Test Result 5 MINS TO ACHIEVE

SARS-COV-2 SARS-COV-2 SARS-COV-2 SARS-COV-2 SARS-COV-2 SARS-COV-2 SARS-COV-2

COVID-19 SCREENING
C C C C C C C SARS-CoV-2 IgM&IgG Rapid Test
IgG IgG IgG IgG IgG IgG IgG
IgM IgM IgM IgM IgM IgM IgM
(Colloidal Gold-Labeled Immunoassay)

Positive Negative Invalid

Specifications
· Packing size: 20 tests/box · Test time: 5-10mins
· Storage condition: 2-30℃ · Sample type: 10ul serum/plasma, or 20ul whole blood
· Shelf life: 18 months

About Edan
Edan is a healthcare company dedicated to improving the human condition around the world by
delivering value-driven, innovative and high-quality medical products and services. For over 20 years,
Edan has been pioneering a comprehensive line of medical solutions that address a broad range of
healthcare practices including:
Diagnostic ECG Ultrasound Imaging In-Vitro Diagnostics
Patient Monitoring Point-of-Care Testing Veterinary
OB/GYN
Healthcare professionals around the world depend on Edan's breakthrough medical technologies
and outstanding customer support.

Global Headquarters:
Edan Instruments, Inc. | No.15 Jinhui Road, Pingshan District, Shenzhen
Kengzi Subdistrict, Pingshan District, Shenzhen | 518122 P.R. China
+86.755.26898326 | www.edan.com | info@edan.com
U.S. and Canada inquiries:
EDAN Diagnostics, Inc. | 9918 Via Pasar, San Diego, CA 92126
+1.858.750.3066 | www.edandiagnostics.com | edan-info@edandiagnostics.com
© Edan Instruments, Inc. All rights reserved. Features and specifications are subject to change without prior notice. ENG-SARS-CoV-2 IgM&IgG Rapid Test
No reproduction, copy or transmission may be made without written permission.
Not all products or features are available in all countries, contact Edan for local availability. -V1.0-20200319
SARS-CoV-2 IgM&IgG Rapid Test Lab test for suspected COVID-19
Colloidal Gold-Labeled Immunoassay
IgM/IgG
Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The
First week
SARS-CoV-2 virus that causes COVID-19 is a novel coronavirus that was first identified during an investi- Retest in one week
gation into an outbreak in China, 2019. At time of writing, cases of COVID-19 continue to rise daily
across the globe. The IgM/IgG that the test detects are specific to the SARS-CoV-2 virus, so a positive
result would indicate the patient has contracted COVID-19. Since there are two analytes of interest (IgM
IgM(+)/IgG(-) IgM(+)/IgG(+) IgM(-)/IgG(+) IgM(-)/IgG(-)
and IgG), there are two test lines on the strip. Only one test line needs to be seen for a positive diagnosis
(as well as the control line). COVID-19 COVID-19 IgG False Positive Not Infected
Acute Infection Acute Infection or Infected before

Incubation IgM IgM + IgG IgG IgM + IgG IgG

period
IgM(+)/IgG(-) IgM(+)/IgG(+) or IgM(-)/IgG(+) or IgG 4 times ↑
IgM(-)/IgG(+) IgM(+)/IgG(+)
IgG 4 times↑
IgM(+) False COVID-19 COVID-19 COVID-19
Antibody Level

positive Acute Infection Acute Infection Acute Infection

10ul serum or plasma 2-3 drops of diluent

First Infection Reinfection
Result
5-10 mins

20ul whole blood 2-3 drops of diluent

SARS-COV-2

C: Quality Control Line

ADVANTAGES
C
IgG IgG: IgG Detection Line
IgM: IgM Detection Line
• Rapid screening for COVID-19 within 5 mins
IgM
• Huge time and cost savings compared to lab screening

Sample Well • Easy to use: only a finger-prick sample to function

• Suitable for point of care testing, no extra training or equipment required