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The firm said that its RAQ SARS-CoV-2 PCR Kit allows the replacement of full nucleic acid extraction with a simple heat treatment, decreasing sample processing time.
Warrior Diagnostics' RT-PCR test detects SARS-CoV-2 RNA in nasopharyngeal swab samples and uses the same primers and probes as the CDC SARS-CoV-2 test.
To enable the use of saliva in addition to other types of samples, Sysmex requested a change to a marketing approval it obtained in March.
Avalon said it intends to establish a facility in the US for the manufacture and assembly of antibody and PCR-based detection systems.
The company said it has scaled up production capacity to two million reactions per week and has the potential to scale up to three million reactions per week.
The new method uses Takara Bio's SmartChip PCR instrument, chips, and reagents to run 5,184 reactions per chip in less than 30 minutes.
The FDA has added an at-home self-collection template to its SARS-CoV-2 EUA guidance as more firms seek to develop sampling kits for use in homes.
The test uses a proprietary at-home PCR nasal swab test with a turnaround time of 24 hours and is authorized for use by at-risk people.
During evaluations of 180 randomized specimens, the Genedrive 96 SARS-CoV-2 Kit achieved 100 percent sensitivity and 98.2 percent specificity, the firm said.
The RT-PCR test targets the N gene and E gene regions of the SARS-CoV-2 genome in a multiplex format.