In vitro diagnostic device for individual use

Description
The COVID-19 SEROLOGICAL TEST is a rapid immunochromatographic test for the qualitative detection of IgG and IgM antibodies against SARS-CoV-2 in human blood samples. A diluent is used to dilute the sample and help it flow down the test strip. This test indicates that the body has been exposed to the SARS-CoV-2 virus, as specific antibodies directed against it are identified. The protective effect of these antibodies against SARS-CoV-2 over time is still being studied by the international scientific community, therefore the detection of these antibodies does not indicate the achievement of protective immunity.

Format
1 piece.

In vitro diagnostic device for individual use

Description
The COVID-19 SEROLOGICAL TEST is a rapid immunochromatographic test for the qualitative detection of IgG and IgM antibodies against SARS-CoV-2 in human blood samples. A diluent is used to dilute the sample and help it flow down the test strip. This test indicates that the body has been exposed to the SARS-CoV-2 virus, as specific antibodies directed against it are identified. The protective effect of these antibodies against SARS-CoV-2 over time is still being studied by the international scientific community, therefore the detection of these antibodies does not indicate the achievement of protective immunity.
Kit contents
- hermetically sealed aluminum bag containing:
1 COVID-19 IgG/IgM RAPID TEST cassette
1 desiccant sachet
- sterile lancets for self-puncture for blood sampling
- dropper vial containing the COVID-19 IgG/IgM RAPID TEST diluent
- plastic bag containing 1 saco de dessecante 1 pipette for blood sampling
- antiseptic skin cleanser gauze
- 1 instructions for use leaflet
Materials required and not provided: absorbent cotton, an instrument for calculating time (ie stopwatch, clock).

