Thermo Fisher Taqpath Covid-19 Combo Kit

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Product Description

Thermo Fisher Taqpath Covid-19 Combo Kit

The Applied Biosystems TaqPath COVID-19 Combo Kit is a fast, highly sensitive multiplex diagnostic solution that contains the assays and controls needed for the real-time PCR detection of RNA from the SARS-CoV-2 virus.

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

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 includes the following components:

TaqPath RT-PCR COVID-19 Kit

--COVID-19 real-time PCR assay multiplexmultiplexed assays that contain three primer/probe sets specific to different SARS-CoV-2 genomic regions and primers/probes for bacteriophage MS2
--MS2 phage controlinternal process control for nucleic acid extraction

TaqPath COVID-19 ControlRNA control that contains targets specific to the SARS-CoV-2 genomic regions targeted by the assays
TaqPath COVID-19 Control Dilution Bufferdilution buffer for the IVT RNA control as defined in the IFU (information for use)

Intended use

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. The 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.