MP Biomedicals 07AG6001BS Rapid Sars-Cov-2 Antigen Test Card Instruction Manual

MP Biomedicals 07AG6001BS Rapid Sars-Cov-2 Antigen Test Card

RAPID SARS-COV-2 ANTIGEN TEST CARD SELF-TEST

•  For private use/home use/self-testing
•  Please follow the instructions for use carefully
•  The repacking of 5 and 20 packs into smaller units is not permitted (separating is prohibited).

INTENDED USE
Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS- CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card shall not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection. Children under 14 years of age should be assisted by an adult.

SUMMARY
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on current epidemiological studies, the incubation period is 1 to 14 days, but mostly 3 to 7 days. The main manifestations include fever, fatigue, loss of smell and / or taste, and a dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

MATERIALS PROVIDED

Components| For 1 Test/Box| For 5 Tests/Box| For 20 Tests/Box
---|---|---|---
Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch)| 1| 5| 20
Sterile swab| 1| 5| 20
Extraction tube| 1| 5| 20
Sample extraction buffer| 1| 5| 20
Instructions for use (this leaflet)| 1| 1| 1
Tube stand| Back of Box| 1| 1

IMPORTANT INFORMATION BEFORE THE EXECUTION

•  Read this instruction guide carefully.

•  Do not use the product beyond the expiration date.

•  Do not use the product if the pouch is damaged or the seal is broken.

•  Store the test device at 4 to 30°C in the original sealed pouch. Do Not Freeze.

•  The product should be used at room temperature (15°C to 30°C). If the product has been stored in a cool area (less than 15°C), leave it at normal room temperature for 30 minutes before using.

•  Handle all specimens as potentially infectious.

•  Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test results.

•  Use the swabs included in the test kit to ensure optimal performance of the test.

•  Correct specimen collection is the most important step in the procedure. Make sure to collect enough specimen material (nasal secretion) with the swab, especially for anterior nasal sampling.

•  Blow the nose several times before collecting specimen.

•  The specimens should be tested as soon as possible after collection.

•  Apply the drops of test specimen only to the specimen well (S).

•  Too many or too few drops of extraction solution can lead to an invalid or incorrect test result.

•  Children under 14 years of age should be assisted by an adult.
  LIMITATIONS

•  The test is to be used exclusively for the qualitative detection of SARS-CoV-2 viral antigen in anterior nasal swab specimens. The exact concentration of SARS-CoV-2 viral antigen cannot be determined as part of this test.

•  Proper specimen collection is critical. Failure to follow the procedure may result in inaccurate test results.

•  Improper collection, storage, or even freezing and thawing of the specimen can lead to inaccurate test results.

•  If the viral load of the specimen is below the detection limit of the test, the test may produce a negative result.

•  As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should be made by the physician after evaluation of all clinical and laboratory results.

•  A negative result does not exclude viral infection except for SARS-CoV-2 and should be confirmed by molecular diagnostic methods (e.g. PCR) if COVID-19 is suspected.

•  A positive result does not rule out an additional infection with other disease-causing agents.

•  The SARS-CoV-2 rapid antigen test can detect both viable and non-viable SARS-CoV-2 material. The performance of the SARS-CoV-2 rapid test is dependent on viral load and may not correlate with other diagnostic methods performed on the same specimen.

•  Users should test specimens as soon as possible after specimen collection and within two hours of specimen collection.

•  Sensitivity for nasal or oropharyngeal swabs may be lower than nasopharyngeal swabs. The method of nasopharyngeal swab sampling should only be performed by healthcare professionals.

•  It could be possible that virus mutations might be detected with lower sensitivity or not at all.

•  The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after day 5-7 of illness are more likely to be tested negative compared to a RT-PCR assay.

•  The kit was validated with the swabs provided. Use of alternative swabs may result in false negative results.

•  The validity of Rapid SARS-CoV-2 Antigen Test Card has not been proven for identification/confirmation of tissue culture isolates and should not be used in this capacity.

