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PlexPCR® SARS-CoV-2

Detect COVID-19 causative coronavirus, SARS-CoV-2

Multiplex RT-qPCR test with dual targets
(RdRp/ORF1ab) and RNA-based internal
control in a single-well

 

Scalable solution supporting surge capacity

Why use PlexPCR® SARS-CoV-2?

The COVID-19 pandemic has impacted testing laboratories globally. Increased testing demands, disruptions in supply, or fluctuations in staffing due to self-isolation practices all have an effect on laboratory efficiency.

PlexPCR® SARS-CoV-2 can help your laboratory work effectively.

  • Security of supply with PlexPCR® – our unique technology de-couples the detection probe from the target sequence. We routinely produce and stockpile large volumes of test reagents to support high volume ordering fluctuations, ensuring no interruptions to your daily laboratory testing.
  • Clinically relevant turnaround times – conserved dual target sequence not impacted by current circulating variants,§ eliminating the need for repeat or confirmation testing by sequencing.
  • Streamlined workflow – compatible with robotic liquid handlers including SpeeDx PlexPrepan automated and intuitive instrument that alleviates laboratory staffing pressures or constraints.

§Monthly reports on sequence alignment are available on request.

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PlexPCR® SARS-CoV-2 workflow solution

Automation compatible workflow to maintain clinically relevant turnaround times. Includes license free, validated SpeeDx analysis software for automated result calling and simple, simultaneous data processing of large sample numbers.

  • Scalable throughput for surge testing – easily adapt to local testing demands caused by a sudden surge in suspected COVID-19 cases.
  • Flexibility in the laboratory – scale throughput up or down from 480 to 1920 samples in an 8hr shift with automated software analysis and PlexPrep liquid handler robotics*

* compatible with other liquid handlers, throughput may vary.

Confidence in your results.

As SARS-CoV-2 continues to mutate, giving rise to variants potentially impacting diagnostic testing, laboratories need continued confidence in the results they are reporting. We routinely monitor the performance of our PlexPCR® SARS-CoV-2 assay against emerging variants to ensure you can continue to report patient test data with no hesitation.§

  • Routine in silico analysis of primer sets against a database of all available SARS-CoV-2 sequences – in accordance with global government organisation recommendations, including Medicine & Healthcare products Regulatory Agency (MHRA)
  • View data on variant analysis against the PlexPCR® SARS-CoV-2 assay here
SARS-CoV-2 workflow

PlexPCR® SARS-CoV-2 Performance Specifications

Demonstrated clinical performance – for more detail please see the PlexPCR® SARS-CoV-2 Instructions for Use.

Clinical evaluation of PlexPCR® SARS-CoV-2  (n=142)
Positive Percent Agreement 93.26%

(95% CI 85.90 – 97.49%)

Negative Percent Agreement 96.23%

(95% CI 87.02 – 99.54%)

Overall rate of Agreement 94.37%

(95% CI 89.20 – 97.54%)

Specifications

PlexPCR® SARS-CoV-2 is a dual-target, single-well, multiplex reverse transcriptase qPCR test for the detection of COVID-19 causing coronavirus (SARS-CoV-2) plus RNA internal control

Targets

Well 1: ORF1ab, RdRp, RNA internal control

 

Sample types

  • Swabs: upper respiratory samples including nasopharyngeal swabs and aspirates, nasal swabs and throat swabs.

 

Amplification instrument

  • Roche LightCycler® 480 Instrument II (LC480 II)
  • Bio-Rad CFX96 Dx (CFX96 Dx)
  • Bio-Rad CFX96 Touch (CFX96 Touch)

Shipping Conditions

Products are shipped on dry ice or ice gel packs.

 

Storage & stability

Expiry dates are stated on the labels. It is recommended that freeze/thaw cycles be limited to less than 10. Store protected from light at – 20°C.

 

Intended use

For in vitro diagnostic use. Not for sale in the USA.

 

Regulatory status

CE-IVD, TGA cleared

Resources

Please contact your local representative if you can’t find what you are looking for.

Information Brochures

 

Package Inserts

Safety Data Sheets

 

Current Software Version

 

Related Products

Certificate of Analysis

For information contact [email protected]

 

Instructions for use

For information contact [email protected]

 

Software Download

For information contact [email protected]

Publications & Media

We are committed to supporting continued scientific discovery and generation of clinically relevant data. Collaborations with key researchers and clinicians around the globe help us improve diagnostics and address urgent clinical needs.

Monitoring the Variants of SARS-CoV-2

In silico monitoring of the PlexPCR® SARS-CoV-2 assay inclusivity is performed monthly, with the aim to ensure new variants of the SARS-CoV-2 virus that emerge can be detected. Focused analysis is also performed on Variants of Concern (VOC) or variants of interest.

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Check back for more relevant papers and publications coming soon.

Ordering Information

Please contact SpeeDx for information about offering SpeeDx diagnostics in your clinic or for a list of current pathology clinics where SpeeDx testing is available.

Product Compatible Size Catalogue
PlexPCR® SARS-CoV-2* LC480 II
BioRad CFX
384 reactions 1301384
PlexPCR® Colour Compensation^ Kit LC480 II 2 reactions 90001

*Not for sale in USA
Validated on LightCycler 480 II, CFX96 Dx and CFX96 Touch
^Supplied upon request. Not for sale in USA. This kit is only required for initial set-up to establish calibration of PlexPCR® and ResistancePlus® kits on the LC480 instrument, see instruction for use for details.

Want PlexPCR® SARS-CoV-2 in your laboratory?