FAQ

 

Symptoms of COVID-19

What are the symptoms of being infected with the SARS-CoV-2 Virus?

About the Pathnostics PCR test

How accurate is the Pathnostics PCR test?

The analytic sensitivity of the Pathnostics-PCR COVID-19 test was determined to be 100% in detecting known amounts of SARS-CoV-2 RNA with no cross-reactivity to other known respiratory pathogens. A Not Detected (negative) test result for this test means that SARS-CoV-2 RNA was not present in the specimen above the manufacturer recommended cutoff value. An interpretation indicating “Not Detected” does not rule out the possibility of COVID-19 and should not be used as the sole basis for treatment or patient management decisions. If COVID-19 is still suspected, based on exposure history together with other clinical findings, re-testing should be considered in consultation with public health authorities. Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions.

How soon after exposure can we detect the virus using nasal swabs?

Studies have been conducted on symptomatic patients; thus, it is unknown the exact exposure date for both symptomatic and asymptomatic patients.  Studies show that asymptomatic patients begin shedding later after exposure* then symptomatic patients and then shed for a longer period of time.  Additionally, asymptomatic patients also produce less antibodies.

*Huff HV, Singh A (2020) Asymptomatic Transmission During the Coronavirus Disease 2019 Pandemic and Implications for Public Health Strategies. Clin Infect Dis. https://doi.org/10.1093/cid/ciaa654

*Long Q-X, Tang X-J, Shi Q-L, et al (2020) Clinical and immunological assessment of asymptomatic SARS-CoV-2 infections. Nat Med 1–5. https://doi.org/10.1038/s41591-020-0965-6

Has the Pathnostics PCR test 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 a 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.

Sampling and Testing Logistics

Who can collect the sample?

The Pathnostics COVID-19 PCR test requires a simple, non-invasive nasal swab that can easily be administered by patients themselves under the supervision of the trained professional. Pathnostics will provide a short live online training demonstrating the sampling process. 

Is the swabbing painful?
No, nasal (anterior nares) sampling is less invasive and results in less discomfort than sampling from other upper respiratory anatomical sites (e.g. the sometimes uncomfortable nasopharyngeal swab). Briefly, a swab is inserted at least 1 cm (0.5 inches) inside the nostril (naris), then the nasal membrane is firmly sampled by rotating the swab and leaving in place for 10 to 15 seconds. Both nostrils are sampled in the manner with the same swab.
What comes in the kit?
The kit includes specimen collection instructions, a requisition form, the collection kit (nasal swab, collection device container), tube label, biohazard bag, alcohol wipe, shipping box, and a FedEx Clin Pak.
How does the ordering and sampling process look like?

Each test kit will be sent to you in an individual package with specimen collection instructions, a requisition form, the testing kit (nasal swab, collection device container), tube label, a biohazard bag, shipping box, and a FedEx Clinical Pak.

  1. Complete the label information with the patient’s full name and date of birth and affix it to the collection device.
  2. Fill out the requisition form, ensuring that all required fields are completed.
  3. Follow the sample collection instructions, to collect the specimen.
  4. Place the swab in the collection device container that will keep the sample stable during transport.
    1. Note: The handle of the swab must be cut so that it will fit inside the collection container with the lid properly screwed on.
  5. Place the specimen tube into a specimen biohazard bag, and place with the requisition form (folded) into the pocket on the outside of the specimen bag.
  6. Place the specimen into the shipping box and close it.
  7. Lastly, place the shipping box containing the collection device and the requisition form in the FedEx Clin Pak
  8. Send to Pathnostics for testing.
  9. Bulk shipment is available upon request. For bulk, follow the same procedure above, except that the shipping box (red) is not required. Instead, place collection containers into the FedEx Clin Pak.
How long can a sample be stored before sending it to Pathnostics? How long until a test kit expires before the collection?

Once the sample has been placed in the collection vial, it will be stable for 15 days post collection. The shelf life of the kit is dependent upon the expiration date of the particular swab and media vial in the kit and is currently 2024/25 for the swabs and 2022 for the media tubes.

Reporting 

When will we get the results?

You will receive the test results from Pathnostics within 24-48 hours from the time of receipt at the laboratory. 

Who do you report the results to?

Pathnostics will report the test results to the state health department and the ordering authorized provider.

What does it mean if a test is reported as "inconclusive"?

The Pathnostics COVID19 test seeks to detect three different SARS-CoV-2 genes (ORF1ab, N gene, and S gene). The COVID-19 test results as positive when a signal is obtained from two or more SARS-CoV-2 targets. If a signal is obtained from only one of the three targets, the test is repeated. If the repeat result is the same, the results would be reported as ‘Inconclusive’. We would expect to see an ‘Inconclusive’ result rarely if at all, as the sequences targeted by the assay are conserved and highly specific to this virus.

Billing

Who will pay for the test?

Medicare, Medicaid and private payers will cover the full cost of COVID-19 testing if the test is medically necessary and ordered by a qualified healthcare professional.

Who pays for the shipping of the samples?

Pathnostics will cover the cost of shipping the samples to you and also back to us. 

Contact us

Who is the primary contact for setting us up to test?

Please contact our Customer Care:
855.600.6181

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