- 20 Test cassettes
- 20 Extraction tubes and tips
- 2 Extraction buffer vials
- 1 Workstation
- 1 Package insert
The Coronavirus Ag Rapid Test Cassette (Swab) is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first ten days of symptom onset.
It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. Negative results from patients with symptom onset beyond ten days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed.
The Coronavirus Ag Rapid Test Cassette (Swab) does not differentiate between SARS-CoV and SARS-CoV-2.
- Rapid testing for SARS-CoV-2 antigen within the first ten days of symptom onset
- Rapid results within 15 minutes
- Facilitates patient treatment decisions quickly
- Simple, time-saving procedure
- No instrumentation required
- Very high sensitivity and specificity
|Time to result||15 minutes|
|Shelf life||24 months|
|Specimen type||Nasopharyngeal swab|
Clinical Performance of the Coronavirus Ag Rapid Test Cassette (Swab) was evaluated by being involved in 7 sites within the US, where patients were enrolled and tested. It has also passed phase 3 UK testing for government approval.
Testing was performed by 24 Health Care Workers that were not familiar with the testing procedure. A total of 317 fresh nasopharyngeal swab samples were collected and tested, which included 61 positive samples and 256 negative samples.
The Coronavirus Ag Rapid Test Cassette (Swab) results were compared to results of USFDA Emergency Use Authorized RT-PCR assays for SARS-CoV-2 in nasopharyngeal swab specimens. Overall study results are shown below.
|Coronavirus Ag Rapid Test Cassette (Swab)||Results||Positive||Negative|
- Relative Sensitivity: 96.72% (95%CI*: 88.65%-99.60%)
- Relative Specificity: 99.22% (95%CI*: 97.21%-99.91%)
- Accuracy: 98.74% (95%CI*: 96.80%-99.66%)