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: (1) Positive Control, (1) Negative control, Package Insert
Determinations: Detection of the SARS-CoV-2 nucleocapsid protein antigen
Storage Requirements: 2° – 8° C
Processing Time: 30 Minutes
The InteliSwabTM COVID-19 Rapid Test Pro Kit Controls are intended as an external quality control reagents to monitor the performance of the InteliSwabTM COVID-19 Rapid Test Pro with direct anterior nasal samples. For use only with the InteliSwabTM COVID-19 Rapid Test Pro. Run the Kit Controls under the following circumstances: Each new operator prior to performing testing on patient specimens, When opening a new test kit lot, Whenever a new shipment of test kits is received, If the temperature of the test kit storage area falls outside of 2°-30°C (35°-86°F), and At periodic intervals as dictated by the user facility, country, state or local regulations and policies.
The InteliSwab™ COVID-19 Rapid Test Pro is 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
