Influenza is a highly contagious, acute, viral infection of the respiratory tract. The causative agents of the disease are immunologically diverse, single-strand RNA viruses known as influenza viruses. There are three types of influenza viruses: A, B, and C. Type A viruses are the most prevalent and are associated with most serious epidemics. Type B viruses produce a disease that is generally milder than that caused by type A. Type C viruses have never been associated with a large epidemic of human disease. Both type A and B viruses can circulate simultaneously, but usually one type is dominant during a given season. Influenza antigens may be detected in clinical specimens by immunoassay.
The Safecare COVID-19 Antigen Rapid Test is a lateral flow immunoassay intended for qualitative detection of nucleocapsid protein antigen in direct nasal swabs or nasopharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
A negative test result may occur if the level of antigen in a sample is below the detection limit of the test. If the test result is negative but clinical symptoms persist, additional testing using other clinical methods is recommended. As with all diagnostic tests, a confirmed diagnosis should only be made by physician after all clinical and laboratory findings have been evaluated.
The COVID-19 Antigen Rapid Test is intended for use by medical professionals or trained operators who are proficient in performing rapid lateral flow tests.
【TEST KIT COMPOSITION】
[Specimen Collection and Handling]
Inadequate specimen collection or improper specimen handling may yield a false result.
Prior to collecting the nasal swab, the patient should be instructed to blow their nose.
To collect a nasal swab sample, carefully insert the swab into the nostril that presents the most secretion under visual inspection. Using gentle rotation, push the swab until resistance is met at the level of the turbinates (less than one inch into the nostril). Rotate the swab several times against the nasal wall then remove it from the nostril.
To collect a nasopharyngeal swab sample, carefully insert the swab into the nostril that presents the most secretion under visual inspection. Keep the swab near the septum floor of the nose while gently pushing the swab into the posterior nasopharynx. Rotate the swab several times then remove it from the nasopharynx.
Specimens should be tested as soon as possible.If transport of the samples is required, the following transport media are recommmended and have been tested and shown not to interfere with the performance of the test: Hank’s balance Mkd salt solution, M5 media, or saline.Alternatively, samples may be stored refregerated(2-8℃) or at room temperature(15-30℃) in a clean,dry, closed container for up to 8 hours before testing.
Insert the swab into the extraction tube which contains buffer. Rotate the swab inside the tube using a circular motion to roll the side of the extraction tube so that the solution is expressed and reabsorbed from the swab. Leave the swab in the extraction tube for one minute.
Add 6 drops of extraction buffer into the extraction tube, and put it on the workstation.
Pinch the extraction tube with fingers and remove the solution from the swab as far as possible. The extracted solution will be used as test specimen.
Insert a dropper tip into the specimen extraction tube tightly.
[INTERPRETATION OF THE RESULT]