FAQ

GeneProof provides a unique concept of universal solution to NA extraction as well as PCR detection in various biological materials (blood, sputum, swab…).Moreover, PCR kits are organized in groups by specifics of differential diagnostics. Using the universal workflow, GeneProof PCR kits can be freely combined within the group for different kinds of diagnostics. This approach allows you to simplify and speed up the laboratory workflow.

GeneProof’s single tube Ready-to-Use Master Mix (RMM) is user-friendly and time-saving. A single tube of reagents contains all components necessary for PCR amplification. Thus, no additional pipetting of PCR reagents is required. The whole approach reduces the demand for qualified laboratory staff and improves end-users’ reproducibility of results. 

Of course, you can. GeneProof provides new users with ‚trial kits ‘. Our support department is here to help you with the correct installation of methods and interpretation of results.

UNIC is a universal internal control of the whole diagnostic process. UNIC is being sold separately and can be used with microbiological GeneProof PCR kits. In case of multiple examinations from a single DNA/RNA isolate, UNIC decreases the need for an extra pipetting of internal controls into one sample.

e-IFU, CoA, SDS and DoC can be downloaded here after registration or login.

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

Yes, they are. Our company has already utilized the opportunity of the transitional period and has got the IVDD CE certificates for all GeneProof PCR kits listed in Lists A and B valid until 2024.

GeneProof is completing all necessary documentation and testings for the technical files. We are not expected to reduce the number of CE IVD kits; contrariwise completing its STI and Respiratory lines.

Yes, you can. It is possible to use CE IVD certified DNA/RNA extractions and you can validate the process by yourself. Of course, we can help you with that.

Our PCR kits are primarily an open platform which can be used with most thermocyclers on the market. However, due to the CE IVD certification, we must perform a validation of each PCR device we recommend regarding our PCR kits. IFU contains a list of validated devices for each PCR Kit (see the Documents section). If there is a device in your laboratory that is not included in this list, GeneProof is able to organize and perform the verification of such device under pre-defined conditions.

The examination duration depends on many factors which are mostly of logistic character and influence the “work-flow” of the laboratory. The detection of nucleic acid in the clinical sample isolate takes approximately 2-4 hours using a GeneProof kit. The total duration then depends on the pre-isolation treatment of a sample, on the selected nucleic acid isolation method, on the thermocycler type, automation level and possibly on the thermocycler capacity utilization level. Filling up the thermocycler capacity will save costs of the examination performance, but it will extend the period between the sample receipt and result expedition.

Please examine only materials that are validated with chosen PCR method. See the list of validated specimens in each PCR kit's Instruction for Use.

The kit must be transported at a temperature of -20 °C or below. The kit will remain stable until the expiry date printed on the package if the storage temperature is kept (-20 ± 5 °C).

The stability of the kit is further defined in its Instruction for Use.

There is some basic information regarding interpretation of results in IFU and in device manuals (available on our websites). Should you not find the answer, please contact us at support@geneproof.com and our experts will help you.

Yes, our kits are regularly tested using Instand e.V., QCMD and NIPH External Quality Control Panels (EQA) by our customers as well as directly in GeneProof laboratories. Our customers regularly and successfully pass external quality controls.

Currently, you can find us at various professional conferences where we present our results and the results from our cooperation with specialists from other molecular microbiology labs over the world. For our customers we organize periodic specialized training events focused on both theoretical and practical activities in a molecular-biological laboratory. For our distributors, we organize a specialized training with focus on the communicating GeneProof product advantages and their professional implementation to end customers’ labs.

Yes, for our customers and distributors we organize on-line training focused on the In Vitro Diagnostic Regulation and its impact on manufacturers, distributors and end-users.

Yes, we supply complete laboratory equipment to ensure your smooth laboratory workflow. Here on the website, take a look at the Laboratory Instruments subsection in the Products section to find out more.

Yes - we consider it one of the fundamental pillars of our work. We are constantly updating and expanding our portfolio based on our research and customer requirements.