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SARS-CoV-2 Antigen Self Test Kit 10 Tests/Kit CE for Nasal Accuracy 99.68%
Materials Provided
Component | Description | Specification |
10 test/kit | ||
Test cassette | Foil ouched test device containing one reactive strip. | 10 |
Sterile swab | For sample collection and transfer. | 10 |
Inside page | Instructions for use. | 1 |
Extraction buffer | Dissolve the sample | 10 |
The certificate of conformity | 1 | |
Packages with holes | Be used as tube stand (optional). | 1 |
Cross Reactivity and Microbial Interference
The cross-reactivity with the following microorganisms was
examined. Samples that tested positive for the following
microorganisms were negative when tested with the SARS-CoV-2
Antigen Rapid Test (Colloidal Gold). The microbial interference
study evaluated whether microorganisms possibly contained in
clinical samples interfere with the detection capability of the kit
which may lead to false negative results. Each microorganism was
tested in the presence of a fabricated SARS-CoV-2 positive sample.
No cross-reactivity or interference with the microorganisms listed
in the table below was found.
No. | Microorganism | Final Test Concentration |
1 | SARS-Cov recombinant protein | 2.5 mg/mL |
2 | MERS-Cov recombinant protein | 2.07 mg/mL |
3 | Adenovirus(Type 1) | 1.0×107 pfu/mL |
4 | Adenovirus(Type 3) | 1.0×107 pfu/mL |
5 | Coronavirus(229E) | 1.0×107 pfu/mL |
6 | Coronavirus(HKU1) | 1.0×107 pfu/mL |
7 | Coronavirus(NL63) | 1.0×107 pfu/mL |
8 | Coronavirus(OC43) | 1.0×107 pfu/mL |
9 | Influenza A Seasonal H1N1 | 1.0×107 pfu/mL |
10 | Influenza B Yamagata | 1.0×107 pfu/mL |
11 | Legionella pneumonila | 1.0×107 pfu/mL |
12 | MERS | 1.0×107 pfu/mL |
13 | Mycobacterium tuberculosis | 1.0×107 pfu/mL |
14 | Mycoplasma pneumoniae | 1.0×107 pfu/mL |
15 | Parainfluenza virus (Type 1) | 1.0×107 pfu/mL |
16 | Respiratory syncytial virus | 1.0×107 pfu/mL |
17 | Rhinovirus(Group A) | 1.0×107 pfu/mL |
18 | Rhinovirus(Group B) | 1.0×107 pfu/mL |
Antigen Self Test Kit Test Procedure
1. Blow your nose. Wash or disinfect your hands. Remove the test
cassette by tearing open the foil pouch and place it in front of
you.
2. Tear off the seal of extraction buffer tube, Press in the
perforated hole on the top of the packaging and use the hole as a
tube stand.
3. Remove the swab. Do not touch the sterile tip of the swab.
Instead, grasp the swab by the handle. Insert the swab about 2.5 cm
deep into your nostril until you feel resistance.
4. Collect sample from left and right nostrils with the same swab:
Rub the swab against the inner wall of the nose and turn it at
least 5 times to ensure sufficient sample is collected. Repeat the
process in the other nostril.
Note: Children under 15 years of age (at least 2 years old), and
people including the elderly and sick who are unable to perform the
test themselves should be tested by another adult. To sample a
child, insert a cotton swab into one of their nostrils until you
feel some resistance (about 2 cm). Rotate the swab against the
nasal wall 5 times. Repeat the sampling process by removing the
swab and inserting the same swab into the other nostril. If the
child feels any pain, do not continue the test.
5. Dip a cotton swab into the tube and make sure it is well mixed
with the extract by stirring and dipping up and down at least 5
times. Let the cotton swab soak for a minute.
6. Slowly pull the swab out of the tube while gently squeezing the
sides of the tube to retain as much liquid in the tube as possible.
7. Place the dropper tip firmly on the extraction buffer tube and
mix the liquid thoroughly.
8. Drop 3 drops into the sample well (S) on the test card.
9. Interpret the test result between 15-20 minutes. The result
after 20 minutes is invalid.
Interpretation Of The Test Result
Check whether a line is visible at the control line (C). The color
thickness of the control line (C) is irrelevant. If it is not
visible, the test was not performed correctly and a new test with a
new test set must be performed.
Storage and disposal
Store at room temperature (2-30°C or 35.6-86 T).
Shelf life 12 months (from production date to expiration date).
Test cassettes must be stored in airtight foil pouches until use.
Do not use after expiration date.
Waste from used tests should be disposed of according to local
regulations.
Early Symptoms
New coronary pneumonia generally has no obvious precursors. In the early stage of the disease after infection with the COVID-19, some patients may not have any obvious symptoms. Most other patients often have fever, dry cough, and fatigue as the main manifestations, but in addition, due to individual differences , The patient may also have muscle pain, chest tightness, itchy throat, sore throat, nasal congestion, runny nose, diarrhea, abnormal taste and other symptoms. These symptoms lack specificity and can be seen in many diseases, not unique to the new crown. Therefore, it is actually difficult for patients to identify whether they are infected with the COVID-19 by their own symptoms. When the above-mentioned symptoms appear, and you believe that you may have been exposed to the COVID-19 or infected people in the past, you should go to a medical institution for relevant examinations as soon as possible to confirm the diagnosis.
Q1: When will it be shipped?
A1: We will ship the goods for you as soon as possible within 7
working days after receiving the payment. (In the event of the
epidemic and other external factors, there may be delays in
shipping)
Q2: Does it support OEM/ODM?
A2: It can be supported, but the specific quantity needs to be more
than 100,000 pieces to facilitate customized products.
Q3: How is your factory doing in terms of quality control?
A3: We have ISO9001 and ISO13485 certified by the state. Our
production process is in accordance with the standard process,
which can ensure that the quality of the products is optimal.
Q4: How is after-sales service provided?
A4: We provide professional online technical after-sales service.
We can provide you with one-on-one guidance in the form of video,
phone calls, etc.
Q5: What is the payment method?
A5: We receive payment by T/T.
Q6: How to ship?
A6: By obtaining quotations from our many cooperative carriers,
choose the best way to ship for you, or you can ship according to
your requirements.