Singapore approves TaqPath COVID-19 combo kit

April 21, 2020 | Tuesday | News

This real-time PCR kit can be used for the presumptive qualitative detection of nucleic acid from SARS-CoV-2 in three types of patient samples.

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The Applied Biosystems™ TaqPath™ COVID-19 Combo Kit has received Provisional Authorisation from the Health Science Authority (HSA) in Singapore.

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.

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 SARS-CoV-2 or with signs and symptoms of COVID-19.The TaqPath COVID-19 Combo Kit is a single, high-throughput (1,000 reactions) kit and is recommended for use with the Applied Biosystems 7500 Fast Dx Real-Time PCR System and the associated Applied Biosystems COVID-19 Interpretive Software

This real-time PCR kit can be used for the presumptive qualitative detection of nucleic acid from SARS-CoV-2 in three types of patient samples. When this kit is used with the Applied Biosystems™ 7500 Fast Dx Real-Time PCR System, the clinical laboratory can benefit from the following features:

End-to-end in vitro diagnostic solution—a complete workflow from viral RNA extraction through to diagnostic report generation in under four hours
Three specimen types—nasopharyngeal swabs, nasal aspirate, and bronchoalveolar lavages (BALs)
Superior specificity—targeted to 100% of currently available complete genomes for SARS-CoV-2
Highly specific (even if the virus mutates)—assays target spike (S) protein and nucleocapsid (N) protein regions having higher specificity and exhibiting lower risk for mutation
High throughput with each run—ability to test up to 94 specimens in a single 96-well plate run
Automatic translation of data into diagnosis—COVID-19 Interpretive Software, which automatically converts genetic analysis data into diagnosis, reducing risk of user interpretation error