A Highly Sensitive Input-to-Answer Diagnostic SARS-CoV-2 Detection Test
Standard BioTools™ has developed a diagnostic molecular test for the qualitative detection of SARS-CoV-2 in nasal swab specimens for use under FDA Emergency Use Authorization (EUA).
The Advanta™ Dx COVID-19 EASE Assay is a qPCR-based test that, by taking advantage of our proprietary microfluidics technology and the Juno™ and Biomark™ HD systems, enables scalable testing of nasal swab samples from patients suspected of SARS-CoV-2 infection. The highly sensitive Advanta Dx COVID-19 EASE Assay with a limit of detection of 0.125 copies/µL provides reliable results to support clinical decision making.
Advanta Dx COVID-19 EASE Assay Reagent and IFC Bundle
Test Platform Highlights
- Highly sensitive: Observed limit of detection (LOD) of 0.125 copies/μL
- Streamlined workflow: Automated with limited hands-on time (<1.5 hours) following extraction
- Low consumables usage: Miniaturized microfluidic operations at the nanoliter scale to reduce waste and cost while conserving precious samples
- Self-contained system: Reduced risk of amplicon contamination and sources of variability
- Scalable throughput: Processes up to 96 samples and controls per run
Workflow and Description of Test Steps
The Advanta Dx COVID-19 EASE Assay is a real-time reverse transcription (RT) PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab, mid-turbinate nasal swab, and anterior nasal swab specimens from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet requirements to perform high-complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Clinical correlation with individual history and other diagnostic information is necessary to determine individual infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The Advanta Dx COVID-19 EASE Assay is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.
The Advanta Dx COVID-19 EASE Assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.
Get more information about the Advanta Dx COVID-19 EASE Assay.
For In Vitro Diagnostic Use. For Use Under Emergency Use Authorization Only. Rx Only.
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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.
Standard BioTools, the Standard BioTools logo, Advanta, Biomark and Juno are trademarks and/or registered trademarks of Standard BioTools Corporation in the United States and/or other countries. All other trademarks are the sole property of their respective owners. ©2022 Standard BioTools Corporation. All rights reserved. 04/2022