The COVID-19 IgG/IgM Rapid Antibody Test has

emerged as a critical part of the arsenal for delivering

a swift diagnosis and discovery of Antibodies — with
results in 15 minutes or less. Deploy these tests in a
variety of locations such as physicians' offices, urgent
care clinics and other point-of-care locations.

Because of its portability and speed, rapid IVD

testing has been crucial in battling COVID-19
across the globe.

TEST PROCEDURE

Step Step
Prick finger
1
Place 2-3
and collect
blood sample 3 drops
on buffer

Step Step
Add 1 drop Read result in 5-10
2 of whole
blood
4 minutes, no later than
15 minutes

I N T E R P R E TAT I O N O F R E S U LT S

P O S I T I V E: PERFORMANCE CHARACTERISTICS:
(a) (b) (c)
• IgM Positive (a): Colored line near • The COVID-19 lgG/lgM Rapid Test has been evaluated
lgM+C = Patient has Covid19 and with the 800 samples (of 708 cases) obtained from patients
is in the early phase exhibiting pneumonia or respiratory symptoms
C C C
• The results were compared to clinical diagnosis of COVID-19
• IgG and IgM Positive (b): Colored line lgM
lgG
lgM
lgG
lgM
lgG
near lgG+lgM+C = Patient has • Among the 800 samples, a total of 40 samples from
Covid19 and is in the advanced phase 19 cases with incomplete information or repeated tests
S S S are excluded
• IgG Positive (c): Colored line near • As a result, 760 samples from 689 cases were included
IgG+C = Patient had Covid19 and in the statistics
now has IgG antibodies

COVID-19 Antibody (lgM/lgG) Combined Test Kit

N E G AT I VE : IN VA L ID :
Colored line near C 1. No line appears
Clinical Case
appears and no other or CONFIRMED EXCLUDED TOTAL
colored line appears 2. Unreadable
Postive 280 39 319

Negative 6 435 441

C C C C C Total 266 474 760

lgM lgM lgM lgM lgM
lgG lgG lgG lgG lgG

Sensitivity.......................... 97.90%
RESULTS Specificity ......................... 91.77%
S S S S S Overall ............................... 94.08%
Features and Benefits
• Qualitative detection of IgG and IgM antibodies
that bind to COVID-19 causing virus
• Simple and easy to use
• Healthcare providers can administer tests at the
point-of care or laboratories
• Results delivered within minutes
DISCLAIMER
• COVID-19 IgG/IgM Rapid Test is a solid phase
immunochromatographic assay used in the rapid, qualitative and
differential detection of IgG and IgM antibodies to the 2019 novel
coronavirus in human whole blood, serum or plasma
• Results from antibody testing should not be used as the sole basis
to diagnose or exclude SARS-CoV-2 infection or to inform
infection status.
• Negative results do not rule out SARS-CoV-2 infection,
particularly in those who have been in contact with the virus.
• Follow-up testing with a molecular diagnostic should be
considered to rule out infection in these individuals.
• Positive results may be due to past or present infection with
non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1,
NL63, OC43, or 229E.
• It is not known whether persons having antibodies to
SARS-CoV-2 are not infectious, can be re-infected or may
experience COVID-19 in the future.
• Not for use in blood screening.
Package Includes
• 25 test per kit
• Each kit includes 25 cassettes, 25 pipettes,
25 lancets, 25 alcohol swabs, 2 buffer solutions
Product Code – COVTEST
• For use only by clinical laboratories and healthcare workers
at the point-of-care. All other use is prohibited.
• Laboratories within the United States and its territories are
required to report all positive results to the appropriate public
health authorities.
• Manufactured in China by Medical System Biotechnology Co., Ltd
(SHE: CN: 300439), a publicly traded Chinese company,
distributed in the US by RapidIVD, a PMT Medical company
• Medical System Biotechnology has notified the FDA that they
have validated and will begin offering the COVID-19 IgG/IgM
Rapid Test. The test is being made available under compliance
with Section IV.D. of the FDA’s Policy for Diagnostic Tests for
Coronavirus Disease-2019 during the Public Health Emergency.
Updated FDA guidance, issued on March 16, 2020, allows the
distribution of this product for diagnostic use by professionals
within highly complex settings and or pharmacies. The updated
policy can be viewed by clicking here.
• This test is FDA EUA approved, but has not been reviewed
by the FDA.