COVID-19 IgG IgM Rapid Test Cassette

The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has not been FDA cleared or approved.

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Availability: Commercially Available

Andy Wright
President
AWright@MercedesScientific.com
+1 800 331 2716 Ext. 205
12210 Rangeland Parkway
Lakewood Ranch, Florida 34211
USA
www.mercedesscientific.com
Manufacturer
Mercedes Scientific
Product Name
COVID-19 IgG IgM Rapid Test Cassette
Detection Category
Biological
Detection Principle
Immunological;
Detection Method
Lateral Flow Hand Held Immunoassay;
Application
Diagnostics;
Product Model Number
HGS GCCOV402A
Equipment Type
Diagnostic
Product Synopsis
The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has not been FDA cleared or approved.
Availability
Commercially Available
Technology Readiness Level (TRL)
9
Market Entry Date
June 2020
User Feedback Sources
Indifferent/No user feedback
No Information Is Available
Transportability
Handheld
Shelf Life
<5 years; 24 Months from Date of Manufacturer at 36° - 86°F (2°-30°C)
Unit Cost
$375.00 for a box of 25 kits
Tested For Biological Agents
anti-SARS-CoV-2 IgM, IgG antibodies
Sample Introduction
Biological sample; Whole Blood, Serum, Plasma
Total Run Time
10 minutes
Other Operational Parameters
Buffer included
No Information Is Available
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