TEST KIT MANUFACTURERS
... The prevalence of HIV-1 infection in people not known to be at increased risk is not known. The HIV-1 antibody enzyme-linked immunassay (EIA) (the abbreviation "ELISA" is equally acceptable) was developed to detect antibodies to HIV-1 and was developed to identify potentially infectious units of donated blood and plasma. It has been established that repeatably reactive units of blood and plasma should be eliminated from the blood supply.
In order to afford maximum protection of the blood supply, the EIA was designed to be extremely sensitive. As a result, non-specific reactions may be seen in samples from some people, who, for example, due to prior pregnancy, blood transfusion, or other exposure, have antibodies to the human cells or media in which the HIV-1 is grown for manufacture of the EIA. Because of these and other nonspecific reactions, it is appropriate to investigate specimens found to be reactive on EIA in a manner that gives improved predictability that HIV-1 antibody, in fact is present. When a specimen reacts in an initial test (is initially reactive), the EIA should be repeated in duplicate on the same sample source. Reactivity in either or both of these duplicate tests (repeatably reactive) is highly predictive of the presence of antibody in people at increased risk for HIV-1 infection (e.g., homosexual men, hemophiliacs, or intravenous drug users). Repeatedly reactive specimens obtained from people at increased risk for HIV-1 infection are usually found to contain antibodies by additional more specific, or supplemental, testing. However, when the EIA is used to screen populations in which the prevalence of HIV-1 infection is low (e.g., blood donors), nonspecific reactions may be more common ....
... Although for all clinical and public health applications of the EIA both the degree of risk for HIV-1 infection of the person studied and the degree of reactivity of the serum may be of value in interpreting the test, these correlations are imperfect. Therefore, in most settings it is appropriate to investigate repeatedly reactive specimens by additional more specific, or supplemental tests."*
"LIMITATIONS OF THE PROCEDURE (of ELISA)
The [Abbot Laboratories] HIVAB HIV-1 EIA antibody procedure and the Interpretation of Results must be followed closely when testing for the presence of antibodies to HIV-1 in plasma or serum from individual subjects. Because the EIA was designed to test individual units of blood or plasma, most data regarding its interpretation were derived from testing individual samples. Insufficient data are available to interpret tests performed on other body specimens, pooled blood or processed plasma, and products made from such pools: testing of these specimens is not recommended.
[Abbot Laboratories] HIVAB HIV-1 EIA detects antibodies to HIV-1 in blood and thus is useful in screening blood and plasma donated for transfusion and further manufacture, in evaluating patients with signs or symptoms of AIDS, and in establishing prior infection with HIV- 1. Clinical studies continue to clarify and refine the interpretation and medical significance of the presence of antibodies to HIV-1. For most uses it is recommended that repeatably reactive specimens be investigated by an additional more specific, or supplemental test. A person who has antibodies to HIV-1 is presumed to be infected with the virus, except that a person who has participated in an HIV vaccine study may develop antibodies to the vaccine and may or may not be infected with HIV. Clinical correlation is indicated with appropriate counseling, medical evaluation and possible additional testing to decide whether a diagnosis of HIV infection is accurate. Such an evaluation should be considered an important part of HIV-1 antibody testing and should include test result confirmation on a freshly drawn sample.**
AIDS and AIDS-related conditions are clinical syndromes and their diagnosis can only be established clinically. 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. A negative test result at any point in the investigation of individual subjects does not preclude the possibility of exposure to or infection with HIV-1. The risk of an asymptomatic person with a repeatably reactive serum sample developing AIDS or an AIDS-related condition is not known.***
Data obtained from testing persons both at increased and at low risk for HIV-1 infection suggest that repeatably reactive specimens with high absorbance on EIA are more likely to demonstrate the presence of the HIV-1 antibodies by additional more specific, or supplemental testing. Reactivity at or only slightly above the cut-off value is more frequently nonspecific, especially in samples obtained from persons at low risk for HIV-1 infection; however, the presence of antibodies in some of these specimens can be demonstrated by additional more specific, or supplemental testing."
"Sensitivity and Specificity
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.
The ABBOT studies show that:
* It is a most disturbing situation that initially indeterminate test results are routinely "interpreted" negative or positive depending on the degree of risk of the person tested. In Ontario's testing laboratories one third of test results are indeterminate.
** One should ask why antibodies induced by a vaccine would be protective when HIV antibodies otherwise are consider not protective?; or conversely, if HIV antibodies induced by vaccine are protective why wouldn't they otherwise be generally protective?
*** This comes very close to saying that the only way to be reasonably certain that an HIV antibody test result is true positive is the appearance of the clinical syndrome. This presents flawed circular logic; as AIDS has no unique symptoms but is a syndrome of up to 29 old diseases, cases can only be confirmed as AIDS by an HIV antibody positive test result. Both the syndrome and the test, each doubting their own validity, rely on each other for support.
