IgM antibody, the antibody will bind to the colloidal gold-
labeled novel coronavirus antigen. The antibody/antigen
COVID-19 INFECTIOUS
DISEASE
IgM-IgG Rapid Test
Instructions For Use
Intended Use |
BioMedomics Rapid IgM-IgG Combined Antibody Test for
COVID-19 is used to qualitatively detect IgG and IgM antibodies
of the novel coronavirus in human serum, plasma or whole
blood in vitro.
Summary |
Coronavirus (CoV) belongs to the Coronaviridae family and
is divided into three types: α, β and γ. Alpha and beta are
only pathogenic to mammals and gamma mainly causes bird
infections. CoV is mainly transmitted through direct contact
with secretions or through aerosols and droplets. There is also
evidence that it can be transmitted through the fecal-oral route
as well. So far there are seven types of human coronavirus
(HCoV) that cause human respiratory diseases: HCoV-229E,
HCoV-NL63, HCoV-OC43, HCoV-HKU1, SARS-CoV, MERS-CoV
and the novel coronavirus (2019). The novel coronavirus (2019)
was discovered in 2019 in Wuhan, China with viral pneumonia
cases and clinical manifestations were fever, fatigue, cough,
and other symptoms which can rapidly develop into severe
pneumonia, respiratory failure, septic shock, multiple organ
failure, severe acid-base metabolism disorders, etc. and is life-
threatening.1,2,3
Test Principle |
BioMedomics Rapid IgM-IgG Combined Antibody Test
for COVID-19 is immunochromatography based. The test
card contains (1) colloidal gold-labeled recombinant novel
coronavirus antigen, (2) two detection lines (G and M lines) and
one quality control line (C) fixed on a nitrocellulose membrane.
M is fixed with monoclonal anti-human IgM antibody for
detecting the novel coronavirus IgM antibody. G is fixed with
monoclonal anti-human IgG antibody for detecting the novel
coronavirus IgG antibody. The quality control antibody is fixed
on the C line.
When an appropriate amount of test sample is added to the
sample well of the test cassette, the sample will move forward
along the test card via capillary action. If the sample contains
Storage Instructions |
complex will be captured by the anti-human IgM antibody The reagent should be stored in the dark at room temperature
immobilized on the membrane, forming a red M line and
indicating a positive result for the IgM antibody.
(2°C to 45°C) and has a shelf-life of 12 months. The container
should be protected from light after being opened. Do not
freeze.
If the sample contains IgG antibodies, the antibody will bind to
the colloidal gold-labeled novel coronavirus antigen and the Sample Requirements |
antibody/antigen complex will be captured by the antibody • Suitable for human serum, plasma, or whole blood samples
immobilized on the membrane, forming a red G line and (capillary or venous) including samples prepared by commonly-
indicating a positive result for the IgG antibody. used anticoagulants (EDTA, heparin, sodium citrate).
If neither antibody is present, a negative result is displayed. The
• Fresh samples should be collected and tested immediately.
• Serum and plasma samples can be stored at 2-8°C for 5 days.
card also contains a quality control line (C). Regardless of what If long-term storage of serum or plasma samples is required,
antibodies are present the C line should appear to indicate store at -20°C and avoid repeated freeze/thaw cycles.
that the sample has been transported properly through the • Anticoagulated whole blood samples can be stored at 2-8°C
membrane. If the C line does not appear it indicates that for 7 days.
the test result is invalid and a new, unopened test cassette is • Before testing, samples stored in refrigerated or frozen storage
required to retest the sample. should be slowly returned to room temperature (15-30° C) and
stirred. When particulates are clearly visible in the sample the
Contents of the Kit | precipitate should be removed by centrifugation before testing.
One test kit contains:
20 Test Cassettes | 1 Buffer Solution Bottle | 1 Package Insert Test Procedure |
One test cassette contains: Do not open pouch until ready to use. Prep necessary
• Dried reagents with stabilizers materials: Test cassette | Buffer solution | Capillary Sampler
• Colloidal gold-labeled novel coronoavirus antigen Label Test cassette with patient ID.
• Anti-mouse IgG polyclonal antibody
• Anti-human IgG monoclonal antibody 1 | Obtain a specimen using standard laboratory protocols.
• Anti-human IgM monoclonal antibody Using capillary sampler, obtain 20µL of fingerstick or venous
whole blood specimen or 10µL of serum or plasma.
Materials not provided but required:
• For intravenous sampling follow standard laboratory protocols.
Capillary Samplers | Lancet | Alcohol Wipes | Gloves | Timer
2 | Dispense the specimen into the Test Cassette sample well.
Warnings and Precautions |
• Ensure that the entire sample is dispensed into the sample
• Only for human in vitro clinical diagnostics only.
well.
• The product should only be used by trained clinical
professionals.
3 | Remove cap of the Buffer Solution bottle and dispense 2-3
• After opening the sealed cassette pouch the test should be
drops into the Test Cassette sample well.
used within one hour.
• Remove any air bubbles in the dropper.
• Do not immerse test cassette in water.
• Do not freeze test cassette or buffer solution.
• Test on a level surface at room temperature.
• Handle specimens in accordance to the OSHA Standard on
4 | Allow test to run for 10 minutes. Read the results by viewing
Bloodborne Pathogens.4
the detection window.
• Wear protective gloves, clothing, and eyewear.
• Test results that have run over 15 minutes are invalid.
• Wash hands thoroughly after handling specimens.
• Do not use test cassette, buffer solution, or any kit component
beyond the indicated expiration date.
Test Method Limitations |
• This product can only be used to detect the IgG and IgM
• Dispose of all used or damaged test cassettes, capillary
antibodies of the novel coronavirus in human whole blood
samplers, or other kit components as biohazardous materials.
(capillary or venous), serum, or plasma. It cannot be used with
• Do not use test cassette, buffer solution, or any other kit
other body fluids or secretions.
components if the pouch is damaged or the seal is broken.
• This product is only for qualitative testing and the specific
• Do not use samples containing lipids, hemolysis, or turbidity
content of each indicator must be measured using other
which can affect results.
quantitative methodologies.
• Not for use with heat inactivated or other inactivated human
• Negative results may be caused by low concentrations of the
specimen (blood, serum, plasma).
novel coronavirus IgG/IgM antibody in the sample and therefore invalid and a new test must be performed. If the problem
Do Not
cannot completely rule out the possibility of infection. persists, please contact your local vendor or BioMedomics for Manufacturer
Reuse
• The results of this test are for clinical reference only and should technical support.
not be the only basis for diagnosis. Results should be used
In Vitro
in combination with clinical observations and other testing Performance Characteristics |
Expiration Diagnostic
methods. Method Comparison | In order to test the detection sensitivity IVD Medical
• Test results can be affected by temperature and humidity. Date
and specificity of this test, blood samples were collected from
Device
COVID-19 patients from multiple Chinese hospitals and Chinese
Display of Results/Expected Values | CDC laboratories. The tests were done separately at each Storage
A total of three detection lines are possible, with the control site. A total of 525 cases were tested: 397 (positive) clinically Batch
Temperature
(C) line appearing when sample has flowed through the confirmed (including PCR test) SARS-CoV-2-infected patients Code
Range
cassette. and 128 non- SARS-CoV-2-infected patients (negative). The
testing results of vein blood without viral inactivation were
1 | Negative Result summarized in the table below: Catalog Contains
• If only the quality control line (C) appears and the detection Number <n> tests
lines G and M are not visible, then no novel coronavirus Positive Test Result Negative Test Result

