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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 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. Clinical laboratories can evaluate 94 specimens in under 3 hours, or 382 specimens in under 6.5 hours, with a single Thermo Scientific KingFisher purification system and Applied Biosystems real-time PCR system combination. When additional approved instruments are utilized, throughput can increase significantly. The kit is approved for use with RNA extracted from patients at risk of exposure to SARS-CoV-2 or with signs and symptoms of COVID-19 (see product label for Intended Use Statement and product information):

  • Bronchoalveolar lavage (BAL)
  • Mid-turbinate swabs
  • Nasal swabs
  • Nasopharyngeal swabs
  • Nasopharyngeal aspirate (nasal aspirate)
  • Oropharyngeal swabs

The TaqPath COVID-19 Combo Kit is a single, high-throughput (1,000 reactions) kit and is for use with an expanding range of Applied Biosystems real-time PCR instruments, including:

  • QuantStudio 5 ( 96-well 0.1 mL and 0.2 mL, 384-well block) and 7 Flex Real-Time PCR Systems
  • 7500, 7500 Fast, and 7500 Fast Dx Real-Time PCR Systems with 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 upper respiratory specimens (such as nasopharyngeal, oropharyngeal, nasal, and mid-turbinate swabs, and 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 upper respiratory 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

The TaqPath RT-PCR COVID-19 Kit, packaged as part of the TaqPath COVID-19 Combo Kit, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens (such as nasopharyngeal, oropharyngeal, nasal, and mid-turbinate swabs, and nasopharyngeal aspirate) and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider.

The TaqPath COVID-19 Combo Kit includes the following components:

  • TaqPath RT-PCR COVID-19 Kit
    • COVID-19 Real-Time PCR Assay, Multiplex—Multiplexed assays that contain three primer/probe sets specific to different SARS-CoV-2 genomic regions and primers/probes for bacteriophage MS2
    • MS2 Phage Control—Internal process control for nucleic acid extraction
  • TaqPath COVID‑19 Control—RNA control that contains targets specific to the SARS-CoV-2 genomic regions targeted by the assays

 

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.

TaqPath COVID-19 Combo Kit

Applied Biosystems TaqPath COVID-19 Combo Kit Image

Features

  • Complete workflow enabling clinical laboratories to evaluate 94 specimens in under 3 hours, or 382 specimens in under 6.5 hours, with a single KingFisher purification system and Applied Biosystems real-time PCR system combination (when additional approved instruments are utilized, throughput can increase significantly)
  • 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
Components

TaqPath RT-PCR COVID-19 Kit
  • Assays targeting regions of 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

Workflow and products

Figure 1. End-to-end workflow for the in vitro diagnosis of 94 specimens in under 3 hours, or 382 specimens in under 6.5 hours, using a single KingFisher purification system and Applied Biosystems real-time PCR system combination. The workflow consists of sample collection, RNA extraction from 94 up to 382 specimens, real-time RT-PCR genetic analysis, and automated translation of data into patient diagnosis.

Authorized laboratories using the TaqPath COVID-19 Combo Kit must run 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.

Applied Biosystem COVID-19 Interpretive Software

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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

About the kit

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

1. TaqPath RT-PCR COVID-19 Kit

The TaqPath RT-PCR COVID-19 Kit, packaged as part of the TaqPath COVID-19 Combo Kit, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens (such as nasopharyngeal, oropharyngeal, nasal, and mid-turbinate swabs, and nasopharyngeal aspirate) and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider.

The TaqPath COVID-19 Combo Kit includes the following components:

  • TaqPath RT-PCR COVID-19 Kit
    • COVID-19 Real-Time PCR Assay, Multiplex—Multiplexed assays that contain three primer/probe sets specific to different SARS-CoV-2 genomic regions and primers/probes for bacteriophage MS2
    • MS2 Phage Control—Internal process control for nucleic acid extraction
  • TaqPath COVID‑19 Control—RNA control that contains targets specific to the SARS-CoV-2 genomic regions targeted by the assays

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 upper respiratory specimens (such as nasopharyngeal, oropharyngeal, nasal, and mid-turbinate swabs, and 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 upper respiratory 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.