August 26, 2020 / The Lindsley F. Kimball Research Institute in New York City announced the results of an independent study showing the IgG/IgM of the Clungene® SARS-CoV-2 virus. The rapid test cassette has a high sensitivity as well as specificity for the detection of COVID-specific antibodies.

The New York Blood Center study was conducted using convalescent blood plasma after it was approved by patients who self-reported Covid-19 infections and had no symptoms for at least 14 days prior to their donation. To determine the presence of COVID-specific antibodies, an IgG/IgM rapid test cassette containing Clungene® SARS-CoV-2 virus was used. The IgG results are consistent with the manufacturer’s clinical performance data of 97.4%, which showed a positive IgG match with the known positive PCR test.

„The ability to accurately identify the presence of antibodies is the first step in understanding the individual immune response to COVID-19 and assessing future exposure risk,“ said Larry Luchsinger, associate member of the Lindsley F. Kimball Research Institute at the New York Blood Center. „This is critical to creating informed public health policy and charting a path for our communities.“

The Clungene® SARS-CoV-2 virus (COVID-19) IgG/IgM rapid test cassette provides rapid results in 15 minutes with a fingerprint of whole blood, serum or plasma. The test does not require laboratory equipment, software or special training to process the readings. Specialist medical staff do not need to send samples to laboratories to obtain results.

The original source of this press release can be found at the following link.

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