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COVID-19 Antigen Swab Test Kit 25 Tests/Kit CE for Nasal Swab Accuracy 99.68%
Materials Provided
Component | Description | Specification |
25 test/kit | ||
Test cassette | Foil ouched test device containing one reactive strip. | 25 |
Sterile swab | For sample collection and transfer. | 25 |
Inside page | Instructions for use. | 1 |
Extraction buffer | Dissolve the sample | 25 |
The certificate of conformity | 1 | |
Packages with holes | Be used as tube stand (optional). | 1 |
Performance data
For the anterior nasal swab method, 645 specimens were collected.
Vitassay qPCR SARS-CoV-2 | Total | |||
Positive | Negative | |||
SARS-CoV-2 Antigen Rapid Test kit | Positive | 238 | 0 | 238 |
Negative | 7 | 400 | 407 | |
Total | 245 | 400 | 645 |
Statistic | Value | 95% CI |
Sensitivity | 97.14% | 94.20% to 98.84% |
Specificity | 99.99% | 99.08% to 100% |
Total coincidence rate | 98.91% | 97.78% to 99.56% |
Antigen Swab 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 test results
Check that the wire is visible at the control wire (C). The color
thickness of the control line (C) does not matter. If it is not
visible, the test was not executed correctly and a new test must be
executed with the new test set.
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.
Disease severity classification
Mild: The clinical symptoms are mild, or even no obvious clinical symptoms, and no pneumonia is seen on imaging.
Ordinary type: with symptoms such as fever and respiratory tract, and pneumonia can be seen on imaging.
Heavy:
Adults meet any of the following:
· Respiratory distress, respiratory rate ≥ 30 breaths/min;
· In resting state, oxygen saturation ≤93%;
Arterial blood oxygen partial pressure (PaO2)/inhaled oxygen concentration (FiO2)≤300mmHg (1mmHg=0.133kPa), high altitude (over 1000 meters above sea level) area should be based on the following formula PaO2/FiO2 x [760/atmospheric pressure (mmHg) ].
In addition, if lung imaging shows that the lesions have progressed more than 50% within 24 to 48 hours, they are managed as severe.
Children meet any of the following:
· Persistent high fever for more than 3 days;
Shortness of breath (<2 months old, RR≥60 times/min; 2~12 months old, RR≥50 times/min; 1~5 years old, RR≥40 times/min; >5 years old, RR≥30 times/min /min), excluding the effects of fever and crying;
·Oxygen saturation ≤93% in resting state;
· Assisted breathing (groaning, alar flaring, three concave signs), cyanosis, intermittent apnea; drowsiness, convulsions;
· Rejection or feeding difficulties, with dehydration.
Critical:
One of the following conditions:
Respiratory failure occurs and requires mechanically assisted exhalation;
· Shock occurs;
· Combined with other organ failure requiring ICU monitoring and treatment.
Severe/critical high-risk groups
Older people over 60 years old; patients with underlying diseases; immunodeficiency; obesity (body mass index ≥ 30); women in late pregnancy and perinatal period; heavy smokers.
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.