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."

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

The test kit list: 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."

www.fda.gov/cber/pma/p9500054.htm
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."
www.fda.gov/cber/pma/p0100010.htm
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."

www.fda.gov/cber/products/hiv1roc121903.htm
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." 

www.fda.gov/cber/products/hivhcvgen060404.htm
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."

www.fda.gov/cber/products/hiv1gen062998.htm
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."

www.fda.gov/cber/pma/P020066.htm
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."

www.fda.gov/cber/products/hiv1cam052898.htm
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."
www.fda.gov/cber/pma/P950004.htm
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."

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