Coronavirus Rapid test kit
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Coronavirus (CoV) belongs to the Cronoaviridae family and is divided into three types: α, β and γ. Alpha and beta are only pathogenic to mammals and gamma mainly causes bird infections. CoV is mainly transmitted through direct contact with secretions or through aerosols and droplets. There is also evidence that it can be transmitted through the fecal-oral route as well. So far there are seven types of human coronavirus (HCoV) that cause human respiratory diseases: HCoV-229E, HCoV-NL63, HCoV-OC43, HCoV-HKU1, SARS-CoV, MERS-CoV and the novel coronavirus (2019).
Test Principle
COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit for COVID-19 is Colloidal gold immunochromatography based. The test card contains (1) colloidal gold-labeled recombinant novel coronavirus antigen and quality control antibody colloidal gold marker, (2) detection lines (T lines) and quality control line (C) fixed on a nitrocellulose membrane. T is fixed with recombinant novel coronavirus antigen for detecting the novel coronavirus total IgM and IgG antibody. The quality control antibody is fixed on the C line.
When an appropriate amount of test sample is added to the sample well of the test cassette, the sample will move forward along the test card via capillary action. If the sample contains IgM and IgG antibody, the antibody will bind to the colloidal gold-labeled novel coronavirus antigen. The antibody/antigen complex will be captured by the recombinant novel coronavirus antigen immobilized on the membrane, forming a red T line and indicating a positive result for the total IgG/IgM antibody.
If neither antibody is present, a negative result is displayed. The card also contains a quality control line (C). Regardless of what antibodies are present the C line should appear to indicate that the sample has been transported properly through the membrane. If the C line does not appear it indicates that the test result is invalid and a new, unopened test cassette is required to retest the sample.
COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit for COVID-19 is Colloidal gold immunochromatography based. The test card contains (1) colloidal gold-labeled recombinant novel coronavirus antigen and quality control antibody colloidal gold marker, (2) detection lines (T lines) and quality control line (C) fixed on a nitrocellulose membrane. T is fixed with recombinant novel coronavirus antigen for detecting the novel coronavirus total IgM and IgG antibody. The quality control antibody is fixed on the C line.
When an appropriate amount of test sample is added to the sample well of the test cassette, the sample will move forward along the test card via capillary action. If the sample contains IgM and IgG antibody, the antibody will bind to the colloidal gold-labeled novel coronavirus antigen. The antibody/antigen complex will be captured by the recombinant novel coronavirus antigen immobilized on the membrane, forming a red T line and indicating a positive result for the total IgG/IgM antibody.
If neither antibody is present, a negative result is displayed. The card also contains a quality control line (C). Regardless of what antibodies are present the C line should appear to indicate that the sample has been transported properly through the membrane. If the C line does not appear it indicates that the test result is invalid and a new, unopened test cassette is required to retest the sample.
- Only for human in vitro clinical diagnostics only.
- The product should only be used by trained clinical professionals.
- After opening the sealed cassette pouch the test should be used within one hour.
- Do not immerse test cassette in water.
- Do not freeze test cassette or buffer solution.
- Handle specimens in accordance to the OSHA Standard on Bloodborne Pathogens.
- Wear protective gloves, clothing, and eyewear.
- Wash hands thoroughly after handling specimens.
- Do not use test cassette, buffer solution, or any kit component beyond the indicated expiration date.
- Dispose of all used or damaged test cassettes, capillary samplers, or other kit component as biohazardous materials.
- Do not use test cassette, buffer solution, or any other kit components if the pouch is damaged or the seal is broken.
- Do not use samples containing lipids, hemolysis, or turbidity which can affect results.
The reagent should be stored in the dark at room temperature (2°C to 30°C) and has a shelf-life of 12 months. The container should be protected from light after being opened. Do not freeze.
- Suitable for human serum, plasma, or whole blood samples including samples prepared by commonly-used anticoagulants (EDTA, heparin, sodium citrate).
