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FDA Grants Emergency Use Authorizations for Seasun Biomaterials, Zeus Scientific Coronavirus Tests

NEW YORK — The US Food and Drug Administration this week granted separate Emergency Use Authorizations for SARS-CoV-2 tests developed by Seasun Biomaterials and Zeus Scientific.

Seasun's AQ-TOP COVID-19 Rapid Detection Kit Plus is a real-time reverse transcription loop mediated isothermal amplification test designed to detect the SARS-CoV-2 ORF1ab and N genes in upper respiratory and bronchoalveolar lavage specimens.

Nucleic acid extraction is performed using either Seasun's TOP Viral DNA/RNA Extraction Kit, Panagene's Panamax 48 Nucleic Acid Extraction System, or Qiagen's QIAamp DSP Virus Kit. The test runs on Bio-Rad Laboratories' CFX96 RT-PCR Detection System or Thermo Fisher Scientific's Applied Biosystems 7500 RT-PCR System.

The test may be used by any lab CLIA-certified to perform high-complexity tests.

Daejeon, South Korea-based Seasun received EUA from the FDA in May for its AQ-TOP COVID-19 Rapid Detection Kit, which detects the Orf1ab gene of SARS-CoV-2.

The Zeus ELISA SARS-CoV-2 IgG Test System is designed to detect immunoglobulin G against the virus in serum and plasma. It runs either manually or using Thermo Fisher's fully automated Dynex Agility ELISA system.

The test may be run in the automated way by any lab CLIA-certified to perform moderate-complexity tests, the FDA said in its authorization. It may be performed in either manual or automated formats by labs certified to perform high-complexity tests.

Branchburg, New Jersey-based Zeus said that it has also submitted an ELISA-based test for the detection of total antibodies against SARS-CoV-2 to the FDA for EUA.