Antigen tests are immunoassays that detect the presence of
a specific viral antigen, which implies current viral infection.
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【What's antigens?】
An antigen is a molecule capable of stimulating an immune response.
They may be proteins, polysaccharides, lipids or nucleic acids.
Each antigen has distinct surface features that are recognized by
the immune system.
SARS-CoV-2, the virus that causes COVID-19, has several known
antigens,
including its nucleocapsid phosphoprotein and spike glycoprotein,
which are the
visible protrusions on its surface.
【What are antigen tests and what can they tell us?】
An antigen test reveals if a person is currently infected with a
pathogen such as
the SARS-CoV-2 virus. Once the infection has gone, the antigen
disappears.
Unlike nucleic acid based tests such as PCR, which detect the
presence of genetic
material, antigen tests detect proteins or glycans, such as the
spike proteins found
on the surface of the SARS-CoV-2 virus.
They can take longer to develop than molecular and antibody tests,
as suitable
antibodies for use in the assays must first be identified and
produced, which can
be a complex and time-consuming process. Accuracy can also be a
problem, with
antigen tests typically having a much lower sensitivity than PCR.
However, they usually provide test results rapidly, are relatively
cheap, and can be
more amenable to point-of-care use, which could make them more
suitable for
testing in the community and in remote regions.
【What's the difference between a PCR and Antigen Covid-19 test?】
All COVID-19 tests start with a sample, but the scientific process
goes very differently
after that.
At this point in the pandemic, you or someone you know has probably
received
at least one COVID-19 test. But do you know which kind of test you
got and the
strengths and weaknesses of these different tests?
Two major types of tests are used to diagnose infection with
SARS-CoV-2:
molecular tests – better known as PCR tests – and antigen tests.
Each detects a
different part of the virus, and how it works influences the test’s
speed and relative
accuracy. So, what are the differences between these types of
tests?
PCR tests are extremely accurate but require special lab equipment
– like the PCR
heating machine seen here – and can take hours or days to perform.
Looking for genetic evidence
The first step for either kind of test is to get a sample from the
patient. This can be
a nasal swab or a bit of saliva.
For PCR tests, the next step is amplification of genetic material
so that even a small
amount of coronavirus genes in the patient’s sample can be
detected. This is done
using a technique called a polymerase chain reaction. A health care
worker takes
the sample and treats it with an enzyme that converts RNA into
double-stranded DNA. Then, the DNA is mixed with a solution
containing an
enzyme called a polymerase and heated, causing the DNA to separate
into two
single-stranded DNA pieces. The temperature is lowered, and
polymerase, with the
help of a small piece of guide DNA called a primer, binds to the
single-stranded
DNA and copies it. The primers ensure that only coronavirus DNA is
amplified.
You’ve now created two copies of coronavirus DNA from the original
one piece of RNA.
Laboratory machines repeat these heating and cooling cycles 30 to
40 times, doubling
the DNA until there are a billion copies of the original piece. The
amplified sequence
contains fluorescent dye that is read by a machine.
The amplifying property of PCR allows the test to successfully
detect even the smallest
amount of coronavirus genetic material in a sample. This makes it a
highly sensitive
and accurate test. With accuracy that approaches 100%, it is the
gold standard for
diagnosing SARS–CoV–2.
However, PCR tests have some weaknesses too. They require a skilled
laboratory
technician and special equipment to run them, and the amplification
process can
take an hour or more from start to finish. Usually only large,
centralized testing
facilities – like hospital labs – can conduct many PCR tests at a
time. Between sample
collection, transportation, amplification, detection and reporting,
it can take from
12 hours to five days for a person to get results back. And
finally, they aren’t cheap
at $100 or more per test.
Rapid Antigen tests
Rapid, accurate tests are essential to contain a highly contagious
virus like SARS-CoV-2.
PCR tests are accurate but can take a long time to produce results.
Antigen tests,
the other major type of coronavirus test, while much faster, are
less accurate.
