Isothermal amplification PCR in 30 minutes with no RNA extraction

Let's return to normal

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

ender MASS 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 direct nasal, nasopharyngeal or throat swabs and saliva from individuals suspected of COVID-19.

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

The ender MASS 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 MASS is the optimal laboratory-based solution for mass testing in a public health setup, where there is a need for identifying all infectious individuals with a sufficiently high virus load to pose a threat to others.

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

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

Approx. 5 minutes sample preparation*

*Depending on sample throughput & automation setup

no RNA extraction required

30 minutes isothermal amplification time

Approx. 5 minutes melting curve analysis**

** 5 – 20 minutes depending on PCR cycler

Specimen collection

(not provided with the kit)

Thermolysis of sample

(reagents provided with the kit)

Isothermal amplification

(reagents provided in kit)

Data Analysis

(according to PCR cycler used)

Your benefits using ender MASS

No RNA extraction needed
Designed for flexible testing units
Performs on any standard real-time PCR cycler
30 minutes for isothermal amplification PCR
5 minutes sample preparation only
Developed for a public health setup with a focus on mass testing
Increases your daily testing capacity on your standard equipment by 8 times
Reduces your internal cost per test due to more efficient workflow with existing personnel
Safe data interpretation through internal amplification control, negative and positive control

Performance Data

Sensitivity 93%

Specificity 100%

PPV 100%

NPV 99.2%

(CI 97.7%-99.7%) at an estimated prevalence of 10%

LOD of 0 c/µl

or 480 copies per reaction

Isothermal amplification PCR in 30 minutes with no RNA extraction

Let's return to normal