- Fresh samples should be collected and tested immediately.
- Serum and plasma samples can be stored at 2-8°C for 5 days. If long-term storage of serum or plasma samples is required, store at -20°C and avoid repeated freeze/thaw cycles.
- Anticoagulated whole blood samples can be stored at 2-8°C for 7 days.
- Before testing, samples stored in refrigerated or frozen storage should be slowly returned to room temperature (15-30°C) and stirred. When particulates are clearly visible in the sample the precipitate should be removed by centrifugation before testing.
Do not open pouch until ready to use. Prep necessary materials: Test cassette |
Buffer solution | Capillary Sampler Label Test cassette with patient ID.
1. Obtain a specimen using standard laboratory protocols.
Using capillary sampler, obtain 20μL of fingerstick or venous whole blood specimen or 10μL of serum or plasma.
For intravenous sampling follow standard laboratory protocols.
2. Dispense the specimen into the Test Cassette sample well.
Ensure that the entire sample is dispensed into the sample well.
3. Remove cap of the Buffer Solution bottle and dispense 2-3 drops into the Test Cassette sample well.
Remove any air bubbles in the dropper.
Test on a level surface at room temperature.
4. Allow test to run for 15 minutes. Read the results by viewing the detection window.
Test results that have run over 20 minutes are invalid.
Buffer solution | Capillary Sampler Label Test cassette with patient ID.
1. Obtain a specimen using standard laboratory protocols.
Using capillary sampler, obtain 20μL of fingerstick or venous whole blood specimen or 10μL of serum or plasma.
For intravenous sampling follow standard laboratory protocols.
2. Dispense the specimen into the Test Cassette sample well.
Ensure that the entire sample is dispensed into the sample well.
3. Remove cap of the Buffer Solution bottle and dispense 2-3 drops into the Test Cassette sample well.
Remove any air bubbles in the dropper.
Test on a level surface at room temperature.
4. Allow test to run for 15 minutes. Read the results by viewing the detection window.
Test results that have run over 20 minutes are invalid.
- This product can only be used to detect the IgG/IgM antibodies of the novel coronavirus in human blood, serum, or plasma. It cannot be used with other body fluids or secretions.
- This product is only for qualitative testing and the specific content of each indicator must be measured using other quantitative methodologies.
- Negative results may be caused by low concentrations of the novel coronavirus IgG/IgM antibody in the sample and therefore cannot completely rule out the possibility of infection.
- The results of this test are for clinical reference only and should not be the only basis for diagnosis. Results should be used in combination with clinical observations and other testing methods.
- Test results can be affected by temperature and humidity.
A total of two detection lines are possible, with the control (C) line appearing when sample has been flowed through the cassette.
1. Negative Result
If only the quality control line (C) appears and the detection T line is not visible, then no novel coronavirus antibody has been detected and the result is negative.
2. Positive Result, G and M
If the quality control line (C) and the detection T lines appear, then the novel coronavirus IgG/IgM antibodies have been detected and the result is positive for coronavirus antibodies.
1. Negative Result
If only the quality control line (C) appears and the detection T line is not visible, then no novel coronavirus antibody has been detected and the result is negative.
2. Positive Result, G and M
If the quality control line (C) and the detection T lines appear, then the novel coronavirus IgG/IgM antibodies have been detected and the result is positive for coronavirus antibodies.
Each Test Cassette device has a built-in control. A red colored line in the detection window at the Control line can be considered an internal positive procedural control.
The Control line will appear if the test procedure has been correctly performed. If the Control line does not appear, the test is invalid and a new test must be performed.
The Control line will appear if the test procedure has been correctly performed. If the Control line does not appear, the test is invalid and a new test must be performed.
Submit Your Request. Wholesale only.
To request more information about our Rapid Coronavirus (Covid-19) test kit-such as clinical trial info, the product insert, and CE documentation, please complete the form below.
