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INNOVA SARS-CoV-2 Antigen Rapid Qualitative Test
* DETECT INFECTION IN 20 MINUTES - CHEEK/NASAL SWAB 
* NO MACHINE OR COLD CHAIN LOGISTICS NEEDED
* COMBINED SPECIFICITY OF 98.98%
* CE APPROVED
* FDA EUA IN PROCESS
The only COVID-19 antigen test that does not require a machine to process results

COVID-19 RAPID DIAGNOSTIC TEST OFFERINGS

ANTIGEN

Device: INNOVA SARS-CoV--2 Antigen Rapid Qualitative Test

ANTIBODY & PCR SWAB

Device: BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test (Antibody)

Device: BIOTIME Virus RNA Collection Kit (inactivated virus)

Device: BIOTIME Novel Coronavirus (SARS-CoV--2) Real-Time Multiplex RT--PCR Kit

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.

an Innova Medical Group Inc. company, (CALIFORNIA)

Authorized, Global Manufacturer's Representative: COVIDSignals™

(MAINE and GERMANY), a Nano LiquiTec Group company.

FDA EUA GRANTED RAPID ANTIBODY TEST

Authorized by the U.S Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) for use by authorized laboratories (EUA201304).

Device: BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test (Antibody)

FOR IN-VITRO DIAGNOSTIC USE ONLY

MANUFACTURED IN CHINA, TURKEY, AND SOON, IN TO THE UNITED STATES

 

DISTRIBUTED BY COVIDSIGNALS™ (MAINE)

Measures levels of IgM and IgG 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

PCR SWAB TESTS

Virus RNA Collection Kit (inactive virus)

Novel Coronavirus (SARS-CoV--2) Real-Time Multiplex RT--PCR Kit

RAPID ANTIBODY  TESTS

SARS-CoV-2 IgG/IgM Rapid Qualitative Test (25T/10T)


SARS-CoV-2 Total Antibody Rapid Qualitative Test


SARS-CoV-2 Antigen Rapid Qualitative Test

FASTEP® RAPID ANTIBODY TEST

Assure COVID-19 IgG/IgM Rapid Test Device (FaStep®)

RAPID ANTIGEN  TEST

INNOVA SARS-CoV--2 Antigen Rapid Qualitative Test

Accurate

* Combined Accuracy: 98.98% 

* No cross-reactivity with other respiratory diseases

 

Easy-to-Use

* Uses cheek or nasal swab, or sputum

 

Scalable

*  Speed >> 20 minutes to obtain positive result – 30 mins to a negative result

*  No machine required to process results

*  Point-of-care - POCT 

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) 

 

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

The BIOTIME, INNOVA, and Assure FaStep® COVID-19 serology and antigen tests are CE Rated and bear 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

The BIOTIME antibody test provides qualitative detection of SARS-CoV-2 and total antibodies in plasma, whole blood, and serum. The INNOVA antigen and BIOTIME antibody tests utilize Colloidal Gold-labeled antigens (nanoparticles) to form a complex and determine results. 

GLOBAL LEADER IN SENSITIVITY & SPECIFICITY

BIOTIME has shipped over 70M tests to over 30 countries, worldwide. This test has been evaluated alongside 40+ competitive antibody

tests and regularly demonstrating superior results.

RESULTS IN MINUTES - POINT-OF-CARE

BIOTIME, INNOVA, and Assure tests provide highly-accurate results in minutes. 

CLINICALLY EVALUATED EFFICACY

Clinical sample set results demonstrate BIOTIME's antibody test's superiority to other COVID-19 antibody tests also granted Emergency Use Authorizations by the FDA. Additional clinical sample set data and a full technical dossier is available for review. Access the document library below.  

DOCUMENTATION LIBRARY

Click linked documents, below, to open or view our entire library

by clicking 'view documentation' and submitting an enquiry:

ANTIBODY TESTS OFFERING SIMPLE CARTRIDGE TESTING - NO MACHINE OR EQUIPMENT REQUIRED TO INTERPRET RESULTS

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

DOCUMENTATION & ENQUIRY

THANK YOU

Our teams in the United States, Germany, the UAE, and the UK are working steadily to respond to the large volume of inquiries we continue to receive regarding the FDA Emergency Use Authorized SARS-CoV-2 IgG/IgM Rapid Qualitative Tests for COVID-19 and the INNOVA Rapid Antigen Test.

 

Thank you for your interest and we look forward to serving you. 

COVIDSIGNALS

COVIDSignals™ (a Nano LiquiTec Group company - USA/Germany/UAE/UK) is the authorized, global manufacturer's representative of the BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test and INNOVA Rapid Anigen Test using the Colloidal Gold Immunochromatography Method, the BIOTIME PCR Swab Tests, and the Assure FaStep® Rapid Antibody Test 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.

FDA EUA GRANTED: Authorized by the U.S Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) for use by authorized laboratories (BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test - EUA201304).

CONTACT US

 

COVIDSignals™

Maine, US

enquiry@covidsignals.com

T: 207-271-9501

© 2020 by COVIDSignals™