CE mark

After around six months, Genetic Signatures anticipates merging its SARS-CoV-2 test with a respiratory disease testing kit.

The anti-SARS-CoV-2 antibodies for classes IgA and IgG are two of the first antibody detection tests to receive CE making and be made available for SARS-CoV-2 testing.

The test, which uses an Applied Bioystems TaqPath assay and real-time PCR technology, detects nucleic acid from SARS-CoV-2, the virus that causes COVID-19.

Biocartis will lead commercialization in Europe as the exclusive distributor of the SeptiCyte Rapid test, while Immunexpress will lead commercialization of the test in the US.

Now, the assay can also be used with the Applied Biosystems 7500 Standard from Thermo Fisher Scientific, Roche's LightCycler 480, and Qiagen's Rotor-Gene Q.

The company, known for clinical chemistry and molecular biology diagnostic kits, is currently working on two test kits for SARS-CoV-2.

The sequencing-based test is designed to detect mutations that cause resistance to 15 first- and second-line antibiotics used to treat tuberculosis.

The company's in vitro diagnostic qRT-PCR test detects viral RNA and targets three genes of the SARS-CoV-2 virus: the N, Orf1ab, and E genes.

The company said the test achieved 100 sensitivity and 100 percent specificity in a study of 210 samples that included 44 from COVID-19 patients.

The Korean company's test qualitatively detects the Orf1a and N genes of the novel coronavirus in specimens from patients with suspected respiratory infection.