Isothermal amplification PCR in 30 minutes for saliva specimens

Let's return to normal

ender EASY is an in-vitro diagnostic test kit based on a rapid molecular isothermal nucleic acid amplification technology.

ender EASY is reliably detecting the mutants from UK (20I/501Y.V1, B.1.1.7), South Africa (20H/501Y.V2, B.1.351) and Brazil (20J/501Y.V3, P.1).

It is intended for the qualitative detection of nucleic acid ORF-1a gene sequence from the SARS-CoV-2 viral RNA in saliva samples collected in the omnigene® oral (OME-505) collection device from individuals who are suspected of COVID-19.

The test is performed on standard real-time Polymerase Chain Reaction (RT-PCR) cyclers.

The ender EASY test kit is intended for use by medical professionals or trained operators who are proficient in using RT-PCR cyclers and performing standard molecular biological laboratory procedures.

ender EASY is the optimal laboratory-based solution for mass screening using saliva sample collection from individuals in a public health set-up. 

ender EASY does require to be used with the omnigene® oral (OME-505, DNA Genotek Inc.) collection device (CE IVD) collection kit. ender EASY does not provide the specimen collection device.

The ender EASY test does not require a conventional RNA extraction, saving hours of laboratory time, reagents and decreasing the use of consumables. 

The Swiss Federal Office of Public Health included saliva as suitable specimen for the detection of SARS-CoV-2 with PCR. For more information read the documentation:

BAG, 11.12.2020, COVID-19: Empfehlungen zur Diagnose im Ambulanten Bereich

The Advantage of ender EASY

With ender EASY specimen collection has never been so simple and comfortable.

Rapid, Reliable and
Cost-Effective

Rapid

5 minutes sample preparation as no RNA extraction is needed & 30 minutes isothermal amplification time.

Reliable

Performance at highest industry level.

Cost-Effective

Significantly increase your throughput with the same infrastructure and staff.

Basic steps & Workflow

saliva sample collection
1
5 minutes sample preparation
2
no RNA extraction required
3
30 minutes for isothermal amplification PCR
4
5 minutes melting curve analysis
5
Saliva specimen collection using the omnigene® oral (OME-505) collection device
(not provided with the kit)​
1
Thermolysis of sample
(reagents provided in kit)​
2
Isothermal amplification
(reagents provided in kit)​
3
Data Analysis
(according to PCR cycler used)
4

Your benefits using ender EASY

Performance Data

Sensitivity 95.7%
Specificity 100%
PPV 100%
NPV 99.6%
CI 99.7%-99.99%) at an estimated prevalence of 1%
LOD of 0 c/µl

ender EASY applied to your needs by enabling the use of saliva specimens

Provide periodical tests:

The solution for:

Get your ender EASY solution here