| PaulKing 2005-04-26, 10:45 pm |
| 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
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