COVID ANTIGEN RAPID TEST KIT
LCH is a distributor for COVID-19 Rapid Antigen Test Kits in Hong Kong & Macau
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)
Antigen Test Kit Specs:
- Sensitivity is 97.89%
- Specificity is 99.39%
- Accuracy is 98.84%
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
About COVID-19 Rapid Antigen Home Test Kit
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 Antigen test?
The accuracy of COVID-19 Antigen Tests can be measured by two factors:
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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.
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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.
Test Kit Specs:
Sensitivity is 98% (94.71%-99.18%)
Specificity is 99% (97.79%-99.83%)
Accuracy is 99% (97.49%-99.47%)
* Confirmed cases were the patients diagnosed according to the treatment plan.
* Confirmed excluded cares were identified by negative PCR results.
https://www.pei.de/EN/newsroom/dossier/coronavirus/test-systems.html