Antigens are substances that cause the body to produce an immune
response –
they trigger the generation of antibodies. These tests use lab-made
antibodies to
search for antigens from the SARS-CoV-2 virus.
To run an antigen test, you first treat a sample with a liquid
containing salt and soap
that breaks apart cells and other particles. Then you apply this
liquid to a test strip
that has antibodies specific to SARS-CoV-2 painted on it in a thin
line.
Just like antibodies in your body, the ones on the test strip will
bind to any antigen
in the sample. If the antibodies bind to coronavirus antigens, a
colored line appears
on the test strip indicating the presence of SARS-CoV-2.
Antigen tests have a number of strengths. First, they are so easy
to use that people
with no special training can perform them and interpret the results
– even at home.
They also produce results quickly, typically in less than 15
minutes. Another benefit
is that these tests can be relatively inexpensive at around $10-$15
per test.
Antigen tests do have some drawbacks. Depending on the situation,
they can be
less accurate than PCR tests. When a person is symptomatic or has a
lot of virus in
their system, antigen tests are very accurate. However, unlike
molecular PCR tests,
antigen tests don’t amplify the thing they are looking for. This
means there needs to
be enough viral antigen in the sample for the antibodies on the
test strip to generate
a signal. When a person is in the early stages of infection, not a
lot of virus is in the
nose and throat, from which the samples are taken. So, antigen
tests can miss early
cases of COVID-19. It’s also during this stage that a person has no
symptoms, so
they are more likely to be unaware they’re infected.
Understanding the strengths and limitations of both PCR and antigen
tests, and
when to use them, can help to bring the COVID-19 pandemic under
control.
So, the next time you get a COVID-19 test, choose the one that is
right for you.
COVID-19 RAPID ANTIGEN TEST
The COVID-19 rapid antigen test detects protein fragments specific
to the
Coronavirus. Rapid antigen testing is a faster way to detect if you
have a current
COVID-19 infection. Rapid antigen testing may be helpful for those
who want
quick results to meet a testing requirement for an event or travel.
For example,
this test can be used if you plan to visit a location or
establishment that requires
testing prior to arrival. Testing requirements vary by location and
may change
over time. This test requires a nasal or nasopharyngeal swab. With
our product
testing, results may come back in as soon as 10 – 15 minutes.
Common COVID-19 symptoms include fever, cough, and shortness of
breath.
How the test works?
A sample is collected through a nasal or throat swab and mixed with
a solution. The solution is then placed onto an indicator device
that may
detect the presence of the virus that causes COVID-19.
Test Purpose: Used to detect an active infection.
Sample Type: Nasal or Nasopharyngeal Swab
Results Time: 10 – 15 Minutes*
(Wait times may vary depending on volume)
All COVID-19 tests start with a sample, but the scientific process
goes very
differently after that.
At this point in the pandemic, you or someone you know has probably
received
at least one COVID-19 test. But do you know which kind of test you
got and the
strengths and weaknesses of these different tests?
Two major types of tests are used to diagnose infection with
SARS-CoV-2:
molecular tests – better known as PCR tests – and antigen tests.
Each detects
a different part of the virus, and how it works influences the
test’s speed and
relative accuracy. So, what are the differences between these types
of tests?
PCR tests are extremely accurate but require special lab equipment
– like the PCR
heating machine seen here – and can take hours or days to perform.
Rapid antigen tests offer a quick and easy way to screen for
COVID-19 at home.
In about 15 minutes, they detect active infections via a nasal
swab, including in
asymptomatic individuals. Often called “rapid tests” or “at-home
COVID tests,”
these rapid antigen tests can be a valuable tool for managing life
during the pandemic
—if you can get your hands on one.
Rapid antigen tests are used as a test to diagnose COVID-19.
This means that if you test positive using a rapid antigen test,
your result
does not need to be confirmed with a PCR test.
In only 15 minutes, you will have the results you need to
confidently return to work,
school, sports and all the things you love to do, with the ability
to store and share
our family's and your test results from Renji Antigen Rapid Test.
