COVID ANTIGEN HOME TEST

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LCH distributes COVID-19 Rapid Antigen Home Test Kits

Tigsun Covid Test Kit
Tigsun Covid Test Kit

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Tigsun Antigen Test Single
Tigsun Antigen Test Single

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Tigsun MSDS 1
Tigsun MSDS 1

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Tigsun Covid Test Kit
Tigsun Covid Test Kit

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Tigsun COVID-19 Rapid Antigen Test Kit is designed to be used anytime without the need of special equipment or facility. It is designed for a qualitative detection of antigens in direct nasal swab samples, where the intuitive visual result will be shown in 15 minutes. The product is one of the first antigen test kits developed in the world, and is authorised by EU CE. The rapid antigen test is independently tested by German Federal Health Agency PEI to have shown a high sensitivity even when the virus load is low. It is clinically validated with overall sensitivity and specificity.

**Supporting document regarding product attached below

(Product Flyer, Instructions, MSDS, In-house Test Report, Germany PEI Independent Evaluation)

Tigsun Antigen Test Kit Specs:

- Sensitivity is 97.89%

- Specificity is 99.39%

- Accuracy is 98.84%

Source: http://www.tigsun.com/Content/2020/08-14/1435055504.html

Independent Study by Paul-Ehrlich-Institut (Federal Institute for Vaccines and Biomedicines, Agency of the German Federal Ministry of Health):

- Sensitivity for Cq ≤ 25 : 100% (High Virus Load, WHO Cutoff as 25)

- Sensitivity for Cq (25 - 30) : 87.0%

- Sensitivity for Cq ≥ 30 : 30.0% (Low Virus Load)

Cq is defined as Quantitative SARS-CoV-2 RNA distributions (quantification cycle (Cq) and copies/mL). World Health Organization (WHO) applies Cq ≤ 25 as the cut-off point for Antigen test COVID-19 detection.  Lower Cq implies higher virus load (copies/mL), higher Cq implies lower load (copies/mL).

Source: https://www.pei.de/EN/newsroom/dossier/coronavirus/test-systems.html

 

Testing Procedures

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About Tigsun COVID-19 Rapid Antigen Home Test Kit

Tigsun COVID-19 Antigen Rapid Test is a lateral flow immunochromatographic assay intended for the rapid and qualitative detection of antigen from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasal and nasopharyngeal samples from individuals suspected of COVID-19 in the first 7 days of symptom onset. Results from the test are for the identification of SARS-CoV-2 antigen. The antigen is generally detectable in upper respiratory samples during the acute phase of infection.

What is Antigen test?

An antigen is a molecule or molecular structure present in a pathogen that, when detected in the human body, can trigger an immune response. In the course of early stage infections (2-3 days), the antigens are found and to be detected in the respiratory tract, and therefore can be used as a device to mark the disease exposure. The procedures for the antigen test is simple and easy, gently insert the swab into nostrils for collecting samples, then the results can be read 15 minutes later.

 

How accurate is Tigsun Antigen test?

The accuracy of COVID-19 Antigen Tests can be measured by two factors:

  1. Sensitivity, which measures the ability to correctly identify positive patient samples. If a test kit has a high sensitivity, it means that the kit has a high positive percentage agreement and a low false negative rate.

  2. Specificity, which measures the ability to correctly identify negative patient samples. If a test kit has a high specificity, it means that the kit has a high negative percentage agreement and a low false positive rate.

Tigsun conducted clinical studies on the sensitivity, specificity, and accuracy of the Antigen test kit.

516 clinical case samples, which include 188 confirmed case samples and 328 confirmed excluded case samples, were obtained for testing, and then compared the test results between Tigsun COVID-19 Antigen Rapid Test and the confirmed case samples. The results of sensitivity and specificity between the two methods are shown below.

Test Kit Specs:

Sensitivity is 98% (94.71%-99.18%)

Specificity is 99% (97.79%-99.83%)

Accuracy is 99% (97.49%-99.47%)

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* Confirmed cases were the patients diagnosed according to the treatment plan.

* Confirmed excluded cares were identified by negative PCR results.

