Problems with the New HIV Tests

Criticisms of the post-2014 testing algorithm.

From the 1990’s to 2014, HIV testing remained relatively unchanged. The problems with the HIV tests were well-documented by Rebecca Culshaw, The Perth Group, Nelville Hodgkinson, and “House of Numbers.” Especially problematic was the non-specificity of the Western Blot used to confirm a diagnosis; however, the Western Blot was deprecated in 2014 when the CDC recommended a completely new algorithm. In March 2023, Skyhorse Publishing released an updated edition to Rebecca Culshaw’s 2007 “Science Sold Out,” which had the clearest explanation of the problems with the HIV tests. Unfortunately, Culshaw did not update her chapter in 2023 to reflect the new algorithm. The same year, the CDC updated the surveillance definition of ‘AIDS’ - also referencing the new algorithm. This article is an attempt to address the problems with the new tests.

The “antigen/antibody combination immunoassay” screening test can include rapid tests but can involve a blood draw. In the past, one would run an ELISA and if that was reactive, the ELISA would be run again. This is suitable for ruling out false negatives but is wholly insufficient to rule out false positives (and, yes, I know it’s difficult to speak of positive and negative tests). In the new paradigm, the ELISA is run only once combined with a p24 antigen test (a sort of ELISA in reverse I’ll explain), so if either test is reactive in the “combination immunoassay,” the test is considered initially reactive/positive. One can see this new algorithm increases the chances of testing initially positive whereas the old algorithm of re-running the ELISA decreased the chance.

This is exactly the opposite of what one wants to do when screening low-prevalence populations, and in 2013, the US Preventative Services Task Force issued new guidelines pushing screening on all Americans aged 15-65 regardless of exposure risk. Due to a mathematical concept called Bayes Law, when screening in low-prevalence populations, the positive predictive value of the test declines and a false-positive problem emerges. The main commercial screening tests are said to be around 99.9% “specific.” A close look at how these were validated shows they were validated not against HIV as a gold standard but against the third generation of tests and against bioengineered reference samples. for 99.39% “specific” tests in pregnant women, testing 10,000 women in a population where 0.4% are positive, one would expect 61 false positives and 40 true positives. Worse, in babies born from pregnant women, antibody tests do not work because of maternal antibodies; therefore, only p24 is used. This means the tests are much less than 99% specific and there are even more false positives. Given that the standard of care is post-exposure-prophylaxis for suspected maternal exposure, many babies are unnecessarily forced on ARV’s.

A May 2018 CDC fact sheet on false positives acknowledges the problem but offers few solutions. Keep in mind the public health messaging is these tests are very accurate - as such, clinicians hear that message and do not question the test results.

The CDC’s justification for the change was to pick up “acute cases of HIV infection” on the theory that during initial infection when a person is viremic (lots of HIV in the blood) there is also lots of p24 protein in the blood (p=protein and 24 = the weight of the protein at 24 kilodaltons) This is the core protein that sort of looks like a cone in the standard model of HIV. The problem is true viremia during acute HIV infection has never actually been observed - what HIV researchers call “viremia” is really PCR amplification. If so many infectious viruses are flooding the bloodstream during acute infection, it should be possible to isolate HIV from filtration.

The Discredited P24 Antigen test

The P24 antigen test has been around since the late 1980’s. Essentially, recombinant (i.e. biotechnology manufactured) antibodies linked to an enzyme are impregnated on a cellulose strip as a band (usually within a mass-manufactured rapid test plastic container) which exposed to blood serum mixed with a solvent, and if p24 or a similar protein is in the serum, a color change is observed on the band. The test has remained essentially unchanged since the early 90’s, so any switch to its use is not due to advances in technology. It is presumed that the p24 comes from HIV and that the amount of p24 reflects the amount of HIV circulating in the blood. The problem is p24 is not specific to HIV, antibodies can cross-react with similar proteins, and there are other medical conditions that might cause p24 to be found in the bloodstream of a person.

AIDS Establishment luminary David Baltimore wrote in 1989 that the result of the p24 test was meaningless:

If this new approach [to drug testing] is to succeed, accurate early markers of drug efficacy should be of great value. None of the currently available “surrogate” markers are completely satisfactory in this regard. Detectable quantities of p24 antigen are found in only a fraction of infected persons, as shown by Ho and Coombs and their co-workers, correlate poorly with the presence or amount of replicating HIV.

Eventually, David Ho would introduce PCR “viral load” as the basis for HIV drug development as the “surrogate marker” that would become satisfactory. What’s amazing is in 2014, the CDC embraced a surrogate marker that was already known to be ‘not completely satisfactory’ in 1989. One of the reasons p24 was rejected in AIDS medicine was the difficulty detecting p24 in AIDS patients made it difficult to recruit subjects for drug trials (source: S. Epstein interview with Mark Harrington). What one can observe is the concern is with drug development - not clinical health.

