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Welcome to AstraGene, the UAE’s first molecular diagnostics manufacturing company, proudly based in Dubai Science Park. We operate seven GMP approved production lines, certified by the Ministry of Health and Prevention. Our products carry CE certification, and our facilities are ISO 13485, ISO 17034, and ISO 9001 certified. AstraGene manufactures over 85 PCR kits, primarily focused on infectious disease diagnostics. Our kits are designed following CDC protocols and are traceable to global standards, ensuring reliability and performance. Nucleic acids are extracted from nasal or oropharyngeal swabs and directly used for amplification. Using Real Time PCR instruments, probe based detection generates fluorescence during each cycle, enabling accurate quantification of target genes. Each kit contains four tubes the PCR amplification mix, Solution B which is the target specific primer probe mix, a negative control, and a positive control. Prepare a clean workspace with pipettes, filtered tips, and PCR tubes before setup. To prepare the master mix, combine 5 microliters of amplification mix with 10 microliters of Solution B per reaction. Mix well and briefly spin down. Aliquot 15 microliters of this mix into each well of a 96well plate. Then add 10 microliters of template RNA or the appropriate control. Seal and spin briefly before loading the plate onto the PCR machine. Run the protocol immediately using the following cycling conditions cDNA synthesis at 55 degrees Celsius for 10 minutes, initial denaturation at 95 degrees Celsius for 15 minutes, followed by 40 cycles of 95 degrees for 5 seconds, 60 degrees for 15 seconds, and 67 degrees for 15 seconds. Always refer to the IFU for machine specific setup instructions. Interpret results based on cycle threshold values. Ct values under 35 are considered positive. Ct values between 35 and 38 are considered presumptive positive and should be retested. Ct values above 38 are considered negative. The internal control must be detected in all samples to rule out PCR inhibition. Our assay’s analytical sensitivity is 10 copies per reaction. Refer to the IFU result table for detailed guidance. Detection of both N and ORF targets confirms a positive result. Thank you for choosing AstraGene. For technical clarifications, please contact us at [email protected].