For in vitro diagnostic use. Others LightMix MERS-CoV Dual-target RT-PCR Kit IVD LightMix® MERS-CoV Dual-target RT-PCR Kit 100 1377683945183 This product is not a Roche product, Roche Global Customer Support is not offering any Support. For any additional information and support please ONLY contact TIB MolBiol directly. Furthermore we can not guarantee that all available information for this product is up to date. PID00000629 Kit with reagents for the 1-step RT-PCR detection of the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) genomic RNA including an Extraction Control using Roche Diagnostics '480' Instruments 07 341 075 001 7 341 075 001 07341075001 7341075001 07341075001 LightMix MERS-CoV RT-PCR Kit LightMix MERS-CoV RT-PCR Kit 04260159332742 Reagents, kits 40-0657-96 96 reactions Not Available false This kit is an in-vitro diagnostic real-time PCR based laboratory test for detection of the Middle East Respiratory Syndrome Coronavirus genomic RNA in nucleic acid extracts from clinical specimen. Typical samples are extracted from lower respiratory tract tracheal aspirates or bronchoalveolar lavage, but nasopharyngeal or oropharyngeal swabs, serum, or fecal samples can also be tested. en This product contains separate MERS-CoV specific assays targeting upE and N-gene, which are together more sensitive than upE alone. This assay is combined with the Control Reaction, monitoring successful extraction, reverse transcription, and absence of amplification-inhibition in a multiplex reaction. All upE/N- gene positive results are confirmed running the Orf1a assay, as recommended by the WHO.6Fragments of 77 bp (upE), 67 bp (N-gene), and 84 bp (Orf1a) are amplified with specific primers. Products are detected with probes, resulting in an increase of the 500 and 530 nm channel fluorescence signals (other instruments read FAM channel). The Control Reaction is monitored with a Atto 647 labeled probe. With Roche '480' Instruments results for first and confirmation PCR are obtained within each one hour.6 WHO. Laboratory Testing for Middle East Respiratory Syndrome Coronavirus 2013 en Analytical SensitivityThe Analytical Sensitivity was determined by testing of dilution series of viral RNA (EQA samples) of known concentration; the limit of detection in probit regression analysis is 9 copies per reactions for Dual- Target (upE + N-gene) and 10 copies per reaction for Orf1a (95% confidence interval).Analytical SpecificityIn-silico analysis indicates no interferences with other pathogens to be expected. Common respiratory viruses, in particular CoV, OC43, NL63, 229E, HKU1, SARS (in-vitro transcript), Influenza A and B, Parainfluenza 1-4, RSV-A/B, MPV, Rhinovirus and Enterovirus have been tested to be negative.Diagnostic Sensitivity and SpecificityIn a mock study with each 50 positive and negative samples of viral RNA (EQA) spiked into nasal swabs, results were 100% in concordance, thus Diagnostic Sensitivity and Specificity are 100%. Field study: From a total of 85 specimens tested in June 2015 in KSA, 82 samples were tested negative and 3 (3.5%) tested positive with all three assays. en

LightMix^® MERS-CoV Dual-target RT-PCR Kit

Kit with reagents for the 1-step RT-PCR detection of the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) genomic RNA including an Extraction Control using Roche Diagnostics '480' Instruments

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LightMix^® MERS-CoV Dual-target RT-PCR Kit

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