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Information requested on Red - Dot Test for HIV 1 & 2
Aug 4, 2001

Dear Doctor, I am seeking some information on a HIV test called Red Dot HIV 1 & 2 . It is a rapid room temperature test for HIV 1 & 2 antibodies . It is manufactured by Cal Test Diagnostics, Chino , California. The brochure also mentions Gold Colloidal conjugate membrane for HIV 1 & 2 antibodies and that it is a screening test.

This is not an academic query I write from a place where being HIV positive has very, very serious consequences and most secret tests are performed using the above HIV test.

My specific queries are:

1. As per my doctor, there has been one instance when this test repeatedly showed a mild reactivity but ELISA on the same serum came back negative. So is this test more sensitive than ELISA ?

2. If not, from your experience, can you offer any explanation / information about this tests reliability or this kind of occurrence ?

3. I do not live in USA and despite my all attempts ( searching the WEB, talking to the local suppliers , etc ) , I am unable to find contact details of the firm ( Cal Test Diagnostics, Chino, California ) that makes these tests. Even their brochures does not have any contact details! You are from USA would you have any idea of their contact details ( their phone number for International callers ) ? I and my doctor need to contact them to have a better understanding of this test .

I am sure you can understand the frustration and tension when a person has mild reactivity on Red Dot test , then the same serum tests negative on ELISA then to resolve this , one ends up doing a western blot ( on same serum ) which ends up being indeterminate.

Response from Dr. Holodniy

The company had been sent a warning letter from the US FDA about the performance of this assay. Buyer beware as to the validity of the results.



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