OEM Covid19 Antigen Rapid Test Kit CE Rtk Saliva Test Accuracy 99%

OEM Covid 19 antigen Rapid Test Kit CE marked

The COVID-19 Antigen Rapid Test device is a lateral flow chromatographic immunoassay for the qualitative

detection of the nucleocapsid(N) protein antigen from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal

swab. It provides an aid in the diagnosis of infection with 2019-nCOV.

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.

The Device uses the principle of the double antibody sandwich method for detecting the nucleoprotein (N) of SARS-CoV-2.

The marker is composed of the anti-N antibody 1 labeled with colored particles. When testing, the sample was added into

the sample well and migrated to the absorbent pad by the capillary effect. If the virus exists, it will react withthe marker and

captured by the anti-N antibody 2 coated in the NC membrane. Then there is a colored line produced at the test area,
indicating a positive result. If there is no virus in the sample, the colored line will not show at the test area and it means a

negative result. Regardless of whether the virus contained in the sample, as a procedural control, a colored line will always

appear at the control area, indicating that proper volume of specimen has been added and the correct test procedure is conducted.

[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.