AS OF 1999, IT WOULD SEEM THE ROCHE AMIPLICOR HIV-1
MONITOR TEST IS THE MOST POPULAR PCR "VIRAL LOAD" TEST.

"The Roche Amplicor HIV-1 Monitor(TM) test kit,  approved by the FDA, was
used by more than 70% of  the laboratories reporting results."

http://www.phppo.cdc.gov/MPEP/pdf/rna/9902rnaa.pdf

The test kit list: http://www.fda.gov/cber/products/testkits.htm 

AMPLICOR HIV-1 MONITOR(TM) TEST

"The AMPLICOR HIV-1 MONITOR Test is not intended to be used  as a
screening test for HIV or as a diagnostic test to confirm
the presence of HIV infection."

http://www.fda.gov/cber/pma/p9500054.htm
http://www.fda.gov/cber/PMAlabel/P9500054LB.pdf 

NucliSens(R) HIV-1 QT -- HIV QT Nov. 13, 2001

"The NucliSens(R) HIV-1 QT assay is not intended to  be used as a
screening test for HIV-1 nor is it to  be used as a diagnostic test to
confirm the presence  of HIV-1 infection."
http://www.fda.gov/cber/pma/p0100010.htm
http://www.fda.gov/cber/pmalabel/P0100010LB.pdf 

COBAS AmpliScreen HIV-1 Test, version 1.5
Approval Date: 12/19/2003

"This test is not intended for use as an aid in diagnosis."

http://www.fda.gov/cber/products/hiv1roc121903.htm
http://www.fda.gov/cber/label/hiv1roc121903LB.pdf 

Procleix(R) HIV-1/HCV Assay -- IN0076-01, Rev. A
Approval Date: 6/4/2004

"The Procleix HIV-1 Discriminatory Assay may be used as an  aid in the
diagnosis of HIV-1 infection." 

http://www.fda.gov/cber/products/hivhcvgen060404.htm
http://www.fda.gov/cber/label/hivhcvgen060404LB.pdf

GENETIC SYSTEMS (TM) rLAV EIA

"The rLAV EIA is intended to be used as a screening test for  donated
blood or plasma and as an aid in the diagnosis of  infection with HIV-1."

http://www.fda.gov/cber/products/hiv1gen062998.htm
http://www.fda.gov/cber/sba/hiv1gen062998S.pdf

VIRONOSTIKAT(R) HIV-1 PLUS O MICROELISA SYSTEM

"System is intended for use as an aid in diagnosis of  infection with
HIV-1. It is not intended for use in  screening blood donors."

http://www.fda.gov/cber/pma/P020066.htm
http://www.fda.gov/cber/pmalabel/P020066LB.pdf

THE CAMBRIDGE BIOTECH HIV-1 WESTERN BLOT KIT

"Accurate diagnosis of HIV-1 infection is important  in determining an
individual's risk for  developing AIDS. Accuracy is complicated by
false-positive and false-negative (EIA) results. It  would appear that in
some limited infections, a  compartmentalized response occurs in which
expression of HIV-1 or its respective Immune  response is limited to a
restricted number of organs  and tissues.(17)"

"Slight ambiguities exist in the designation of the  molecular weights of
the HIV-I antigens. The designations  listed in Figure 1 have been
established by both internal  testing with known markers and consensus of
published
literature.(5-10)"

"Although a blot POSITIVE for antibodies to HIV-1  indicates infection
with the virus..."
"POSITIVE blot results using any specimen type  (serum, plasma, or urine)
should be followed with  additional testing. Such testing may rely on
alternative test methods or specimen types. The  clinical implications of
antibodies to HIV-1 in an  asymptomatic person are not known."

"The sensitivity ... using urine was evaluated by  comparing the urine
results to the results obtained  from testing paired serum specimens
collected from  individuals who were HIV-1 seropositive and from
individuals clinically diagnosed as AIDS patients."

http://www.fda.gov/cber/products/hiv1cam052898.htm
http://www.fda.gov/cber/label/hiv1cam052898Lb.pdf 

OraSure(R) HIV-1 Western Blot Kit

"The OraSure HIV-l Western Blot Kit is an in vitro  qualitative assay for
the detection of antibodies to  individual proteins of the Human
Immunodeficiency  Virus Type 1 (HIV-l) in human oral fluid specimens
obtained with the OraSure HIV-l Oral Specimen  Collection Device.

The OraSure HIV-l Western Blot Kit is not intended  for use with blood,
serum/plasma or urine specimens,  or for screening or reinstating
potential blood donors."
http://www.fda.gov/cber/pma/P950004.htm
http://www.fda.gov/cber/pmalabel/P950004Lb.pdf 

Reveal(TM) Rapid HIV -1 Antibody Test
"The Reveal" Rapid HIV -1 Antibody Test is intended for  use as a
point-of-care test to aid in the diagnosis of  infection with HIV -1. This
test is suitable for use in  multi-test algorithms designed for
statistical validation of rapid HIV test results."

http://www.fda.gov/cber/pma/p000023.htm
http://www.fda.gov/cber/pmalabel/P000023LB.pdf