With Renji COVID-19 Antigen Rapid Test, you can test yourself after
being out in
public. Early and regular testing helps you better care for
yourself and protects
your friends, family, and community members from potential
exposure.
【PRODUCT NAME】
SARS-CoV-2 (COVID-19) Antigen Rapid Test Kit(Colloidal Gold)
【SPECIFICATION】
1 test/kit;20 tests/kit; 25 tests/kit; 50 tests/kit.
【INTENDED USE】
This kit is intended to be used for the qualitative detection of
SARS-CoV-2 antigen
in human respiratory specimens, sputum, and other samples. This kit
uses cellulose
membrane immunochromatography technology.
Antigen detection is used for auxiliary diagnosis or
epidemiological investigation
of human infection with SARS-CoV-2.
【When should I use a rapid antigen test?】
If you are a close contact, you can use an rapid antigen test for your initial and day
6 test. You can also purchase and use rapid antigen tests from us:
- before entering a high risk setting, e.g. healthcare or aged care
- before going out where there may be crowds
- before going to work, especially if it is a critical worksite
- to provide reassurance if you have no symptoms but are feeling
anxious
or worried.
【When should I get a standard PCR test?】
You should get a PCR test as soon as you develop any COVID-19
symptoms and
are not a close contact.
COVID-19 symptoms include:
• fever (a temperature of 37.5˚C or higher) or chills
• cough
• loss of taste or smell
• sore throat
• tiredness (fatigue)
• runny or blocked nose
• shortness of breath (difficulty breathing)
• nausea, vomiting or diarrhoea
• headache
• muscle or joint pain
• loss of appetite
You will also need to get a PCR test if you have COVID-19 symptoms
and test
negative using a rapid antigen test to confirm your result.
Accessing rapid antigen tests
If you are not a close contact, rapid antigen tests are sold
commercially in
supermarkets and pharmacies.
【PACKING LIST】
Components | 1T | 20T | 25T | 50T |
| 1. SARS-CoV-2 test card | 1 PIECE | 20 PIECES | 25 PIECES | 50 PIECES |
| 2. Disposable sampling tube(with sample diluent buffer) | 1 PIECE | 20 PIECES | 25 PIECES | 50 PIECES |
| 3. Disposable sampler | 1 PIECE | 20 PIECES | 25 PIECES | 50 PIECES |
| 4. Instructions | 1 COPY | 1 COPY | 1 COPY | 1 COPY |
Note: The components in the kits of different batch numbers are not
interchangeable.
The materials and instruments necessary for the test but not
provided are as follows:
Lancet;
Absorbent paper or similar material;
Timer;
Micropipette corresponding to the range;
Laboratory safety protection equipment such as disposable gloves,
etc.
【RESULTS ANALYSIS】
The interpretation of visual interpretation results (as shown
below):
1. The results can be read directly by naked eyes as shown in the
figures below:
Positive result: a visible band
can be seen in both line C and line T.
2. Negative result: A visible band can be seen in line C only.
3. Invalid result: A visible band cannot be seen in line C, and the
test must be
repeated using a new strip.
【MANAGEMENT OF RESULTS】
【REPORTING YOUR RESULT】
You are legally required to report all positive rapid antigen test
results. You must
report your positive result if you get your test from a designated
RAT Collection
Point, from a retail outlet, from your workplace or through any
other means
(i.e. over the internet).
You can also report negative and invalid test results to help
provide a full picture
of rates of COVID-19 testing in the state.
【WHAT DO I DO IF I HAVE A POSITIVE RESULT?】
If you test positive in a rapid antigen test, this is considered a
case. You do not need
to get a PCR test to confirm your result.
You must:
• report your result as soon as possible
• isolate for 10 days from the day you had a positive result
• notify your close contacts that you have tested positive.
Read more information about what to do if you test positive to
COVID-19.
If you are a close contact with no COVID-19 symptoms and test
positive in your day
6 test, you are able to get a PCR test to confirm your result.