How to use
1) Wash your hands with soap and warm water, rinse with clean water and dry or use the cleaning gauze provided.
Note: the use of hot water facilitates capillary blood sampling as it induces vasodilation.
2) Prepare the necessary material as follows: open the foil bag, take only the cassette and throw away the desiccant sachet. Open the plastic bag containing the pipette.
3) Carefully turn the protective cap of the lancing device 360° without pulling it. Pull out and discard the released cap.
4) Carefully massage the phalanx chosen for the puncture (the side of the ring finger is recommended). It is important that the massage is done from the palm to the phalanx, to improve blood flow. Press the lancet, on the side from which the cap was removed, against the fingertip. The lancet tip automatically retracts safely after use. If the hand does not work properly, use the second hand provided. If, on the other hand, the latter is not necessary, it can be disposed of without particular precautions.
5) Keeping the hand pointing down, massage the finger until a large drop of blood forms. It is important that the massage is done from the palm to the phalanx, to improve blood flow.
6) Take the pipette without pressing the bulb. Two sampling methods are suggested: - hold the pipette horizontally without pressing the bulb and put it in contact with the drop of blood, it will enter autonomously by capillarity. Remove the pipette when reaching the black line. If there is not enough blood, continue massaging the finger until that line is reached.
- place the pipette on a flat and clean surface making the tip protrude, at this point put the drop of blood in contact with the pipette, it will enter autonomously by capillarity. Move your finger away when you reach the black line. If there is not enough blood, continue massaging the finger until that line is reached. Avoid, as far as possible, breaking contact between the blood and the pipette to prevent the formation of air bubbles.
7) Deposit the blood collected with the pipette in the well indicated (S) on the cassette, by pressing the bulb of the pipette.
8) Unscrew the blue cap from the dropper vial (leave the white cap tightly screwed on). Deposit 2 drops in the well indicated on the cassette, waiting approximately 5 seconds between the first and second drop.
9) Wait 10 minutes.
Interpretation of results
Read the result at 10 minutes.
Do not read results after 20 minutes.
IgG positive : two colored lines appear in the reading window at the C (Control line) and G (IgG test line) marks. This means that the test detected the presence of class G immunoglobulin (IgG) in the sample. This result does not indicate that protective immunity has been acquired. You should contact your doctor immediately and report this result.
IgM positive : two colored lines appear in the reading window at the C (Control line) and M (IgM test line) marks. This means that the test detected the presence of class M immunoglobulin (IgM) in the sample. This result does not indicate that protective immunity has been acquired. You should contact your doctor immediately and report this result.
IgG AND IgM positive : three colored lines appear in the reading window corresponding to the C (Control), G (IgG) and M (IgM) marks. This means that the test has detected the presence of class G and M immunoglobulins in the sample (IgG + IgM). This result does not indicate that protective immunity has been acquired. You should contact your doctor immediately and report this result. *Note: The color intensity in the control and test line regions may vary depending on the concentration of SARS-CoV-2 antibodies present in the sample (as visible in the images). Therefore, any color tone in the region of the G and M lines should be considered positive. False positive results could be due to past or current infections with other Coronaviruses or other interferers.
Negative : A colored line appears in the control line region (C). No line appears in region G (IgG) and region M (IgM). The test did not detect the presence of class G or M immunoglobulins in your sample. They are not present or are present in very low concentrations and such as not to be detected by this diagnostic system. If you have symptoms attributable to COVID-19, contact your doctor anyway.
Invalid : the control line does not appear. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line absence (invalid result). Review the procedure and repeat the test with a new device and sample.
- The test detects the presence of IgG and IgM class antibodies against SARS-CoV-2 thanks to specific antibodies and colloidal gold nanoparticles incorporated in the reactive strip.
- COVID-19 SEROLOGICAL TEST can be carried out at any time of the day. The test can be conducted by anyone who has had suspected contact with infected people, people with COVID-19 symptoms, people residing in areas proximal to any outbreaks or by anyone who wants to be aware of any infection that has occurred. In case of exposure to the virus, the appearance of IgG and/or IgM antibodies against SARS-CoV-2 is observed within 19 days of the onset of symptoms (in 60% of cases within the first week and in 90% within the second week ). If the test is carried out too soon, the result obtained may not be indicative and it is therefore recommended to repeat the test 10-20 days after the onset of symptoms. If you are under pharmacological treatment, check with your doctor if the drugs you are taking (e.g. immunosuppressive drugs, steroids, etc.) can alter the levels of circulating antibodies. COVID-19 SEROLOGICAL TEST is not to be used in emergency situations.
- The COVID-19 SEROLOGICAL TEST detects only the presence of IgG and/or IgM antibodies in the blood sample, an indication of infection by the virus and of the subsequent immune response. The test does not necessarily detect ongoing SARS-CoV-2 infection.
- The result is correct as long as the instructions are carefully followed. However, the result may not be correct if: the device comes into contact with other liquids before being used, if the amount of blood and/or diluent is insufficient, if the number of drops dispensed into the well is incorrect or if the time result reading is not respected. The supplied plastic pipette allows you to be sure that the volume of blood collected is correct. False positive results could be due to past or current infections with other Coronaviruses or other interferers. Cross-interferences with RSV IgG, Common Coronavirus NL63 IgG, Rheumatoid Factor (RF), Mycoplasma pneumoniae IgG/IgA and IgM are possible. Due to the current lack of samples with very high concentrations of antibodies, the manufacturer cannot exclude the possibility that very high concentrations of antibodies against SARS-CoV-2 in the blood sample may lead to false negative results (hook effect).
- The color and intensity of the lines are not important for the interpretation of the result. Refer to the indications in the section "Interpretation of results" to correctly evaluate the result.
- The test must be read 10 minutes after the conclusion of the procedure and no later than 20 minutes. Results read after 20 minutes may not be correct (false positive results).
- If the result obtained is positive (for IgG and/or IgM) it means that there are IgG and/or IgM antibodies against SARS-CoV-2 in the blood sample. You must consult your doctor and communicate the result obtained with this test. The positive result is neither sufficient to indicate the development of the COVID-19 pathology nor the current SARS-CoV-2 infection, however it is advisable to discuss it with your doctor who will decide how to continue the diagnostic investigation. False positive results can be obtained due to cross-interference with pre-existing antibodies to other pathogens (such as other Coronaviruses) or other possible causes. Cross-interferences with RSV IgG, Common Coronavirus NL63 IgG, Rheumatoid Factor (RF), Mycoplasma pneumoniae IgG/IgA and IgM are possible.
- If the result is negative, it means that the test has not identified the presence of IgG and/or IgM antibodies against SARS-CoV-2. This result may mean that a SARS-CoV-2 infection has not occurred or that it is at an early stage in which specific antibodies have not yet been developed. In addition, there have been reports of no antibody response in PCR-positive SARS-CoV-2 patients, suggesting that not all infected people develop antibodies. In the presence of symptoms such as fever, dry cough, exhaustion, soreness and muscle pain, sore throat, diarrhoea, conjunctivitis, headache, loss of taste or smell, skin rash, it is recommended to contact your doctor, even if the test generates a negative result.

Warnings
- COVID-19 SEROLOGICAL TEST does not indicate the presence of the virus (and therefore whether a person is contagious or not as in the case of rhino-oropharyngeal swabs) but only the existence of antibodies against it.
- Read these instructions for use carefully before carrying out the Test. The Test is reliable if the instructions are carefully followed.
- Keep the Test out of the reach of children.
- Do not use the Test after the expiry date or if the package is damaged.
- Follow the procedure exactly respecting the indicated quantities of blood and diluent.
- Use the Test and the lancet only once.
- The Test is for external use only. Do not swallow.
- Not recommended for use by people taking medicines that thin the blood (anticoagulants) or people who have haemophilia problems.
- After use, dispose of all components according to local regulations in force, ask your pharmacist for advice.
- In vitro diagnostic device for individual use.

storage
Store the test components at a temperature between +4°C and +30°C. Do not freeze.

Format
1 piece.

Bibliography
1. European Center for Disease Prevention and Control, Disease background of COVID-19 (https://www.ecdc.europa.eu/en/2019-ncovbackground- disease)
2. https://www.who.int/emergencies/diseases/novel-coronavirus-2019
3. https://ec.europa.eu/info/live-work-travel-eu/health/coronavirus-response_en
4. Long, Q., Liu, B., Deng, H. et al. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med (2020)
5. European Center for Disease Prevention and Control. An overview of the rapid test situation for COVID-19 diagnosis in the EU/EEA. April 1, 2020.
6. FIND. Rapid Diagnostic Tests For Covid-19. https://www.finddx.org/wp-content/uploads/2020/05/FIND_COVID-19_RDTs_18.05.2020.pdf