Gargle Nucleic Acid Extraction Reagents

The product mainly consists of the gargle, highly-absorbant superparamagnetic nanospheres mixture, and unique lysis reagents. The unique embedded magnetic beads have a good affinity for the physical components (including free viruses and virus-infected cells). When contacting the lysis solution, the non-ionic cell/nucleus-membrane-breaking surfactants and protease inhibitors in the solution could restrain the activity of DNA/RNA enzyme, and stabilize the nucleic acid. All nucleic acid substances in the physical components of gargle are efficiently released into the lysis solution, quickly acquiring the nucleic acid. The gargle samples using this kit do not require nucleic acid purification, which can directly apply to downstream nucleic acid detection kit. Sample requirements: 1. Applicable to the nucleic acid extraction and enrichment of the gargle samples. 2. The gargle sample shall be added to the enrichment solution B in time after collection. The retrieved magnetic beads shall be transferred to the lysis buffer C immediately. Samples added to the lysis buffer C can be stored at room temperature. Packing specification: 1 piece/box, 10 pcs/box, 30 pcs/box, and 50 pcs/box. Storage conditions: The enrichment solution B and lysis solution C should be stored for 12 months at 2-8℃, and other components could be stored for 12 months under r room temperature; The kit could be transported and stored temporarily under the ambient temperature, wwhich shall not exceed 5 days. Period of validity: 12 months Medical device record certificate No./product technical requirement No.: HJXB No. 20220086. Date of approval and revision of the Instructions: Date of approval: Oct. 26, 2022The components are shown in table 1.

Table 1 Components and Loading in Kit

Component name	Main components	Size (1)	Size (10)	Size (30)	Size (50)
1. Gargle A	NaCl	8mL/tube	8mL/tube *10 tubes	8mL/tube *30 tubes	8mL/tube *50 tubes
2. Gargle Collector	PP	1 piece	10 pcs	30 pcs	50 pcs
3. Enrichment Solution B	Magnetic beads	2mL/tube	2mL/tube *10 tubes	2mL/tube *30 tubes	2mL/tube *50 tubes
4 Lysis Buffer C	Protease K	0.2mL/ piece	0.2mL/piece*10 pcs	0.2mL/piece*30 pcs	0.2mL/piece*50 pcs
5. Magnetic Cap	Magnet	1 piece	10 pcs	30 pcs	50 pcs

The components are valid for 12 months. Components that are required in the nucleic acid extraction, but are not included in the kit: 1. Consumables: 1.5ml EP tube; 2. Equipment: Water bath (or metal bath), pipettes , and centrifuge.