Blog
January 19, 2022

COVID-19 Antigen Self Test

By Marcia Ray

Description

The Healgen Rapid COVID-19 Antigen Self Test is an in vitro immunochromatographic assay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in direct nasal swab specimens directly from persons suspected of COVID-19 within the first ten days. from the onset of symptoms.

This antigen test can be used to detect variants of concern in wild and mutant SARS-CoV-2, including Omicron (B.1.1.529), Delta (B.1.617.2), UK (B.1.1.7), South Africa (B.1.351) and Brazil (P.1). The Healgen Rapid COVID-19 Antigen Self Test will be able to detect the Omicron variant as a result of where the mutation is located. The nucleocapsid protein found in the cell wall (envelope) can be detected by the test.

Key benefits:

• the UK Approved Self Test
• Day 2 antigen test compliant with QR code and unique reference
• Results produced in 15 minutes!
• No additional equipment or instruments required
• One of the few UK government-approved COVID-19 test kits
• Less invasive than a nasopharyngeal swab. The tip of the swab only needs to be inserted 2 cm.

Nasal Swab: Clinical Performance

A total of 237 fresh nasal swab samples were collected and tested, including 109 positive samples and 128 negative samples. Results from the Rapid Coronavirus Ag Test Cassette (Swab) were compared to results from USFDA Emergency Use-Licensed RT-PCR assays for SARS-CoV-2 on nasopharyngeal swab specimens.

Sensitivity: 97.25%

Specificity: 100%

Sample: nasal swab

Time to results: 15 minutes

Shelf Life: 24 months from the date of manufacture

Storage: Room temperature or refrigerated between 2-30°C

Components for a test kit

  • Test cassettes: 1
  • Sterile swabs: 1
  • Extraction tubes: 1
  • Dropper tips: 1
  • Buffers: 1
  • Workstation: 1
  • Package insert: 1

How does it work?

1. Insert the swab into one nostril of the patient. The tip of the swab should be inserted up to 2-4 cm until resistance is met.

2. Roll the swab 5 times along the mucosa inside the nostril. Using the same swab, repeat this process for the other nostril.

3. Remove the swab from the nasal cavity.

4. Insert the test draw tube into the kit port as marked.

5. Carefully remove the sealing film from the extraction tube to prevent the liquid from spilling.

6. Insert the swab into the extraction tube containing 0.3 mL of extraction buffer. Roll the swab at least 6 times while pressing the head against the bottom and side of the collection tube.

7. Leave the swab in the extraction buffer for 1 minute. Squeeze the tube several times from the outside to submerge the swab. Remove the swab.

8. Insert the tip into the extraction tube.