HYGISUN COVID-19 Rapid Test: Clinical Grade Accuracy for Home & Office
The HYGISUN COVID-19 Antigen Rapid Test (Colloidal Gold) is a premium diagnostic tool designed for the qualitative detection of SARS-CoV-2 antigens. Approved by the BfArM (Federal Institute for Drugs and Medical Devices) under special approval file number 5640-S-058/21, this kit is specifically validated for use by laypeople, making it an essential resource for Irish businesses, schools, and households.
This kit stands out for its versatility and user comfort. It utilizes a non-invasive testing method, allowing for samples to be taken via a simple nasal swab or a saliva discharge (colloquially known as the “spit test”). This eliminates the discomfort associated with deep nasopharyngeal swabbing while maintaining exceptional clinical standards. With a sensitivity of 98.19% and a specificity of 100%, the HYGISUN test provides peace of mind with results visible in as little as 15 minutes.
Key Benefits
- Exceptional Accuracy: Validated with 100% specificity, ensuring no false positives in clinical evaluations.
- User-Friendly Design: Includes pre-filled sample tubes to minimize errors and simplify the testing process.
- Rapid Turnaround: Get clear, readable results in 15-20 minutes—ideal for screening before meetings or travel.
- Non-Invasive Options: Suitable for those who prefer the saliva “spit” method or a shallow nasal swab.
- Certified for Self-Use: Fully compliant with Section 11 (1) of the Medical Devices Act (MPG) for laypeople.
Who This Is For
Reliable testing for various Irish environments:
- Workplaces & Offices: Ensure employee safety with regular, easy-to-administer screenings.
- Schools & Childcare: The non-invasive spit test is ideal for testing children with minimal distress.
- Travel & Events: Quick verification for peace of mind before social gatherings or domestic trips.
- Retail & Hospitality: Maintain a “COVID-secure” environment for both staff and customers.
Technical Specifications
| Test Type | Antigen Rapid Test (Colloidal Gold) |
|---|---|
| Sensitivity | 98.19% |
| Specificity | 100% |
| Sample Method | Nasal or Saliva (Spit Test) |
| Approval No. | BfArM 5640-S-058/21 |

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