Planned to be CE-IVD labeled within in April 2021
Acceleration of SARS-CoV-2 testing: Simply skip the step of RNA extraction.
- Ideal for screening of large cohorts under time pressure*
- Works from RNA extracts as well as from crude samples (direct from swabs & direct from throat wash samples)
- Super fast turnaround time: from sample to result approx. 1 h (depending on real-time PCR cycler speed, without RNA extraction)
- Easy delivery: Shipped on ice-packs, world-wide
The kit contains our thermostable Master Mix (which can also be obtained CE-IVD certified) and a duplex primer/probe mix for both SARS-CoV-2 (N1 gene specific) and RNaseP control.
The mutations of the "British variant (B.1.1.7)" do not affect the test.
*See examples in "Applications"
Rapid detection and identification of SARS-CoV-2
The Direct SARS-CoV-2 RT-PCR Detection Kit without RNA Extraction enables the application of a simple RT-PCR protocol without the time-consuming and costly isolation of viral SARS-CoV-2 RNA. The core element is an optimized, thermostable DNA polymerase that is optimized to convert the SARS-CoV-2 genetic material (part of the N1 gene) from RNA to DNA and to start amplification of the DNA in one, single step.
Our customers use this kit mainly for rapid and safe PCR-based screening
e.g. when high numbers of positive results are expected:
The samples are collected e.g. by pharyngeal lavage (throat wash) with sterile water or oral swab.
PCR pre-screening is performed without RNA isolation and strongly positive virus carriers (up to Ct 30) can be detected quickly and reliably.
Samples with a negative result are retested e.g., with this kit but with prior RNA purification. This ensures that infected persons with Ct over 30 are also identified.
or for surveillance of cohorts of symptom-free individuals by repetitive testing:
The samples are taken repeatedly (e.g. once a week) as described above. PCR pre-screening is carried out without RNA isolation and strong positive virus carriers (up to Ct 30) can be detected quickly and reliably. Subsequently, contact persons of identified virus carriers are tested e.g., with this kit but with prior RNA purification. This ensures that infected persons with Ct over 30 are also identified.
The University of Konstanz is employing the Direct SARS-CoV-2 RT-PCR detection kit without RNA extraction in a campus-wide surveillance study of symptom-free staff and students who are tested at least once a week. For details, please have a look at campus.kn - The online magazine of the University of Konstanz (Link)
Highly competitive prices and additional cost-savings
100x reactions (50 µl) for 400 € (4,00 €/rxn)
500x reactions (50 µl) for 1800 € (3,60 €/rxn)
1000x reactions (50 µl) for 3300 € (3,30 €/rxn)
2000x reactions (50 µl) for 5600 € (2,80 €/rxn)
Bulk quantities are offered with even better pricing!
We are ISO 13485 certified and can deliver bulk amounts if requested.
Additional cost savings in comparison to standard PCR testing: No need for time-consuming and costly isolation of viral SARS-CoV-2 RNA.
This saves you resources - people, material, equipment usage.
Direct SARS-CoV-2 RT-PCR detection kit without RNA extraction - Manual
- The method was originally developed and validated in cooperation with the University of Konstanz, a DAkkS accredited laboratory, and the Konstanz Clinics. (see peer-reviewed publication below)
myPOLS Biotec has further developed the method to a duplex format that detects both, SARS-CoV-2 (N1 gene specific) and the RNaseP-based control in one reaction.
The Direct SARS-CoV-2 RT-PCR Detection Kit without RNA Extraction enables a simple RT-PCR-based detection method without the time-consuming and costly isolation of viral SARS-CoV-2 RNA.
Please note: For research use only. For clinical testing, you may use the kit a a laboratory developed test by obeying the applicable regulatory requirements.
For IVD requirements please consult our IVD Services and Products (Link).
Publication: "Detection of SARS-CoV-2 from raw patient samples by coupled high temperature reverse transcription and amplification"