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New COVID-19 (SARS-CoV-2) antigen test

Product code: SELF-TEST-COVID-19

Rapid antigen test used by Polish hospitals.
Intended for the qualitative identification of SARS-CoV-2 virus antigen by immunochromatography in a nasopharyngeal swab. It is a self-monitoring product.

Correctly detects variants of SARS-CoV-2 virus:
Alpha (British)
Beta (South African)
Gamma (Brazilian)
Delta (Indian)

Test performance confirmed by independent scientific studies.
It should not be used as the sole method to diagnose or rule out SARS-COV-2 infection.

Intended use:
This product is designed for the qualitative in vitro detection of SARS-CoV-2 antigen in a human nasal swab sample. It is intended for personal use, by untrained individuals, as a rapid test method for new coronavirus infections. Do not make medical decisions based on the test result without consulting your doctor.
The product is suitable for users over 15 years of age. Users under 15 years of age should take the test under adult supervision. Both symptomatic and asymptomatic infections can be tested.
Sensitivity: 96.4% (95% CI: 90.8% - 98.2%)
Specificity: 99.8% (95% CI: 94.4% - 99.9%)

• check the expiry date of the kit
• prepare a timer
• Place the set on a clean and dry surface
• wash your hands
• check the contents of the kit
• make sure that no part is damaged or broken
• read the instructions for use
• blow your nose several times before swabbing

At least 2 hours before the test:
• do not eat
• do not drink
• do not chew gum
• do not rinse your mouth and nose
• do not brush your teeth
• do not take medication
• do not smoke

Test result
If the sample contains SARS-CoV-2 antigens, a red line will appear in the test line area (T) indicating a positive test result.
If the sample does not contain SARS-CoV-2 antigens, no red line appears in the test line (T) area, indicating a negative result.
Each test contains an internal control (line C) that should stain regardless of the staining of the test line. If the C line remains uncoloured, the test result is invalid and the procedure must be repeated with a new test kit.

The test kit may be disposed of with normal household waste in accordance with applicable local regulations.
Contents of the package
• DEEP BLUE test equipment (test plate)
•- sterile swab
• antigen extraction tube with reagent
• extraction solution
• instructions for use
• waste bag
Declaration of Conformity - Self-testing Declaration of Conformity Download
Data sheet - Test Covid-19 Data sheet Download
Declaration of Conformity - Statement Declaration of Conformity Download
Instruction - Test Covid-19 Instruction Download

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