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+8618588888527
info@union-delta.com
Flat/rm 1502(12)
Easey Commercial Building 253-261 Hennessy road
Wanchai, Hongkong
info@union-delta.com
Flat/rm 1502(12)
Easey Commercial Building 253-261 Hennessy road
Wanchai, Hongkong
© 2019 UNION DELTA LTD | Privacy policy
Privacy Policy
This Privacy Policy describes how your personal information is collected, used, and shared when you visit or make a purchase from www.union-delta.com .
Personal information we collect
When you visit the Site, we automatically collect certain information about your device, including information about your web browser, IP address, time zone, and some of the cookies that are installed on your device. Additionally, as you browse the Site, we collect information about the individual web pages or products that you view, what websites or search terms referred you to the Site, and information about how you interact with the Site. We refer to this automatically-collected information as "Device Information".
We collect Device Information using the following technologies:
- "Cookies" are data files that are placed on your device or computer and often include an anonymous unique identifier. For more information about cookies, and how to disable cookies, visit http://www.allaboutcookies.org.
- "Log files" track actions occurring on the Site, and collect data including your IP address, browser type, Internet service provider, referring/exit pages, and date/time stamps.
- "Web beacons", "tags", and "pixels" are electronic files used to record information about how you browse the Site.
Additionally when you make a purchase or attempt to make a purchase through the Site, we collect certain information from you, including your name, billing address, shipping address, payment information (including credit card numbers, email address, and phone number. We refer to this information as "Order Information".
When we talk about "Personal Information" in this Privacy Policy, we are talking both about Device Information and Order Information.
How do we use your personal information?
We use the Order Information that we collect generally to fulfill any orders placed through the Site (including processing your payment information, arranging for shipping, and providing you with invoices and/or order confirmations). Additionally, we use this Order Information to:
- Communicate with you;
- Screen our orders for potential risk or fraud; and
- When in line with the preferences you have shared with us, provide you with information or advertising relating to our products or services.
We use the Device Information that we collect to help us screen for potential risk and fraud (in particular, your IP address), and more generally to improve and optimize our Site (for example, by generating analytics about how our customers browse and interact with the Site, and to assess the success of our marketing and advertising campaigns).
We may also share your Personal Information to comply with applicable laws and regulations, to respond to a subpoena, search warrant or other lawful requests for information we receive, or to otherwise protect our rights.
Behavioral advertising
As described above, we use your Personal Information to provide you with targeted advertisements or marketing communications we believe may be of interest to you. For more information about how targeted advertising works, you can visit the Network Advertising Initiative's ("NAI") educational page at http://www.networkadvertising.org/understanding-online-advertising/how-does-it-work.
You can opt-out of targeted advertising by using the links below:
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Additionally, you can opt out of some of these services by visiting the Digital Advertising Alliance's opt-out portal at: http://optout.aboutads.info/.
Do not track
Please note that we do not alter our Site's data collection and use practices when we see a Do Not Track signal from your browser.
Your rights
If you are a European resident, you have the right to access personal information we hold about you and to ask that your personal information be corrected, updated, or deleted. If you would like to exercise this right, please contact us through the contact information below.
Additionally, if you are a European resident we note that we are processing your information in order to fulfill contracts we might have with you (for example if you make an order through the Site), or otherwise to pursue our legitimate business interests listed above. Additionally, please note that your information will be transferred outside of Europe, including to Canada and the United States.
Data retention
When you place an order through the Site, we will maintain your Order Information for our records unless and until you ask us to delete this information.
Changes
We may update this privacy policy from time to time in order to reflect, for example, changes to our practices or for other operational, legal or regulatory reasons.
Minors
The Site is not intended for individuals under the age of 16.
