Products

AffiDX® SARS-CoV-2 Antigen Lateral Flow Test

Accurate detection, comfortable sample collection and interpretation of results in just 20 minutes

The AffiDX® SARS-CoV-2 Antigen Lateral Flow Test is intended for point-of-care and decentralised testing to identify individuals with higher viral loads of SARS-CoV-2 that increase the likelihood of transmitting the infection to others. Wholly developed and manufactured in the UK utilising accurate, flexible Affimer® technology, and validated against emerging variants of SARS-CoV-2.

Intended Use:

The Avacta AffiDX® SARS-CoV-2 Antigen Lateral Flow Test is a qualitative in vitro diagnostic (IVD) test to detect SARS-CoV-2 antigen in human anterior nasal swabs. The test is intended for professional use only. Assay validation and clinical evaluations of the test were conducted in the UK and EU using routine prospective samples in general population and healthcare settings*.

Features and Benefits

  • Patient-Friendly – Anterior nares (nasal) swabs samples for more comfortable collection
  • Reliable Results – Accurate for identifying individuals likely to be infectious: 98% sensitivity and 99% specificity
  • Validated Against Delta and Omicron Variant – Routine monitoring of all emerging variants to ensure continued diagnostic accuracy
  • U.K. Made – Developed and manufactured in the United Kingdom
  • Accessible – Suitable for Point of Care settings and allows for decentralised testing
  • Rapid & Simple – Easy to use, simple work-flow, results in only 20 minutes
  • Convenient – Contains everything needed to run a test with no additional equipment required
  • Practical – Room temperature storage, transportation and testing
  • Environmentally-Friendly Packaging – Cardboard kit box can be recycled after use

Learn more about our approach to monitoring and validation of the AffiDX® SARS-CoV-2 Antigen LFT with Variants of Concern.

Clinical Evaluation:

Ct = Ct Value = the number of amplification cycles needed for a virus to be detected by PCR; the lower the Ct, the higher the viral load in the sample.

*Clinical evaluation study conducted at Hospital Carlos III and Hospital Universitario La Paz, Madrid, Spain between March-April 2021 using samples from patients with a recently confirmed SARS-CoV-2 RT-qPCR test result, from a variety of settings including hospital in-patients, walk-in test centres and participants in epidemiological studies. The performance of this test was established using available clinical specimens at the time of the clinical evaluation. Performance of the test may depend on the variants of SARS-CoV-2 in circulation at the time of testing. Avacta® Diagnostics actively monitors the emergence of new SARS-CoV-2 Variants of Concern (VOC) using the Public Health England (PHE) and World Health Organisation (WHO) lists. Results of current VOC validations can be found HERE.

Product information
Product code 11711125
Product name AffiDX® SARS-CoV-2 Antigen Lateral Flow Test
Pack size 1 carton containing 25 test kits

Kit contents
25 lateral flow devices
25 buffer capsules
25 sterile swabs
25 swab extraction tubes
1 Instructions For Use

The Avacta AffiDX® SARS-CoV-2 Antigen Lateral Flow Test is now affiliated to The NHS National Microbiology Framework. Click here for more details.

For further information, please contact your local Avacta distributor or email us.

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Disclaimer: The AffiDX® SARS-CoV-2 rapid antigen test is not currently available for sale in the United States.