Description
Regulatory Status: FDA EUA Authorized – this test has not been FDA cleared or approved but has been authorized by the FDA under an EUA for use by authorized laboratories. CLIA WAIVED
Contents: InteliSwab™ COVID-19 Limit of Detection (1 device), InteliSwab™ COVID-19 Low Positive (1 device), InteliSwab™ COVID-19 Negative (1 device), Instructions for Use for InteliSwab™ COVID-19 Rapid Test Pro Visual Reference Panel
Designed for Qualification for New Operators
The InteliSwab™ COVID-19 Visual Reference Panel is available separately for use with the InteliSwab™ COVID-19 Rapid Test Pro. The InteliSwab™ COVID-19 Visual Reference Panel consists of three devices that have been manufactured to represent limit of detection, low positive and negative test result. New operators must be able to correctly interpret all test results in the InteliSwab™ COVID-19 Visual Reference Panel prior to using the InteliSwab™ COVID-19 Rapid Test Pro to test patient samples. Failure to read low intensities can result in the inability to detect specimens near the limit of detection of the InteliSwab™ COVID-19 Rapid Test Pro and may result in false negative results
About the The InteliSwab™ COVID-19 Rapid Test:
A manually performed, visually read immunoassay for the qualitative detection of SARSCoV-2 nucleocapsid protein antigen using a proprietary integrated collection swab to directly collect samples from the anterior nasal cavity. The InteliSwab™ COVID-19 Rapid Test Pro is comprised of both a single-use test device and a vial containing a pre-measured amount of a buffered developer solution. The test consists of a sealed pouch with two separate compartments for each component. The InteliSwab™ COVID-19 Rapid Test Pro utilizes a proprietary lateral flow immunoassay procedure.
InteliSwab™ results were compared to highly sensitive molecular FDA Authorized SARS-CoV-2 assays to determine test performance. InteliSwab™ correctly identified 84% of the positive samples with both low levels and high levels of virus.
Additionally, InteliSwab™ correctly identified 98% of negative samples.
InteliSwab™ is a lateral flow in vitro diagnostic antigen test to detect COVID-19. Antigen tests are designed to detect active infection in individuals. A clinical study was conducted during February and April of 2021 to determine the performance of the InteliSwab™ test.
A total of 146 individuals with signs and symptoms of COVID-19 within the first 7 days of symptom onset were enrolled across 5 different locations in the US. Subjects 18 years or older independently collected the lower nasal sample and completed the home use test.
There are no confusing steps, no batteries and no mailing to labs.
You just swab your nostrils with the gentle swab, swirl it in the tube, and see results in minutes.
It’s just that simple. That’s the power of InteliSwabTM.
See product links above for additional information or contact your local Stat Technologies sales representative
