1st email:
Thank you for contacting American Bio Medica Corporation. Your email was forwarded to Beth Eitleman and she will be contacting you shortly.
Thank you,
Donna Elmendorf
Supervisor, Global Customer Relations / American Bio Medica Corporation
2nd email:
Good afternoon,
Thank you for your inquiry!
Under these unprecedented times the EUA will allow you the ability to not follow usual FDA protocol.
We are placing orders weekly the turnaround is around 3 weeks. If you are interested we will be putting in an order in the next day or 2.
Here is some of the information from the manufacture of the COVID -19 tests on the first attachment.
Below is general information.
Q: What is the sensitivity and specificity?
A: These are great numbers! (see page 2 of the PI attached)
Clinical Performance for IgM Test:
Relative Sensitivity: 95.7%, Relative Specificity: 97.3%, Overall Agreement: 96.8%
Clinical Performance for IgG Test:
Relative Sensitivity: 91.8%, Relative Specificity: 96.4%, Overall Agreement: 95.0%
Q: What is the time needed from exposure to detect the IgG and IgM antibodies?
A: IgG and IgM antibodies to 2019 Novel Coronavirus can be detected with 2-3 weeks after exposure. IgG remains positive, but the antibody level drops over time. (see page 1 of the PI under "Introduction"
Q: How long does it take to get results?
A: Wait for the colored line(s) to appear. The result should be read in 10 minutes. Positive results may be visible as soon
as 2 minutes. Do not interpret the result after 15 minutes.
Q: What type of sample is used for testing?
A: Whole Blood/Serum/Plasma
Q: If doing finger stick, how much is needed?
A: Very small amount 5uL
Beth
Thank you,
Beth Eitleman
Regional Sales
beitleman@abmc.com
