COVID-19 IgG/IgM Rapid Test
(Colloidal Gold)
COVID-19 IgG/IgM Rapid Test
(Colloidal Gold)
【Catalog Number】
REF CoV19-RT
CoV19-RT-10 - CoV19-RT-5 - CoV19-RT-1
【Package Size】
□ 20 Tests/box □ 10 Tests/box
□ 5 Tests/box □ 1 Tests/box
【Intended Use】
The COVID-19 IgG/IgM Rapid Test is intended for use to
qualitatively detect IgG and IgM antibodies of the novel
coronavirus in human serum, plasma or whole blood in
vitro.
The COVID-19 IgG/IgM Rapid Test is only used as a
supplementary indicator for the detection of suspected
new coronavirus nucleic acid negative cases, or is used
in coordination with nucleic acid detection in the
diagnosis of suspected cases. It can not be used as a
basis for the diagnosis and exclusion of new coronavirus
infection pneumonia, and is not suitable for general
population screening.
【Test Principle】
1. Colloidal gold labeling and membrane immunechro -
matography is applied to detect COVID-19 IgM/IgG
antibodies in samples.
2. Sample well contains colloidal gold-labeled COVID-
19 recombinant protein that binds to COVID-19 IgM
or IgG to form a complex;
3. G-line (IgG detection line) is coated with mouse anti-
human IgG that captures the COVID-19 IgG positive
complex, and a red purple line will be generated to
indicate the sample is COVID-19 IgG positive,
otherwise the sample is COVID-19 IgG negative or
below the limit of detection;
4. M-line (IgM detection line) is coated with mouse anti-
human IgM that captures the COVID-19 IgM positive
complex, and a red purple line will be generated to
Revision: 1.1
Instructions For Use
indicate the sample is COVID-19 IgM positive,
otherwise the sample is COVID-19 IgM negative or
below the limit of detection;
5. C-line (control line) is a built-in control line that
captures control substrates and generates a red
purple line to indicate the whole procedure is
standardized and under control.
【Contents of the Kit】
1. One test cassette contains:
Dried reagents with stabilizers
Colloidal gold-labeled novel coronoavirus antigen
Colloidal gold-labeled mouse IgG
Goat anti- mouse IgG polyclonal antibody
Mouse anti-human IgG monoclonal antibody
Mouse anti-human IgM monoclonal antibody
2. Sample Dilution contains:
20mM pH 7.4 Phosphate Buffer Saline (PBS), 0.05%
Tween20, 0.02% Proclin300.
3. Materials: Capillary Sampler
4. Materials not provided but required:
Lancet | Alcohol wipes | Gloves | Timer
【Storage and Handling】
1. Store at 2-30°C in a dry place and avoid direct
sunlight. Do not freeze.
2. After opening the inner package, the test card will fail
due to moisture absorption. Please make it within 1
hour.
【Sample Requirements】
1. Suitable for human serum, plasma and whole blood
samples;
2. Serum or plasma samples are collected by vein via
conventional methods and obtained via proper
centrifugation, suitable anticoagulant includes
sodium heparin, EDTA or sodium citrate;
3. Collected samples are suggested to be tested
immediately, serum/plasma samples can be stored
at 2-8°C for 5 days, at -20°C for long-term storage
with repeated freeze-thaw cycles avoided.
4. Avoid samples with large amounts of lipids, apparent
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 COVID-19 IgG/IgM Rapid Test
(Colloidal Gold)
Instructions For Use

