COVID-19 Antigen Nasal Swab Test Kit Coloidal Gold CE Marked For Self Testing

››› Reliable & Rapid Antigen Testing Kit!

››› Results in 15 minutes!!

››› Easy, Safe, Money-saving!!!

【PRODUCT NAME】

SARS-CoV-2 (COVID-19) Antigen Rapid Test Kit (Colloidal Gold)

【PACKAGE SPECIFICATION】

25 tests/kit & 50 tests/kit.

【INTENDED USE】

【COVID-19 RAPID ANTIGEN TEST】

【 What are 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.

 

 

【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.

 

【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.

 

【When should I use a rapid antigen test?】

 

If you are a close contact, you can use a 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.

 

【KIT COMPONENTS】

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.

【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.

【SAMPLE REQUIREMENTS】

Sample type: nasal swabs, throat swabs, deep cough sputum, respiratory tract extracts,

bronchial lavage fluid, alveolar lavage fluid, etc.

Sample collection: the collection and testing of patient samples must be performed in accordance

with the “Guidelines on Laboratory Testing Techniques for COVID-19 Caused by SARS-CoV-2”

(The 4th edition) released by the National Health Commission.

Sample processing:

1. Take 500 µL (deep cough sputum, respiratory tract extract, bronchial lavage fluid, alveolar

lavage fluid) from sample to be tested, mix it with 500 µL of sample diluent solution (1:1), and

then take 100 µL into the sample well for testing;

2. Samples such as nasal swabs or throat swabs are directly put into 500 µL sample diluent

solution, mixed thoroughly, and then about 100 µL of the supernatant is taken for testing.

Sample storage: the samples should be processed for testing in time after collection; if not,

they should be stored in accordance with the requirements of the “Guidelines on Laboratory

Testing Techniques for COVID-19 Caused by SARS-CoV-2” (The 4th edition) released by the

National Health Commission.

Sample safety: all samples should be treated as potentially infectious materials and subject to

the relevant standards and guidelines.

【EXPERIMENT WORKFLOW】

Please read the instruction for use carefully before using this kit. All reagents should be

incubated at room temperature (10-30°C) for 30 minutes prior to use. The test should be

carried out at room temperature and the operation procedure is described below:

1. Open the sealed bag and remove the Detection Strip. Mark the sample ID on the test strip

and lay the strip flat on the table.

2. Specimen collection

1). Carefully insert the swab into the nostril of the patient, reaching the surface of the posterior

nasopharynx, that presents the most secretion under visual inspection.

2). Swab over the surface of the posterior nasopharynx. Rotate the swab several times.

3). Withdraw the swab from the nasal cavity.

3. Sample preparation

1). Insert the sample diluent tube into the pipe rack, make sure that the tube is standing firm

and reaches the bottom of the pipe rack.

2). Open the purple cap of the sample diluent tube. Insert the swab into the diluent tube which

contains 0.5 mL of the diluent buffer. Roll the swab at least 6 times while pressing the head

against the bottom and side of the diluent tube.

3). Leave the swab in the diluent tube for 1 minute.

4). Squeeze the tube several times with fingers from outside of the tube to immerse the swab.

Remove the swab, close the cap. The diluent solution will be used as test sample.

5). Open the small cap on the top of the sample dilution tube. Add 3-4 drops (~100 μL) of the

sample diluent buffer immediately to the sample well.

6). Allow the strip to develop for 10-15 minutes at room temperature. A visible band can be

read by naked eyes.

【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 the line C, and the test must be repeated

using a new strip.

【CUT-OFF VALUE】

1. Determination of the cut-off value, the product is a qualitative detection kit of antigens to

the SARS-CoV-2. When the quality control line (C line) and the test line (T line) are formed,

regardless of a weak T line, as long as it is visible to the normal naked eyes, the test result

should be judged as positive.

2. The test for the normal population should be negative. Positive test results indicate that an

individual may have been exposed to SARS-CoV-2, and should be combined with clinical

symptoms and other diagnostic results for further confirmation.

【INTERPRETATION OF TEST RESULTS】

1. Common mistakes that may lead to false-positive or negative results include: the kit is used

after its expiration; the kit has been improperly stored; the operating temperature is too low

(<4°C) or too high (>30°C); the procedures outlined in this protocol were not strictly adhered to.

2. Any final clinical interpretation should consider a combination of test results, clinical

symptoms, and other indicators.

【LIMITATIONS OF INSPECTION METHODS】

1. If the patient has clinical symptoms but the test result is negative, it is recommended to use

the PCR method for confirmation and the doctor will make a comprehensive judgment to

confirm the diagnosis. The negative result cannot be the only evidence to rule out the

SARS-CoV-2 infection.

2. The product can only be used for clinical diagnosis and on-site screening of the SARS-CoV-2.

The positive results of all Detection Strips must be confirmed by a qualified laboratory. The

positive result of antigen detection should be combined with other clinical features to ensure

an accurate diagnosis.

3. In order to ensure the accuracy of the SARS-CoV-2 antigens detection, high temperature

and humidity must be avoided.

【WARNINGS】

• This kit is for clinical in vitro diagnosis only.
• Please read the instructions carefully before testing, and operate in strict accordance with the instructions.
• Different batches of reagents and treatment solutions should not be mixed.
• Sample collection, storage and testing should be in strict accordance with the novel Coronavirus related testing technical guides and biosafety guides. The remaining sample disposal solution, swabs, test cassettes and all wastes must be disposed of in accordance with laboratory biosafety requirements.
• It is recommended to treat the waste as infectious material, and use ethyl ether, 75% ethanol, chlorine-containing disinfectant, peracetic acid, chloroform and other solvents to soak the waste generated during the detection process, to inactivate the virus.
• The test cassette is ready to use, valid within 1 hour after opening, and the test cassette cannot be reused.
• The test results of this kit are for clinical reference only. Diagnosis should be made after comprehensive judgment of the clinical symptoms, signs, medical history and other laboratory examination results of the patient.

【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.

【INDEX OF SYMBOL】

【EXPORTER】

Magnus International Limited

F12, New City International Mansion A, 234 Huapao Ave.

Liuyang, Hunan Province 410300 China

Contact: Goodwellmedical@gmail.com

【MANUFACTURER】

Changsha Renji Medical Equipment Co., Ltd.

No.18 Xiangtai Road, Liuyang Jingkai District,

Changsha City, Hunan Province 410300 China

【AUTHORIZED REPRESENTATIVE】

Lotus NL B.V.

Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.

【FACTORY VIEW】

【FACTORY WORKSHOP】

【PRODUCT AND STANDARDS】

【CERTIFICATIONS】

【FAQ】