COVID-19 rapid diagnostic test GenomeCoV19

adenovirusStreptococcus pneumoniaeinfluenza A

Co-developed with Applied Biological Materials (abm), GenomeMe's GenomeCoV19 Detection Kit is a real-time reverse transcription polymerase chain reaction (RT-qPCR) test intended for the qualitative detection of RNA from SARS-CoV-2 in human nasopharyngeal and oropharyngeal swab specimens. Specifications DETECTION: Specifically detects the RdRP and N SARS-CoV-2 genes as recommended by WHO and US CDC INTERNAL CONTROL: Positive control template and negative extraction controls included SPECIMEN COLLECTION: Nasopharyngeal and oropharyngeal swab KIT TYPE: Fluorescent Probe-based RT-qPCR EQUIPMENT COMPATIBILITY: Compatible with Agilent MX300P, Agilent MX4000, Agilent AriaMx, BioRad CFX96, BioRad iCycler iQ, Cepheid Smartcycler II, Illumina Eco, Qiagen Rotor Gene Q 5plex, Roche LightCycler 480, Roche Cobas z 480, ABI 7500*, QBI QuantStudio 6/7*, Thermo ViiA 7*. *ROX passive dye will need to be turned off. ANALYTICAL SENSITIVITY: Limit of Detection (LoD) of 5 cp/reaction ANALYTICAL SPECIFICITY: No cross-reactivity with influenza A virus, influenza B virus, adenovirus, Staphylococcus epidermidis, HCoV-SARS, HCoV-OC43, HCoV-HKU1, or Streptococcus pneumoniae. See Datasheet for full test results. REGULATORY STATUS: CE-IVD, FDA permit for distribution under Section IV.C.