Description
FIRSTCOVID
COVID-19 NEUTRALISATION IgG
SEROLOGICAL TEST
Description
Immunochromatographic test for the qualitative detection of IgG antibodies directed against the Spike protein of SARS-CoV-2 in human whole blood samples.
A diluent is used to dilute the sample and help it flow along the test strip.
How to use
Leave the kit components at room temperature (15-30°C) before performing the test if the test has been stored in the refrigerator.
Prepare the necessary material as follows: open the aluminum bag, take only the cassette and throw away the desiccant sachet. Open the plastic bag containing the pipette.
Wash your hands with warm water and soap, rinse with clean water and dry. Note: the use of warm water facilitates the collection of capillary blood because it induces vasodilation.
Use the gauze provided to clean the puncture site. Carefully rotate the protective cap of the lancet 360° without pulling it. Remove and discard the released cap. Carefully massage the phalanx chosen for the puncture (the side of the ring finger is recommended). It is important to massage from the palm of the hand to the phalanx, to improve blood flow. Press the lancet, on the side from which the cap was removed, against the fingertip. The tip of the lancet automatically retracts safely after use. If the lancet does not work properly, use the second one provided. If the latter is not needed, it can be disposed of without special precautions.
Keeping your hand facing down, massage your finger until a large drop of blood forms. It is important to massage from the palm of your hand to the phalanx, to improve blood flow. Take the pipette without squeezing the bulb.
Two withdrawal methods are suggested:
- hold the pipette horizontally without pressing the bulb and put it in contact with the drop of blood, it will enter by capillarity. Move the pipette away when you reach the black line. If the blood is not enough, continue to massage your finger until you reach that line.
- place the pipette on a flat and clean surface, making sure the tip sticks out, then put the drop of blood in contact with the pipette, it will enter by itself by capillary action. Remove your finger when you reach the black line. If there is not enough blood, continue to massage your finger until you reach that line.
Avoid, as far as possible, interrupting contact between the blood and the pipette to prevent the formation of air bubbles.
Drop the blood collected with the pipette into the sample well (S), by pressing the bulb of the pipette. Unscrew the blue cap from the dropper bottle (leave the white cap tightly screwed on). Drop 2 drops of diluent into the well indicated on the cassette (S), waiting approximately 5 seconds between the first and second drop.
Wait 10 minutes and interpret the results as follows.
Interpretation of results
Read the result at 10 minutes. Do not read the results after 15 minutes.
POSITIVE: Two colored lines* appear near the C (Control) and T (Test) regions. This means that the test has detected the presence of immunoglobulin class G (IgG) against COVID-19 in the sample.
- Vaccinated: Antibodies against COVID-19 have been produced and detected. However, this result does not indicate that protective immunity has been acquired. It is important to follow public recommendations regarding COVID-19. If you have symptoms suggestive of COVID-19 or have recently been in contact with a positive individual, it is recommended that you contact your doctor.
- Not vaccinated: antibodies against COVID-19 have been produced and have been detected. The Test cannot distinguish between active and past infection, as antibodies persist long after the infection has ended. You should contact your doctor immediately for more information on local provisions. Report to your doctor the test result, symptoms (if any) and potential contact with positive/infected people. A positive result is not sufficient to indicate the development of COVID-19 disease, however, it is recommended to discuss it with your doctor who will decide how to continue the diagnostic investigation. Furthermore, a positive result does not indicate that protective immunity has been acquired.
NEGATIVE: A single colored line (of any intensity) appears near the C (Control) region. No lines appear near the T (Test) region.
- Vaccinated: the test did not detect the presence of IgG immunoglobulins against COVID-19 in the sample. They are not present or are present in very low concentrations, undetectable by this diagnostic device. The test was probably done too early: the production of antibodies may not have occurred yet or the concentration of antibodies in the sample may be lower than the minimum detection limit of the test. Try to take the test again later, at least a couple of weeks after the end of the vaccination cycle. If you have symptoms attributable to COVID-19, contact your doctor anyway, who will decide how to continue the diagnostic tests.
- Not vaccinated: The test did not detect the presence of IgG immunoglobulins against COVID-19 in the sample. They are not present or are present in very low concentrations, undetectable by this diagnostic device. The test will give negative results in the following conditions: the concentration of antibodies against the Spike protein of SARS-CoV-2 in the sample is lower than the minimum detection limit of the test; the production of antibodies has not yet occurred at the time of sample collection; the subject has contracted a variant of SARS-CoV-2 that has undergone significant mutations in the Spike protein. The antibodies produced as a result may not be recognized by the Test. If you experience symptoms such as fever, dry cough, fatigue, muscle aches and pain, sore throat, diarrhea, conjunctivitis, headache, loss of taste or smell, skin rash, contact your doctor even if the test results are negative.
INVALID: The line adjacent to the C (Control) does not appear. Review the procedure and repeat the test with a new test and specimen. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the absence of the control line (invalid result).
NOTE: The color intensity of the control and test lines may vary depending on the concentration of antibodies against the SARS-CoV-2 Spike protein present in the specimen. Therefore, any color shade in the T region should be considered positive. False positive results may be due to past or current infections with other Coronaviruses or other potential interferents present in the specimen.
