99.05% Rapid Lateral Flow Antigen Test Kit CE Rtk Antigen Saliva Test

[INTENDED USE]

The COVID-19 Antigen Home Test (Saliva) is a lateral flow chromatographic immunoassay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in saliva specimen directly from individuals within 7 days of symptom onset to suspect COVID-19 infection. The COVID-19 Antigen Home Test (Saliva) is intended for self-use or lay person testing in a non-laboratory setting.

[SUMMARY]

The novel coronaviruses belong to the β genus. COVID-19 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.

[WARNINGS AND PRECAUTIONS]
l For in vitro diagnostic use only.
l For healthcare professionals and professionals at point of care sites.
l Do not use after the expiration date.
l Please read all the information in this manual before performing the test.
l The test device should remain in the sealed pouch until use.
l All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent. Wear gloves

ifneed, don’t touch the membrane.
l The used test device should be discarded according to federal, state and local regulations.
l The test is intended to be read at 15 minutes. If the test is read before 15 minutes or after 20 minutes, false negative or false positive

results may occur, and the test should be repeated with a new test cassette.
l The test device is a disposable product. Please dispose properly after use.