Description
Biosynex autotest COVID-19 is a rapid immunochromatographic self-test for the qualitative detection of IgG and IgM antibodies against SARS-CoV-2 from a drop of capillary blood. The test consists of SARS-CoV-2 antigens (called RBD - Receptor Binding Domain) associated with colloidal gold particles capable of detecting IgG and IgM antibodies to SARS-CoV-2. This diagnostic self-test allows you to know if you have come into contact with the virus responsible for COVID-19. Biosynex autotest COVID-19 allows you to identify people who do not know they have been infected because they have no symptoms or because of the incorrect diagnosis of the symptoms presented. This means that the self-test can identify “silent” infections, as well as people who were previously ill and then cured. The test should be used on adults only or under adult supervision if performed on a child.
Sensitivity and specificity
The Biosynex COVID-19 self-test was compared with the (confirmed) clinical diagnoses. The study involved 456 IgG and 466 IgM samples.

	Sensitivity	Specificity
IgG	100%	99.5%
IgM	92.6%	99.2%

How to use
Read the instructions in the user manual carefully and if necessary ask your pharmacist for advice. If in doubt about the result obtained, consult your doctor.
1) Read the package insert carefully. Bring a watch or timer.
2) Wash your hands with warm soapy water and dry them before moving on to the next step.
3) Open the box and remove all the pieces from their respective packaging. Take the pipette and lancing device out of the bag as well. Place them on a flat, clean surface. Identify all the elements of the kit.
4) Tear off the edge of the sachet. Remove the cassette. Use the test within one hour.
5) Unscrew the cap of the reagent bottle and place it vertically on the work surface.
6) Disinfect the fingertip with the alcohol wipe. It is recommended to prick the middle finger.
7) Dry the traces of alcohol with the gauze.
8) Remove the lancing device cap by pulling upwards.
9) Place the lancing device against the tip of the finger (the end that is applied to the finger is the one covered by the cap) and press firmly to cause the puncture.
10) Press hard on the fingertip so that a large suspended drop of blood is formed.
11) Without pressing the bulb, put the pipette in direct contact with the drop of blood: the pipette will fill automatically.
12) Fill the pipette completely with blood up to the black line.
13) Empty the pipette into the square well "Sang / Blood" (blood) of the cassette by pressing the bulb of the pipette.
14) Add 2 drops of reagent to the round well “Diluant / Diluent” (reagent) of the cassette. Leave the cassette on a flat surface.
15) Activate the timer or note the deposit time. Wait 10 minutes before reading the result. Don't wait more than 20 minutes. In the meantime, apply the patch.

Interpretation
The test result is negative if a colored line appears only in the control zone (C) and not in the IgG and IgM zones (regardless of the intensity of the line). A negative result indicates the absence of antibodies against COVID-19. The body did not contract COVID-19. A negative result does not rule out a recent SARS-CoV-2 infection. If you think you have contracted the virus (through an infected person) in the days before the test was performed, please do a second self-test 10 days after the last exposure. It is necessary to continue to observe the protection rules and to maintain social distancing.
The result is positive if 2 or 3 colored lines appear on the membrane. The colored lines appear one at the level of the control zone (C) and one at the level of the IgG and / or IgM zone, regardless of the intensity of the lines. A positive result shows that the body has contracted the COVID-19 virus and that the immune system has reacted by producing IgM and / or IgG antibodies. A positive result with Biosynex COVID-19 autotest does not allow to know if the patient is still a carrier of the virus and therefore contagious.
If no line appears at the level of the control zone (C) - even if there is one at the level of the IgG and / or IgM zone -, Biosynex autotest COVID-19 is then invalid. A new test is required.

Limitations of the test
The test is not a molecular type diagnostic test (antigen detection) capable of detecting the presence of the virus, but it does detect a reaction of the patient's immune system against COVID-19. The test allows to identify asymptomatic "silent" infections (current or past) and those in people who have been sick and are then cured. The test does not determine whether the patient is contagious, but only indicates whether the person has contracted the virus at any time. A false negative result may appear in patients with early symptoms. Repeat the test in the following days in order to highlight the presence of a seroconversion. At the onset of infection, the anti-SARS-CoV-2 IgM concentration may be below detectable levels. The test only indicates the presence of anti-SARS-CoV-2 antibodies in the specimen and should not be used as the sole diagnostic criterion. The test does not replace a medical examination or the result of a biological analysis carried out in a medical analysis laboratory.
Incorrect results may be obtained:
- If the test is not performed according to the instructions in the package insert.
- If the foil pouch is damaged or if the test is not carried out in the minutes following the opening of the foil pouch.
- If the storage conditions are not respected or if the test is carried out after the expiry date indicated on the foil pouch.
A positive result must be confirmed by laboratory analysis. Please consult your doctor. There is a potential for false positive results, especially in some cases of patients with rheumatoid arthritis. Cases of cross-reactivity have been observed with SARS-CoV-1 and other seasonal coronaviruses. A positive result showing the presence of antibodies does not mean that you are immune to COVID-19. The immune system response is unique to each individual. Antibodies can disappear in some individuals as early as a few weeks after infection.

Warnings
Make sure the blood has been deposited correctly before adding the reagent. Keep the self-test and its components out of the reach of children: the reagent can be a hazard if swallowed and the lancing device can cause injury. The used test cassette and all its components can be disposed of together with household waste in a tightly closed bag. All components included in the kit are intended for this test only. Do not reuse the test and / or components. The test must be carried out at room temperature (15-30 ° C). The test is for single use only. The test should be used immediately after the blood drop is taken from the fingertip.
Do not use the test beyond the expiration date indicated on the foil pouch and on the outside of the cardboard box. The test cannot be frozen. The test cassette should remain in the sealed pouch until use.

storage
Store in a dry place at a temperature between 2 ° C and 30 ° C.

Format
Pack containing 1 envelope with:
- 1 test cassette
- 1 hand
- 3 pipettes
- 1 thinner
- 1 alcohol wipe
- 1 gauze
- 1 dressing

Cod.859081

Bibliography
https://www.has-sante.fr/upload/docs/application/pdf/2020-04/cahier_des_charges_test_serologique_covid19.pdf
https://www.has-sante.fr/upload/docs/application/pdf/2020-05/rapport_tests_serologiques_rapides_covid-19_vd.pdf
https://covid-19.sante.gouv.fr/tests
Sethuraman N, Jeremiah SS, Ryo A. Interpreting Diagnostic Tests for SARS-CoV-2. JAMA. 2020; 323 (22): 2249-2251.
doi: 10.1001 / jama.2020.8259