SARS-CoV-2 Antigen Home Test Kit Colloidal Gold 5 Tests / Kit CE
Nasal Swabs
Intended Use
The SARS-CoV-2 Antigen Rapid Test(Colloidal Gold) is an
immunochromatographic test for the rapid qualitative detection of
SARS-CoV-2 nucleocapsid protein antigens in human nasal swabs. It
is intended to be used as a self-test during the acute phase of
infection in cases of suspected COVID-19. The SARS-CoV-2 Antigen
Rapid Test cannot be used as a basis for diagnosis or exclusion of
SARS-CoV-2 infection. Children under 18 years of age must be
supervised by adults when performing the test.
Summary
COVID-19 is an acute respiratory infectious disease caused by the
novel coronavirus SARS-CoV-2. Humans are generally susceptible to
it. Currently, patients infected with the novel coronavirus are the
main source of infection; asymptomatically infected people may also
be a source of infection. Symptoms include fever, fatigue, loss of
smell and/or taste, and dry cough. In some cases symptoms may
include a stuffy or runny nose, sore throat, muscle aches, and
diarrhea may occur.
Materials Provided
| Component | Description | Specification |
| 5 test/kit |
| Test cassette | Foil ouched test device containing one reactive strip. | 5 |
| Sterile swab | For sample collection and transfer. | 5 |
| Inside page | Instructions for use. | 1 |
| Extraction buffer | Dissolve the sample | 5 |
| 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 physician or local health
department. Follow local guidelines for self isolation and have a
PCR confirmatory test performed.
*Note: The thickness of the line is irrelevant; any reddish line in
the test line (T) should be interpreted as a positive test result.
A positive test result must be confirmed by molecular diagnostics
(e.g. PCR test).
Negative Test Result
If only a colored line is visible in the area of the control line
(C), but not at the test line (T), the test result is negative.
This indicates that no or too few SARS-CoV-2 antigens are present
in the nasal sample and that there is probably no infection 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.
Storage and Disposal
Store at room temperature (2-30°C or 35.6-86 T).
12 months of shelf life (production date to expiration date).
The test cassettes must be stored in the sealed foil pouch before
use. Do not use after the expiration date.
Waste from used tests should be disposed according to the 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.
