DEVICE: MGB Alert® HDV Primer Mix ASR (03661540952906)

Device Description: Product Description MGB Alert® HDV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the Hepatitis Delta Virus RNA. The mix consists of a total of 2.5 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 57 bp region of the Hepatitis Delta Virus RNA. Each product lot will go through functional testing with an approved test method. Storage and Handling Requirements The reagent contained in this package shall be shipped on dry ice, protected from light and stored at less than -10degrees Celsius when received. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles. Warnings and Precautions Carefully read this entire package insert. - The operator must be trained to perform high complexity work and avoid distractions which may lead to errors. - Use general precautions and wear appropriate personal protective equipment when handling the reagents. - Do not eat, drink, or smoke in designated work areas. - Wash hands thoroughly after handling reagents. - Prevent reagent carryover by working in a nuclease-free area keeping one tube open at a time during reagent preparation and PCR setup. Completed PCR tubes or sealed plates should not be opened. - Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations.