FOR PROFESSIONAL USE ONLY
COVID-19 RAPID DIAGNOSTIC TESTS
Biotime's Serology Test Offerings:
SARS-CoV-2 IgG/IgM Rapid Qualitative Test
SARS-CoV-2 IgM Rapid Qualitative Test
Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
a Portfolio Company of Pasaca Capital Inc. (CALIFORNIA)
Distributor: COVIDSignals™ (MAINE)
Biotime's COVID-19 IgM/IgG antibody test is a rapid, qualitative, and convenient immunochromatographic in-vitro assay for the differential detection of IgM and IgG antibodies to the COVID-19 virus in human serum, plasma, or whole blood samples.
It is designed to aid in the determination of recent or previous exposure to COVID-19, as well as virus tracking for the status of the disease after virus infection.
This test measures the level of both IgM and IgG antibodies, while a second option measures only IgM antibodies.
IgM Positive = Virus is active and recent
IgM and IgG Positive = Virus is active and recent
IgG Positive = Virus is hidden, inactive, or dormant
FOR IN-VITRO DIAGNOSTIC USE ONLY
MANUFACTURED IN CHINA, TURKEY, AND SOON, IN TO THE UNITED STATES
DISTRIBUTED BY COVIDSIGNALS™ (MAINE)
REGISTERED - THE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) (UK)
Xiamen Biotime is registered with the MHRA.
The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom and is responsible for ensuring that medicines and medical devices work and are acceptably safe.
LABORATORY TESTED BY BRITAIN'S NATIONAL HEALTH SERVICE (NHS)
"To further elaborate, the test picked up IgM positives in early-stage disease, IgG positives in later-stage disease, and IgM/IgG positive in mid-stage. We are very pleased with these findings and are recommending the service approve these tests.”
CE RATED - MEETING HEALTH, SAFETY, AND ENVIRONMENTAL STANDARDS
Biotime's COVID-19 serology test is CE Rated and bears the CE marking. The CE marking is the manufacturer's declaration that the product meets the European Union's standards for health, safety, and environmental protection.
COLLOIDAL GOLD IMMUNOCHROMATOGRAPHY METHOD
Provides qualitative detection of SARS-CoV-2 and total antibodies in human whole blood, serum, or plasma. COVID-19 antibodies combine with Colloidal Gold-labeled antigens (nanoparticles) to form a complex and determine results.
GLOBAL LEADER IN SENSITIVITY & SPECIFICITY
Biotime has shipped over 30M tests to, at least, 12 countries, worldwide. This test has been evaluated alongside 40+ competitive antibody
tests. Results from the Biotime test continue to be superior to all others.
Results within 10 minutes - a strong, positive sample will show a visible red color band at the test line in approximately 1-minute.
CLINICALLY EVALUATED EFFICACY
Clinical sample set results demonstrate Biotime's superiority to all COVID-19 antibody tests granted Emergency Use Authorizations by the FDA, to date. Additional clinical sample set data and a full technical dossier is available for review. Access the document library below.
View the following documents immediately:
Clinical Test Results
Report From Britain’s National Health Service (NHS)
FDA EUA Filing Acknowledgement
Clinical Use Instructions
Antibody Test Comparison Table
Doctor's Explanation on Antibody Tests
Technical File Review Report & CE Mark
SIMPLE CARTRIDGE TESTING - NO MACHINE OR EQUIPMENT REQUIRED TO INTERPRET RESULTS
1 test/pouch, 25 tests/box
DOCUMENTATION & ENQUIRY
Our team is working steadily to respond to the large volume of enquiries we continue to receive regarding the Biotime Rapid Diagnostic IgG/IgM Antibody Test for COVID-19.
Thank you for your interest and enquiry.