CE Certification PRL test Reagent Exporters – COVID-19 Ag (FIA) – Aehealth

The COVID-19 Antigen test along with Aehealth FIA Meter is intended for vitro quantitative determination of SARS-CoV-2 in human nasal swabs, throat swabs or saliva from individuals who are suspected of COVID-19 by their healthcare provider. The novel coronaviruses belong to the β genus of Coronaviruses. 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 results are for the identification of SARS-CoV-2 nucleocapsid antigen. The antigen is generally detectable in upper respiratory samples or lower respiratory samples during the acute phase of infection. The positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. The positive results do not rule out bacterial infection or co-infection with other viruses. The antigen detected may not be the definite cause of disease. The negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. The negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2 and confirmed with a molecular assay, if necessary, for patient management.

This rapid test kit is based on fluorescence immunoassay technology. During the test, specimen extracts are applied to the test cards. If there are SARS-CoV-2 antigen in the extract, the antigen will bind to the SARS-CoV-2 monoclonal antibody. During lateral flow, the complex will move along the nitrocellulose membrane toward the end of the absorbent paper. When passing the test line (line T, coated with another SARS-CoV-2 monoclonal antibody) the complex is captured by SARS CoV-2 antibody on test line. Thus the more SARS-CoV-2 antigen is in specimen, the more complexes are accumulated on test strip. Signal intensity of fluorescence of detector antibody reflects amount of SARS CoV-2 antigen captured and Aehealth FIA Meter shows SARS-CoV-2 antigen concentrations in specimen.

1. Store the product at 2-30℃, the shelf life is 18 months tentatively.

2. Test cassette should be used right after opening the pouch.

3. Reagents and devices must be at room temperature(15-30℃) when used for testing.

Positive Test:

Positive for the presence of SARS-CoV-2 antigen. 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. The antigen detected may not be the defifinite cause of disease.

Negative Test:

Negative results are presumptive. Negative test results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions, including infection control decisions, particularly in the presence of clinical signs and symptoms consistent with COVID-19, or in those who have been in contact with the virus. It is recommended that these results would be confifirmed by a molecular testing method, if necessary, for patient management Control.