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EURORealTime SARS-CoV-2 - 1

PCR test for specific detection of SARS-CoV-2 including the new variants VOC*202012/01 (B.1.1.7 lineage) and 501.V2 (B.1.351 lineage) Quick and simple pathogen detection by means of reverse transcription and real-time PCR in one step High sensitivity due to simultaneous detection of two SARS-CoV-2 target sequences Only one reaction per sample ) UA Technical data Test principle Test procedure Reagents Controls CE-IVD mark Test kit format Order number Reverse transcription of the SARS-CoV-2 genome followed by PCR amplification and real-time detection using specific primers and probes Reverse transcription and real-time PCR in one test (approx. 90 min) Ready for use Internal inhibition and extraction control (RNA), SARS-CoV-2 positive control (RNA), negative control Test system validated for the following real-time PCR cyclers: LightCycler® 480 II (Roche), 7500 Fast Real-Time PCR Instrument (Applied Biosystems), CFX 96 Touch (Bio-Rad), RotorGene Q (Qiagen), qTower3 (Analytik Jena); other devices should be validated individually by the user. 25, 50, 100, 200 or 1000 reactions MP 2606-0125, -0225, -0425, -0100, -0200, -1000 Clinical significance Severe acute respiratory syndrome coronavirus 2 ( (SARS-CoV-2, previously called 2019-nCoV) belongs to the family of corona) viruses and, like SARS-CoV, is classified in the genus Betacoronavirus. At the end of 2019, SARS-CoV-2 was identified as the causative pathogen in a cluster of pneumonia cases of unclear origin. The virus caused an infection wave that has spread rapidly over the world and was declared a pandemic by the WHO at the beginning of 2020. SARS-CoV-2 is mainly transmitted via aerosols during coughing or sneezing or at close contact with an infected person. Health care personnel and family members are among the high-risk populations. The zoonotic reservoir of the virus appears to be bats. The incubation time of SARS-CoV-2 is three to seven, maximally 14 days. The symptoms of SARS-CoV-2 infection are fever, coughing, breathing difficulties and fatigue. In most patients the infection manifests with symptoms of a mild febrile illness with irregular lung infiltrates. Some patients, especially elderly or chronically ill patients, develop acute respiratory distress syndrome (ARDS). The disease is fatal in up to 3 % of cases. In February 2020, the disease caused by SARS-CoV-2 was named COVID-19 by the WHO. Suitable methods for diagnosis of SARS-CoV-2 infections are direct detection of the virus by reverse transcriptase polymerase chain reaction (RT-PCR) primarily in sample material from the upper (nasopharyngeal or oropharyngeal swab) or lower respiratory tract (bronchoalveolar lavage fluid, tracheal secretion, sputum, etc.) and the detection of antibodies against SARS-CoV-2 in blood. The determination of antibodies enables confirmation of SARS-CoV-2 infection in patients with typical symptoms and in suspected cases without symptoms. It also contributes to monitoring and outbreak control. For significant serological results, two patient samples should be investigated, one from the acute phase (week 1 of the illness) and one from the convalescent phase (3 to 4 weeks later). Cross reactions with antibodies within the genus Betacoronavirus are known. Currently, there is no medication or vaccine available against infection with this new virus. For the diagnosis of SARS-CoV-2 infections, direct detection of the pathogen by means of nucleic acid amplification is the method of choice. It allows pathogen detection even in subclinical or asymptomatic cases within a few days after virus contact up to approx. 14 days after the onset of symptoms (Liu et al., 2020). However, with the start of the immune response and the associated reduction in the viral load the sensitivity of the direct detection decreases. The pathogen cannot be detected in all patients any more. Autoimmundiagnostik Molekulargenetische Diagnostik EUROIMMUN Medizinische Labordiagnostika AG · Seekamp 31 · 23560 Lübeck · Tel.: 0 451 20 32-0 · info@euro

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EURORealTime SARS-CoV-2 - 2

Test principle The test system uses a one-tube reaction based on reverse transcription (RT) for conversion of viral RNA into complementary DNA (cDNA), followed by PCR amplification and fluorescence-based real-time detection of two defined sections in the ORF1ab and N genes of the SARS-CoV-2 genome. Reverse transcription, amplification and detection of the SARSCoV-2 cDNA are performed by means of specific primers and probes. The test contains an internal amplification control, which serves as an inhibition control and can additionally be used as an extraction control. A SARS-CoV-2 positive control...

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