Intended use:

The test is a real-time RT-PCR for the direct and qualitative detection of norovirus. The test contains an Internal Control RNA (ICR, consisting of MS2-bacteriophage) as an internal control of sample preparation procedure and to determine possible PCR-inhibition.

The use of the SureFast® PREP DNA / RNA Virus kit is recommended.

General information:

The real-time PCR assay can be used with established real-time PCR instruments, equipped for detection of two fluorescence emissions at 522 nm and 553 nm (FAM and VIC/HEX) at the same time. The technical validation of instruments was performed on Agilent Mx3005P, BioRad CFX 96, Roche LightCycler® 480 II, Roche LightCycler® 2.02, Applied Biosystems 7500 and Qiagen RotorGene Q.

Using Roche LightCycler 1.5 or 2.0: These instruments require to perform (only once) a Color Compensation before using the new PLUS kits. For this a SureCC Color Compensation Kit II  is available.

Art. No. F7001
Comment In 1972, Norovirus was firstly detected by immuno-electron microscopic examinations of an outbreak of gastroenteritis in Norwalk (Ohio/USA) in 1968. Since 2002, this and all other genetic variations are concluded in the term Norovirus (former Norwalklike- virus). Norovirus particles have a diameter of ca. 35 nm and consist of a capside and a single strand RNA, 7300 – 7700 nucleotides in size. Noroviruses are cause of more than 90 % of non bacterial gastroenteritis cases. One reason therefore is their stability in environment. Particularly in community facilities, e.g. hospitals, rest homes or nursery homes, Norovirus causes outbreaks of gastroenteritis that can develop to considerable scale.

Vomiting, diarrhoea and nausea are typical symptoms of a Norovirus infection. Infections can appear all year long. Nevertheless, an increased number of cases are registered during winter months (“winter vomiting disease”). Virus particles are either transferred directly from person to person, or indirectly via contaminated surfaces, devices, food (e.g. mussels, fruits or vegetables) or water. The minimal infection dose is 10-100 virus particles.
Test format 100 reactions
LOD (Detection limit) The SureFast® Norovirus PLUS real-time RT-PCR has a limit of detection of ≤ 25 RNA copies. The assay limit of detection depends on RNA preparation and RNA content.
Cross reactivity

no known interferences

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