INFECTIOUS

DISEASE

Rapid IgM-IgG
COVID-19 Combined Antibody test
for Coronavirus
BioMedomics’ new rapid test provides accurate
COVID-19 infection diagnosis in 15 minutes.
It is widely accepted that IgM provides the first line of defense
during viral infections, follwedby the generation of adaptive, high
affinity IgG responses for long term immunity and immunological
memory. Therefore testing of COVID-19 IgM and IgG antibodies is
an effective method for the rapid diagnosis of COVID-19 infection.
Furthermore, detection of COVID-19 IgM antibodies tends to
indicate a recent exposure to COVID-19, whereas detection of
COVID-19 IgG antibodies indicates a later stage of infection. Thus,
this combined antibody test could also provide information on the
stage of infection.

4 Simple Steps
1 2 3 4
C
G
C
G
M
M

C
G
M
Collect blood Add blood sample Place 2-3 drops of Read results after
sample to sample well buffer in sample well 15 minutes

Comparison With PCR Nucleic Acid Tests

PCR Nucleic Acid Tests BioMedomics IgM/IgG Rapid Test

Turnaround Time > 1 Hour 15 Minutes

Facility Requirement PCR Laboratory No special facilities needed
Requires trained technicians Whole blood, serum, or plasma
Requires expensive equipment Test can be used anywhere
Operation
Complicated operation No specialized training required
Prone to False Negatives Results are clear and easy to read
Transport/Storage Requires cold-chain Room Temperature
Clinical Value Commonly used, gold standard Highly specific, can detect “silent infections”

Results
• Easy to use
• Works with whole blood, serum,
• and plasma
• Tests for 2 antibodies
• 4 simple steps, results in 15
• minutes
• No special equipment needed
• No sample transport required

