FDA Authorizes First
Point-of-Care Antibody Test for COVID-19

COVID-19
IgG/IgM POC RAPID TEST

What does POC authorization mean?

This authorization means finger stick blood samples can now be tested in POC settings like doctor's offices, hospitals urgent care centers, and emergency rooms rather than having blood drawn to be tested in a central lab.

Why authorize a Point-of-Care Antibody Test for COVID-19?

"Authorizing point-of-care serology tests will enable more timely and convenient results
for individuals who want to understand if they have previously been infected with the
virus that causes COVID-19."

Benefits:
• Results in 15 minutes
• High accuracy
• Easy to use
• No equipment required

Packing Contents:
• Tests
• Disposable pipettes
• Sterile safety lancet
• Buffer
• Package insert
• Alcohol Prep pad

Features:
• Packing Size: 20pcs/Box,640pcs/carton
• Sample: Whole Blood/Serum/Plasma
• Testing time: 15 minutes
• Shelf Life: 9 months
• Storage Condition: 2 °C ~ 30 °C

EUA Authorized Serology Test Performance – Hangzhou Biotest Biotech RightSign COVID-19 IgG/IgM Rapid Test Cassette

• Developer: Hangzhou Biotest Biotech
• Test: RightSign COVID-19 IgG/IgM Rapid Test Cassette
• Technology: Lateral Flow
• Target: Spike



Links:
FDA Letter of Authorization

Instructions for use

IgG/IgM Rapid Test Cassette Package Insert