ViroReal® Kit RT-LAMP SARS-CoV-2 is an in vitro diagnostic test for the detection of RNA of SARS-CoV-2 of persons who are in an infectious stage. Testing takes between 30-53 minutes, depending on the
(real-time) PCR device.
Samples with an RNA concentration of approx. 20,000 target copies per ml and more (approx. 100 copies per RTLAMP reaction, corresponding to a real-time PCR Cq value of approx. 31) can be detected with a sensitivity of 95% and a specificity of 99%.
The test is based on one-step RT-LAMP technology (reverse transcription loop-mediated isothermal DNA amplification) and detects RNA of a part of the ORF1ab region of SARS-CoV-2 in patients with or without a suspected SARS-CoV infection.
For oropharyngeal swabs in isotonic saline solution (NaCl 0.9%) there is no need for RNA extraction, because virus
inactivation and lysis occur during the isothermal amplification step. Other native specimens or transport media are
not suitable. It is however possible to also use extracted RNA. In this case, proper specimens are samples from the
upper respiratory tract (throat rinsing fluid, nasopharyngeal and oropharyngeal swabs, nasopharyngeal wash/aspirate
and nasal aspirates).
This test is compatible with real-time PCR instruments detecting fluorescence in SYBR Green / FAM channel and with conventional block-PCR instruments. ViroReal® Kit RT-LAMP SARS-CoV-2 has been validated with the Applied Biosystems® (ABI) 7500 instrument (Thermo Fisher Scientific), Mx3005P® (Agilent), MIC instrument (bio molecular systems) and GeneAmp® PCR System
9700 (Thermo Fisher Scientific).
After amplification, a visual check of the reaction tubes must be performed (colorimetric detection of amplification by change of color from red to yellow, based on the pH indicator dye used in the LAMP reaction), which allows the test to be used in conventional block PCR devices. The drop in pH value is due to the large amount of generated DNA.
Cooperation project with “Klinikum Donaustadt” (Contact Person: Dr. Armin Robubi)
For more detailed product information see here.
To download the product manual click here.