Healgen Covid-19 Antigen Rapid Test (20 Kits). 98.9% Accurate - 15 Minute Results
20 Kits Included

The Healgen Lateral Flow Rapid Antigen testing kit facilitates the detection of COVID-19 with rapid return of results.

Healgen Covid-19 Antigen Test is a UK Government approved Rapid Antigen Test.

This test is intended for use by clinical professionals.

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).

• Qualitative, visually read results in 15 minutes
• No instrument required
• Room temperature storage or refrigerated (2-30°C / 36-86°F)
• Procedural internal control included
• Sterile Swabs, Extraction Buffer and Extraction Tubes included
• Shelf Life: 24 months from the date of manufacture

The Rapid COVID-19 Antigen Test is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) swab from individuals who are suspected of COVID-19 by their healthcare provider. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections.

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. Currently, individuals infected by SARS-CoV-2 are the main source of transmission; asymptomatic carriers are also known as a source of transmission. Based on the current epidemiological information, the incubation period can last from 1 to 14 days, where the average time before symptoms occur is about 5 days. Symptoms include fever or chills, cough, shortness of breath, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, runny nose, nausea or vomiting and diarrhea.

This item line is exempt from our usual returns policy. This item is non-returnable or exchangeable.

Technical Specification

Detailed Technical Information

• 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

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.

Validation and Approval

• Rapid diagnosis of SARS-CoV-2 infections
• Approved by Public Health England & validated by the UK government
• This test is being rolled out by the UK government to mass test the population in Liverpool and other cities, See www.gov.uk for more information (test 3 on the list).