despite the increased number of HIV tests, there is still no manufacturer that claims their test can be used to diagnose
infection with HIV. All of the RNA based tests for viral load and genotyping clearly state they are 'NOT intended for use in diagnosing HIV infection.' Because they don't show anything about 'HIV' or 'IDS'.
TEST KIT DISCLAIMERS
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/99...
The test kit list: http://www.fda.gov/cber/products/testkit...
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/P950005...
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/P010001...
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/hiv1roc...
http://www.fda.gov/cber/label/hiv1roc121...
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/hivhcvg...
http://www.fda.gov/cber/label/hivhcvgen0...
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/hiv1gen...
http://www.fda.gov/cber/sba/hiv1gen06299...
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/P020066...
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/hiv1cam...
http://www.fda.gov/cber/label/hiv1cam052...
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/P950004...
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/P000023... oops ,i've got comfused That is a good question. Im certain by now, 25 years into the disease, it should be a vitual certainly to be able to diagnose te disease.
my guess is avoidance of lawsuits. Quantative RNA tests for HIV viral load are not sensitive enough to rely on for diagnosing HIV. If the virus is present in small enough numbers, then the test will read "undetectable". If used for diagnostic purposes this would be a false negative.
While there are some qualitative RNA tests for HIV these are too expensive to use for routine screening. HIV antibody tests (Elisa followed by an immunoblot test if the Elisa is positive) are more sensitive than quantitative RNA tests, and only these have been approved in most countries for making the diagnosis of HIV infection.
The different tests are for different purposes. Eltoporides below lists some of the tests that can be used for diagnosing HIV infection (scroll down to the last few - the first ones are viral load tests, not diagnostic tests) litigation |