| www.BioMedomics.com | info@BioMedomics.com

COVID-19
INFECTIOUS
DISEASE
IgM-IgG Rapid Test
Instructions For Use
For Research Use Only. Not for Use in
Diagnostic Procedures.
Contents of the Kit |
One test kit contains:
20 Test Cassettes | 1 Buffer Solution Bottle | 1 Package Insert
One test cassette contains:
• Dried reagents with stabilizers
• Colloidal gold-labeled novel coronoavirus antigen
• Colloidal gold-labeled rabbit IgG
• Goat anti-rabbit IgG polyclonal antibody
• Mouse anti-human IgG monoclonal antibody
• Mouse anti-human IgM monoclonal antibody
Materials not provided but required:
Capillary Sampler | Lancet | Alcohol wipes | Gloves | Timer
Warnings and Precautions |
• For research use only. Not for use in diagnostic procedures.
• The product should only be used by trained clinical
professionals.
• After opening the sealed cassette pouch the test should be
used within one hour.
• Do not immerse test cassette in water.
• Do not freeze test cassette or buffer solution.
• Handle specimens in accordance to the OSHA Standard on
Bloodborne Pathogens.1
• Wear protective gloves, clothing, and eyewear.
• Wash hands thoroughly after handling specimens.
• Do not use test cassette, buffer solution, or any kit component
beyond the indicated expiration date.
• Dispose of all used or damaged test cassettes, capillary
samplers, or other kit component as biohazardous materials.
• Do not use test cassette, buffer solution, or any other kit
components if the pouch is damaged or the seal is broken.
• Do not use samples containing lipids, hemolysis, or turbidity
which can affect results.
Storage Instructions | • Test results can be affected by temperature and humidity.
The reagent should be stored in the dark at room temperature
Display of Results/Expected Values |
(18° to 26°C) and has a shelf-life of 12 months. The container
should be protected from light after being opened. Do not A total of three detection lines are possible, with the control
freeze. (C) line appearing when sample has been flowed through
the cassette.
Sample Requirements |
• Suitable for human serum, plasma, or whole blood samples 1 | Negative Result
including samples prepared by commonly-used anticoagulants • If only the quality control line (C) appears and the detection
(EDTA, heparin, sodium citrate). lines G and M are not visible, then no novel coronavirus
• Fresh samples should be collected and tested immediately. antibody has been detected and the result is negative.
• Serum and plasma samples can be stored at 2-8°C for 5 days.
If long-term storage of serum or plasma samples is required, 2 | Positive Result, M only
store at -20°C and avoid repeated freeze/thaw cycles. • If both the quality control line (C) and the detection line M
• Anticoagulated whole blood samples can be stored at 2-8°C appears, then the novel coronavirus IgM antibody has been
for 7 days. detected and the result is positive for the IgM antibody.
• Before testing, samples stored in refrigerated or frozen storage
should be slowly returned to room temperature (15-30° C) and 3 | Positive Result, G only
stirred. When particulates are clearly visible in the sample the • If both the quality control line (C) and the detection line G
precipitate should be removed by centrifugation before testing. appears, then the novel coronavirus IgG antibody has been
detected and the result is positive for the IgG antibody.
Test Procedure |
Do not open pouch until ready to use. Prep necessary 4 | Positive Result, G and M
materials: Test cassette | Buffer solution | Capillary Sampler • If the quality control line (C) and both detection
Label Test cassette with patient ID. lines G and M appear, then the novel coronavirus
IgG and IgM antibodies have been detected and the
1 | Obtain a specimen using standard laboratory protocols. result is positive for both the IgG and IgM antibodies.
Using capillary sampler, obtain 20µL of fingerstick or venous
whole blood specimen or 10µL of serum or plasma.
• For intravenous sampling follow standard laboratory protocols.
2 | Dispense the specimen into the Test Cassette sample well.
• Ensure that the entire sample is dispensed into the sample
well.
3 | Remove cap of the Buffer Solution bottle and dispense 2-3
drops into the Test Cassette sample well.
• Remove any air bubbles in the dropper.
• Test on a level surface at room temperature.
4 | Allow test to run for 15 minutes. Read the results by viewing
the detection window.
• Test results that have run over 20 minutes are invalid.
Test Method Limitations |
• This product can only be used to detect the IgG and IgM
antibodies of the novel coronavirus in human blood, serum, or
plasma. It cannot be used with other body fluids or secretions.
• This product is only for qualitative testing and the specific
content of each indicator must be measured using other
quantitative methodologies.
• Negative results may be caused by low concentrations of the
novel coronavirus IgG/IgM antibody in the sample and therefore
cannot completely rule out the possibility of infection.
DECLARATION OF NOTIFICATION
As the EU Representative, SUNGO Europe B.V., hereby declare that:

Jiangsu Medomics medical technology Co.,Ltd

F3,Building D,No.3-1 Xinjinhu road,Jiangbei new area, Nanjing,China

has signed the EC Declaration of Conformity in agreement with the Annex III of the
European Directive 98/79/EC on In Vitro Diagnostic Medical Devices and has
submitted the required technical documentation, for the following IVD products (for
professional use only):

Name Device Reference Numbers

A Rapid IgM-IgG Combined Antibody Test Kit for SARS-CoV-2 (ICA ) 20200558
SARS-CoV-2 (ORF1ab, E & N genes) nucleic acid test kit
20200558
(Fluorescent Probe-based real-time PCR assay)
Influenza A, Influenza B andSARS-CoV-2 nucleic acid test kit
20200558
(Fluorescent Probe-based real-time PCR assay)
19 types of respiratory pathogens nucleic acid multiplex test panel
(SARS-CoV-2 included, Fluorescent Probe-based real-time PCR 20200558
assay)

The notification to the Netherlands Competent Authorities has been carried out on
March 10, 2020 by SUNGO Europe B.V., the appointed Authorized Representative of
Jiangsu Medomics medical technology Co.,Ltd

Information on the notification to the competent Authorities of other European countries

is available upon request.

SUNGO Europe B.V.

Authorized Representative

SUNGO Europe B.V. | Office Address: Olympisch Stadion 24, 1076DE Amsterdam,
Netherlands