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

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.

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.

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.

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.

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.

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.

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.

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

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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.

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.

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).