antibody has been detected and the result is negative. Sample Quantity 397 128
See
IgG & IgM Positive 256 1 Consult
2 | Positive Result, M only Instructions
Instructions
• If both the quality control line (C) and the detection line M
IgG Positive 24 1 For Use
appears, then the novel coronavirus IgM antibody has been IgM Positive 72 10

detected and the result is positive for the IgM antibody.
3 | Positive Result, G only
• If both the quality control line (C) and the detection line G
appears, then the novel coronavirus IgG antibody has been
detected and the result is positive for the IgG antibody.
4 | Positive Result, G and M
• If the quality control line (C) and both detection
lines G and M appear, then the novel coronavirus
IgG and IgM antibodies have been detected and the
result is positive for both the IgG and IgM antibodies.
Sensitivity 88.66%
Buffer Instructions
Specificity 90.63% Solution For Use
Cross Reactivity | In testing, this test did not cross-react with
Authorized EU
FLuA, FluB or RSV antibodies. SARS-COV1 has not yet been Test Cassette
Representative
tested.
Notes for Clinical Use in United States |
Laboratories and healthcare providers must include this
information in their patient test report as specified in FDA
guidance:
References
1. Li, etc., Early Transmission Dynamics in Wuhan, China of Novel Coronavirus–
• This test has not been reviewed by the FDA. Infected Pneumonia,DOI: 10.1056/NEJMoa2001316.
• Negative results do not rule out SARS-CoV-2 infection, 2. Li Taisheng, Peking Union Medical College Hospital’s Proposal for Diagnosis
particularly in those who have been in contact with the virus. and Treatment of “Novel Coronavirus Infected Pneumonia” (V2.0), Union Medical
Journal, 2020.1.27.
Follow-up testing with a molecular diagnostic should be 3. Wei Qiuhua, Disinfection measures for pneumonia epidemic sources of novel
considered to rule out infection in these individuals. coronavirus infection in 2019, Chinese Journal of Disinfection, 2020 (37) 1,59-62.
4. Chao, E.L.; Henshaw, J.L., Occupational Safety and Health Administration:
• Results from antibody testing should not be used as the sole Model Plans and Programs for the OSHA Bloodborne Pathogens and Hazard
basis to diagnose or exclude SARS-CoV-2 infection or to Communications Standards. OSHA 3186-06R, 2003.
inform infection status.
• Positive results may be due to past or present infection with Scan for intructions
non-SARS-CoV-2 coronavirus strains, such as coronavirus in other languages
HKU1, NL63, OC43, or 229E.
• Not for the screening of donated blood

Internal Quality Control Procedure |

Each Test Cassette device has a built-in control. A red
BioMedomics, Inc.
colored line in the detection window at the Control line can 1100 Perimeter Park Dr., Ste. 104
be considered an internal positive procedural control. The Morrisville, NC 27560, USA MT Promedt Consulting GmbH
+1-919-890-3070 Altenhofstrasse 80
Control line will appear if the test procedure has been correctly
66386 St. Ingbert, Germany
performed. If the Control line does not appear, the test is www.BioMedomics.com | info@BioMedomics.com +49-68-94-58 10 20

51-PI-002.EN-04