Warnings
COVID-19 NEUTRALISING IgG SEROLOGICAL TEST does not indicate the presence of the virus (and therefore whether a person is contagious or not as in the case of naso-oropharyngeal swabs) but only the existence of IgG antibodies against the Spike protein of SARS-CoV-2.
Please read these instructions for use carefully before performing the Test. The Test is reliable if the instructions are carefully followed.
Keep the test components out of the reach of children.
Do not use the test after the expiration date or if the package is damaged.
Use the Test and the lancet only once.
The Test is for external use only.
Do not ingest.
In vitro diagnostic medical device for individual use.
Follow the procedure exactly, respecting the indicated quantities of blood and diluent.
Once used, the used test must be disposed of according to local regulations. Ask your pharmacist for advice.
Not recommended for use by people taking medicines that thin the blood (anticoagulants) or people who have haemophilia problems.
Open the sealed aluminum bag only before performing the Test, pay attention to the opening sign. The desiccant bag must not be used. Dispose of it with waste, without opening it.
Conservation
Store the Test components at temperatures between +4°C and +30°C. Do not freeze.
Validity with intact packaging: 30 months.
Format
The kit contains:
- 1 hermetically sealed aluminum pouch containing 1 COVID-19 IgG SPIKE RAPID TEST cassette and 1 desiccant sachet;
- 1 dropper bottle containing COVID-19 IgG SPIKE RAPID TEST DILUENT sufficient for 1 test;
- 1 sterile lancet for self-pricking blood sampling;
- 1 plastic bag containing 1 pipette for blood sampling,
- 1 antiseptic skin cleansing gauze;
- 1 instruction sheet for use.
Bibliography
1. European Center for Disease Prevention and Control, Disease background of COVID-19 (https://www.ecdc.europa.eu/en/2019-ncov-background-disease)
2. https://www.who.int/emergencies/diseases/novel-coronavirus-2019
3. HUANG, Yuan, et al. Structural and functional properties of SARS-CoV-2 spike protein: potential antivirus drug development for COVID-19. Acta Pharmacologica Sinica, 2020, 41.9: 1141-1149.
4. SHANG, Jian, et al. Structural basis of receptor recognition by SARS-CoV-2. Nature, 2020, 581.7807: 221-224
5. Jeyanathan, M., Afkhami, S., Smaill, F., Miller, M. S., Lichty, B. D., & Xing, Z. (2020). Immunological considerations for COVID-19 vaccine strategies. Nature Reviews Immunology, 20(10), 615-632.
Code 800165-1
Immunochromatographic test for the qualitative detection of IgG antibodies directed against the Spike protein of SARS-CoV-2 in human whole blood samples.
A diluent is used to dilute the sample and help it flow along the test strip.
How to use
Leave the kit components at room temperature (15-30°C) before performing the test if the test has been stored in the refrigerator.
Prepare the necessary material as follows: open the aluminum bag, take only the cassette and throw away the desiccant sachet. Open the plastic bag containing the pipette.
Wash your hands with warm water and soap, rinse with clean water and dry. Note: the use of warm water facilitates the collection of capillary blood because it induces vasodilation.
Use the gauze provided to clean the puncture site. Carefully rotate the protective cap of the lancet 360° without pulling it. Remove and discard the released cap. Carefully massage the phalanx chosen for the puncture (the side of the ring finger is recommended). It is important to massage from the palm of the hand to the phalanx, to improve blood flow. Press the lancet, on the side from which the cap was removed, against the fingertip. The tip of the lancet automatically retracts safely after use. If the lancet does not work properly, use the second one provided. If the latter is not needed, it can be disposed of without special precautions.
Keeping your hand facing down, massage your finger until a large drop of blood forms. It is important to massage from the palm of your hand to the phalanx, to improve blood flow. Take the pipette without squeezing the bulb.
Two withdrawal methods are suggested:
- hold the pipette horizontally without pressing the bulb and put it in contact with the drop of blood, it will enter by capillarity. Move the pipette away when you reach the black line. If the blood is not enough, continue to massage your finger until you reach that line.
- place the pipette on a flat and clean surface, making sure the tip sticks out, then put the drop of blood in contact with the pipette, it will enter by itself by capillary action. Remove your finger when you reach the black line. If there is not enough blood, continue to massage your finger until you reach that line.
Avoid, as far as possible, interrupting contact between the blood and the pipette to prevent the formation of air bubbles.
Drop the blood collected with the pipette into the sample well (S), by pressing the bulb of the pipette. Unscrew the blue cap from the dropper bottle (leave the white cap tightly screwed on). Drop 2 drops of diluent into the well indicated on the cassette (S), waiting approximately 5 seconds between the first and second drop.
Wait 10 minutes and interpret the results as follows.
Interpretation of results
Read the result at 10 minutes. Do not read the results after 15 minutes.
POSITIVE: Two colored lines* appear near the C (Control) and T (Test) regions. This means that the test has detected the presence of immunoglobulin class G (IgG) against COVID-19 in the sample.
