DETERMINE COVID-19
EXPOSURE WITHIN 10-MINUTES

 
Superior specificity & sensitivity with data-backed results for the detection of SARS-CoV-2 antibodies, IgM & IgG
DETECTS EXPOSURE & VIRUS TRACKS AFTER INFECTION

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.

NHS.jpg

LABORATORY TESTED BY BRITAIN'S NATIONAL HEALTH SERVICE (NHS) 

 

We have performed tests using the Biotime COVID-19 serology

test on 50 PCR confirmed patients. The test picked up every,

single infected patient."

 

"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.

10-MINUTE RESULTS

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.  

DOCUMENTATION LIBRARY

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

Cassette Format 
  • 1 test/pouch, 25 tests/box
 

DOCUMENTATION & ENQUIRY

THANK YOU

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. 

COVIDSIGNALS

COVIDSignals™ is the distributor of Biotime's SARS-CoV-2 IgG/IgM Rapid Qualitative Tests using the Colloidal Gold Immunochromatography Method 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 COVID-19 virus infection.

This test is CE Rated and bears the CE marking. The CE marking is the manufacturer's declaration that the product meets EU standards for health, safety, and environmental protection.

CONTACT US

 

COVIDSignals™

Maine, US

enquiry@covidsignals.com

T: 207-271-9501

© 2020 by COVIDSignals™