It looks like the test used in this study (and the LA study) was actually manufactured by Hangzhou Biotest Biotech Co., Ltd and is not FDA approved. Premier Bio

It looks like the test used in this study (and the LA study) was actually manufactured by Hangzhou Biotest Biotech Co., Ltd and is not FDA approved. Premier Biotech is simply the US distributor. [1] Given the news reports of Chinese companies shipping tons of faulty tests this does raise a serious question as to the reliability of this data. [2] The manual for the test also indicates it will produce a positive test result for other coronaviruses, which seems like a huge red flag. [3] > Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. [1] http://en.biotests.com.cn/newsitem/278470281 http://en.biotests.com.cn/newsitem/278470281 [2] https://www.nytimes.com/2020/04/19/us/coronavirus-antibody-tests.html https://www.nytimes.com/2020/04/19/us/coronavirus-antibody-t... [3] https://imgcdn.mckesson.com/CumulusWeb/Click_and_learn/Premier_Biotech_COVID19_Package_Insert.pdf https://imgcdn.mckesson.com/CumulusWeb/Click_and_learn/Premi...