Information Source:

http://www.tigsun.com/Content/2020/08-14/1435055504.html

https://www.pei.de/EN/newsroom/dossier/coronavirus/test-systems.html

Product Certificates

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Product Instructions

Product Material Safety Data Sheet & CE Certificate

Tigsun In-house Test & Germany PEI (Federal Agency) Independent Antigen Sensitivity Study

About Beijing Tigsun

Beijing Tigsun Diagnostics Co,.Ltd. was founded in 2004 with headquartered in the capital city of Beijing, specialises in the field of medical test. It is a high-tech enterprise integrated with the R & D, production, operation and sales of China's professional chemiluminescence in vitro diagnostic products. Supporting equipment research and development, production and sales. They have 100,000 grade in vitro diagnostic reagents production department certified by  and  production facilities. They have the strength for research and development, production, and product registration.

The company has two divisions: Chemiluminescence Division and Quick Diagnosis Division.

Tigsun has 12 categories of chemiluminescent immunoassay reagents. The company is a major supplier, covering all provinces, municipalities and autonomous regions in China. Their products are used by currently nearly 1,200 hospitals. Based on the tenet of  "Customer Service and keep improving ", Beijing Tigsun Diagnostics Co,.Ltd. develops, manufactures and provides "in vitro diagnostic (IVD) products that are reliable, stable, easy to operate and clinically needed."

About LCH

Founded in 1940, Luen Cheong Hong (LCH) Ltd is one of the leading healthcare companies as pharmaceuticals supplier, medical supplies & medical equipment wholesale distributor in Hong Kong and Macau, supplying name-brand drugs, generic drugs, injectables, health-care products, and medical consumables. 

LCH is a Licensed Wholesale Dealer and Licensed Pharmaceutical Manufacturer (Secondary Packaging) for medicine and injectables. LCH product range covers hospital supplies, surgical supplies, dental supplies, vet supplies, rehabilitation products, home care, elderly care, pet supplies, medicine, injectables, PPE, face mask, nitrile gloves, surgical equipment, wound treatment, and first-aid. LCH also has an online store for direction distribution of consumable medical supplies to end users.

LCH was founded in Shanghai in the 1940s, and incorporated as a limited company in Hong Kong in 1952, being one of the oldest pharmaceutical and medical supplies distributors in the region. LCH primarily focused on wholesale distribution and marketing of high quality medicine, injections, healthcare products, medical equipment,  and medical consumable product. Over the past 80 years, LCH helped a number of the largest international pharmaceutical and medical product companies from USA, United Kingdon, Japan, Australia, Europe, and China to establish their presence, sales, and distribution in the Asia Pacific region. LCH has assisted their partners manage the logistics and distribution of their products, marketing, local legal registration of products, participate in government tender bidding, direct sales, and establish their brand recognition.

Today, LCH distribute hundreds of types of medical products, injections, and pharmaceutical products in Hong Kong and Macau. Supplying all of the major public and private hospitals, pharmacies, clinics, NGOs, hotels, and restaurants. With one of the largest warehouses and most established logistics system in the region, we have managed to create a seamless sales and after sales experience for our customers.

LCH currently represent a number of top pharmaceutical companies to distribute medical products including medicine, injections, personal protective equipment, and medical consumable products. Our distribution partners include Australia's Alphapharm Pty Ltd, Australia's Arrow Pharmaceuticals, South Africa's Aspen Pharmacare, USA's Ecolab, USA's Mylan, N Medical, United Kingdom's Mirius Coventry, Spain's Grifols Therapeutics, France's Anios Laboratoires, Japan's Otsuka Pharmaceuticals, India's Wockhardt, China's Zhende, and Intco.

We hope to continue to work closely with existing partners and new partners to further grow our businesses together in local and international markets.​

Hong Kong Medical License Reference:

https://www.drugoffice.gov.hk/eps/do/en/healthcare_providers/news_informations/relicList.html?indextype=2A

https://www.drugoffice.gov.hk/eps/do/en/healthcare_providers/news_informations/relicList.html?indextype=7A

Macau Medical License Reference:

https://www.ssm.gov.mo/pubssmweb/Daf/frmPN.aspx