Rapid diagnostic test for the qualitative detection of SARS-CoV-2 antigens in human nasopharyngeal swab samples in 15 minutes.
To assist in the rapid diagnosis of COVID-19 or for use in testing programs (1).
- Approved by the French Ministry of Health and CE-IVD marked
- Based on the N protein : detects the VOC-202012/01 variant strain
- High sensitivity:
- (97,5% (IC95% :91,3 – 99,3%) for samples with Ct values ≤ 33**, n=81)
- 93,8% (IC95% :80,3 – 94,9) n=65 for symptomatic patients, tested between the 1st and 7th day of symptoms.
- Excellent specificity (>99,9%)
- Swab material and kit buffer allow for optimized released of secretions, for superior sensitivity
- Developed, produced and assembled in France
Rapid and easy-to-use
- Simple protocol ; no additional material or equipment required (3)
- Results in 15 minutes
- Transport and store at room temperature
Optimized user security and comfort
- The elution buffer inactivates the virus, thereby reducing the risk of staff exposure (2)
- The slim swab improves patient comfort
- The swab breaking point is located far from the sampling tip
- The kit includes tube racks made of recycled cardboard
- The test is in a cardboard strip format without any plastic to limit waste (70% less waste than with a
(1) Respect all recommendations provided by Health authorities and all regulations in vigour
(2) The buffer composition inactivates the SARS-CoV-2 virus by lysis by detergents (NP40), and therefore allows also to reduce the exposure risk of testing staff. Inactivation has been shown in publications, after a 30-minute contact time (Welch SR, et al. 2020). Analysis of inactivation of SARS-CoV-2 by specimen transport media, nucleic acid extraction reagents, detergents, and ﬁxatives. J Clin Microbiol 58:e01713-20). However, all samples must be considered as potentially infectious, and therefore individual personal protective equipment must be worn.
(3) In vitro diagnostic medical device. Read the instructions for use carefully. All kits are designed for in vitro diagnostic use and may only be used by healthcare professions. The test is not designed for home use.
|Method||Method Rapid antigen test|
|Specimens||Human nasopharyngeal swab samples|
|Coated antibody||Anti-SARS-CoV-2 nucleocapsid monoclonal antibody|
|Conjugate||Anti-SARS-CoV-2 nucleocapsid monoclonal antibody labeled with red beads|
|Product code||Reactions||Kit format||Plate format|