COVID RAPID TEST FEATURES
The Healgen Covid-19 Rapid Antigen Test (Swab) is intended for the rapid detection of COVID-19 - results available within 15 minutes with high accuracy.
- It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections.
- The Healgen Covid-19 Antigen Test (Swab) does not differentiate between SARS-CoV and SARS-CoV-2.
- Each kit contains everything required to carry out the tests, no additional equipment is needed.
- Approved by Public Health England & validated by the UK government.
- Results in 15 minutes.
- Each kit includes clear instructions and is easy to use.
The Healgen Covid-19 Antigen Test is one of only three UK Government approved Rapid Antigen Test. It is in high demand from schools, councils and companies.
- This test is being rolled out by the UK government to mass test the population in Liverpool and other cities, click here for UK Government approval (test 3 on the list).
- This test is intended for use by clinical professionals (eg Doctor/Practice Nurse/Employer Occupational Health depts etc).
- An application for exceptional use of a COVID-19 rapid test, to be used by members of the public for home use, was approved on the 23rd December 2020 by the Medicines and Healthcare products Regulatory Agency (MHRA), click here for details.
- Positive Percent Agreement (PPA): 97.3%
- Negative Percent Agreement (NPA): 99.6%
- Overall Percent Agreement (OPA): 98.9%
- Specimen: Nasopharyngeal (NP) Swab
- Time to Results: 15 minutes
- Shelf Life: usually 24 months from the date of manufacture
- Rapid testing for SARS-CoV-2 antigen within 15 minutes
- Facilitates patient treatment decisions quickly
- Simple, time-saving procedure
- All necessary reagents provided & no equipment needed
- High sensitivity and specificity
Each kit contains:
- 20 Test cassettes
- 20 Sterile swabs
- 20 Extraction tubes and dropper tip
- 1 Workstation
- 2 Buffers
- 1 Package insert
- The Healgen Covid-19 Antigen Test (Swab) has been evaluated with specimens obtained from patients.
- A commercialised molecular assay was used as the reference method.
- The results show that the Healgen Covid-19 Antigen Test (Swab) has a high overall relative accuracy.
Storage: The kit can be stored at room temperature or refrigerated (2-30°C), please follow instructions on each pack. The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. Please read instructions fully before starting any of the tests. DO NOT FREEZE. Do not use beyond the expiration date.