Linea COVID-19 PCR Logo

Helping to Stop the Coronavirus Outbreak

DNA in test tubes

Applied DNA Sciences’ Linea™ COVID-19 Assay is a real-time polymerase chain reaction (RT-PCR) test for the qualitative detection of SAR S-CoV-2 RNA in upper respiratory specimens. The Linea™ COVID-19 Assay Kit provides a high-throughput solution to help laboratories address the urgent need for patient testing during the Coronavirus pandemic.

For Emergency Use Authorization (EUA) only. For prescription use only. For in vitro diagnostic use.

The Kit

LineaCOVID-19 kit
  • Detection of two highly-conserved sequences (S1 and S2) contained in SARS-CoV-2 Spike (S) Gene.
  • High sensitivity with Limit of Detection of 1.25 copies per µL with 100% confidence limit.
  • Results within hours.
  • For use with the Thermo Fisher QuantStudio™ Dx real-time PCR system with software v1.0.3.

Applications

Medical Team in Hospital Corridor

HEALTHCARE SYSTEMS

garbage collection workers

MUNICIPALITIES

Zoom meeting displayed on laptop

CORPORATIONS

lab assistant holding test tube with blood sample

LABORATORIES

Speaker at Business Conference

COLLEGES/UNIVERSITIES

Airport checkin

PUBLIC AUTHORITIES

Sample Collection

doctor taking COVID nasal swab from a driver

NASOPHARYNGEAL SWAB

OROPHARYNGEAL SWAB

Doctor performing oral swab on patient
Anterior nasal swab

ANTERIOR NASAL SWAB

Validation

Stony Brook University Hospital exterior shot
Stony Brook University Hospital logo

The Linea™ COVID-19 assay was validated in conjunction with Stony Brook University, a world-class medical institution. Ongoing optimization efforts include the addition of robotic technologies to help improve assay processing efficiency.

Key information

  • Detects two highly conserved portions of the SARS-CoV-2 S gene
  • High sensitivity with limit of detection of 1.25 copies per μL.
  • Rapid detection – Results in under 1 hour
  • Configured for high-throughput analysis

Several versions of kits are available:

Catalog Number               Description

DX-1001-001-000            Assay Kit, 100 reactions

DX-1001-002-000            Assay Kit, 500 reactions

DX-1001-003-000            Assay Kit, 1000 reactions

Dr. Mohan Chellani

Contact us to learn more

Mohan Chellani, Ph.D., Director

QuantStudio™ is trademark of Thermo Fisher Scientific

The Linea™ COVID-19 SARS-CoV-2 assay kit has not been FDA cleared or approved; it has been authorized by FDA under an EUA for use by authorized laboratories. This assay kit has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The Linea™ COVID-19 SARS-CoV-2 assay kit is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.