Close Menu

emergency use authorization

Company officials credited investments in information technology, as well as R&D for RT-PCR-based tests, with driving up the firm's billable testing numbers.

The tests use a range of different specimens including self-collected nasal swabs, bronchoalveolar lavage, sputum, and nasopharyngeal washes.

The tests are semi-quantitative, meaning that they estimate the quantity of a patient's antibodies produced against infection, the FDA said.

Zeesan's test may be used by any CLIA-certified high-complexity lab, while UCSD's test, which uses pooled samples, must be performed by the university.

According to the company, the test has shown to be more sensitive and accurate than a COVID-19 anterior nasal swab test in the firm's EUA validation study.

The seven technologies feature different methods, including CRISPR and microfluidics, and can be performed in many settings and with a variety of sample types.

Both of the RT-PCR-based tests are designed to detect the SARS-CoV-2 nucleocapsid gene in a variety of swab samples and other specimens.

A number of diagnostic labs have considered saliva-based SARS-CoV-2 testing but decided against it, while other groups continue to pursue it.

The assays are both designed to detect immunoglobulin M and G antibodies against SARS-CoV-2 in blood samples, with results in 10 minutes.

A lab evaluation by the National Cancer Institute showed the company's SARS-CoV-2 IgG/IgM test to be sensitive and specific.

Pages