Pathnostics Launches COVID-19 PCR Test, A Laboratory-Based Molecular Test

 

On May 04, 2020, Pathnostics launched our COVID-19 PCR testing. Additional information available in our PRESS RELEASE.

What makes a PCR test different from a serology (blood) test?  

  • PCR detects the genetic information of the virus.  That’s only possible if the virus is there and someone is actively infected.
  • The COVID-19 PCR Test is a sensitive molecular test that targets the detection of three SARS-CoV 2 genes and provides information as to those patients that are currently infectious. 
  • PCR test results give a good indication of who is infected.  This is information that can break the transmission chain of the virus. 

 

The COVID-19 PCR Test offers:  

  • Simple specimen collection – Samples are collected with a nasal swab, which is fast and painless.
  • Safe chain of custody measures – Samples are transferred from the patient to the lab in a proprietary buffer that inactivates the virus, keeping healthcare and other essential workers safe during specimen transit. 
  • Cash pay price is $100. 

COVID-19 PCR Test Performance Characteristic

The diagnostic sensitivity of the Pathnostics COVID-19 test was determined to be 100% in detecting known amounts of SARS-Cov-2 RNA. A negative result for this test means that SARS-CoV-2 RNA was not present in the specimen above the limit of detection of the assay (10 copies of SARS-CoV-2 RNA, equal to the limit of detection of the EUA Thermo Fisher TaqPath COVID-19 Combo kit). Detection depends upon proper sample collection and the spread of the virus to the collection site; a negative result does not rule out COVID-19 as it could be present below the limit of detection and is therefore reported as “Not Detected” instead of “Negative”. A “Not Detected” result should not be used as the sole basis for treatment or patient management decisions according to CDC guidelines. In general, it is believed that nasal swabs (nasopharyngeal, mid-turbinate, anterior nares) method of collection in conjunction with PCR testing reliably detects 70-80% of true COVID-19 positive cases.

We also demonstrated Analytic Specificity at 100%. In addition to in silico analysis completed with the Thermo Fisher EUA, we tested and demonstrated no cross-reactivity with 41 other known respiratory pathogens.

Has the Pathnostics PCR test for COVID-19 been approved by the FDA?

The Pathnostics COVID-19 PCR test is a Laboratory Developed Test (LDT) employing real-time PCR (RT-PCR) for the molecular detection of SARS-CoV-2 RNA and has been modified from the Thermo Fisher Scientific, Inc. Taqpath COVID-19 Combo Kit that was authorized for Emergency Use on 3/13/2020. As referenced in the FDA “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency”, a laboratory certified under Clinical Laboratory Improvement Amendments (CLIA) that meets the CLIA regulatory requirements to perform high complexity testing may use their LDT test without a new or amended EUA where the test is validated using a bridging study to an EUA-authorized test. Pathnostics is a CLIA laboratory authorized to perform high complexity testing and the Pathnostics COVID-19 PCR test has been validated with a bridging study to the EUA TaqPath COVID-19 Combo Kit.

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