The BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test
Emergency Use Authorization (EUA) granted by the U.S. Food & Drug Administration (FDA) on 24 July 2020
Used to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection
Delivers a demonstrated superior, high-accuracy in specificity and sensitivity of 98+%
Results within 10-minutes, a strong positive result in as little 1 minute
No machine or equipment required to interpret results
Identifies SARS-CoV-2 IgM and IgG antibodies
Incorporates a German Nitrocellulose membrane, the most advanced in the world
Clinical sample testing performed with data available for review
Carries a CE Rating
Successfully evaluated by Britain's National Health Service (NHS)
Xiamen Biotime is registered with the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA)
FDA Authorized Product Details
The BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test is a qualitative test for the detection and differentiation of IgG and IgM antibodies against SARS-CoV-2 in human serum, plasma (potassium EDTA), and potassium EDTA venous whole blood. The product is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.
COVIDSignals™ can deliver 100,000 test kits a day while ramping to produce and deliver 500,000, then 1 million test kits daily
(over 30 million test kits monthly) to customers in finance, healthcare, manufacturing, transportation, entertainment, industry, infrastructure, government, laboratories, and organizations with proper test administering capabilities.
PRODUCTION IN CHINA, TURKEY, AND COMING SOON TO CALIFORNIA, USA
Ramping to produce 1M tests per day
Initial US production commences in summer 2020 with 100,000 units/day on a single production line and ramp-up to 500,000 units/day using
five lines. Production will ramp-up to 1M tests/day. Orders of 100k tests and above will only require a one week lead time.
Current Output in China and Turkey: 1M units/day in production
DEDICATED PRODUCTION LINES - ALLOCATED ON REQUEST
When demand requires, BIOTIME will continue adding capacity and dedicating specific lines to individual customers, upon request.
Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.
INTENDED FOR IN-VITRO, PROFESSIONAL USE ONLY