TaqPath™ COVID-19 CE-IVD RT-PCR Kit

The TaqPath COVID-19 CE-IVD RT-PCR Kit contains assays, controls, and master mix required for the real-time PCR detection of RNA from the SARS-CoV-2 virus.

Features of the newly developed multiplex diagnostic kit:
• Detection using real-time PCR to diagnostic report generation in under 2 hours
• Assays cover all of the SARS-CoV2 genomes of high sequence quality and complete sequence length that are currently available through the GISAID Initiative
• Assays target genomic regions of the SARS-CoV-2 genome that are not present in other coronaviruses (e.g., SARS, MERS, bat SARS-like coronavirus, etc.)
• COVID-19 Interpretive Software, which automatically converts genetic analysis data into diagnosis, helping reduce risk of user interpretation error

The kit can be used by clinical and public health laboratories to quickly evaluate up to 382 patient specimens in under 2 hours. The kit contains the reagents 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.

The TaqPath COVID-19 CE-IVD RT-PCR kit is a single, high throughput (1,000 reactions) kit and is approved for use on Applied Biosystems real-time PCR systems including the 7500, 7500 Fast, or 7500 Fast Dx real time systems or the QuantStudio 5 (96 well, 0.1 mL and 0.2 mL; 384 well), 5 Dx, or 7 Flex (384-well) real-time PCR instruments,  as well as with the associated Applied Biosystems COVID-19 Interpretive Software.

The Applied Biosystems TaqPath COVID-19 CE-IVD RT-PCR Kit includes the following components:
• TaqPath COVID-19 RT-PCR Kit, 1000 reactions
    --TaqPath COVID-19 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—RNA control to verify the efficacy of the sample preparation and the absence of inhibitors in the PCR reaction. To perform the control, add MS2 Phage Control to the samples before extraction of the RNA.
• TaqPath COVID-19 Control—RNA control that contains targets specific to the SARS-CoV-2 genomic regions targeted by the assays
• TaqPath COVID-19 Control Dilution Buffer
• TaqPath 1-Step Multiplex Master Mix (No ROX)
• Package insert—provides the instructions and the link to download the Instructions for Use

TaqPath 1-Step Multiplex Master Mix (No ROX) is a fast, single-tube, 4X RT-qPCR mix that provides for of up to four different RNA/DNA targets in a single multiplex reaction. Particularly useful for diagnostics, virus detection, and high throughput gene expression workflows, the mix includes thermostable MMLV reverse transcriptase, dNTPs, UNG, and thermostable Fast DNA polymerase all in a single tube.

Access the Instructions for Use approved for your country › 

Intended use

The TaqPath COVID-19 CE-IVD RT-PCR Kit contains the reagents 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.

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 in European countries* may be required to report all positive results to the appropriate Competent 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 CE-IVD RT-PCR 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 following countries require the CE-marked In Vitro Diagnostics: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, UK, Norway, Iceland, Liechtenstein, Switzerland, Turkey.