Wholesale CE Certification Medical Equipment Manufacturers Exporters – 2019-nCoV Ag Test (Latex Chromatography Assay) / Self-Test / Saliva – INNOVITA Manufacturer and Supplier

CE Certification Medical Equipment Manufacturers Exporters – 2019-nCoV Ag Test (Latex Chromatography Assay) / Self-Test / Saliva – INNOVITA

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CE Certification Medical Equipment Manufacturers Exporters – 2019-nCoV Ag Test (Latex Chromatography Assay) / Self-Test / Saliva – INNOVITA Detail:

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Innovita® 2019-nCoV Ag Test is intended for the direct and qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in saliva that is self-collected by an individual aged 18 years or older or is collected by an adult from young individuals. It only recognizes the N protein and cannot detect the S protein or its mutation site.
The kit is intended for layperson as self-testing at home or at work (in offices, for sports events, airports, schools, etc.).

What is self-test:

A self-test is a test that you can carry out yourself at home, to reassure yourself that you are not infected before going to school or work. Self-test is recommended regardless whether you have symptoms or not to quickly check whether you need immediate attention. If your self-test produces a positive result, you probably have been infected with coronavirus. Please contact test center and doctor to arrange for a confirmation PCR test and follow the local COVID-19 measures.

Composition:

Packing Size	Test cassette	Extraction diluent	Saliva collector	Specimen bags	IFU
1 test/box	1	1	1	1	1
2 tests/box	2	2	2	2	1
5 tests/box	5	5	5	5	1

Test Procedure:

1.Preparation

● Read the instructions carefully before starting the test.
● Find a clean and light work surface with enough space. Have a watch or device that can time next to the test cassette.
● Allow the test device to equilibrate to room temperature (15–30℃) prior to opening the pouch.
● Wash or disinfect your hands before starting the test and after finishing the test

2.Specimen Collection and Handling

	Rinse mouth with water.
	Unscrew the cap of the extraction diluent.
	Place the saliva collector on the extraction diluent tube.ž
	Cough deeply three times.
	Spit out saliva from the posterior oropharynx into the open funnel. Collect saliva through the saliva collector up to the fill line. Do not exceed the fill line.
	Remove the saliva collector and screw the cap of the tube back on. Shake the tube 10 times so that the saliva mixes thoroughly with the extraction diluent. Then let stand for 1 minute and shake well again.
* If the saliva specimen is visibly cloudy, leave it to settle before testing.

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