There are many people I have talked to about Aids but every time I ask them whether they would go for a HIV test of their own volition, they cast me such an icy look that I retract and recoil.
One friend of mine told me something to the effect that he would rather not know his HIV status (and live happily) than know that he has Aids and die of despair and despondency.
Many countries around the world have taken HIV/AIDS very seriously so much so that Voluntary Counselling and Testing clinics are in virtually every town. Home testing kits, too, are easy to come by. But people are still jittery about getting to know their HIV status. Why is this so? Would you be ready to go for a HIV test if asked to do so?
1 comment:
Most People do not realize that although the FDA markets the erroneous antibody tests for HIV infection as Diagnostic tests the Manufacturer's reckognize that the intended use of their test is not Intended for Diagnosis with HIV infection. The lack of FDA approval simply means that HIV testing has never been approved for diagnostic purposes.The prognostic HIV tests are used in point of care settings or to be used as "AN AID" in a diagnosis.
The world has a right to know what they are getting into,since the tests do not detect or isolate HIV or the CDC construct of AIDS directly from human beings.
S E E * I N T E N D E D * U S E
SOURCE * FDA.GOV
http://www.fda.gov/Cber/products/testkits.htm
Roche Amplicor HIV-1 Monitor Test
Applicant: Roche Molecular Systems, Inc., Branchburg, NJ
"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/PMAlabel/P9500054LB.pdf
NucliSens HIV-1 QT
Applicant: bioMerieux, Inc., Durham, NC
"The NucliSensÒ 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/pmalabel/P0100010LB.pdf
Proper Name: Human Immunodeficiency Virus Type 1
HIV-1/Polymerase Chain Reaction)
COBAS AmpliScreen HIV-1 Test, version 1.5
Manufacturer: Roche Molecular Systems, Inc, License #1636
""This test is not intended for use an aid in diagnosis""
http://www.fda.gov/cber/label/cobashiv1LB.pdf
Procleix HIV-1/HCV Assay
Manufacturer: Gen-Probe, Inc, License #1592
"The PROCLEIX® HIV-1 Discriminatory Assay may be used as an aid in the diagnosis of HIV-1 infection"
http://www.fda.gov/cber/label/hiv1hcvnatLB.pdf
Applicant: bioMerieux, Inc, Durham, NC
Vironostika HIV-1 Plus O Microelisa System
"The Vironostika HIV-1 Plus O Microelisa 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"
Published data indicate a strong correlation between the acquired immunodeficiency syndrome (AIDS) and a retrovirus referred to as Human Immunodeficiency Virus (HIV)
http://www.fda.gov/cber/pmalabel/P020066LB.pdf
Applicant: ABBOTT Molecular, Inc
Abbott RealTime HIV-1 Amplification Reagent Kit,
Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit
"This assay is not intended to be used as a donor screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection"
http://www.fda.gov/cber/pmalabel/p060002LB.pdf
Applicant: Roche Molecular Systems, Inc
COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests
COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L
"The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test is not intended for use as a screening test for the presence of HIV-1 in blood or blood products or as a diagnostic test to confirm the presence of HIV-1 infection
http://www.fda.gov/cber/pmalabel/p050069LB.pdf
Proper Name: Human Immunodeficiency Virus Type 1 (HIV-1)
HIV-1 (Western Blot)
Manufacturer: Maxim Biomedical, Inc
Do not use this kit as the sole basis of diagnosis of HIV-1 infection
http://www.fda.gov/cber/sba/hiv1cam052898S.pdf
OraSure HIV-1 Western Blot Kit
Applicant: Epitope, Inc., Beaverton, OR
The OraSure HIV-1 Western Blot Kit is not intended for use with blood, serum/plasma or urine specimens or for screening potential blood donors
An OraSure sample that is reactive in both EIA screening test and Western blot assay IS PRESUMED to be positive FOR ANTIBODIES.
http://www.fda.gov/cber/pmalabel/P950004Lb.pdf
Applicant: MedMira Laboratories, Inc, CANADA
MedMira Reveal 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
The Reveal™ Rapid HIV-1 Antibody Test is not approved for use to screen donors of blood, plasma, cells or tissues
http://www.fda.gov/cber/pmalabel/P000023LB.pdf
Applicant: Trinity Biotech plc, Wicklow, Ireland
Trinity Biotech Uni-Gold Recombigen HIV,
Uni-Gold Recombigen HIV Positive and Negative Controls
Uni-Gold™ Recombigen® HIV is intended for use in point of care settings as an aid in diagnosis of infection with HIV-1
http://www.fda.gov/cber/pmalabel/P0300250LB.pdf
ELISA TESTING
"EIA testing alone cannot be used to diagnose AIDS, even if the recommended investigation of reactive specimens suggests a high probability that the antibody to HIV-1 is present
At present there is no recognized standard for establishing the presence and absence of HIV-1 antibody in human blood
Therefore sensitivity was computed based on the clinical diagnosis of AIDS and specificity based on random donors
Abbott Laboratories, Diagnostic Division, 66-8805/R5; January, 1997
Orasure Technologies,Inc
Belhlehern, PA 18015 USA
1- (800) ORASURE (800-672-7873)
The OraQuicP ADVANCERapid HIV-1 HIV 2 Antibody Test is intended lor use as a point-of-care test to aid in the
diagnosis of infection with HIV-I and HIV-2.
http://www.fda.gov/Cber/pmalabel/P01004716LB.pdf
Words from TheBody.com
"I cannot answer why testing is not standardized"
http://www.thebody.com/Forums/AIDS/Labs/Archive/Miscellaneous/Q55774.html
"The standard algorithm is still in place. Viral load is not an FDA approved test for the diagnosis of HIV infection"
http://www.thebody.com/Forums/AIDS/Labs/Archive/TestingHIV/Q7184.html
"I do not know why it is not approved"
http://www.thebody.com/Forums/AIDS/Labs/Archive/TestingHIV/Q132512.html
YOUTUBE Video
Christine Johnson on HIV tests
http://youtube.com/watch?v=Fq7L48vtEXU
http://youtube.com/watch?v=4O9YLNDJFMM
CERTIFICATE OF ACCURACY
Should a physician insist that you, or your child, test, insist that they first sign this document. If they are certain that HIV tests are accurate, they should agree without hesistation to stand behind their recommendations and provide, in writing, their assurance for your health and safety.
http://www.virusmyth.com/aids/data2/testcert.htm
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