rTest COVID-19 qPCR SuperRapid

ROOM TEMPERATURE STABLE COVID-19 DIAGNOSTIC KIT

Main Features:

  • 1-Step RT-qPCR method 
  • No RNA extraction necessary
  • Fast results: Reaction time reduced to < 45 minutes
  • At least 2 weeks room temperature stability
  • Improved sensitivity of proprietary RdRP and E assays together with RNase P assay as an internal control
  • SARS-CoV-2 full genomic RNA spiked with human RNA used as a positive control
  • 100% clinical accuracy
  • 100% specific for SARS-CoV-2
  • Validated on real clinical samples
  • No cold chain shipping needed
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Product description

rTEST COVID-19 qPCR SuperRapid kit is a diagnostic kit designed to detect SARS-CoV-2 genomic RNA from samples obtained by gargling without prior RNA extraction. 

The rTEST COVID-19 qPCR SuperRapid kit is an innovative, improved, and re-designed version of the WHO-recommended Charitè, Berlin protocol. The kit contains three sets of primers and hydrolysis probes (TaqMan®) for multiplex detection of SARS-CoV-2 specific E gene and RdRP gene, together with human RNase P. TaqMan® probes for E gene are conjugated to fluorophore YY, TaqMan® probes for the RdRP gene they are conjugated to the fluorophore FAM and the TaqMan® probe for RNase P is conjugated to the fluorophore Cy5. Such labelling allows for multiplexed detection of SARS-CoV-2 and human RNase P, which serves as an internal control to verify proper sampling and assay performance. To detect the SARS-CoV-2 E gene and the RdRP gene, we have developed patented dual TaqMan® probes, the use of which increases the sensitivity and specificity of our 1-step RT-qPCR.  The kit is intended exclusively for use in a diagnostic laboratory with the appropriate equipment, safety standards and properly trained personnel. One package of the kit is sufficient for 400 tests. 

Registration code: P1430A

MultiplexDX, s.r.o.
IČO: 50111965
Ilkovičova 8, 841 04 Bratislava, Slovenská republika
+421 2 902 68 310
info@multiplexdx.com

© 2020 MultiplexDX, s.r.o. All rights reserved.
rTest COVID-19 is a trademark of MultiplexDX, Ltd.
All other product names and trademarks are the property of their respective owners

FAQs

Can MultiplexDX supply gargle sample collection kits as well?

Yes, we can provide CE certified sample collection kits validated on our PCR tests. For more details, contact orders@multiplexdx.com

Are you updating your existing PCR kits for new mutations?

Yes, we have an active bioinformatics surveillance program in place as we take potential issues arising from new mutations with utmost importance. We are constantly updating our products to solve challenges encountered by our customers.

Does MultiplexDX supply lab instrumentation as well?

This is not a part of our business, but such requests can be discussed with company representatives, and if feasible we will try to accommodate our customer’s needs to ensure smooth functioning of their operations.

Can I pass an EQA test when using MultiplexDX PCR kits?

Yes, our kits are regularly tested using European Centre for Disease Prevention and Control, performed by National Institute for Public Health and the Environment The Netherlands (RIVM) External Quality Control Panels (EQA), by our customers as well as directly in MultiplexDX laboratories. Our customers regularly and successfully pass external quality controls.

Can I contact you for help with result interpretation?

There is some basic information regarding interpretation of results in IFU and in device manuals. Should you not find the answer, please contact us at rtest@multiplexdx.com and our experts will help you.

What are the recommended storage conditions of MultiplexDX PCR kits?

The kit does not need to be transported on dry ice (cold chain shipping). The kit will remain stable for 2 weeks at room temperature and thereafter until the expiry date printed on the package if stored at -20 ± 5 °C.

Stability of the kit is further defined in its IFU. Repeated freezing and thawing of master mix and positive control may result in lower detection quality. We, therefore, recommend to aliquot master mix and controls and store them at -20 ± 5 °C.

How long does sample-to-result by a MultiplexDX PCR kit take?

Time necessary to obtain results greatly varies based on a multitude of factors such as laboratory workflow, level of automation, usage and type of nucleic acid extraction, capacity utilization and technical specifics of used PCR device. In general, kits designed to work in the “direct” mode, i.e. without nucleic acid extraction, are faster by 1-2 hours. Amplification times vary by kit and by PCR device used.

Can I use MultiplexDX PCR kits with any open PCR system or only those which are listed as having been validated?

Our PCR kits are designed to be used on open platforms and in principle can be used with any such system on the market. However, due to the CE IVD certification, we must specifically perform a validation of each PCR device we recommend for a given kit. IFU contains a list of validated devices for each PCR Kit. If you want to use one of our kits with a device not included in this list, MultiplexDX is able to organize and perform the verification of such device under pre-defined conditions.

Are all MultiplexDX PCR kits CE IVD certified?

Yes, they are. All MultiplexDX PCR kits are CE IVD certified and comply with the EU regulations for in vitro diagnostics.

Can I try MultiplexDX PCR kit out in my laboratory? On what terms?

Of course, you can. MultiplexDX provides new users with “trial kits”. Our support department is here to help you with implementing proper workflow and interpretation of results.

Can rTEST COVID-19 qPCR SuperRapid be used with sample types other than gargle?

rTEST COVID-19 qPCR SuperRapid has been specifically developed and validated to detect SARS-CoV-2 in patient samples obtained by gargling with no prior RNA extraction. However, internally we’ve seen equivalent or better analytical results (sensitivity/specificity) with nasopharyngeal/nasal swabs eluted in selected non-denaturing viral transport media. The kit also works as expected with extracted RNA eluted in PCR-grade water. Due to the vast number of viral transport media types on the market it is not possible to test the functionality of all of them. However, if you are interested in using rTEST COVID-19 qPCR SuperRapid with a specific biological matrix/medium, MultiplexDX can offer consultation/analytical validation services under pre-defined conditions. Please, contact our representatives for further information.

What are the key advantages of using rTEST COVID-19 qPCR SuperRapid?

rTEST COVID-19 qPCR SuperRapid provides a highest level of PCR testing concept. It is not just an environmentally friendly option (transportation and storage at room temperature; no dry-ice and thermal boxes used), but users can save significant time & costs (very short sample processing & amplification time).

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rTest COVID-19 qPCR SuperRapid

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