Background: Coronaviruses are positive single-stranded RNA viruses of the family Coronaviridae. Several different strains of coronaviruses are currently known to infect humans (HCoV-229E, HCoV-NL63, HCoV-OC43, HCoV-HKU1, MERS-CoV, SARS-CoV, SARS-CoV-2, NCoV and HCoV-EMC). Strains HCoV-229E, HCoV-NL63, HCoV-OC43, MERS-CoV and HCoV-HKU1 cause cold, upper respiratory infection, bronchiolitis and pneumonia in humans. SARS-CoV, a beta coronavirus, causes the Severe Acute Respiratory Syndrome (SARS). SARS-CoV-2 is a beta coronavirus that emerged in Wuhan, China in December 2019. The virus is responsible for the disease COVID-19 (corona virus disease 2019). Fever, cough and breathing difficulties are described as the most frequent initial symptoms, later on it can lead to pneumonia. The main route of SARS-CoV-2 transmission is via respiratory uptake of virus particles (droplets or smaller aerosols).

The new SARS-CoV-2 variant from the UK B.1.1.7. (VOC-202012/01) is also detected by ViroReal® Kit RT-LAMP SARS-CoV-2!

Description: 

ViroReal® Kit RT-LAMP SARS-CoV-2 is an in vitro diagnostic test based on one-step RT-LAMP technology for the detection of RNA of SARS-CoV-2. This test is used as a screening tool for samples from patients of all age groups with and without suspected COVID-19 disease. The test takes between 30-53 minutes, depending on the (real-time) PCR device used.

The test is suitable for the detection of SARS-CoV-2 of persons who are in an infectious stage. Samples with an RNA concentration of approximately 20,000 copies per ml or more (equivalent to approximately 100 copies per RT-LAMP reaction, which corresponds to a real-time PCR Cq value of approx. 31) can be reliably detected with a sensitivity of 95% and a specificity of 99%.

The results of ViroReal® Kit RT-LAMP SARS-CoV-2 represent a snapshot of the infection status of the tested person and should not be used as the sole basis for patient management decisions. Persons with a positive or questionably positive test result should be retested by real-time PCR (gold standard).

This test can either be used with native specimens (without prior extraction) or with extracted RNA. Proper native specimens are oropharyngeal swabs (posterior throat swabs) in 2 ml of isotonic saline solution (NaCl 0.9%), solely. There is no need for RNA extraction, because virus inactivation and lysis occur during the isothermal amplification step. Caution: Other native specimens or transport media are not suitable. Suitable purified (extracted) test materials are samples from the upper respiratory tract (throat rinsing fluid, nasopharyngeal and oropharyngeal swabs, nasopharyngeal wash/aspirate and nasal aspirates). This test material must be prepared with a suitable RNA extraction procedure before testing.

Interpretation of data

A real-time PCR instrument should be used. The generated DNA amplicon is detected via an intercalating fluorescent dye (included in the kit reaction mix) by amplification curves and melting curves. After amplification, a visual check of the reaction tubes can 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.

Figure 1 Visual endpoint control of the color change in the reaction tube. In a real-time PCR instrument, the amplification and melting curves are recorded in the fluorescence channel for SYBR Green / FAM.

For more detailed information see here.

ViroReal® Kit RT-LAMP SARS-CoV-2
OrdernumberReactionsChannel PathogenChannel IPCTarget
DHUV02610100SYBR Green / FAM channelORF1ab
DHUV02610x5500SYBR Green / FAM channelORF1ab
For in vitro diagnostic use.
Shipping Temperature: 4°C
Product Features:
  • Amplification and detection: ORF1ab region of SARS-CoV-2
  • One-step RT-LAMP technology
  • Detection of amplification via amplification curve and melting curve. Additionally colorimetric detection of amplification by change of color from red to yellow
  • Inhibited activity at room temperature
  • PCR- platforms: runs on all established standard real-time PCR- platforms and conventional block-PCR instruments
  • Available formats: Kit (with reaction mix)

PCR platforms: 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).

Declaration of Conformity