Sejoy 1T Covid-19 Antigen Rapid Cassette Layman

How is the Sejoy Rapid Test packaged?

The test is individually packaged in 1-unit boxes.

How does the Sejoy Rapid Test antigen test work?

The Sejoy SARS-CoV-2 antigen test is a fast and reliable test for detecting SARS-CoV-2. The sample is taken gently in the nasal area. The test result is available in just 10 minutes.

Can I perform the Sejoy Rapid Test from home?

Yes, you can perform the Sejoy Rapid Test from home.

Is the Sejoy Rapid Test easy to use?

Yes, the Sejoy SARS-CoV-2 antigen test is simple and convenient to use and is particularly suitable for private users who want to test themselves.

How quickly is the test result of the Sejoy Rapid Test available?

The test result of the Sejoy SARS-CoV-2 antigen test is available in just 10 minutes.

What type of samples do I need for the Sejoy Rapid Test?

You need a nasal swab for the Sejoy Corona self-test.

How confident is it that the Sejoy Rapid Test detects Omicron?

All of the tests listed in our shop recognize Omicron, including the Sejoy Rapid Test listed here.

Is the Sejoy SARS-CoV-2 antigen test CE certified and listed on the BfArM list?

Yes, the Sejoy SARS-CoV-2 antigen test is CE certified and listed on the BfArM list. This makes it approved throughout Europe and can be easily and conveniently purchased.

What is the sensitivity and specificity of the Sejoy SARS-CoV-2 antigen test?

The sensitivity of the Sejoy SARS-CoV-2 antigen test is 97.06%, and the specificity is 98.71%. In addition, it does not show cross-reaction with other common infectious diseases.

What is included in the Sejoy Rapid Test box?

The Sejoy SARS-CoV-2 antigen rapid test box contains a Covid antigen test cassette, a sample extraction solution, a disposable swab, a pipette for single use, and a manual/kit.

Packaging

1 pack

Carton

500 pieces

Standards and Market Conformity

Self-test for laypeople

Approved in Germany

TÜV Süd EN ISO 13485:2016

BfArM number: AT082 / 20

CE-certified and reimbursable test listed with the Federal Institute for Drugs and Medical Devices according to the Coronavirus Test Regulation (TestV)

97.6% sensitivity · 98.4% specificity

With separate buffer solution

SARS-Cov-2 Antigen Rapid Test Leaflet

INSTRUCTIONS FOR USE

1. Preparation before starting:

• Choose a location where the test can lie UNDISTURBED for 15-30 minutes. Allow the test cassette, the sample extraction reagent, and test components to sit at room temperature {15-30°C (59°F-86F)} for 15-30 minutes.

• Wash your hands for at least 20 seconds with soap and water before the test. If soap and water are not available, use a hand sanitizer with at least 60% alcohol.

• It is not recommended to clean the nasal cavity before the test to prevent the viral load from being too low. Unless the nasal cavity is too moist or too dry, take a sample at least 30 minutes after cleaning the nasal cavity.

• When you open your test kit, you should find:

2. Sample collection:

• Remove the cap and the cover of the extraction reagent. Carefully peel off the aluminum foil on the extraction buffer tube and place the tube in the tube holder (see Fig. 1 and 2).

• Take the swab out of the packet and make sure not to touch the soft end, the absorbent tip. See Fig. 3 and 4.

• Gently insert the swab 2-4 cm (1-2 cm in children) into one nostril until you feel slight resistance. See Fig. 5.

• Rub the swab with medium pressure slowly in circular motions 5 times within 7-10 seconds on the inner wall of your nostril.

• Repeat the process with the same swab in the other nostril. See Fig. 6 and 7

ATTENTION: If the swab is contaminated during sample collection, use a new swab. Users should pay attention to the safety of sample collection when using the swab. Avoid inserting too deeply into the nasal cavity, which can cause pain and bleeding.

3. Handling the Sample

• Insert the swab into the extraction tube and immerse the entire tip of the swab into the extraction buffer.

• Soak the sampling swab under the liquid level of the extraction reagent. Rotate the swab and press it for about 10 seconds. (Insert the swab into the extraction tube. Rotate and press the swab head 3 to 5 times in the extraction reagent against the edge of the tube). See Fig. 8 and 9.

• Press the swab head against the inside of the extraction tube. Then remove the swab and tightly place the extraction tube cap onto the extraction reagent. (Squeeze the extraction reagent from the swab tip while removing the swab stick). See Fig. 10 and 11.

4. Sample Preservation: 

The sample can be stored at room temperature {15-30°C (59°F-86°F)} for up to one hour.

TEST PROCEDURE

• Open the aluminum foil bag of the test cassette and place the test cassette on a flat surface. See Fig. 12 and 13.

• Lay the cassette flat and add 2 drops of the treated sample to the sample well of the test cassette. Read the test result after letting the sample sit for 10 minutes. A result that appears after 10 minutes is invalid. See Fig. 14 and 15.

DISPOSAL OF SAMPLE AND CLEANING

• The test cassette, sample extraction reagent, and disposable virus sample collection swab are collected in a biohazard bag and disposed of according to local regulations.

• Apply surface disinfectant.

RESULT INTERPRETATION

NEGATIVE RESULT: 

A colored line appears in the control line area (C). No line appears in the test area (T). A negative result means that the SARS-CoV-2 antigen is not present in the sample or is below the detection limit of the test.

POSITIVE RESULT:

Two lines appear. One colored line should be in the control region (C) and the other visible colored line should be in the test region (T). A positive result means that SARS-CoV-2 has been detected in the sample.

INVALID RESULT:

The control line does not appear. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for the control line not appearing. Review the procedure and repeat the test with a new test. If the problem persists, discontinue use of the test kit immediately and contact your local dealer.

NOTE:

The intensity of the color in the test line region (T) depends on the concentration of the SARS-CoV-2 antigen present in the sample. Therefore, any color shading in the test line region (T) should be considered positive.

You can download this manual here here

How does Odem ensure high quality at such a fair price?