hemolysis or turbidity.
【Test Method】
Components of the kit should be used under after POSITIVE RESULT
Visible C-line and G-
returning to room temperature (25°C±5°C) as follows: line indicates
1. Remove the test strip from the sealed package, COVID-19 IgG
positive
mark the sample number, and lay it flat on the
Visible C-line and M-
working surface;
line indicates
2. Pipettes 10μL sample into the sample well vertically, COVID-19 IgM
positive
and add 2 drops of sample dilution (roughly 100μL)
into the sample well immediately; Visible C-line, G-line
and M-line indicates
3. Read the result within 10-15 minutes. COVID-19 IgG and
Note: Do not interpret the result after 15 minutes, for IgM positive
NEGATIVE RESULT
long-term preservation please take photos.
Visible C-line
【Interpretation of Results】 indicates COVID-19
Total of three detection lines are possible, with the IgG and IgM
negative
control (C) line appearing when sample has been flowed
INVALID RESULT
through the cassette.
1. Negative Result
If only the quality control line (C) appears and the
detection lines G and M are not visible, then no novel
Invisible C-line
coronavirus antibody has been detected and the result is indicates that the
result is invalid and a
negative.
re-test is required
2. Positive Result, M only
If both the quality control line (C) and the detection line
M appears, then the novel coronavirus IgM antibody has
been detected and the result is positive for the IgM
Note: The color depth of line is related to the
antibody.
concentration of test substrates, the result should be
3. Positive Result, G only
determined by the appearance of the colored line
If both the quality control line (C) and the detection line
regardless of the color intensity.
G appears, then the novel coronavirus IgG antibody has
【Quality Control】
been detected and the result is positive for the IgG
1. Each Test Cassette device has a built-in control. A
antibody.
red colored line in the detection window at the
4. Positive Result, G and M
Control line can be considered an internal positive
If the quality control line (C) and both detection lines G
procedural control.
and M appear, then the novel coronavirus IgG and IgM
2. The Control line will appear if the test procedure has
antibodies have been detected and the result is positive
been correctly performed. If the Control line does not
for both the IgG and IgM antibodies.
appear, the test is invalid and a new test must be
5. Invalid Result
performed.
If the quality control line (C) is not visible, then that
【Performance Characteristics】
the result is invalid and a re-test is required.
1. Comprehensively collect the test results of 600

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 COVID-19 IgG/IgM Rapid Test
(Colloidal Gold)
Instructions For Use

samples including 319 negative samples and 281
positive Nucleic Acid Test clinical confirmed samples.
The specificity is 98.43% (314/319), and the
sensitivity is 87.54% (246/281).
2. No cross reaction with other coronaviruses or other
viruses has been found, such as ocal human
coronavirus (hku1, OC43, nl63 and 229E), SARS
coronavirus and mers coronavirus;H1N1 (new H1N1
4. Fresh samples are highly recommended.
5. Wear protective clothing, gloves, mask, goggles for
safety.
6. Desiccants packed in aluminum foil bag should not
be taken orally.
【Disposal of the device】
The test samples shall be regarded as infectious
products, and the handling of reagents and samples

influenza virus (2009), seasonal H1N1 influenza shall be in accordance with the operation specifications

virus), H3N2, H5N1, h7n9, influenza B Yamagata, of infectious diseases laboratory, and attention shall be

Victoria, respiratory syncytial virus A, B, paid to the biosafety operation. All samples and reagents
used shall be in accordance with the specification for
parainfluenza virus 1, 2, 3, rhinovirus a, B, C,
infectious medical waste.
adenovirus 1, 2, 3, 4, 5, 7, 55, enterovirus a, B, C, D,
【Contact Information】
human lung virus, human partial lung virus, EB virus,
measles Virus, human cytomegalovirus, rotavirus,
norovirus, mumps virus, varicella zoster virus; also
Long Island Biotech, Inc.
no cross reaction with bacterial cells as Mycoplasma
pneumoniae and Chlamydia pneumonia. Add: #2, 22 Sawgrass Drive, Bellport, NY 11713, U.S.A

【Limitations】 Tel: +1-347-8292268

1. This product can only be used to detect the IgG
and IgM antibodies of the novel coronavirus in
Obelis s.a.
human blood, serum, or plasma. It cannot be used
Add: Bd. Général Wahis 53, 1030 Brussels, Belgium
with other body fluids or secretions.
2. This product is only for qualitative testing and the
specific content of each indicator must be measured Manufacturer
using other quantitative methodologies.
Authorized EU Representative
3. Negative results may be caused by low
concentrations of the novel coronavirus IgG/IgM Expiration Date

antibody in the sample and therefore cannot LOT Batch Code

completely rule out the possibility of infection.
REF Catalog Number
【Warnings and Precautions】
1. This product is a one-time consumable in vitro Consult Instructions
diagnostic reagent that should be used strictly in
accordance with this user manual, should not be Do not Reuse

reused, or used under damage or expiration.

IVD In Vitro Diagnostic Medical Device
2. Use of this product should follow all clinical laboratory
precautions.
3. Load sample as soon as possible after removing the
test strip from the sealed package as moisture
absorption may cause failure.

Revision: 1.1 3/3 Date: 2020.04.05