Technology

The ender Technology

The ender diagnostics COVID-19 assays are in-vitro diagnostic (IVD) test kits based on a proprietary rapid molecular isothermal nucleic acid amplification technology method. They are intended for the qualitative detection of nucleic acid ORF-1a gene sequence from the SARS-CoV-2 Viral RNA in direct nasal, nasopharyngeal or throat swabs and saliva from individuals suspected of COVID-19.

Test Principles

The ender products are based on an isothermal amplification and real-time detection technology of the SARS-CoV-2 ORF-1a gene sequence. The amplification reaction takes place at a constant temperature of 65 °C for 30 min.

No thermal cycling is required since the polymerase harbors a helicase activity. Thus, primer binding and amplification happen instantaneously and continuously. A separate reverse transcription step is not required due to reverse transcription activity of the enzyme used. Reverse transcribed and amplified DNA is detected by a fluorescent DNA-intercalating dye. After isothermal amplification, a melting curve analysis is performed to distinguish the SARS-CoV-2 amplicon from the included internal amplification control (IC). The two targets are identified based on their melting temperature.

Sample Preparation

Works with a simple 3 minutes thermolysis prior to amplification / real-time detection.
Works with a simple 3 minutes thermolysis prior to amplification / real-time detection.
Uses RNA extraction by a commercially available extraction kit or an automated extraction system.

Workflow

saliva sample collection
1
Approx. 5 minutes sample preparation*
*Depending on sample throughput & automation setup
2
no RNA extraction required
3
30 minutes isothermal amplification time
4
Approx. 5 minutes melting curve analysis**
** 5 – 20 minutes depending on PCR cycler
5
Approx. 5 minutes sample preparation*
*Depending on sample throughput & automation setup
1
No RNA extraction required
2
30 minutes isothermal amplification time
3
Approx. 5 minutes melting curve analysis**
** 5 – 20 minutes depending on PCR cycler
4
Standard RNA extraction
1
Time required for RNA extraction depending on the methodology and number of samples
2
30 minutes isothermal amplification time
3
Approx. 5 minutes melting curve analysis*
* 5 – 20 minutes depending on PCR cycler
4

Isothermal Amplification

Our isothermal amplification PCR enables a reliable identification of infectious SARS-COV-2 carriers and an increase in testing capacity.

If you want to read more about our solution for your demand in test capacity for screening, download this overview paper:
Infected vs. Infectious and testing solutions.

ender LAB and ender MASS are 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).

Benefits

We provide a novel approach for the effective management of the COVID-19 pandemic with patented technology.

Shorter time to result

Uncompromised sensitivity and specificity

Higher sample throughput