FaStep Antibody IgM & IgG Test

Assure COVID-19 IgG/IgM Rapid Test
https://www.peachmedicalsourcing.com/antibody-test
FDA Status: EUA Authorized: July 6, 2020
Test Type: Rapid Antigen; Nucleocapsid20 ASSAY BUFFER

Fast, accurate, point-of-care results.
This is a point-of-care authorized test. CLIA-certified laboratories with Waiver, Moderate, or High Complexity certification may perform the test at point-of-care or in a laboratory setting.

Manufacturer Background
Assure Tech (Hangzhou) Co. Ltd. was established in 2008 and is one of China’s leading lateral flow assay developers. The company specializes in point-of-care IVD tests and has nearly 400,000 square feet of R&D and manufacturing space for its advanced colloidal gold diagnostic reagents product lines, with annual production capacity of hundreds millions of devices.

Specifications

Tube Type – 15mL polypropylene plastic tubes with screw cap
Swab Types – Does not come with swabs. May be paired with any of the swabs we have available.
Volume of Media – 2.0mL or 3.0mL
Transport Media Type – Sterile viral transport media with salts, antibiotics and collection tube.
pH of Media – 7.1-7.5
Storage Temperature – Cold or room temperature, 2-25°C

Clinical Studies

• 100% Sensitivity, 98.8% Specificity (FDA Study)
• Specificity testing: No cross-reaction with other species
• No interfering drugs or other factors identified.

Specifications

• Lateral flow immunoassay intended for the qualitative detection
  and differentiation of IgM and IgG antibodies to SARS-CoV-2.

*FDA clinical study. See Instructions for Use for additional clinical data.