•  Cross-reactivity of the test was evaluated by testing viruses and other microorganisms. The final test concentrations of viruses and other microorganisms are documented in the Cross-Reactivity-Study. The listed viruses and other microorganisms have no effect on the test results, except the Human SARS-coronavirus. Positive test results do not rule out co-infections with other disease-causing agents. Positive results may occur in cases of infection with SARS-CoV.

PREPARATION

•  Wash your hands.
•  Clear clean and dry a flat surface.
•  Check the kit contents.
•  Make sure that nothing is damaged or broken.
•  Have a timer ready.
•  Blow your nose several times before taking the sample.
•  Wash your hands again.

PROCEDURE

• Rotate the lid of sample extraction buffer bottle.
  CAUTION:
  Open it away from your face and be careful not to spill any of the liquid.

• Squeeze all extraction buffer out of the bottle into the extraction tube.
  CAUTION:
  Avoid touching the bottle against the tube.

• Find the swab in the sealed wrapper. Identify the soft, fabric tip on the swab.

• Peel open the wrapper of the swab and carefully pull out the swab.
  CAUTION:

• Do not touch the soft, fabric tip of the swab with your hands.
  Carefully insert the swab into one nostril. The swab tip should be inserted no less than 2.5 cm from the edge of the nostril. Roll the swab 3-4 times along the mucosa inside the nostril to ensure that both mucus and cells are collected. Leave swab in the nostril for several seconds. Using the same swab, repeat this process for the other nostril.
  CAUTION:
  This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain.
  Place the swab with the sample into the extraction tube. Rotate the swab 3-5 times. Leave the swab in the extraction solution for 1 minute.
  Pinch the extraction tube together with fingers while removing the swab to leave as much solution in the tube as possible. Place the swab back into the swab wrapper.
  Install the nozzle cap onto the sample extraction tube tightly.
  Open the foil pouch and remove the test card. Place the test card on a flat and level surface.
  CAUTION:
  Once opened, the test card must be used immediately.
  Invert the extraction tube and add 3 drops (75 μl) of test specimen into
  the specimen well (S), by gently squeezing the extraction tube.
  CAUTION:
  The formation of air bubbles in the specimen well (S) must be avoided.
  Read the results at 15-20 minutes.
  CAUTION:
  Results after 20 minutes may not be accurate.

DISPOSAL INSTRUCTIONS

Place the used test components into a durable, preferably tear-resistant waste bag and dispose of them in the trash according to local waste regulations.

INTERPRETATION OF RESULTS

NEGATIVE

If one colored band appears in the Control Zone (C) and no colored band appears in the Test Zone (T) within 15-20 minutes, the test result is negative and valid. A negative result does not exclude a viral infection with SARS- CoV-2 and should be confirmed by molecular diagnostic methods if COVID-19 is suspected.

POSITIVE

If two colored bands appear, with one colored band in the Control Zone (C) and another in the Test Zone (T) within 15-20 minutes, the test result is positive and valid. The resultshould be considered as positive no matter how faint the colored band is in the Test Zone(T). A positive result does not rule out an additional infection with other disease-causing agents.

INVALID

If no colored band appears in the control area (C) within 15-20 minutes, the test is invalid. Repeat the test with a new test card.

QUALITY CONTROL
THE CONTROL LINE IS AN INTEGRATED REAGENT AND IS USED TO CONTROL THE PROCEDURE. THE CONTROL LINE APPEARS WHEN THE TEST HAS BEEN PERFORMED CORRECTLY AND THE REAGENTS ARE REACTIVE.

1. How does the detection work?
   The N protein of the SARS-CoV-2 virus reacts with the stripe-like coating of the test line and, if present, results in a color change, i.e. a red line appears. Therefore, if the sample does not contain any viral proteins or antigens, there will be no red test line (T).