- Vaccinated: Antibodies against COVID-19 have been produced and detected. However, this result does not indicate that protective immunity has been acquired. It is important to follow public recommendations regarding COVID-19. If you have symptoms suggestive of COVID-19 or have recently been in contact with a positive individual, it is recommended that you contact your doctor.
- Not vaccinated: antibodies against COVID-19 have been produced and have been detected. The Test cannot distinguish between active and past infection, as antibodies persist long after the infection has ended. You should contact your doctor immediately for more information on local provisions. Report to your doctor the test result, symptoms (if any) and potential contact with positive/infected people. A positive result is not sufficient to indicate the development of COVID-19 disease, however, it is recommended to discuss it with your doctor who will decide how to continue the diagnostic investigation. Furthermore, a positive result does not indicate that protective immunity has been acquired.
NEGATIVE: A single colored line (of any intensity) appears near the C (Control) region. No lines appear near the T (Test) region.
- Vaccinated: the test did not detect the presence of IgG immunoglobulins against COVID-19 in the sample. They are not present or are present in very low concentrations, undetectable by this diagnostic device. The test was probably done too early: the production of antibodies may not have occurred yet or the concentration of antibodies in the sample may be lower than the minimum detection limit of the test. Try to take the test again later, at least a couple of weeks after the end of the vaccination cycle. If you have symptoms attributable to COVID-19, contact your doctor anyway, who will decide how to continue the diagnostic tests.
- Not vaccinated: The test did not detect the presence of IgG immunoglobulins against COVID-19 in the sample. They are not present or are present in very low concentrations, undetectable by this diagnostic device. The test will give negative results in the following conditions: the concentration of antibodies against the Spike protein of SARS-CoV-2 in the sample is lower than the minimum detection limit of the test; the production of antibodies has not yet occurred at the time of sample collection; the subject has contracted a variant of SARS-CoV-2 that has undergone significant mutations in the Spike protein. The antibodies produced as a result may not be recognized by the Test. If you experience symptoms such as fever, dry cough, fatigue, muscle aches and pain, sore throat, diarrhea, conjunctivitis, headache, loss of taste or smell, skin rash, contact your doctor even if the test results are negative.
INVALID: The line adjacent to the C (Control) does not appear. Review the procedure and repeat the test with a new test and specimen. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the absence of the control line (invalid result).
NOTE: The color intensity of the control and test lines may vary depending on the concentration of antibodies against the SARS-CoV-2 Spike protein present in the specimen. Therefore, any color shade in the T region should be considered positive. False positive results may be due to past or current infections with other Coronaviruses or other potential interferents present in the specimen.
Warnings
COVID-19 NEUTRALISING IgG SEROLOGICAL TEST does not indicate the presence of the virus (and therefore whether a person is contagious or not as in the case of naso-oropharyngeal swabs) but only the existence of IgG antibodies against the Spike protein of SARS-CoV-2.
Please read these instructions for use carefully before performing the Test. The Test is reliable if the instructions are carefully followed.
Keep the test components out of the reach of children.
Do not use the test after the expiration date or if the package is damaged.
Use the Test and the lancet only once.
The Test is for external use only.
Do not ingest.
In vitro diagnostic medical device for individual use.
Follow the procedure exactly, respecting the indicated quantities of blood and diluent.
Once used, the used test must be disposed of according to local regulations. Ask your pharmacist for advice.
Not recommended for use by people taking medicines that thin the blood (anticoagulants) or people who have haemophilia problems.
Open the sealed aluminum bag only before performing the Test, pay attention to the opening sign. The desiccant bag must not be used. Dispose of it with waste, without opening it.
Conservation
Store the Test components at temperatures between +4°C and +30°C. Do not freeze.
Validity with intact packaging: 30 months.
Format
The kit contains:
- 1 hermetically sealed aluminum pouch containing 1 COVID-19 IgG SPIKE RAPID TEST cassette and 1 desiccant sachet;
- 1 dropper bottle containing COVID-19 IgG SPIKE RAPID TEST DILUENT sufficient for 1 test;
- 1 sterile lancet for self-pricking blood sampling;
- 1 plastic bag containing 1 pipette for blood sampling,
- 1 antiseptic skin cleansing gauze;
- 1 instruction sheet for use.
Bibliography
1. European Center for Disease Prevention and Control, Disease background of COVID-19 (https://www.ecdc.europa.eu/en/2019-ncov-background-disease)
2. https://www.who.int/emergencies/diseases/novel-coronavirus-2019
3. HUANG, Yuan, et al. Structural and functional properties of SARS-CoV-2 spike protein: potential antivirus drug development for COVID-19. Acta Pharmacologica Sinica, 2020, 41.9: 1141-1149.
4. SHANG, Jian, et al. Structural basis of receptor recognition by SARS-CoV-2. Nature, 2020, 581.7807: 221-224
5. Jeyanathan, M., Afkhami, S., Smaill, F., Miller, M. S., Lichty, B. D., & Xing, Z. (2020). Immunological considerations for COVID-19 vaccine strategies. Nature Reviews Immunology, 20(10), 615-632.
Code 800165-1
