Serological Controls in Test Kits

MHughes77 at aol.com MHughes77 at aol.com
Thu Nov 2 14:07:35 EST 1995


To fellow Diagnostics Newsgroup members:

I am a scientist at a small diagnostics company involved in developing rapid,
easy-to-use tests designed to be used primarily in doctors' clinics or
veterinary practices for diagnosing a wide variety of infectious diseases, as
well as for screening donated blood for infectious agents.  Our kits come
with ready-to-use reagents in dropper bottles and have good stability for
12-18 months at 4 degrees C and 3-6 months at room temperature.  We would
like to be able to offer human serological controls for some of the test
kits, preferably with the same desirable stability characteristics.

Perhaps some of you would have some information or suggestions regarding the
following questions we have:

1. What is the best way to inactivate viruses without appreciably affecting
the antibody and/or antigen activity?

2. How do we stabilize the controls so that we can provide them in the
ready-to-use liquid format?

3. Can the controls be diluted samples?

4. Are there any universal regulations or guidelines regarding serological
controls?

We appreciate any help that is offered.  : )

Mark Hughes
Empyrean Diagnostics Inc.
mhughes77 at aol.com




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