NEW YORK – QuestCap announced Thursday it has secured exclusive rights to sell Hangzhou Laihe Biotech's lateral flow IgM/IgG antibody test kit within North America.
The Lyher Novel Coronavirus (2019-nCOV) IgM/IgG Antibody Combo Test Kit received Emergency Use Authorization from the US Food and Drug Administration in June and is available for immediate sale in the US. The immunochromatography-based lateral flow assay is designed to detect immunoglobulin M and G antibodies against SARS-CoV-2 in human serum and plasma.
The test was evaluated by the National Cancer Institute's Frederick National Laboratory for Cancer Research and reported a combined IgG/IgM sensitivity of 100 percent and specificity of almost 99 percent. It will be used at high- and moderate-complexity labs and healthcare facilities, the firm said.
Blackport Holdger Partners assigned the exclusive rights to QuestCap through its role as the North America representative of Hangzhou Laihe's Lyher tests. Hangzhou Laihe Biotech is based in Zhejiang, China and develops point-of-care tests and other diagnostic technologies.