TaqPath COVID-19

Introducing a real time SARS-CoV-2 PCR multiplex test with optimized reagent volumes for lower limit of detection workflows

Detect the presence of SARS-CoV-2 in clinical samples with low concentrations of RNA using the Applied Biosystems TaqPath COVID-19 Combo Kit Advanced—a real-time PCR multiplex test that enables detection down to 50 GCE/mL.

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TaqPath COVID-19 Combo Kit Advanced

The TaqPath COVID-19 Combo Kit Advanced is a multiplex solution that is compatible with some of the most widely used real-time PCR instruments in the world. It is a real-time PCR multiplex test with reagent volumes optimized for workflows that enable detection down to 50 GCE/mL. It has been optimized with market-leading sensitivity and specificity to 100% of available complete genomes* for SARS-CoV-2. Simplify scaling your COVID-19 testing by adding to your existing testing menu and infrastructure while maintaining low operational costs and workflow simplicity.

  • A complete clinical workflow: evaluate 94 specimens in under 3 hours or 382 specimens in under 6.5 hours with the combination of a single Thermo Scientific KingFisher purification system and Applied Biosystems real-time PCR system combination
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  • Highly specific: get targeted specificity to 100% of available complete genomes* for SARS-CoV-2
  • Automated analysis and reporting: Applied Biosystems COVID-19 Interpretive Software automatically converts data into a readable report, helping to reduce risk of user interpretation error
  • Multiple sample types: compatible with 6 specimen types (bronchoalveolar lavage (BAL), mid-turbinate swabs, nasal swabs, nasopharyngeal swabs, nasopharyngeal aspirate (nasal aspirate), and oropharyngeal swabs) requiring only 400 µL of sample

Ordering information
Product name Catalog number Ordering information
TaqPath COVID-19 Combo Kit Advanced, 200 rxn A47813 Request a quote

* Those available as of September 8, 2020

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

 

TaqPath COVID-19 Combo Kit Advanced 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 Advanced 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 Advanced 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 Advanced is only for use under the Food and Drug Administration’s Emergency Use Authorization.

The TaqPath RT-PCR COVID-19 Kit Advanced, packaged as part of the TaqPath COVID-19 Combo Kit Advanced, 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 Advanced
  • COVID-19 Real Time PCR Assay Multiplex Advanced
  • 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

Find additional recommended products to run your real-time PCR workflow for the detection of RNA from the SARS-CoV-2 virus.

Learn more ›

TaqPath COVID-19 Combo Kit Advanced 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 Advanced 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 Advanced 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 Advanced is only for use under the Food and Drug Administration’s Emergency Use Authorization.

The TaqPath RT-PCR COVID-19 Kit Advanced, packaged as part of the TaqPath COVID-19 Combo Kit Advanced, 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 Advanced
  • COVID-19 Real Time PCR Assay Multiplex Advanced
  • 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

Find additional recommended products to run your real-time PCR workflow for the detection of RNA from the SARS-CoV-2 virus.

Learn more ›


Applied Biosystems 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 Advanced
  • 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