TaqPath COVID-19 Diagnostic PCR Kit

Intended use

The TaqPath COVID-19 Diagnostic PCR Kit is 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 and anterior nasal specimens from individuals with signs and symptoms of respiratory tract infection.

 

The TaqPath COVID-19 Diagnostic PCR Kit is intended for use as an aid in the diagnosis of COVID-19 if used in conjunction with other clinical observations, epidemiological information and laboratory findings. The SARS-CoV-2 RNA is generally detectable in upper respiratory (anterior nasal and nasopharyngeal swabs) specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Positive results do not rule out bacterial infection or co-infection with other pathogens. The agent detected may not be the definite cause of disease.

 

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.

 

The TaqPath COVID-19 Diagnostic PCR Kit is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

Target genes

ORF1ab*

N gene

S gene

The sequence of this gene remains relatively stable across different viral isolates, allowing for accurate and reliable detection of the virus.

This gene is responsible for encoding the nucleocapsid protein, which plays a crucial role in the virus's structure and replication.

The Spike protein is highly specific for the SARS-CoV-2 virus, allowing for specific detection of the virus. It is also a hotspot for SARS-CoV-2 mutations, so monitoring it can help identify variants.

 

* Jin YH, Cai L, Cheng ZS et al. (2020) A rapid advice guideline for the diagnosis and treatment of 2019 novel coronavirus (2019-nCoV) infected pneumonia (standard version). Mil Med Res. 7(1):4. Published 2020 Feb 6. doi:10.1186/s40779-020-0233-6

IVD workflow

Receive samples

 

Sample prep

PCR

Results

Nasopharyngeal (NP) swabs

 

KingFisher Flex Purification System

QuantStudio 5 Dx Real‑Time PCR System, 96-well,
0.2 mL block

Applied Biosystems COVID‑19 Interpretive Software IVD Edition

Anterior nasal (AN) swabs

 MagMAX Viral/Pathogen II Nucleic Acid Isolation Kit

7500 Fast Dx Real‑Time PCR System

About the Dx instrument

Accurate, sensitive, and reliable real-time PCR system designed for the clinical laboratory

The Applied Biosystems QuantStudio 5 Dx Real-Time PCR System is designed to streamline workflows and minimize training needs, helping you get clinical answers quickly by integrating seamlessly into your established workflow

Ordering information

For In Vitro Diagnostic Use.