BOSON 1N40C5-2 Rapid Sars-Cov-2 Antigen Test Card Installation Guide

BOSON 1N40C5-2 Rapid Sars-Cov-2 Antigen Test Card

RAPID SARS-COV-2 ANTIGEN TEST CARD
INSTRUCTION GUIDE FOR ANTERIOR NASAL SWAB SPECIMENS For private use/home use /self-testing 

Please follow the instruction leaflet carefully. 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 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 the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and 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| 1 (packaging)| 1| 1

PERFORMANCES (SENSITIVITY AND SPECIFICITY)

Rapid SARS-CoV-2-Antigen Test Card was compared to the confirmed clinical diagnosis. The Study involved 156 samples.

A feasibility study demonstrated that:

• 99,10% of non-professionals carried out the test without requiring assistance
• 97,87% of the different types of results were interpreted correctly

INTERFERENCES

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

(HAMA):

60 ng/mL

Biotin: 1200 ng/mL|

IMPORTANT INFORMATION BEFORE THE EXECUTION

1. Read this instruction guide
2. Do not use the product beyond the expiration
3. Do not use the product if the pouch is damaged or the seal is
4. Store the test device at 4 to 30°C in the original sealed Do Not Freeze.
5. 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.
6. Handle all specimens as potentially
7. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test
8. Use the swabs included in the test kit to ensure optimal performance of the
9. Correct specimen collection is the most important step in the Make sure to collect enough specimen material (nasal secretion) with the swab, especially for anterior nasal sampling.
10. Blow the nose several times before collecting
11. The specimens should be tested as soon as possible after
12. Apply the drops of test specimen only to the specimen well (S).
13. Too many or too few drops of extraction solution can lead to an invalid or incorrect test
14. Children under 14 years of age should be assisted by an

LIMITATIONS

1. 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.
2. Proper specimen collection is 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.
3. If the viral load of the specimen is below the detection limit of the test, the test may produce a negative
4. 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
5. A negative result does not exclude viral infection except for SARS-CoV-2 and should be confirmed by molecular diagnostic methods if COVID-19 is
6. A positive result does not exclude coinfection with other
7. The SARS-CoV-2 rapid antigen test can detect both viable and non-viable SARS-CoV-2 The performance of the SARSCoV-2 rapid test is dependent on viral load and may not correlate with other diagnostic methods performed on the same specimen.
8. Users should test specimens as soon as possible after specimen collection and within two hours of specimen
9. Sensitivity for nasal or oroparyngeal swabs may be lower than nasopharyngeal It is recommended to use the nasopharyngeal swab specimens by healthcare professionals.
10. Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope
11. The amount of antigen in a sample may decrease as the duration of illness Specimens collected after day 5-7 of illness are more likely to be tested negative compared to a RT-PCR assay.
12. The kit was validated with the assorted Use of alternative swabs may result in false negative results.
13. The validity of Rapid SARS-CoV-2 Antigen Test Card has not been proven for dentification/confirmation of tissue culture isolates and should not be used in this capacity.
14. Cross-reactivity of the Test Device 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 therein following viruses and other microorganisms except the Human SARS-coronavirus have no effect on the test results of the Test Positive test results do not rule out co-infections with other pathogens. Positive results may occur in cases of infection with SARS-CoV.

PREPARATION

• Clear, clean and dry a flat
• Check the test kit Make sure that nothing is damaged or broken.
• Timer at
• Blow your nose several times before collecting
• Wash

DISPOSAL

The test kit may be disposed of with normal household waste in accordance with the applicable local regulations.

PROCEDURE

This test is suitable for people of all ages. The recommended operators are aging from 14 to 90. Children under 14 years of age should be tested by an adult. Do not continue the test if the child feels any pain.

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 in front of you. Identify the soft, fabric tip of the swab.

Peel open the swab packaging and gently take out the swab.

Caution: Never touch the soft, fabric tip of the swab with your hands.

Carefully insert swab into one nostril. The swab tip should be inserted no less than 2.5 cm (1 inch) from the edge of the nostril. Roll swab 3-4 times along the mucosa inside the nostril. Leave swab in the nostril for several seconds. Using the same swab, repeat this process for the other nostril. Withdraw swab from the nasal cavity.

Caution: This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain. Place swab into extraction tube. Roll swab three to five (3-5) times. Leave swab in extraction buffer for 1 minute.

Pinch extraction tube with fingers and remove the solution from swab as much as possible.
Install the nozzle cap onto the sample extraction tube tightly.

Bring the kit components to room temperature before testing. Open the pouch and remove the card. Place the 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 (about 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.

The used device may be disposed of with normal household waste in accordance with the applicable local regulations.

INTERPRETATION OF RESULTS

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.

Caution: No matter how faint the colored band is in the Test Zone (T), the result should be considered as positive.

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.

Invalid:

If no color line 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.

FREQUENTLY ASKED QUESTIONS (FAQ)

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).

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.

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.

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.

I have taken the test, but I don’t see a control line (C). What should I do?

Your test result is invalid. Observe the answer to question 4 and repeat the test according to the instructions for use.

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.

My result is positive. What should I do?

If your result is positive and the test kit thus clearly indicates the control line as well as the test line, you should contact the nearest medical facility as recommended by your local authorities. Your test result may be double- checked and the authority or facility will explain the appropriate next steps.

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.

How can I dispose of the product?

The test kit may be disposed of with normal household waste in accordance with the applicable local regulations.

ACCESSORIES:

EXPLANATION FOR SYMBOLS

Manufacturer: Xiamen Boson Biotech Co., Ltd.

90-94 Tianfeng Road, Jimei North Industrial Park, Xiamen, Fujian, 361021, P.R.China.

Authorized Representative: Lotus NL B.V.

Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.

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