HEALGEN COVID-19 Rapid Test (20 Tests)
This swab test 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.
This swab test 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.Cannot be shipped to a USA address.
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 designed 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.
Clinical Evaluation:Positive Percent Agreement (PPA): 97.3%Negative Percent Agreement (NPA): 99.6%Overall Percent Agreement (OPA): 98.9%Specimen: Nasopharyngeal (NP) SwabTime to Results: 15 minutesShelf Life: usually 24 months from the date of manufacture
Benefits:Rapid testing for SARS-CoV-2 antigen within 15 minutesFacilitates patient treatment decisions quicklySimple, time-saving procedureAll necessary reagents provided & no equipment neededHigh sensitivity and specificity
Each kit contains:20 Test cassettes20 Sterile swabs20 Extraction tubes and dropper tip1 Workstation2 Buffers1 Package insert
Performance Characteristics: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.
This test has been authorized by FDA under an EUA for use by authorized laboratories.
This test has not been FDA cleared or approved.
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
This product is intended for professional use and not for home use.
Not for the screening of donated blood.