In response to the current coronavirus (SARS-CoV-2, the virus that causes COVID-19) 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 U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for a Thermo Fisher Scientific test that can be used immediately by CLIA high-complexity laboratories in the U.S. to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19.
The authorized test uses Applied Biosystems TaqPath Assay technology and is designed to provide patient results within four hours of a sample being received by a lab.
The estimated time-to-result also includes time for sample preparation and instrument analysis.
(Thermo Fisher is proud to be one of several companies working with the government’s public-private partnership to create 1.4 million more tests next week and 5 million within a month. Courtesy of Thermo Fisher and YouTube. Posted on Mar 13, 2020.)
NEW Applied Biosystems TaqPath COVID-19 Combo Kit
The TaqPath COVID-19 Combo Kit consists of both the TaqPath RT-PCR COVID-19 Kit and the TaqPath COVID-19 Control Kit for simplified ordering.
The kit can be used by clinical and public health laboratories to quickly evaluate up to 94 patient specimens in under 4 hours.
The kit is approved for use with RNA extracted from nasopharyngeal swabs, nasopharyngeal aspirate (nasal aspirate), and bronchoalveolar lavage (BAL) from patients at risk of exposure to the SARS-CoV-2 virus or with signs and symptoms of COVID-19 (see product label for Intended Use Statement and product information).
The TaqPath COVID-19 Combo Kit, which comes in two reaction sizes (100 reactions and 1,000 reactions), is to be used with the Applied Biosystems 7500 Fast Dx Real-Time PCR instrument and the associated Applied Biosystems COVID-19 Interpretive Software.
“The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” explains Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific.
“At Thermo Fisher, our Mission is to enable our customers to make the world healthier, cleaner and safer.”
“In partnership with the FDA and regulatory authorities around the world, we are committed to expanding the availability of diagnostic testing to prevent the spread of this disease.”
The EUA test is optimized for use on the company’s Applied Biosystems 7500 Fast Dx Real-time PCR instrument, which is covered under the EUA and already used in clinical laboratories worldwide.
This test has not been FDA cleared or approved, however, the FDA can issue an EUA to permit use of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition, as in the case of the novel coronavirus when the secretary of the U.S. Department of Health and Human Services (HHS) declares a public health emergency.
HHS Secretary Alex Azar declared an emergency for COVID-19 on January 31.
The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests 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.
Features of the newly developed multiplex diagnostic kit:
- A complete workflow from viral RNA extraction from up to 94 specimens and genetic analysis using real-time PCR to diagnostic report generation in under 4 hours
- Targeted specificity to 100% of currently available complete genomes for SARS-CoV-2
- Assay targets spike (S) protein and nucleocapsid (N) protein regions having higher specificity and exhibiting lower risk for mutation
- COVID-19 Interpretive Software, which automatically converts genetic analysis data into diagnosis, helping reduce risk of user interpretation error
For Emergency Use Authorization (EUA) only. For prescription use only. For in vitro diagnostic use.
(Patrick Luetdke, Director of Public Health at the Unified State Laboratories in Taylorsville, Utah discusses how the Applied Biosystems 7500 Fast Dx Real-time PCR System is used in microbiology testing and speeds their time to actionable results. Courtesy of Thermo Fisher Scientific and YouTube.)