Renji Medical SARS-CoV-2 Home Test Kit Colloidal Gold Immunochromatography

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.

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.

Diagnostic Kit for SARS-CoV-2 (COVID-19) Antigen Rapid Detection Kit produced

by Changsha Renji Medical Equipment Co., Ltd. is the assessment object. According

to “Administrative Measures for the Registration of In-vitro Diagnostic Reagents”

and “Guidelines for clinical testing of in vitro diagnostic reagents”, the applicant

should conduct clinical experiments to evaluate the products’ clinical value

after laboratory assessment and pilot production of three sequential batches of

products. Obtain related experimental data by comparing the results of test kits and

method of PCR test, then calculate relevant evaluation indicators and perform

statistical analysis. Using statistics above to provide a scientific basis and make sure

that the test kit meets the clinical requirements.

【FEATURES】

【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.

SARS-COV2 Antigen Rapid Test Card contains a gold-labeled novel coronavirus N protein

monoclonal antibody pre-coated on the bonding pad and a paired novel coronavirus N protein

monoclonal antibodies fixed in the test line (T) and corresponding antibodies in the quality

control line (C).

SARS-COV2 Antigen Rapid Test Kit can detect the virus from the first phase of infection (2-3

days before potential symptom onset) to the last phase of infection (7-10 days after potential

symptom onset).

• Used to test COVID-19 antigen

• Card-like format detects the nucleocapsid (N) protein of the virus.

• Gold-labelled SARS-CoV-2 N protein monoclonal antibodies immobilized on the test area,

   with corresponding antibodies in the quality control area.

• Swabbed specimens from the nasopharynx or oropharyngeal, resulting in 15 minutes.

【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.

Accessing rapid antigen tests

If you are not a close contact, rapid antigen tests are sold commercially in

supermarkets and pharmacies.

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?】

【WHAT DO I DO IF I HAVE A NEGATIVE RESULT?】

If you are 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.

【EXPERIMENT DESIGN】

General design and plan description To evaluate the sensitivity and specificity of the product

from the clinical perspective, the experiment has chosen a) patients who have been confirmed

to be diagnosed with SARS-CoV-2 infection as a case group and b) patients who have other

diseases or healthy people as a control group. The experiment has chosen the results of the

SARS-CoV-2PCR test as a comparison using the blinding method to compare the designs.

The confirmed case group and control group results of the PCR test have been used for the blind

test of the product. The complete and true clinical data should be recorded and submitted to

the statistic responsible. The data should be counted using the statistical method in the clinical

experiment and then the response should evaluate the coincidence rate and consistency of

the product with the PCR test. The experiment procedure should follow the flow chart below:

【CLINICAL PERFORMANCE】

The performance of the kit was established using clinical samples, with kit results compared

to nucleic acid test results. The kit showed a sensitivity of 96.330% and specificity of 99.569%.

In addition, separate oropharyngeal swabs, nasal swabs, and nasopharyngeal swabs were

collected from 50 patients and compared for homologous consistency. There was agreement

in paired results (100% in all cases) from nasal swabs and oropharyngeal swabs, nasopharyngeal

swabs, and oropharyngeal swabs, and nasal swabs and nasopharyngeal swabs.

【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.