus. SARS-CoV-2 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.
Influenza (commonly known as ‘flu’) is a highly contagious, acute viral infection of the respiratory tract. It is a communicable disease easily transmitted through the coughing and sneezing of aerosolized droplets containing live virus.1 Influenza outbreaks occur each year during the fall and winter months. Type A viruses are typically more prevalent than type B viruses and are associated with most serious influenza epidemics, while type B infections are usually milder.
The gold standard of laboratory diagnosis is 14-day cell culture with one of a variety of cell lines that can support the growth of influenza virus.2 Cell culture has limited clinical utility, as results are obtained too late in the clinical course for effective patient intervention. Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a newer method that is generally more sensitive than culture with improved detection rates over culture of 2-23%.3 However, RT-PCR is expensive, complex and must be performed in specialized laboratories.