COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed with alternative testing method(s) and clinical findings.
|Date EUA Issued||Diagnostic (Letter of Authorization)||Technology||Authorized Setting(s)1||Authorization Documents2||Manufacturer|
|05/29/2020||COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)||Serology IgM and IgG||H, M||HCP, Recipients, IFU||Healgen Scientific LLC|
FOR PROFESSIONAL USE ONLY!
All clinical study reports and data have been completed and are pending FDA Approval.
|Antibody||Performance Measure||Estimate of Performance||95% Confidence Interval|
|IgM||Sensitivity||100% (30/30)||(88.7%; 100%)|
|IgM||Specificity||100% (80/80)||(95.4%; 100%)|
|IgG||Sensitivity||96.7% (29/30)||(83.3%; 99.4%)|
|IgG||Specificity||97.5% (78/80)||(91.3%; 99.3%)|
|Combined||Sensitivity||100% (30/30)||(88.7%; 100%)|
|Combined||Specificity||97.5% (78/80)||(91.3%; 99.3%)|
|Combined||PPV at prevalence = 5%||67.8%||(34.9%; 88.3%)|
|Combined||NPV at prevalence = 5%||100%||(99.4%; 100%)|
Box of 25 Includes – 25 Test Cassettes, 25 Droppers, 1 Bottle of Buffer, Product Insert
*One bottle of buffer per box. (Each test requires 2 drops of buffer. A bottle of buffer contains 50 drops.)
*Lancets and Alcohol Prep Pads are not included
Our Covid-19 Test is covered by most insurance companies!
1. Remove the test cassette from the sealed foil pouch and use it as soon as possible.
2. Lay device on flat surface and add specimen (see specific instructions for each specimen type below):
a. For Serum or Plasma Specimen: With the plastic dropper provided, draw serum/plasma specimen to exceed the specimen line, as shown in the diagram above. Hold the dropper vertically and transfer drawn serum/plasma specimen into the sample well (S). Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.
b. For Whole Blood Specimen: Hold the plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the sample well (S) of the test device. Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.
3. Wait for the control line (C) to change from blue to a red color. If, after 2 minutes, the sample has not moved across the test window or if blood is still present in the sample well (S), add 1 additional drop of sample buffer to the buffer well (B).
4. The results should be read in 10 minutes. Do not interpret the result after 15 minutes.
Antibody testing can play a critical role in the fight against COVID-19. It can help identify individuals who may have been exposed to COVID-19 and have developed an immune response. Using antibody tests and clinical follow-up can also provide more information on immunity against COVID-19 for research and medical developments for the virus.
Antibody Testing may help to identify an active virus (IgM) especially helpful in asymptomatic people that don’t know they are infected or if a PCR test gave a false negative. This knowledge is critical to help reduce the spread by following quarantine & social distancing guidelines. IgM can be retested until negative and only IgG is positive which would indicate recovered status.
If the IgG antibody is present this can be used to help those currently fighting an uphill battle with Covid especially those immune compromised and unable to make antibodies on their own.
Blood Banks are relying on Antibody Testing of people donating blood to provide a vital service by supplying a lifesaving commodity for surgical and other patients.
Antibody testing can help tell a more detailed story & piece the puzzle together when used in conjunction with PCR/ diagnostic testing to further help identify & contain the spread of the virus.
If you have been diagnosed with SARS-CoV-2, antibody testing may help determine what phase of the virus you are in. 5-10 days after exposure and PCR diagnosis an antibody test will likely indicate IgM positive and this test can be repeated until only IgG is positive, potentially indicating recovery.
Can be used to alleviate anxiety or offer a piece of mind for those curious if they have been exposed to the virus. If IgG is positive, this indicates recent exposure to the virus & possible recovery.
If you were diagnosed with SARS, MERS or other Coronavirus infection a year+ ago, and test positive for the IgG antibody now, this is likely a result of recent exposure to the Novel Coronavirus and not a false positive due to a previous Coronavirus infection.
Some Researchers believe antibody testing could be the “passport” back to “normalcy.” Further research is still being conducted.
Even once a vaccine is available, antibody tests can be useful to determine if the vaccine is working by identifying those with the IgG antibody present after being vaccinated.
IgM negative, IgG negative: Patient not exposed or too early. A medical professional should observe symptoms and epidemiology of patients. Retesting should be considered if symptoms appear or persist.
IgM positive, IgG positive/negative: Acute or recent infection.
IgM negative, IgG positive: Previous, distant infection.
Results will appear in 2-10 minutes.
The incubation period for IgM is 3-5 days. This is the amount of time it takes for antibodies to appear in your body after being exposed to the SARS-CoV-2 virus.
This will test for IgG & IgM antibodies related to the SARS-CoV-2 virus.
Please follow the instructions on the product insert to ensure you collect the sample correctly. View the product insert.
Sensitivity: IgG 96.7%; IgM 100%; Combined 100%
Specificity: IgG 97.5%; IgM 100%; Combined 97.5%
These tests are under an EUA (Emergency Use Authorization) with the FDA as of 5/29/20.
No. These tests are only for medical professional use and must be purchased by a licensed professional. Please give us a call for more information.
If you test IgM positive, this means you are actively infected with Covid-19 and are beginning to build up antibodies. IgM antibodies build up within 3-5 days after initial contraction of the virus. At this point, you should alert everyone you have recently been in contact with and consult a doctor.
If you test IgG positive, this means you have already been infected with Covid-19 in the past and have completely built up the antibodies. Evidence suggests you are a low risk for reinfection, but research is still being conducted on this statement. Additionally, your blood can be used to treat currently infected individuals who do not have the antibodies completely built up yet and help to develop a vaccine.
Yes. We have these tests in stock and they will ship out the same day on orders placed before 3:00 pm EST.
For additional questions please contact: email@example.com