Since the current Coronavirus outbreak ThermoFisher Scientific worked rapidly to develop RT-PCR solutions that enable clinical and public health laboratories to diagnose COVID-19 caused by SARS-Cov2 infection.

On March 21, 2020, the Applied Biosystems TaqPath COVID-19 CE-IVD RT-PCR Kit was approved for in vitro diagnostic use throughout Europe, including Ireland.

For details on further access to this product please contact Jane Fitzgerald

The TaqPath COVID-19 CE-IVD RT-PCR Kit contains all Assays, Controls and Mastermixes required to perform RT PCR based detection of the SARS-Cov-2 viral RNA. The kit is approved for use with RNA extracted from nasopharyngeal swabs, nasopharyngeal aspirate (nasal aspirate), and broncho-alveolar lavage (BAL) from patients who meet clinical and/or epidemiological criteria for Coronavirus Disease 2019 (COVID-19) testing.

The TaqPath COVID-19 CE-IVD RT-PCR Kit a 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). The test provides clinical and health care professionals to evaluate 94 patient specimens in under 2 hrs. Test is intended to be used with the new Applied Biosystems COVID-19 Interpretive Software which automatically converts genetic analysis data into diagnosis, helping reduce risk of user interpretation error. COVID-19 Interpretive Software download is available upon kit purchase. Following instrument data analysis, the COVID-19 Interpretive Software performs a QC check against all controls on the plate. Software also generates a report for each specimen.

The kit contains:

• SARS-Cov specific multiplex assays

Primers and probe sets for three coronavirus genes (1 wet tube): orf-1ab, gene for the S protein, gene for the N protein, and the MS2 Phage control . The included 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.) Assay use FAM, VIC, ABY fluorescent dyes for the SARS-Cov2 specific assays and JUN dye for the MS2Phage control detection.

• MS2 Phage Control

Verify the efficacy of the sample preparation and the absence of inhibitors in the Reverse Transcription reaction. The MS2 Phage control is added to the samples just before lysis during the extraction of the RNA.

• TaqPath COVID-19 control

Contains targets specific to the SARS-CoV-2 genomic regions targeted by the assays, but does not contain the MS2 Phage template.

• TaqPath™ COVID-19 Control Dilution Buffer

• TaqPath™ 1-Step Multiplex Master Mix (No ROX™)

Viral nucleic acid isolation products

Recommended viral nucleic acid isolation method is using the King Fisher Flex system to automate MagMAX™ Viral/Pathogen Nucleic Acid Isolation Kit.

Please note that additional Singleplex assay kit for SARS-CoV-2 pathogen detection is also available with the corresponding control solutions. (For Research Use Only) See details at: TaqMan 2019-nCoV Assay Kit v1

You can find further information on ThermoFisher Scientific SARS-Cov2 research solutions including Sanger Sequencing and NGS Research Solution, at the following link: Research Solutions for 2019 Coronavirus SARS-CoV-2 (COVID-19)

Gyongyi Lukacs, PhD, FAS (Field Application Specialist)