COVID-19 New Coronavirus Antigen Rapid Test Kit ISO13485 CE

COVID -19 New Coronavirus Antigen Rapid Test Kit ISO13485 / CE

Product Name:
COVID-19 New Coronavirus Antigen rapid screen Test Cassette

Accessories:
Instruction for use, buffer, pipette
Principle of Test:
Immunochromatographic assay

Intended Use:

The COVID-19 Antigen Rapid Test device is a lateral flow chromatographic immunoassay for the qualitative detection of the Novel coronavirus in human samples. It provides an aid in the diagnosis of infection with 2019-nCOV.

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.

TEST PRINCIPLE

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 colloidal gold. 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 with the 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.

INTERPRETATION OF RESULTS

Positive:

Two red lines are visible in the result window. The intensity of the test line may be

weaker or darker than that of the control line. This still means a positive result.

Negative:

The control line appears in the result window, but the test line is not visible.

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.