WARNING: This Coronavirus COVID-19 rapid test not been reviewed by FDA and not under FDA EUA. The test is not recommended for diagnostic purposes in the US and may be used Only for Researches, Training, and Forensic Needs. Please pay attention: this test approved by the Australian government, ANVISA – Brasil AGÊNCIA NACIONAL DE VIGILÂNCIA SANITÁRIA, World Health Organisation, and widely used in EC.
The 1st officially approved antibody test in China!
The World Health Organization (WHO) on March 11 declared COVID-19 a pandemic, pointing to the over 118,000 cases of the coronavirus illness in over 110 countries and territories around the world and the sustained risk of further global spread. To stop further global spread of the virus, the world needs a screening test that is fast and reliable. We started to develop a rapid test cassette against the COVID-19.
Though the POC antibody rapid tests based on LFIA showed reliable performance in the detection of SARS-CoV-2-specific antibodies, the results of these tests should be interpreted and applied appropriately in the context of antibody dynamic of COVID-19 infection. COVID-19 patients are complicated with pneumonia exhibited earlier anti-SARS-CoV-2 antibody response than COVID-19 patients without pneumonia.
Below are some studies results: There have been more than 40,000 reported cases of coronavirus disease (COVID-19) in Brazil until May 8, 2020. Recurrent testing among health care professionals is the key step to be undertaken by hospitals, as the completely asymptomatic infection might occur among these professionals. Hospital das Clinicas is the main hospital dedicated to COVID-19 response in the city of Sao Paulo, with 224 intensive care unit beds.
We have set up a PCR testing program to detect COVID-19 among symptomatic health care professionals in the early phase of the epidemic. However, an antibody-based screening program was difficult to establish because of the lack of available antibody tests in Brazil. Recently, we received a donation of Wondfo One Step COVID-19 rapid test kits (Guangzhou, China) from a Brazilian company. The test is generally performed on capillary blood samples, but it can also be performed on peripheral blood, plasma, and serum.
We collected 47 paired samples (capillary and serum) from health care workers within 15 days of their confirmed diagnosis of COVID-19 by PCR to validate the test. The results were compared with those of the Euroimmun IgG EIA test (Luebeck, Germany).
The rapid test showed on serum samples sensitivity to that of the Euroimmun IgG EIA assay (96%).
WARNING: This Coronavirus COVID-19 rapid test not been reviewed by FDA and not under FDA EUA. The test is not recommended for diagnostic purposes in the US and may be used Only for Researches, Training, and Forensic Needs.