A clinical trial conducted in the United States with a Clungene® rapid COVID-19 test, approved by an institutional review committee, found a specificity of 100% (95% CI, 88.4%-100.0%) in patients with confirmed negative Covid-19 by RT-PCR, i.e. there was a 100% match between a negative RT-PCR and a negative Clungene® serological test result.

There was an over 90% match between the Clungene® SARS-CoV-2 Virus IgG/IgM 15-minute rapid test and a polymerase chain reaction (PCR) test in patients who tested positive for the virus after 13 days.

The results suggest that these tests could be an effective tool for detecting antibodies in people who have contracted the virus. The study was conducted by Sharp Healthcare in San Diego, California, and included patients in both inpatient and outpatient settings.

The study was conducted before vaccines were widely available. The original peer-reviewed research was published in the LymphoSign Journal (https://lymphosign.com/journal/lpsn).

„These results are incredibly encouraging because they demonstrate that the CLUNGENE® SARS-COV-2 VIRUS (COVID-19) IgG/IgM rapid test cassette is highly effective in identifying individuals with an adaptive immune response that indicates recent or previous infection, as required by the U.S. FDA’s current emergency response policy,“ said Dr. Fadi Haddad, an infectious disease expert at the Sharp Medical Community Group, who helped to conduct the study. „This is incredibly important at a time when millions of people remain unvaccinated and the potential for infection is still a very real concern.“

The Clungene SARS-CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Cassette provides results in 15 minutes. The test does not require complicated laboratory equipment to process the results.

The test is manufactured by Hangzhou Clongene Biotech and is intended for healthcare professionals only.