Point-of-Care (POC)

Carolina Liquid Chemistries is now offering the Point-of-Care (POC)/Waived/Fingerstick, FDA Emergency Use Authorized Fastep® COVID-19 IgG/IgM Rapid Test Device by Assure Tech.

Product Description

The point-of-care (POC)/waived/fingerstick Fastep® COVID-19 IgG/IgM Rapid Test Device by Assure Tech. 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. In addition to CLIA moderate and high complexity laboratories, this test has been Emergency Use Authorized for use with fingerstick whole blood specimens at the point-of-care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The test is for professional use only. External controls sold separately.

Warnings

  • This product is intended for professional use and not for home use.
  • Not for the screening of donated blood.

External Controls

Part Number: AZCOVID-19CTRL

The external control package for the Fastep Rapid Antibody Test Device is packaged as follows:

They are packaged as a lyophilized cake of 2 negatives and 1 positive in each packet.

10 total cassettes(5 negative and 5 positive).The control uses 5 uL.

The shelf life is minimally 12 months from the date of manufacture.

Once the lyophilized material is reconstituted the stability is 7 days.Stored at 2-8 for 7 days.Otherwise, the product is stored at room temp.