Hotgen 新型冠狀病毒快速檢測劑使用指南

With the recurring COVID-19 pandemic, many citizens are purchasing large quantities of rapid antigen test kits for unforeseen circumstances. Currently, various types of kits are available on the market.Rapid testing kitWhen purchasing, you should check the list of government-approved rapid testing kits to avoid buying products whose quality is not guaranteed.Hotgen rapid test kitAs one of the brands recognized by the Hong Kong government for distribution, it has obtained EU CE certification, so you can buy and use it with confidence.

What is the Hotgen COVID-19 rapid test kit?

This test kit is an in vitro qualitative reagent used to detect SARS-CoV-2 antigen in human anterior nasal cavity samples. It can be used for rapid detection of SARS-CoV-2 antigen in individuals suspected of having COVID-19, those within seven days of symptom onset, or asymptomatic individuals. Children and adolescents under 18 years of age should be tested under adult supervision.

Hotgen Novel Coronavirus Rapid Test Kit Principle

This kit uses a double-antigen sandwich method. The double-antigen sandwich method relies on the simultaneous and specific binding of antigens and antibodies on both sides of the virus, effectively reducing false positives from a reaction mechanism perspective. It is unaffected by factors such as rheumatoid factor, and its specificity is higher than that of capture and indirect methods. Simultaneously, it improves detection sensitivity, making it a superior method currently available for detecting COVID-19 antibodies.

Hotgen COVID-19 rapid test kit certification

It has EU CE certification, is listed in the EU's list of approved rapid COVID-19 test kits, and is one of the brands approved for distribution by the Hong Kong government.

Hotgen COVID-19 rapid test kit: country of origin/research institution

Beijing Hotgen Biotech Co., Ltd., established in June 2005, is a high-tech enterprise focusing on in vitro diagnostics (IVD) in the biopharmaceutical field. The company was listed on the Science and Technology Innovation Board (STAR Market) in September 2019. The company specializes in the research, development, production, and sales of medical and public safety testing products. After years of development, Hotgen Biotech has built eight major technology platforms: an in vitro diagnostic reagent bioactive raw material R&D platform, a glycan abnormal protein detection (glycan capture) R&D technology platform, a magnetic microparticle chemiluminescence R&D technology platform, an upconversion luminescence R&D technology platform, a colloidal gold immunochromatography R&D technology platform, an enzyme-linked immunosorbent assay (ELISA) R&D technology platform, a molecular diagnostic R&D technology platform, and an instrument R&D technology platform. This forms a closed-loop system for in vitro diagnostic R&D and production. Since its establishment, Hotgen Biotech's business has continuously grown, and it has now achieved group-based development. Currently, it has established several subsidiaries, including Hotgen (Langfang), Hotgen (Jilin), and Shunjing Biotech.

Hotgen COVID-19 rapid test kit specifications

1 nasal swab for collecting nasal fluid
1 nasal discharge collector
1 tester
1 instruction manual

Hotgen Novel Coronavirus Rapid Test Kit Product Features

European Union CE marking
Nasal swab sampling method
One of the brands distributed by the government
Test results are available in 15 minutes.
With a sensitivity of up to 96% and a specificity of 99.13%, it achieves this.

Hotgen COVID-19 rapid test kit: suitable for which populations?

This test kit can be used for rapid detection of SARS-CoV-2 antigen in individuals suspected of having COVID-19, those within seven days of symptom onset, or asymptomatic individuals. Children and adolescents under 18 years of age should be tested under adult supervision.

Hotgen COVID-19 Rapid Test Kit Usage Instructions

1. Please wash and dry your hands thoroughly before testing.
2. Remove the swab from the packaging, and do not touch the sampling end.
3. Carefully insert the swab 1.5 cm into one nostril until you feel some resistance. Apply slight pressure to keep the swab against the inside of the nasal cavity and rotate it 4-6 times for at least 15 seconds.
4. Repeat the above sampling steps in the other nostril using the same swab.
5. Open the wide opening side of the sample tube and place the swab after sampling into the sample tube.
6. Immerse the swab in the buffer solution for at least 15 seconds, rotate the swab several times, and squeeze the sampling end of the swab 3 times.
7. When removing the swab, press it against the tube wall to squeeze out the liquid.
8. Put the cap on the sample tube.
9. Tear open the aluminum foil bag of the test card and place the test card on a flat surface.
10. Open the small cap at the front of the sample tube and add 4 drops of the processed sample into the sample well (S) of the test card.
11. Observe the results after reacting at room temperature for 15 minutes. The test results are invalid after more than 30 minutes.
12. After completing the test, place all test components into a biosafety bag, seal the bag, and discard it along with any other household waste. Do not reuse.
13. Please wash or disinfect your hands again.

Hotgen COVID-19 Rapid Test Results Interpretation

Positive: Two red lines are visible in the observation window. When both the control line (C-line) and the test line (T-line) appear, the antigen test result of the sample is positive, which means that the sample is suspected of being infected with COVID-19.
Negative: If only the red line in the control area (C) is visible, it may mean that you are negative or that the viral load is below the detection limit.
Invalid: If the line in the control area (C) does not develop color, the test is invalid, possibly due to incorrect test execution. Please obtain a new test kit and retest according to the instructions.

Precautions for Hotgen COVID-19 Rapid Test Kit

1. This test reagent is for in vitro diagnostic use only. Please read the instructions for use carefully before performing the test.
2. Please be sure to use the swabs and sample extraction solution provided with the kit. Do not substitute components from other kits for the sample extraction solution in this kit.
3. Please be sure to use an undamaged kit.
4. Please be sure to follow the instructions for use when operating the kit, and do not mix different batches of kits.
5. Do not drink the sample extract. If accidentally ingested, seek medical attention immediately.

Hotgen COVID-19 rapid test kit results

I received a positive test result, what should I do?
When both the control area (C) and the test area (T) show color, the test result is positive. This indicates a suspected case of COVID-19. In this case, please immediately self-isolate as directed by local guidelines and contact your general practitioner/physician or local health authority as instructed by your local authority. Your test result will then be confirmed with a PCR test, and you will be informed of the next steps to take.

I received a negative test result, what should I do?
If only the horizontal line in the control zone (C) is visible, it likely indicates a negative result or that the viral load is below the detection limit. If you experience symptoms such as headache, migraine, fever, loss of smell, or loss of taste, please contact the nearest healthcare facility that follows local regulations. Alternatively, you can obtain a new test kit and retest. If in doubt, please retest after 1-2 days, as the coronavirus may not be accurately detected at various stages of infection. Please always adhere to social distancing and personal hygiene guidelines.