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”
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