COVID-19 TESTING INFORMATION

COVID-19 TESTING INFORMATION

Roxby Labs utilizes automated processes & high-throughput methodologies to rapidly deliver accurate, high-quality test results to patients. For the patient’s comfort & convenience, we collect nasal swabs for COVID19 PCR testing, which are less invasive and less painful than nasopharyngeal swabs. Our patient portal enables patients or physicians to access their results immediately after they are verified by our professional medical laboratory scientists.

Roxby Labs uses the Applied Biosystems® 7500 Real-Time PCR System, along with the Integra Assist Plus Automatic Pipetting system for superior performance, accuracy, & efficiency. The Lyra SARS-CoV-2 Assay by Quidel is the lab’s real-time RT-PCR assay intended for the in vitro qualitative detection of human coronavirus SARS-CoV-2 from viral RNA extracted from nasal, nasopharyngeal or oropharyngeal swab specimens. Below you can find more information about each of these systems.

The Lyra Direct SARS-CoV-2 Assay

Quidel Lyra Direct 

The Lyra Direct SARS-CoV-2 Assay detects SARS-CoV-2 viral RNA that has been extracted from a patient sample using a simple heat step. Roxby Labs is using Applied Biosystems 7500 Fast Dx to amplify the extracted RNA. Identification of the SARS-CoV-2 virus occurs by the use of target specific primers and fluorescent labeled probes that hybridize to a conserved region of the non-structural polyprotein of the SARS-CoV2 virus. ​​

Disclaimer 

The Lyra®Direct SARS-CoV-2 Assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests. The Lyra®Direct SARS-CoV-2 Assay is only for use under the Food and Drug Administration’s Emergency Use Authorization. ​

  • 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. 

Results 

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 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 patient history and do not rule out bacterial infection or co-infection with other viruses. 

Negative results must be combined with clinical observations, patient history, and epidemiological information. 

Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. 

The patient fact sheet for the Quidel Lyra Direct SARS-CoV-2 assay can be found here.

The instruments

Applied Biosystems 7500 FAST DX​

The Applied Biosystems® 7500 Fast DX Real-Time PCR Instrument amplifies selective nucleic acid sequences for detection with a five-color fluorescence system. The ABS 7500 Fast DX uses Peltier block technology to deliver the performance required for in-vitro diagnostic use.​

More Details on Applied Biosystems 750 Fast Dx Real-Time PCR Instrument (PDF)

 

The Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument 

Integra ASSIST Plus robot​

​The Integra ASSIST Plus robot automates serial or multi-channeling pipetting for the full Real-Time PCR workflow. The Integra ASSIST pipetting robot increases reproducibility of prolonged pipetting protocols, while also increasing efficiency for faster test results. Prolonged pipetting can be physical and mental challenging, thus leading to human error or injury. Find out more about the Integra ASSIST Plus here.

 

Pricing

The Coronavirus Aid, Relief, and Economic Security (CARES) Act was enacted on March 27, 2020. Section 3202(b) of the CARES Act requires the cash price of COVID-19 diagnostic testing be publicly available. 

Roxby Labs is an approved vendor with the state of WV for COVID-19 PCR testing & can provide free testing to any WV resident.

Roxby Labs will not turn anyone away regardless of their ability to pay. Self-pay discounts or payments plans are available. We will work with you to ensure you get the care you need.

For insurance billing or self-pay for non-WV residents please see our diagnostic testing pricing list

Schedule your COVID PCR test today

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Schedule your COVID PCR test today

Click Here
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