FastPlex™ Triplex SARS-CoV-2 Detection Kits

qPCR (CE) and Digital PCR assays (FDA-EUA) for Coronavirus (COVID-19) 

PreciGenome FastPlex Triplex SARS-CoV-2 Detection Kit is a fast, highly sensitive multiplex diagnostic solution. It consists of both the assays and controls, which are needed for the real-time PCR RNA detection  from the SARS-CoV-2 virus. It is a multiplex RT-PCR diagnostic kit, enabling quick and precise diagnosis of COVID-19 caused by SARS-CoV-2 infection. 

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FastPlex™ 1 Step SARS-CoV-2 Detection Kit

(RT-PCR)

Cost-effective solution

RNA Extraction Free Kit.

Catalog #: 02.01.1020

The 1 step SARS-CoV-2 detection kit is based on the PCR method which uses a fluorescent probe and a specific primer to detect two specific regions within the novel coronavirus (SARS-CoV-2) nucleocapsid protein N gene. This molecular panel aids in the detection of viral RNA from SARS-CoV-2, the causative agent of COVID-19. The kit is used with Rainamp™ VTM with proprietary releasing agent which enables the user to use crude Nasal or throat swabs directly in their PCR reactions. By simply mixing the Rainamp VTM with the sample, the viral RNA is immediately stabilized, and can be released efficiently with extraction step. This eliminates the need for laborious, costly RNA extraction and purification steps, drastically improving upon the traditional workflow of PCR, while removing potential sample loss and contamination.

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  • Workflow

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  • Kit Components

Catalog #: 02.01.1020

* FastPlex 1 Step SARS-CoV-2 Detection Kit (RT-PCR) is a CE marked product, and for In Vitro Diagnostic Use.

* FastPlex 1 Step SARS-CoV-2 Detection Kit (RT-PCR) is not FDA cleared.

  • Documents

Instruction for User (IFU)

FastPlex™ Triplex SARS-CoV-2 Detection Kit

(RT-PCR)

Catalog #: 02.01.1038

  • Detection Principle

This kit uses the 2019-Novel Coronavirus (Covid-19) ORF 1ab and the specific conserved sequence encoding the nucleocapsid protein N gene as the target regions to carry out the dual-target genes design. A one-step reverse transcription-polymerase chain reaction (RT-PCR) combined with Taqman hydrolysis probe technology was used to detect the RNAs in the sample by a fluorescence quantitative PCR instrument with changes in fluorescence signal.

The PCR detection kit includes endogenous internal standard primers and probes and monitors the sample collection and extraction process by detecting whether the internal standard is normal to avoid false-negative results.

Typical S-shape amplification curves for postive SARS-CoV-2 specimens

Amplification curves for negative SARS-CoV-2 specimens

  • Assay information

  • Kit Components

* FastPlex Triplex SARS-CoV-2 Detection Kit (RT-PCR) is a CE marked product, and for In Vitro Diagnostic Use.

* FastPlex Triplex SARS-CoV-2 Detection Kit (RT-PCR) is not FDA cleared.

Catalog #: 02.01.1038

  • Sample Requirements

1. Applicable sample types: upper respiratory tract samples (including throat swabs, nasal swabs, nasopharyngeal extracts, deep cough sputum); lower respiratory tract samples (including respiratory tract extracts, bronchial lavage fluid, lung tissue biopsy samples).

2. Sample collection: Collect according to the conventional sample collection method.

3. Sample storage and transportation: The collected specimens should be submitted for analysis in time, or stored at 4°C for 24 hours; it is best to store at -70°C for more than 24 hours and avoid repeated freeze-thaw cycles.

  • Documents

Performance Characteristics

Instruction for User (IFU)

 
 

FastPlex™ Triplex SARS-CoV-2 Detection Kit (RT-Digital PCR)

Catalog #: 02.01.1019

  • Detection Principle

This kit employs digital PCR technology combined with Taqman fluorescent probe, and provides qualitative detection of the 2019-Novel Coronavirus (Corvid-19).

The sample is randomly partitioned upto 25 thousand partitions, where PCR reaction is then performed. After the PCR reaction, the fluorescent signal from each partition is acquired and further analyzed based on Poisson distribution. As a result, genes specific to SARS-CoV-2 can be detected with high precision.

In particular, the Covid-19 ORF1ab probe contains FAM label, E gene probe contains HEX label, and RRP30 is used as reference gene with Cy5 label.

  • Assay information

  • Kit Components

* FastPlex Triplex SARS-CoV2 Detection Kits (RT-Digital PCR) are sold for Emergency Use Authorization (EUA) only. For in vitro diagnostic use.

  • Documents

FDA EUA Approved Documents: IFUFact Sheet For PatientsFact Sheet For Providers.

 

FastPlex™ SARS-CoV-2 and Influenza A & B Detection Kit (RT-PCR)

Catalog #: 02.01.1042

  • Features

  • One tube detects Influenza A, influenza B and SARS-CoV-2 simultaneously.

  • FAM channel detects SARS-CoV-2, HEX channel detects Influenza A, Cy5 channel detects Influenza B,ROX channel detects Human internal reference gene as quality control

  • Compatible with most 96 well plate real time fluorescence PCR instruments

  • < 250 copies/ml LoD for flu A, flu B and COVID-19 virus

  • Less than 90 minutes sample to results

  • Best screening tool during flu season and COVID-19 pandemic

Kit_targets.JPG
 
 

COVID-19 Lab Guidance & Diagnostics

FastPlex™ SARS-CoV-2 Detection & Identification Kit for UK and South Africa Variants (RT-PCR)

Catalog #: 02.01.1022

Catalog #: 02.01.1040

Catalog #: 02.01.1044

  • Features

  • UK B.1.1.7, South Africa B.1. 351 and Brazil P1 variants identification

  • Compatible with most 96 well plate real time fluorescence PCR instruments

  • < 250 copies/ml LoD for flu A, flu B and COVID-19 virus

  • Less than 90 minutes sample to results with regular 96-well PCR instrument

  • Less than 45 minutes sample to results with portable mini PCR instrument for fast detection

  • Best screening tool during flu season and COVID-19 pandemic

 
 

References

  1. (2020) 2019-Novel coronavirus (2019-nCoV) real-time rRT-PCR panel primers and probes. US Centers for Disease Control and Prevention.

  2. (2020) 2019 Novel Coronavirus (2019-nCoV), Wuhan, China. [Online] US Centers for Disease Control and Prevention.

  3. (2020) Real-time RT-PCR panel for detection 2019-novel coronavirus. US Centers for Disease Control and Prevention. 

  4. (2020) Emergency use authorization. [Online] US Centers for Disease Control and Prevention.

Reference Papers Citing PreciGenome PCR Kits