What are the key advantages of using GeneProof PCR kits?
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 PCR kits utilize a single tube Ready-to-Use Master Mix – what are the advantages?
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.
Can I try GeneProof PCR kits out in my laboratory? On what terms?
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.
How does GeneProof Universal Internal Control (UNIC) work and help?
UNIC is a universal internal control of the whole diagnostic process. UNIC is being sold separately and can be used with all 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.
Are all GeneProof PCR kits CE IVD certified?
Yes, they are. All GeneProof PCR kits are CE IVD certified and comply with the EU regulations for in vitro diagnostics.
Are GeneProof PCR kits going to comply with the new IVD Regulation valid from 2022?
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.
Can I use different nucleic acid extractions instead of those validated with GeneProof PCR kits?
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.
Can I use GeneProof PCR kits also with other cyclers or only with those which are included in the List of validated devices?
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.
How long does it take to perform an examination by a GeneProof PCR kit?
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.
What clinical materials can I examine by the PCR method?
The PCR method is the so-called direct diagnostic method and it can examine virtually any biological material. To assure a clinically valid result it is necessary to examine only clinical materials specific for the presence of the sought-after pathogen (for example, Mycobacterium tuberculosis examination in sputum is much more relevant than in peripheral blood, etc.).
What are the recommended storage conditions and what is your experience with PCR kit stability?
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).
Stability of the kit is further defined in its Instruction for Use. Repeated freezing and thawing of Master Mix and Positive control may result in lower detection quality. We, therefore, recommend to aliquot prepared Master Mix and controls directly to PCR tubes and store them at -20 ± 5 °C.
Can I contact you for help with result interpretation?
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 email@example.com and our experts will help you.
How can you help us with the transfer of our examinations to GeneProof diagnostics? We are an accredited laboratory and we are interested in using GeneProof PCR kits. Change of supplier is complicated due to the re-accreditation of new methods.
The GeneProof technologies are CE IVD certified, therefore, re-accreditation and the change of methods are simple. We developed a special program for new customers, including special offers of PCR kits, help with introduction of new methods, testing and accreditation in the laboratory.
Can I pass an EQA test when using GeneProof PCR kits?
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.
Does GeneProof organize workshops focused on PCR in microbiology?
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.