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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 Applied Biosystems TaqPath COVID-19 Combo 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.

For Emergency Use Authorization (EUA) only. For prescription use only. For in vitro diagnostic use.

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 3 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 is a single, high-throughput (1,000 reactions) kit and is recommended for use with either the Applied Biosystems 7500 Fast Dx Real-Time PCR System or the 7500 Fast Real-Time PCR System (RUO version) and the associated Applied Biosystems COVID-19 Interpretive Software.

The 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 qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider. TaqPath COVID-19 Combo Kit is for use only under Emergency Use Authorization (EUA). Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

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 the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

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 qualified and 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 Food and Drug Administration’s Emergency Use Authorization.

The TaqPath COVID-19 Combo Kit consists of two products:

1. TaqPath RT-PCR COVID-19 Kit

TaqPath RT-PCR COVID-19 Kit is a multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) test which includes three primer and probe sets designed to detect RNA from the SARS-CoV-2 virus in nasopharyngeal swab, nasopharyngeal aspirate (nasal aspirate), and bronchoalveolar lavage (BAL) specimens from patients who meet CDC COVID-19 clinical criteria (e.g., signs and symptoms associated SARS-CoV-2 infection) in conjunction with CDC 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). 

In addition to the primers and probes, the TaqPath RT-PCR COVID-19 Kit contains MS2, an internal positive control that serves as an extraction, reverse transcription, and PCR amplification positive control for each well.

2. TaqPath COVID-19 Control Kit

The TaqPath COVID-19 Control Kit contains an external positive RNA control that is run on each plate. The RNA control contains in vitro transcribed (IVT) RNA, which is specific to N, S, and ORF1ab regions of SARS-CoV-2. The kit also contains TaqPath COVID-19 Control Dilution Buffer. This buffer is used to dilute the TaqPath COVID-19 Control from a stock concentration of 104 genomic copy equivalents (GCE)/µL to a working stock of 25 GCE/µL.

The TaqPath RT-PCR COVID-19 Kit and TaqPath COVID-19 Control Kit are available for single unit purchase or together as part of the TaqPath COVID-19 Combo Kit. This is because the sizing of the kits is not one-to-one, and one kit may be consumed faster than the other.  

Data obtained from the TaqPath COVID-19 Combo Kit will be analyzed using Applied Biosystems COVID-19 Interpretive Software. This software calculates and analyzes Ct values for the controls and specimens of each run, indicates if results are valid/invalid, and provides the user with a printed report containing data interpretation and associated actions.

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

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Workflow and products

Figure 1. End-to-end workflow for the in vitro diagnosis of COVID-19 in under three hours. The workflow consists of sample collection, RNA extraction from up to 94 specimens, real-time RT-PCR genetic analysis, and automated translation of data into patient diagnosis.

Authorized laboratories using the TaqPath COVID-19 Combo Kit will perform the TaqPath COVID-19 Combo Kit as outlined in the Instructions for Use. Deviations from the authorized procedures, including the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to perform the TaqPath COVID-19 Combo Kit are not permitted.

TaqPath COVID-19 Combo Kit

The Applied Biosystems TaqPath COVID-19 Combo Kit contains:

TaqPath RT-PCR COVID-19 Kit
  • Three coronavirus genes: orf-1ab, gene for the S protein, gene for the N protein
  • MS2 phage control
TaqPath COVID-19 Control Kit
  • Contains COVID-19 control RNA (orf-1ab, gene for the S protein, and gene for the N protein)

TaqPath COVID-19 Control Dilution Buffer

Product name

Catalog number

Ordering information

TaqPath COVID-19 Combo Kit, 1,000 rxn A47814 Request a quote

Applied Biosystem COVID-19 Interpretive Software

covid-19 interpretive software splash screen

The Applied Biosystems COVID-19 Interpretive Software helps your lab decrease analysis and interpretation time and reduce risk of user interpretation error:

  • Automatically interpret genetic analysis results from the TaqPath COVID-19 Combo Kit
  • Following instrument data analysis, the COVID-19 Interpretive Software performs a QC check against all controls on the plate
  • Software generates a report for each specimen
  • COVID-19 Interpretive Software download is available upon kit purchase

Components required for the complete end-to-end workflow using the TaqPath COVID-19 Combo Kit

Additional general laboratory products are also available, please contact your local representative to order.

About the kit

The TaqPath COVID-19 Combo Kit consists of two products:

1. TaqPath RT-PCR COVID-19 Kit

TaqPath RT-PCR COVID-19 Kit is a multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) test which includes three primer and probe sets designed to detect RNA from the SARS-CoV-2 virus in nasopharyngeal swab, nasopharyngeal aspirate (nasal aspirate), and bronchoalveolar lavage (BAL) specimens from patients who meet CDC COVID-19 clinical criteria (e.g., signs and symptoms associated SARS-CoV-2 infection) in conjunction with CDC 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). 

In addition to the primers and probes, the TaqPath RT-PCR COVID-19 Kit contains MS2, an internal positive control that serves as an extraction, reverse transcription, and PCR amplification positive control for each well.

2. TaqPath COVID-19 Control Kit

The TaqPath COVID-19 Control Kit contains an external positive RNA control that is run on each plate. The RNA control contains in vitro transcribed (IVT) RNA, which is specific to N, S, and ORF1ab regions of SARS-CoV-2. The kit also contains TaqPath COVID-19 Control Dilution Buffer. This buffer is used to dilute the TaqPath COVID-19 Control from a stock concentration of 104 genomic copy equivalents (GCE)/µL to a working stock of 25 GCE/µL.

The TaqPath RT-PCR COVID-19 Kit and TaqPath COVID-19 Control Kit are available for single unit purchase or together as part of the TaqPath COVID-19 Combo Kit. This is because the sizing of the kits is not one-to-one, and one kit may be consumed faster than the other.  

Data obtained from the TaqPath COVID-19 Combo Kit will be analyzed using Applied Biosystems COVID-19 Interpretive Software. This software calculates and analyzes Ct values for the controls and specimens of each run, indicates if results are valid/invalid, and provides the user with a printed report containing data interpretation and associated actions.

Intended Use and Emergency Use Authorization information

The 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 qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider. TaqPath COVID-19 Combo Kit is for use only under Emergency Use Authorization (EUA). Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

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 the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

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 qualified and 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 Food and Drug Administration’s Emergency Use Authorization.