COVID-19/Influenza A+B
Antigen Combo Rapid Test Cassette
For professional use only.For in vitro diagnostic use only.
[INTENDED USE]
The COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette is a lateral flow immunoassay intended for the qualitative detection of SARS- CoV-2, influenza A and influenza B viral nucleoprotein antigens in nasopha- ryngeal 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 B 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.
[SUMMARY]
The novel corona viruses 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 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 (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 B viruses that routinely spread in people (human influenza viruses) are responsible for seasonal flu epidemics each year.
[PRINCIPLE]
The COVID-19 Antigen Rapid Test is a lateral flow immunoassay based on the principle of the double-antibody sandwich technique. SARS-CoV-2 nucleocapsid protein monoclonal antibody conjugated with color micro- particles is used as detector and sprayed on conjugation pad. During the test, SARS-CoV-2 antigen in the specimen interact with SARS-CoV-2 antibody conjugated with color microparticles 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 SARS- CoV-2 nucleocapsid protein monoclonal antibody. A colored test line (T)
would be visible in the result window if SARS-CoV-2 antigens are present in the specimen. Absence of the T line suggests a negative result. The control line (C) is used for procedural control, and should always appear if the test procedure is performed properly.
The Influenza A+B Rapid Test is a lateral flow immunoassay based on the principle of the double-antibody sandwich technique. The monoclonal antibodies against influenza A and influenza B conjugated with color microparticles are used as detectors and sprayed on conjugation pad. During the test, antigen and labeled antibody complexes are formed and migrate on the membrane via capillary action. If the specimen contains influenza A antigen, the complex will be captured by the pre-coated influenza A monoclonal antibody to form a visible colored line at the A region in the result window. If the specimen contains influenza B antigen, the complex will be captured by the pre-coated influenza B monoclonal antibody to form a visible colored line at the B region in the result window. The control line (C) is used for procedural control, and should always appear if the test procedure is performed properly.
[WARNINGS AND PRECAUTIONS]
?For in vitro diagnostic use only.
?Do not use this product as the sole basis to diagnose or exclude SARS-CoV-2, influenza A or influenza B infection, or to inform infection status of COVID-19 or influenza.
?Do not use after the expiration date.
?Please read all the information in this leaflet before performing the test.
?The test cassette should remain in the sealed pouch until use.
?All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
?The used test cassette should be discarded according to federal, state and local regulations.
[COMPOSITION]
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
Timer
[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.
[SPECIMEN]
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.
Specimen Collection
Only the swab provided in the kit is to be used for nasopharyngeal swab collection.
Insert the swab through the nostril parallel to the palate (not upwards) until resistance is encoun- tered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx. Swab should reach depth equal to distance from nostrils to outer opening of the ear. Gently rub and roll the swab. Leave swab in place for several seconds to absorb secretions.
Slowly remove swab while rotating it. Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides if the minitip is saturated with fluid from the first collection. If a deviated septum or blockage creates difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the other nostril.
Specimen Transport and Storage
Do not return the nasopharyngeal swab to the original swab packaging. Freshly collected specimens should be processed as soon as possible, but no later than one hour after specimen collection. Specimen collected may be stored at 2-8℃ for no more than 24 hours; Store at -70℃ for a long time, but avoid repeated freeze-thaw cycles.
[SPECIMEN PREPARATION]
1.Unscrew the lid of an extraction reagent. Add all of the specimen extraction reagent into an extraction tube, and put it on the work station.
2.Insert the swab sample into the extraction tube which contains extraction reagent. Roll the swab at least 5 times while pressing the head against the bottom and side of the extraction tube. Leave the swab in the extraction tube for one minute.
3.Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. The extracted solution will be used as test specimen.
4.Insert a dropper tip into the extraction tube tightly.
