COVID-19 Ag Self Test Kit 25 Tests/Kit CE for Nasal Swab
Specificity 100%
Typical Symptoms
The main symptoms of patients with new coronary pneumonia are
fever, dry cough, and fatigue. There are also some patients with
nasal congestion, runny nose, sore throat, decreased or lost sense
of smell and taste, conjunctivitis, muscle pain and diarrhea as the
main manifestations.
COVID-19 pneumonia patients who have been vaccinated and infected
with Omicron strains are mainly asymptomatic and mild. Patients
with new coronary pneumonia with clinical symptoms mainly have
upper respiratory tract infection symptoms such as moderate to low
fever, sore throat, dry throat, nasal congestion, and runny nose.
Mild patients may present with low-grade fever, mild fatigue,
disturbance of smell and taste, etc., without pneumonia.
Severe patients develop dyspnea and/or hypoxemia one week after the
onset, and severe cases can rapidly progress to acute respiratory
distress syndrome, septic shock, refractory metabolic acidosis and
coagulation dysfunction and Multiple organ failure, etc.
A very small number of patients may also have central nervous
system involvement and avascular necrosis of the extremities.
It is worth noting that severe and critically ill patients may have
moderate to low fever or even no obvious fever during the course of
the disease.
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% |
Positive Test Result
If a colored line is visible in the test line region (T) and a
colored line is visible in the control line region (C), indicating
positive test result. This means that SARS CoV-2 antigens are
detectable in your nasal sample and indicates with high probability
of COVID-19 infection.
Please stay home and call your doctor or local health department.
Follow local self-isolation guidelines and take a PCR confirmation
test.
* Note: Line thickness is irrelevant; any reddish lines in the test
line (T) should be interpreted as a positive test result. Positive
test results must be confirmed by molecular diagnostics such as PCR
testing.
Negative test result
If only colored lines are visible in the area of the control line
(C), but not at the test line (T), the test result is negative.
This suggests that the nasal samples were either absent or too
little of the SARS-CoV-2 antigen and probably not infected with the
SARS-CoV-2 virus.
Continue to follow applicable rules regarding contact with others
and applicable protective measures. In case of suspicion, repeat
the test using new test kit, as SARS-CoV-2 virus cannot be
accurately detected at all stages of infection. A negative result
does not rule out infection with SARS CoV-2 and should be confirmed
by PCR testing if suspected.
INVALID TEST RESULT
If no line is visible in the control line (C) or only one line is
visible in the test line area (T), indicating the test is not
performed correctly and the result is invalid. It is important to
follow the instructions for the test carefully. Please repeat the
test with new sample and new test set.
If test results remain invalid, please contact a physician or
COVID-19 testing center.
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.
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.
