1) The document describes an IgG/IgM rapid test cassette that uses a lateral flow immunochromatographic assay to detect antibodies in whole blood, serum, or plasma that are produced in response to COVID-19 infection. 2) The test works by detecting IgG and IgM antibodies that bind to COVID-19 antigens conjugated with colloid gold, which migrate through the cassette to test lines containing immobilized antibody. Positive results indicate recent or past COVID-19 infection. 3) The test cassette has received FDA Emergency Use Authorization as a qualitative detection tool to aid in identifying individuals with an adaptive immune response to COVID-19. However, clinical diagnosis requires consideration of additional factors and follow-up testing may

1. IgG/IgM Rapid Test Cassettes
(Whole Blood/Serum/Plasma)
Lateral Flow Immunochromatographic Assay
Covid-19 Introduction
• Coronaviruses are enveloped RNA viruses distributed broadly among humans, other
mammal and birds that cause respiratory, enteric, hepatic and neurologic diseases.
• Three strains: SARS-CoV, MERS-CoV and 2019 Novel Coronavirus (COVID-19) are
zoonotic in origin.
• IgM antibodies appear within blood 3-5 days in symptomatic patients & 7 days for
asymptomatic patients. Overtime, IgM becomes undetectable
• IgG antibodies appear in blood within 2 weeks after infection. IgG remains elevated
overtime
• Seroconversion rate and antibody levels increase rapidly during the first two (2) weeks
• Positive results for both IgG and IgM could occur after infection and can be indicative of
acute or recent infection.
Covid-19 IgG/IgM Test Cassettes5/1/2020

2. IgG/IgM Rapid Test Cassettes
(Whole Blood/Serum/Plasma)
Lateral Flow Immunochromatographic Assay
Principle
• Uses anti-human IgM antibody (test line IgM, anti-human IgG (test line IgG) and
rabbit IgG (control line C) immobilized on a nitrocellulose strip.
• Conjugate pad contains colloidal gold conjugated to recombinant COVID-19
antigens conjugated with colloid gold (COVID-19 conjugates)
• When a specimen followed by assay buffer is added to the sample well, IgM &/or
IgG antibodies, if present, will bind to COVID-19 conjugates making antigen
antibodies complex.
• The complex migrates through nitrocellulose membrane by capillary action
• Complex meets the immobilized antibody line and the results appear
Covid-19 IgG/IgM Test Cassettes 25/1/2020

3. IgG/IgM Rapid Test Cassettes
with
FDA Emergency Use Approval/Authorization
Rapid Test Cassettes Description
Covid-19 IgG/IgM Test Cassettes 35/1/2020
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
framework/emergency-use-authorization

4. IgG/IgM Rapid Test Cassettes
Lateral Flow Immunochromatographic Assay
Results via Fingerstick
• IgG POSITIVE: *The colored line in the control line region (C) appears and a colored line appears in test
line region IgG. The result is positive for 2019-nCOV-IgG antibodies.
• IgM POSITIVE: *The colored line in the control line region (C) appears and a colored line appears in test
line region IgM. The result is positive for 2019-nCOV-IgM antibodies and is indicative of primary 2019-
nCOV infection.
• IgG AND IgM POSITIVE: *The colored line in the control line region (C) appears and two- colored lines
should appear in test line regions IgG and IgM. The color intensities of the lines do not have to match. The
result is positive for IgG & IgM antibodies.
• *NOTE: The intensity of the color in the test line region(s) IgG and/or IgM will vary depending on the
concentration of 2019-nCOV antibodies in the specimen. Therefore, any shade of color in the test line
region(s) IgG and/or IgM should be considered positive.
• NEGATIVE: The colored line in the control line region (C) appears. No line appears in test line regions IgG
or IgM.
• INVALID: There is no line appear in the c region.
Covid-19 IgG/IgM Test Cassettes 45/1/2020

5. IgG/IgM Rapid Test Cassettes
Lateral Flow Immunochromatographic Assay
Internal Quality Control
• Internal procedural controls are included in the test. A color line appearing
in the control region
• (C) is an internal positive procedural control It confirms sufficient specimen
volume and correct procedural technique.
• Control standards are not supplied with this kit however it is recommended
that positive and negative controls be tested as a good laboratory practice
to confirm the test procedure and to verify proper test performance.
Covid-19 IgG/IgM Test Cassettes 55/1/2020

6. IgG/IgM Rapid Test Cassettes
Lateral Flow Immunochromatographic Assay
Rapid Test Cassettes Description
• For professional in vitro diagnostic use only. Do not use the kit beyond the
expiration date.
• 2. Do not eat, drink or smoke in the area where the specimens or kits are
handled.
• 3. Do not use the test if the pouch is damaged.
• 4. Handle all specimens as if they contain infectious agents. Observe established
precautions against microbiological hazards throughout testing and follow the
standard procedures for proper disposal of specimens.
• 5. Wear protective clothing such as laboratory coats, disposable gloves and eye
protection when specimens are being tested.
• 6. The used test should be discarded according to local regulations.
Covid-19 IgG/IgM Test Cassettes 65/1/2020

7. IgG/IgM Rapid Test Cassettes
Lateral Flow Immunochromatographic Assay
7
TEST KIT MATERIALS PROVIDED MATERIALS REQUIRED – NOT PROVIDED
1. Test Devices
2. Disposable for plastic pipette
3. Lancets (for finger stick whole
blood only)
4. Buffer
5. Package Insert
6. Alcohol pad
1. Specimen collection
containers
2. Gloves
3. Micropipette
4. Centrifuge (for plasma only)
5. Timer

8. IgG/IgM Rapid Test Cassettes
Lateral Flow Immunochromatographic Assay
Limitations
1. The accuracy of the test depends on the sample collection process. Improper sample collection, improper storage of samples, unfresh
samples, or repeated freeze-thaw cycles of samples will affect the test results.
2. The test cassette only provides qualitative detection of the COVID-19 antibody in the sample. If you need to detect the specific content of an
indicator, please use the relevant professional instruments.
3. The test result of this kit is for clinical reference only and should not be used as the sole basis for clinical diagnosis and treatment. The clinical
management of patients should be considered in combination with their symptoms/signs, medical history, other laboratory tests, and treatment
responses.
4. It is recommended to review the suspicious negative results by using nucleic acid detection or virus culture identification methods.
5. Analysis of the possibility of false negative results：
① Unreasonable sample collection, transportation and processing may lead to false negative results.
② Genetic variations of virus can cause changes in antibody determinants, which can lead to false negative results.
③ The optimal sample type and sampling time after infection have not been verified, so collecting samples at different times on the
same patient may avoid false negative results.
Covid-19 IgG/IgM Test Cassettes 85/1/2020

9. IgG/IgM Rapid Test Cassettes
Lateral Flow Immunochromatographic Assay
Our Kits
HAVE
FDA Emergency Use Authorization
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-
regulatory-and-policy-framework/emergency-use-authorization
Covid-19 IgG/IgM Test Cassettes 95/1/2020

10. IgG/IgM Rapid Test Cassettes
Lateral Flow Immunochromatographic Assay
Sensitivity: The ability of a test to correctly identify those with the disease
(true positive rate)
Specificity: The ability of the test to correctly identify those without the
disease (true negative rate).
Covid-19 IgG/IgM Test Cassettes 105/1/2020