2. When should/can I test myself?
   You can test yourself whether you have symptoms or not. Studies show that earlier testing within the first 4 days of illness typically means a higher viral load, which is easier to detect. Since the test result is a snapshot valid for that point in time, testing should be repeated as recommended by local authorities.

3. What can affect my test result? What should I pay attention to?
   Be sure to blow your nose multiple times before collecting the specimen. Be sure to visibly collect sample material (nasal secretions). Perform the test immediately after taking the sample. Follow the instructions for use carefully.
   Apply the drops of extraction solution only to the sample well (S).Too many or too few drops of extraction solution can lead to an invalid or incorrect test result.

4.  The test strip is clearly discolored or smudged? What is the reason for this?
   Please note that the test card should not be used with more than 3 drops of sample, as the liquid absorption of the test strip is naturally limited. If the control line does not appear or the test strip is badly smudged or discolored, making it unreadable, please repeat the test according to the instructions.

5. I have taken the test, but I don’t see a control line (C). What should I do?
   Please note that the test card should not be used with more than 3 drops of sample, as the liquid absorption of the test strip is naturally limited. If the control line does not appear or the test strip is badly smudged or discolored, making it unreadable, please repeat the test according to the instructions.

6. I am unsure about reading the result. What should I do?
   For the result to be positive, 2 straight horizontal lines must be clearly visible with the full width of the cassette. If you are still unsure about the results, contact the nearest health facility according to the recommendations of your local authorities.

7. My result is positive. What should I do?
   If your result is positive and the test kit clearly indicates the control line as well as the test line, then the result must be confirmed by a PCR test. You should immediately contact the nearest medical facility (e.g. your family doctor) by telephone, as recommended by your local authorities. The medical facility will explain the appropriate next steps to take. Avoid contact with other people until the result of the PCR test is available.

8. My result is negative. What should I do?
   If the test kit only clearly shows the control line, this may mean that you are negative or that the viral load is too low to be detected. If you experience symptoms (headache, fever, migraine, loss of sense of smell or taste, etc.), please consult your primary care physician, or the nearest health care facility as recommended by your local authorities. If you are not sure, you can repeat the test. Even with a negative result, continue to adhere to social distancing rules, contact restrictions, and hygiene measures. If you’re not sure, you can repeat the test. Even if the test result is negative, you should still follow the rules for social distancing, contact restrictions and hygiene.

LAYMEN STUDY
Physician run studies were conducted to evaluate:

•  the capability of a non-professional to perform the self-test without additional assistance
•  the capability of a non-professional to interpret the results of the self-test 99% of participants were capable of independent home testing. 91% of participants were capable of interpreting all the different possibilities of results.

ACCURACY FOR NASAL SWAB SAMPLES (professional use study)
The accuracy of the SARS-CoV-2 antigen rapid test card was determined using 156 nasal swabs collected from individual symptomatic patients (within 7 days of onset) suspected of having COVID-19. The following table summarizes the accuracy of the SARS-CoV-2 antigen rapid test card compared to RT-PCR.

INTERFERENCE
None of the following substances at the tested concentration showed any interference with the test.

• Whole Blood 1%
• Phenylephrin 15%
• Menthol 0,15%
• Fluticasone Propionate 5%
• Oseltamivir Phosphate 0,5%
• Biotin 1200 ng/m
• Alkalol 10% Mucin 2%
• Phenylephrin 15% Tobramycin 0,0004% Oxymetazoline 15%
• Menthol 0,15% Cromolyn 15% Benzocaine 0,15%
• Fluticasone Propionate 5% Mupirocin 0,25% Zicam Nasal Spray 5%
• Oseltamivir Phosphate 0,5% sodium chloride 5%
• Human Anti-mouse Antibody (HAMA) 60 ng/mL

EXPLANATION OF SYMBOLES

Pursuant to EC regulation 1272/2008 (CLP), hazardous components are classified and labelled as follows: Sample extraction buffer H317: Warning! Liquid components may cause an allergic skin reaction.

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