RT-PCR COVID-19 Test
RT–PCR is a nuclear-derived method for detecting the presence of specific genetic material in any pathogen, including a virus. Originally, the method used radioactive isotope markers to detect targeted genetic materials, but subsequent refining has led to the replacement of isotopic labelling with special markers, most frequently fluorescent dyes. This technique allows scientists to see the results almost immediately while the process is still ongoing, whereas conventional RT–PCR only provides results at the end of the process.
Real time RT–PCR is one of the most widely used laboratory methods for detecting the COVID-19 virus. While many countries have used real time RT–PCR for diagnosing other diseases, such as the Ebola virus and Zika virus, many need support in adapting this method for the COVID-19 virus, as well as in increasing their national testing capacities.
About Thermo Fisher Scientific TaqPath™ COVID-19 Test
In response to the novel coronavirus (SARS-CoV-2) outbreak, Thermo Fisher Scientific has worked rapidly to develop a new multiplex real-time RT-PCR diagnostic kit to enable clinical and public health laboratories to quickly diagnose COVID-19 caused by SARS-CoV-2 infection. The Applied Biosystems TaqPath COVID-19 kit is a fast, highly sensitive multiplex diagnostic solution that contains both the assays and controls needed for the real-time PCR detection of RNA from the SARS-CoV-2 virus.
TaqPath COVID-19 Combo Kit contains the assays and controls for a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the presumptive qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL) specimens from individuals meeting COVID-19 clinical criteria (e.g., clinical signs and symptoms associated with SARS-CoV-2 infection) in conjunction with COVID-19 epidemiological criteria (e.g., history of residence in or travel to a geographic region with active SARS-CoV-2 transmission at the time of travel, or other epidemiologic criteria for which SARS- CoV-2 testing may be indicated).
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL) specimens during the acute phase of infection. Positive results are indicative of active infection but do not rule out bacterial infection or coinfection with other viruses. The agent detected may not be the definite cause of disease.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
Testing with the TaqPath COVID-19 Combo Kit is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The TaqPath COVID-19 Combo Kit is only for use under the Health Canada Special Authorization.
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