Contact us
For more information about our privacy practices, if you have questions, or if you would like to make a complaint, please contact us by e‑mail at info@union-delta.com or by mail using the details provided below:
Union-Delta Co.,LTD
Union Delta Co., Ltd, FLAT/RM 1502(12) EASEY COMMERCIAL BUILDING, 253-261 HENNESSY ROAD WANCHAI, Hong kong, Hong Kong Island Hong Kong SAR China
Personal information we collect
When you visit the Site, we automatically collect certain information about your device, including information about your web browser, IP address, time zone, and some of the cookies that are installed on your device. Additionally, as you browse the Site, we collect information about the individual web pages or products that you view, what websites or search terms referred you to the Site, and information about how you interact with the Site. We refer to this automatically-collected information as "Device Information".
We collect Device Information using the following technologies:
- "Cookies" are data files that are placed on your device or computer and often include an anonymous unique identifier. For more information about cookies, and how to disable cookies, visit http://www.allaboutcookies.org.
- "Log files" track actions occurring on the Site, and collect data including your IP address, browser type, Internet service provider, referring/exit pages, and date/time stamps.
- "Web beacons", "tags", and "pixels" are electronic files used to record information about how you browse the Site.
Additionally when you make a purchase or attempt to make a purchase through the Site, we collect certain information from you, including your name, billing address, shipping address, payment information (including credit card numbers, email address, and phone number. We refer to this information as "Order Information".
When we talk about "Personal Information" in this Privacy Policy, we are talking both about Device Information and Order Information.
How do we use your personal information?
We use the Order Information that we collect generally to fulfill any orders placed through the Site (including processing your payment information, arranging for shipping, and providing you with invoices and/or order confirmations). Additionally, we use this Order Information to:
- Communicate with you;
- Screen our orders for potential risk or fraud; and
- When in line with the preferences you have shared with us, provide you with information or advertising relating to our products or services.
We use the Device Information that we collect to help us screen for potential risk and fraud (in particular, your IP address), and more generally to improve and optimize our Site (for example, by generating analytics about how our customers browse and interact with the Site, and to assess the success of our marketing and advertising campaigns).
We may also share your Personal Information to comply with applicable laws and regulations, to respond to a subpoena, search warrant or other lawful requests for information we receive, or to otherwise protect our rights.
Behavioral advertising
As described above, we use your Personal Information to provide you with targeted advertisements or marketing communications we believe may be of interest to you. For more information about how targeted advertising works, you can visit the Network Advertising Initiative's ("NAI") educational page at http://www.networkadvertising.org/understanding-online-advertising/how-does-it-work.
You can opt-out of targeted advertising by using the links below:
- Facebook: https://www.facebook.com/settings/?tab=ads
- Google: https://www.google.com/settings/ads/anonymous
- Bing: https://advertise.bingads.microsoft.com/en-us/resources/policies/personalized-ads
Additionally, you can opt out of some of these services by visiting the Digital Advertising Alliance's opt-out portal at: http://optout.aboutads.info/.
Do not track
Please note that we do not alter our Site's data collection and use practices when we see a Do Not Track signal from your browser.
Your rights
If you are a European resident, you have the right to access personal information we hold about you and to ask that your personal information be corrected, updated, or deleted. If you would like to exercise this right, please contact us through the contact information below.
Additionally, if you are a European resident we note that we are processing your information in order to fulfill contracts we might have with you (for example if you make an order through the Site), or otherwise to pursue our legitimate business interests listed above. Additionally, please note that your information will be transferred outside of Europe, including to Canada and the United States.
Data retention
When you place an order through the Site, we will maintain your Order Information for our records unless and until you ask us to delete this information.
Changes
We may update this privacy policy from time to time in order to reflect, for example, changes to our practices or for other operational, legal or regulatory reasons.
Minors
The Site is not intended for individuals under the age of 16.
Contact us
For more information about our privacy practices, if you have questions, or if you would like to make a complaint, please contact us by e‑mail at info@union-delta.com or by mail using the details provided below:
Union-Delta Co.,LTD
Union Delta Co., Ltd, FLAT/RM 1502(12) EASEY COMMERCIAL BUILDING, 253-261 HENNESSY ROAD WANCHAI, Hong kong, Hong Kong Island Hong Kong SAR China