The New York Blood Center Lindsley F. Kimball Research Institute announced the results of an independent study that showed the Clungene® SARS-CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Cassette possesses a high degree of sensitivity and specificity for detecting COVID-specific antibodies.
The study by the New York Blood Center was done with convalescent blood plasma, following authorization from patients who self-reported COVID-19 infections and had not experienced symptoms for at least 14 days prior to their donation. Clungene® SARS-CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Cassette were used to determine the presence of COVID-specific antibodies. The IgG results are consistent with the manufacturer’s 97.4% clinical performance data which showed positive IgG agreement with known positive RT-PCR test. The IgM results are consistent with recently published data which shows that IgM can persist more than 23 days after symptom onset and can be earlier, synchronous or later than IgG.
“Having the ability to accurately identify the presence of antibodies is the first step in understanding individual immune response to COVID-19 and evaluating future risk for exposure,” said Larry Luchsinger, Assistant Member, Lindsley F. Kimball Research Institute of the New York Blood Center. “This is critical for creating informed public health policies and charting a path forward for our communities.”
The Clungene® SARS-CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Cassette produces rapid results in 15 minutes from a finger prick of whole blood, serum or plasma. The test does not require laboratory equipment, software or specialized training to process readouts. Users do not have to send samples to labs in order to obtain results. The test is manufactured by Hangzhou Clongene Biotech and is distributed in the U.S. by Proven Pharmaceuticals.
The test has been submitted to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) and is awaiting approval. The FDA is currently allowing the test to be made available in the U.S. as the agency reviews its EUA application.