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• autotest VIH^®
• autotest COVID-VIRO ALL IN^®

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About this test

 

autotest COVID-VIRO ALL IN^® is an in vitro diagnostic device for one-time use only.

autotest COVID-VIRO ALL IN^® kit requires no special equipment other than what is included in the box. The test can be done at home or with the help of a healthcare professional.

 

Inside the single-test box, you will find :

• illustrated instructions on how to do the test,
• 1 pouch containing 1 self-test.

Before you do the test, ensure the self-test kit is at room temperature (15-30°C), read the user manual and watch the demo video. It is easy to get and read the result from autotest COVID-VIRO ALL IN^®. The result appears as lines in just 15 minutes.

If you have any doubts about your results, contact your doctor.

 

 

 

 

Features and performance

Packaging: 10 tests per box (AS-COV-005) or 1 test per box (AS-COV-007)

Storage conditions: between 2 and 30 °C 

Sample type: nasal

Reliability: a comparative clinical study conducted at Orléans Regional Hospital showed a 97,5% correlation between results from autotest COVID-VIRO ALL IN^® and those form the RT-PCR laboratory test.

Sensitivity: the sensitivity of this self-test has been estimated at 93,02% (with confidence intervals ranging from 81,4% to 97,6%), i.e. 6,98% flase negatives*.

Specificity: the specificity of this self-test has been estimated at 100% (with a confidence interval ranging from 95,2% to 100%). No false positives were identified**.

Usability: the usability study of this self-test by lay people showed that 98% of participants who use this self-test obtain an interpretable result and that 99% of self-tests are interpreted correctly.

Interference: examination of samples containing substances likely to distort the results of this test and from people with conditions likely to do so revealed no notable interference.

*False negative: a sample known to be positive for the target marker and wrongly classed as negative by the device.

**False positive: a sample known to be negative for the target marker and wrongly classed as positive by the device.

 

Precautions and warnings

• autotest COVID-VIRO ALL IN^® is intended only for private use to detect the COVID-19 virus; under no circumstances should it be used for other diagnoses or other purposes.

• Store the self-test in its original package in a cool and dry place between 2°C and 30°C.

• If the box is stored in a refrigerator (between 2°C and 8°C), it must be brought to room temperature (between 15°C-30°C) before use.

• The self-test is for single use only. Do no reuse it under any circumstances.

• Do not open the packege until you are ready to do the test.

• Do not use the self-test after the expiry date.

• Do not use the cassette if the packaging is open or damaged.

• Do not do the test in a room where there is a strong current of air, such as from a fan or powerful air-conditioning.

• Storing the test in conditions other that those stated, or failing to comply with the limitations of use may produce inaccurate results.

• Despite the reliability of this test, there may be false negative and false positive results. If you are in any doubt about the result of your self-test, contact your doctor.

• The self-test user should not make any medical decisions without consulting his/her doctor, whether the test is positive or negative.

• Do not mix the components of differents batches of autotest COVID-VIRO ALL IN^®.

• The test instructions must be followed strictly to obtain an accurate result.

• Do not use nasal sprays in the 12 hours before carrying out the test.

• The diluent contains a solution with a preservative. If the solution comes into contact with the skin or eyes, rinse thoroughly with water.

• AAZ-LMB accept no liability arising from any use, distribution or dispensing of the autotest COVID-VIRO ALL IN^® or its parts that falls outside the indications and limitations of use stated in the current version of the instruction leaflet.