Our molecular qPCR laboratory utilizes the latest technologies from ThermoFisher and operates under the Emergency Use Authorization (EUA) guidance issued by the FDA and CAP and CLIA quality standards.
COVID-19 Testing & Diagnostics
Quantitative PCR (qPCR)-Based Testing
According to the World Health Organization, the CoVs are a large family of single-stranded RNA viruses (+ssRNA) and are enveloped viruses with nucleocapsid. It is important to note that quantitative PCR-based testing provides extreme accuracy in detecting COVID-19 within hours not days.
xymbio’s molecular qPCR laboratory utilizes industry leading equipment including the latest technologies from ThermoFisher and operates under the Emergency Use Authorization (EUA) guidance issued by the FDA and CAP and CLIA quality standards.
Our full Respiratory Panel includes COVID-19, allowing providers to quickly and accurately identify the cause of symptoms related and/or not related to COVID-19. Unlike available “Rapid” or “Serology” tests which studies show report 30% false negatives, qPCR results are extremely accurate.
We are a biotechnology company focused on improving patient, provider and facility healthcare outcomes for Infectious Disease. Our advanced, proprietary solution combines technology, diagnostics, data management, decision platforms and outcomes analysis utilizing Artificial Intelligence (AI). With the largest data set of Infectious Disease targets available in the world, xymbio offers tremendous flexibility, extremely precise diagnosis, treatment guidance for patients and improved antibiotic stewardship.
Key Components of xymbio’s Molecular Diagnostics Solution:
- Diagnostics with Extreme Sensitivity and Specificity
- Comprehensive Sample Types Including Complicated Biofilms
- Rapid Results in Hours Rather than Days
- Actionable Results to Drive Targeted Treatment Decisions
- Decreased Potential for Human Error
- Fully Integrated IT and Data Outcomes Analyses
- Turnkey Implementation Processes and Procedures
- Regulatory and Compliance Protocols
- CLIA and CAP Accredited
- Pharmacy and Experienced ID Expert Advice
- Ongoing Training and Continuing Education
- Reduce Inappropriate Antimicrobial Use and Spread of Resistance
- Research and Development to Drive Future Innovation
ANSWERS TO TOP QUESTIONS
What Is COVID-19?
COVID-19 also known as Coronaviruses are a large family of viruses, some causing respiratory illness in people. Signs and symptoms, similar to the common cold or the flu, include a runny nose, cough, sore throat, fever, and general feeling of being unwell.
A novel coronavirus is a new coronavirus that has not been previously identified. The virus causing coronavirus disease 2019 (COVID-19), is not the same as the coronaviruses that commonly circulate among humans and cause mild illness, like the common cold.
A diagnosis with coronavirus 229E, NL63, OC43, or HKU1 is not the same as a COVID-19 diagnosis. Patients with COVID-19 will be evaluated and cared for differently than patients with common coronavirus diagnosis. CDC
The Testing Process Explained
The swab tests (typically taken from within the nasal cavity) are used to match the genetic material captured on the swab with the genetic code of COVID-19. It is important to note that the test is at the molecular level and not done through the culture growing process. If the RNA genetic material matches that of the known virus markers a positive result is indicated. It is important to note that current swab methods should be performed by a qualified healthcare professional. The President announced (3/18/2020) that the Federal Government is working on an approved swab and method for the individual but is not available at this time. In either case, the sample must be sent to an approved CLIA laboratory for the molecular level testing.
How is COVID-19 Effectively Tested?
The swab tests (nasopharyngeal swab – typically taken from within the nasal cavity) are used to match the genetic material collected on the swab with the genetic code (known as RNA) of Covid-19. It is important to note that the test is at the molecular level and not done through the culture growth process. If the RNA genetic material matches that of the known virus markers a positive result is indicated.
Are All Tests Equal?
No. For detecting the COVID-19 virus you must test at the RNA level (Ribonucleic acid, a nucleic acid present in all living cells. Its principal role is to act as a messenger carrying instructions from DNA for controlling the synthesis of proteins, in the COVID-19 virus the RNA carries the genetic information)
Polymerase Chain Reaction (PCR) and the more specific Real-time Quantitative Polymerase Chain Reaction (qPCR) testing tests against millions of targets and offers a dynamic range of detection – from as little as a single strand of target material. All done in just hours.
qPCR testing is an automated technique that simultaneously allows for the ability to precisely measure the amount of amplicon (a piece of DNA or RNA) at each cycle.
This allows highly accurate quantification of very low levels of infectious disease organisms.
How Many Tests Do I Really Need?
Return to Work Criteria – Test based strategy: CDC guidelines
Test-based strategy. Exclude from work until
- Resolution of fever without the use of fever-reducing medications and
- Improvement in respiratory symptoms (e.g., cough, shortness of breath), and
- Negative results of an FDA Emergency Use Authorized molecular assay for COVID-19 from at least two consecutive nasopharyngeal swab specimens collected ≥24 hours apart (total of two negative specimens