【WHAT DO I DO IF I HAVE A NEGATIVE RESULT?】
If you are a close contact with no COVID-19 symptoms and test negative, you do not
need to get a PCR test to confirm your result.
If you have COVID-19 symptoms and test negative, you must get a PCR test to
confirm your result. Rapid antigen tests are not as sensitive as
PCR tests, which
means that just because you have a negative result in a rapid
antigen test, it does
not mean that you do not have COVID-19.
【STORAGE CONDITIONS AND SHELF LIFE】
Stored at 2°C ~ 30°C, and kept away from direct sunlight.
The validity period is 12 months.
After the aluminum foil bag is opened, the Detection Strip should
be used within 1 hour.
The Sample Diluent Buffer should be capped immediately after usage.
Usage after the date of expiration is not recommended.
The date of manufacture & expiration is indicated on the label and
package.
【FACTORY VIEW】
【FACTORY WORKSHOP】
【EXPORTER】
Magnus Internationa Limited
F12, New City Internationa Mansion A, 234 Huapao Ave.
Liuyang, Hunan Province 410300 China
Contact: Goodwellmedical@gmail.com
【AUTHORIZED REPRESENTATIVE】
Lotus NL B.V.
Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
【PRODUCT AND STANDARDS】
【FAQ】
1. Q: How about your healthcare and medical product quality?
A: Quality is our top priority. We have a professional quality
control team to ensure the
quality with a high standard and regulated with the pro
certifications. The QC team is
responsible for quality checking in each process and inspect every
batch of our production
and ship them only after QC approval.
2. Q: What is your order MOQ?
A: Please contact the customer service, and the price is negotiable
for large quantity.
3. Q: How about your product packing for shipment or mailing?
A: We prepared well neutral package for our products. We could also
make OEM package,
OEM/ODM Custom Package/Multi-packing package/Cartons with well
protective wrapping.
4. Q: What level of your product price?
A: We are the factory and direct manufacturer and offer competitive
prices. We also offer
the volume pricing with more benefits depend on your order quantity
level. Please let us know
your ordering volume while you make the inquiry to us to help you
obtaining better benefits.
5. Q: What's the price terms?
A: The price is based on FOB of Hunan, China with exchange rate at
RMB6.40 for USD$1.00.
If the exchange rate floating sharply lower than 6.3 or higher than
6.5, we should adjust the
price with real-time exchange rate.
6. Q: What's the payment terms?
A: We accept T/T wire transferring, PayPal, Western Union, etc. 50%
down payment after
signing the contract and rest 50% before shipping confirmation.
7. Q: How could I get some samples?
A: We are able to deduct your samples expense once your orders
confirmed with us.
The shipping fee will be calculated with the sample volume what you
demand.
8. Q: Could you accept OEM order?
A: Yes, we could. We have professional designers who can design the
logo or artwork and offer
best solution & styles for your OEM product choices.
9. Q: How long will the shipping or express take?
A: (1) For the international expresses such as DHL, UPS, FedEx,
TNT, or EMS, etc., it usually
takes 5-7 working days to your location or destination.
(2) If shipping with containers, they will take about 30-60 days to
process depending on
the vary ports or door locations.
(3) We will arrange your products delivery or shipping within 1-3
days after full payment
has been confirmed. We may not ship your products out until your
payments arrive to
our bank account successfully.
10. Q: How do you deliver the goods to us?
A: If the order of small volume package, we could deliver by
courier such as DHL, UPS, FedEx,
TNT, EMS. For the large volume order, we could ship with bulk cargo
containers by sea.
We will provide you cost-saving recommendations for your product
shipping.
11. Q: What is the warranty time.
A: One year for each product.
【CERTIFICATIONS】
【SHIPPING】
We are a trust healthcare and medical supplies from China.
Be free to contact us at any time!
You are very welcome to email us today at:
Goodwellmedical@gmail.com for inquiry!
We are exciting to build a reliable and long-term business with you
at our best!
