coronavirus

The agency confused and upset many in the healthcare community last month when it said asymptomatic patients did not need to be tested.

The test targets antibodies for the viral spike protein and can characterize a vaccine-induced immune response.

Visby's test is a fully integrated PCR device that detects SARS-CoV-2 RNA, while SNIBE's test comprises assays for two different antibodies against the virus.

The test, which received EUA from the US Food and Drug Administration in April, is designed to detect human IgG antibodies in serum and plasma.

In 2018 Qiagen purchased a 19.9 percent stake in Ann Arbor, Michigan-based NeuMoDx along with the right to acquire the remaining shares.

The Manhattan-based lab will scale its capacity to process 20,000 tests per day by November and provide results dedicated to the city.

AACC noted that the number of sites performing clinical lab testing in the US has risen to 266,000 in 2020 from 154,000 in 1993.

The company's revenues for the first half of the year were up over 900 percent on strong sales of its PCR-based SARS-CoV-2 test and related products.