covid test

Covid-19 Testing

Covid-19 Testing at Scale

Exceltox laboratories is currently reaching out to state and local governments to supplement their testing capacity for Covid-19.

Workflow

A complete workflow from viral RNA extraction from up to 94 specimens and genetic analysis using real-time PCR to diagnostic report generation in under 4 hours.

Targeted specificity to 100% of currently available genomes for SARS-CoV-2.

Exceltox - Workflow
Exceltox - Targets

Targets

Assay targets spike (S) protein and nucleocapsid (N) protein regions having higher specificity and exhibiting lower risk for mutation.

Interpretive Software

Covid-19 Interpretive Software, which automatically converts genetic analysis data into diagnosis, helping reduce risk of user interpretation error.

Exceltox - Interpretive Software

Our Laboratory

Exceltox is a CAP accredited high complexity laboratory and CLIA accredited utilizing ThermoFisher R…

Exceltox is a CAP accredited high complexity laboratory and CLIA accredited utilizing ThermoFisher Real Time PCR instrumentation and FDA/EUA approved test kits.

Exceltox has been in business since 2013 providing testing to the medical community.

Exceltox has been in business since 2013 providing testing to the medical community.

At full capacity, clients can expect a 24-48 hour turnaround time from the time testing kit specimen…

At full capacity, clients can expect a 24-48 hour turnaround time from the time testing kit specimens arrive at the lab.

Test Process


  • 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 SARSCoV-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 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


References

  1. EUA Approval Letter- https://www.fda.gov/media/136113/download
  2. Provider Handout- https://www.fda.gov/media/136111/download
  3. Patient Handout- https://www.fda.gov/media/136114/download

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