Getein™ SARS-CoV-2 Antigen Rapid Test Kit - Immunofluorescence - FIA - Nasal Swab 25 tests

Intended use

The SARS-CoV-2 rapid antigen test kit (immunofluorescence assay) is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab samples from patients suspected of COVID-19 infection by a healthcare worker.

Content

1. for Getein1100

Package specifications: 25 tests/box

• Getein SARS-CoV-2 antigen test card in a sealed pouch with desiccant
• Sample extraction solution: 25 tubes/box
• Sampling swab: 25 pieces/box
• User manual: 1 piece/box
• SD card: 1 piece/box

Specifications

• Test Item: SARS-CoV-2 Antigen
• Sample: Nasal
• Storage: 4-30℃
• Method: Immunofluorescence Assay
• Result: 15 min
• Validity: 24 months

Applicable Device (not included)

Getein1100 Immunofluorescence Quantitative Analyzer

Clinical Application

1. This test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in combination with clinical presentation and the results of other laboratory tests.
2. This test is intended for professional and laboratory use only, not for testing at home
3. Test results should not be used as the sole basis for diagnosis and exclusion of SARS-CoV-2 infection.
4. As this is a new diagnosis of a disease under study, please refer to the latest guidelines for diagnosis and treatment of COVID-19

Interpretation of results

The result of the test is shown numerically in terms of COI - Cut Off Index:

• if the COI value is less than 1.0 the test is negative;
• if greater than 1.0 is certainly positive.

DOCUMENTATION

• Declaration of Conformity
• Getein FIA test brochure
• IFU-Getein FIA test SARS-CoV-2 Antigen