IgM antibody, the antibody will bind to the colloidal gold- Storage Instructions |

labeled novel coronavirus antigen. The antibody/antigen The reagent should be stored in the dark at room temperature
complex will be captured by the anti-human IgM antibody (2° to 45°C) and has a shelf-life of 12 months. The container

COVID-19 INFECTIOUS
DISEASE
immobilized on the membrane, forming a red M line and
indicating a positive result for the IgM antibody.
should be protected from light after being opened. Do not
freeze.

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

2 | Positive Result, M only Sample Quantity 397 128 See

Consult
• If both the quality control line (C) and the detection line M IgG & IgM Positive 256 1 Instructions
Instructions
appears, then the novel coronavirus IgM antibody has been For Use
IgG Positive 24 1
detected and the result is positive for the IgM antibody. IgM Positive 72 10

Sensitivity 88.66% Buffer Instructions

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

Internal Quality Control Procedure |

BioMedomics, Inc.
Each Test Cassette device has a built-in control. A red 1100 Perimeter Park Dr., Ste. 104
colored line in the detection window at the Control line can Morrisville, NC 27560, USA MT Promedt Consulting GmbH
+1-919-890-3070 Altenhofstrasse 80
be considered an internal positive procedural control. The
66386 St. Ingbert, Germany
Control line will appear if the test procedure has been correctly www.BioMedomics.com | info@BioMedomics.com +49-68-94-58 10 20

51-PI-002.EN-02