True Diagnostics is Now Offering FDA Emergency Use Authorized Tests
DiaSure Assure COVID-19 IgG/IGM Rapid Test Device
Product Description
Our DiaSure test device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum or plasma. The test is for professional use only.
Warnings
- This product is intended for professional use and not for home use.
- Not for the screening of donated blood.
Instructions for Use
- Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
- Add the specimens
For Serum or Plasma Specimens
a) Using the provided disposable pipette, draw the specimen up to the Fill Line, and transfer all the specimen (appr. 5µL) into the specimen well of the test device, then add 2 drops of buffer and start the timer.
For Venous Whole Blood Specimens
a) Using the provided disposable pipette, draw the specimen above the fill line (avoid the specimen entering the bubble of disposable pipette) and transfer one drop of the specimen into the specimen well of the test device, then add 2 drops of buffer and start the timer. - Wait for the blue line change to red line, read results at 15 minutes.
Important Documents:
- Instructions for Use
- Fact Sheet for Healthcare Providers
- Fact Sheet for Recipients
- Emergency Use Authorization Letter from the FDA
- Clinical Performance Study
- MSDS DiaSure COVID-19 IgG/IgM Rapid Test Device
- FDA Guidance – Policy for Diagnostic Tests for COVID-19 during the Public Health Emergency
- Emergency Use Test Purchase Agreement
Related Products
- DiaSure Kit Controls 29003-PNC
- TrueDX Risk Management Tool (coming soon.)
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