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Approved by Public Health England & validated by the UK government.
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.
• Rapid testing for the SARS-CoV-2 infection
• Rapid results within 15 minutes
• Facilitates patient treatment decisions quickly
• Simple, time-saving procedure
• No instrumentation required
• Very high sensitivity and specificity
The Coronavirus Ag Rapid Test Cassette (Swab) is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS CoV-2 in direct nasopharyngeal (NP) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first ten days of
symptom onset.
It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. Negative results from patients with symptom onset beyond ten days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed.
The Coronavirus Ag Rapid Test Cassette (Swab) does not differentiate between SARS-CoV and SARS-CoV-2.
Each kit contains
- 20 Test cassettes
- 20 Sterile swabs
- 20 Extraction tubes and dropper tip
- 1 Workstation
- 2 Buffers
- 1 Package insert
Clinical Evaluation
- Positive Percent Agreement (PPA): 95.7%
- Negative Percent Agreement (NPA): 99.6%
- Overall Percent Agreement (OPA): 98.9%
- Specimen: Nasopharyngeal (NP) Swab
- Time to Results: 15 minutes
- Shelf Life: 24 months from the date of manufacture
Product code.GCCOV-502a
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), See https://www.gov.uk/government/news/mhra-issues-exceptional-use-authorisation-for-nhs-test-and-trace-covid-19-self-test-device