Now from the test to confirm the above test:
Epitope, Inc. Product Number 72827
PN201-3039 Revision #8
A sample that is reactive in both the EIA screening test and the Western blot is presumed to be positive for antibody to HIV-1, indicating infection with this virus except in situations of passively acquired antibody or experimental vaccination."
"LIMITATIONS OF THE PROCEDURE
1. The assay must be performed in strict accordance with these instructions to obtain accurate, reproducible results.
2. Although a Positive result may indicate infection with the HIV-1 virus, a diagnosis of Acquired Immunodeficiency Syndrome (AIDS) can be made only if an individual meets the case definition of AIDS established by the Centers for Disease Control. A repeat test on an independent sample should be considered to control for sample mix-up or operator error, and to verify a positive test result.
3. Individuals with HIV-1 infection may present incomplete patterns due to the natural history of AIDS or other immunodeficiency states, e.g.:
a. AIDS patients may lose antibody reactions to p24 & p31;
b. Infants born to HIV-1 infected mothers, but who are uninfected, may display incomplete patterns as passively acquired maternal antibodies begin to disappear ;
c. Individuals who have recently seroconverted may display incomplete band patterns;
d. Infected patients with malignancies and individuals receiving immunosuppressive drugs may fail to develop a Positive result;
e. Individuals infected with HTLV-I/II or HIV-2, may exhibit incomplete cross-reactivity;
f. Individuals may develop incomplete patterns that reflect the composition of experimental HIV sub-unit vacines that they may have received.
5. Since reactivity of any degree with any of the virus-specific proteins identified on the strip is possible evidence of antibodies to HIV-1, all samples interpreted as Indeterminate should be repeated using the original specimen. In addition, it is recommended that samples interpreted as Indeterminate be retested after six months, using a fresh specimen.
6. Do not use this kit as the sole basis of diagnosis of HIV-1 infection. 7. A Negative result does not exclude the possibility of HIV-1 infection. Antibody testing should not be used in lieu of donor self-exclusion by blood collection establishments."
Sensitivity and Specificity
Sensitivity and specificity of the HIV-1 Western Blot Kit was determined in comparative studies with a previously licenced HIV-1 Western blot using EIA repeatedly reactive samples from high AIDS risk and low risk populations respectively."*
"INTERFERING FACTORS AND SUBSTANCES
Testing was performed on specimens from individuals with clinical conditions unrelated to HIV-1 which might result in a reactivity with proteins present. Samples studied included 25 from persons with auto immune diseases, 12 with elevated gammaglobulins, 110 with viral infections unrelated to HIV-1 and 38 other conditions. The viral infections included samples positive in clinical tests for Cytomegalovirus (12), Infectious mononucleosis (10), Epstein-Barr virus (3), Rubells (12), Varcella-Zoster (3), Herpes Simplex (12), HBsAg (7), and HTLV-1 (39). Although bands were occasionally present at viral locations, none of the strips could be interpreted as positive."**
* Although the Western Blot is supposed to be a "more specific" test to confirm the results of the EIA (ELISA), the specificity and sensitivity are assumed by the same indirect means. No gold standard was applied, such as isolating HIV-1 from fresh patient plasma, in any of these studies. These studies confuse specificity with a high reproducibility of EIA by Western Blot.
** The samples studied to establish whether false positives resulted from interfering factors appear to represent individuals with isolated incidents of these factors. Even so, 38% had reactions on one or more "viral" bands of the Western Blot. People at risk for AIDS typically have accumulated many of these factors. One would assume that this would lead to higher reactivity on the Western Blot. This presents a catch 22 situation: these factors may be the cause of AIDS-like syndromes but are considered HIV-1 related because the patients react positive on EIA and Western Blot tests.
So what is the story with PCR "viral load" tests?
The AMPLICOR HIV-1 MONITOR test is an in vivo nucleic acid amplification test for the quantification of Human Immunodeficiency Virus Type 1 (HIV-1) in human plasma. The test is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis.
The test has been used as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. The clinical significance of changes in HIV RNA measurements has not been fully established although several large studies that will more fully determine the role of comparative HIV RNA measurements in patient management are now in progress. HIV-1 RNA levels as measured by PCR were used as one of the surrogate markers in the accelerated approval process for the protease inhibitor drugs INVIRASE, CRIXIVAN and NORVIR, and for the reverse transcriptase inhibitor drug EPIVIR. The utility of plasma HIV-1 RNA in surrogate endpoint determinations has not been fully established.
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.
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 hesitation to stand behind their recommendations and provide, in writing, their assurance for your health and safety.