Currently not for sale in the USA
PlexPCR® SARS-CoV-2
Scalable solution supporting surge capacity
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.
Why use PlexPCR® SARS-CoV-2?
The COVID-19 pandemic impacted testing laboratories globally,and highlighted the need for laboratory efficiency. PlexPCR® SARS-CoV-2 can help your laboratory work effectively.
Our unique PlexPCR® technology de-couples the detection probe from the target sequence, and we routinely produce and stockpile large volumes of test reagents.
We can scale our production runs 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.
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 with automated software analysis and your inhouse liquid handler robotics
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)
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%) |
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: nasopharyngeal swabs
Amplification instrument
Roche LightCycler® 480 Instrument II (LC480 II)
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 – 25°C to – 15°C.
Intended use
For in vitro diagnostic use.
Current software
PlexPCR SARS-CoV-2 (LC480) v1.1
Regulatory status
TGA cleared, MoH Cleared
Specifications
Publications
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.
†Validated on Instrument. ^Supplied upon request.
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.