In 1988, Harvey Bialy, writing in Nature/Bio-Technology that the p24 test was unvalidated, it is unknown what, exactly, the test measures, and how, exactly it measures it. He assailed the uncritical use of the test, the shoddy peer review backing it up, and demonstrated that the claimed results of the test could not possibly be true.

The HIV-1/HIV-2 Differentiation Immunoassay

In 2014, the CDC replaced the Western Blot with this new test, which is far less specific than what was previously the gold standard. On the Western Blot, one tested for 11 bands associated with HIV, but on the new test, one tests positive for HIV-1 when there is a reaction only for gp41.

What is astonishing about the CDC’s 2014 recommendation was at the time there were no FDA-approved differentiation assays on the market! One wonders if the recommendation was simply to patent and jack up the price of the confirmatory test (the Western Blot had never been patented) or simply to manufacture more cases among Black Americans by now testing for an antibody associated with the mysterious HIV-2, a completely different unrelated virus to HIV-1.

Certainly, the CDC’s decision to change testing algorithms put pressure on the FDA to approve the new test without thorough review. A similar situation occurred in 2012 with Hepatitis C when the CDC removed a confirmatory test called a RIBA from its algorithm, causing all test kits to be withdrawn from the market. Overnight, cases jumped by 25% with the entire increase being cases that would have been considered false positives just a year before. The false positive problem was particularly acute in the Veterans Affairs system.

Just testing for antibodies to gp41 cannot possibly confirm HIV-1 infection. When Luc Montagnier initially claimed to isolate LAV (which would be renamed HIV) in 1983, he stated that gp41 was likely a contaminant - the ubiquitous cellular protein actin, with a mass of between 41 and 42 kilodaltons. Gallo did not find p41 in 1984 but instead found gp42, which was the basis of the mass-manufacture of the first HIV tests. Jay Levy did not find p41 either. The Perth Group’s magisterial 1993 article on the Western Blot remains the landmark critique of the non-specificity of this test. The fallibility of this test was one of Project Censored’s top 25 stories from 1995.

Nucleic Acid Testing

If the confirmatory p41 is indeterminant or non-reactive, one moves onto PCR “viral load” to settle the difference of an initially-positive ELISA or P24. Recall that the initial screening test lights up if either the ELISA or the P24 is positive not necessarily both. In the past, if the Western Blot was indeterminant or negative, the algorithm would have stopped, but now it goes onto PCR. One can see that this is an overall loosening of the algorithm. What’s interesting is the newfound concern with HIV-2 does not match the fact there are no FDA approved “viral load” tests for HIV-2, so it’s not in the algorithm. Yet, Africa is said to be swarming with HIV-2 dominating over HIV-1. All the AIDS drugs are approved for HIV-1, not HIV-2 because they reduce HIV-1 “viral loads.”

One thing this algorithm does reduce the of the embarrassment of “elite controllers” - the excuse-word given to those who test HIV-antibody positive but have undetectable “HIV-1 viral loads.” Sometime in 2008, the FDA allowed “viral loads” to be used as aids in diagnostic because they were more accurate - but just because the FDA says something does not make it true. The method used for the determination of the alleged “HIV viral load” does not include the isolation of retroviral particles. The analyzed pellets have never been controlled through electron microscopy to verify the presence of such particles. As the CDC’s own 2014 algorithm documents state, the new algorithm was tested against the third generation test results, not HIV itself.

Corona has heightened the problems of PCR testing, and the landmark paper of false positive HIV Viral Loads remains Matt Irwin’s from 2001 and the summation by Alive and Well. I have corresponded with Dr. Irwin, and he says the paper needs updating. Even in 1995, ACT-UP/San Francisco was denouncing the new “viral load” tests as “Anthony Fauci’s Wet Dream.” Eteinne de Harven has claimed that given 7-8% of the human genome consists of Human Endogenous Retrovial sequences including those analogous to HIV-1, what may be picked upon “viral load” tests are the expression of RNA from these sequences during times the body is under persistent stress.

Conclusion: Just don’t take the test

I’ve always thought that free speech is incompatible with those who say, “well, don’t take this as medical advice.” It would be impossible to have medical journalism otherwise. When a standard-of-care is provably harmful and when my own research is more thorough than most medical professionals, I’m not afraid to speak out and say: don’t take the test. Just DON’T take the test. PERIOD.

That was the conclusion of the late and great Liam Scheff. If we end HIV testing, we end AIDS.

The justification for HIV testing nowadays is ARV therapy will prolong life if you treat asymptomatics. But ARV therapy was approved on the basis of bogus surrogate markers such as CD4 counts (fell apart in 1994) and “viral loads” (fell apart in 2006). The prominent journal Science has stated “blood levels do not predict immune decline). Anthony Fauci simply made up the slogan “U=U” in a concept paper on the basis of no evidence, but even John C Mellors in 1997 and Jay Levy in 2001 claimed that there was no evidence for U=U. It’s simply a marketing slogan to coerce people onto ARV’s.

Close to his retirement, Henry Gadsden the CEO of ARV manufacturer Merck told Fortune magazine of his distress the company’s potential markets had been limited to sick people. His desire was to make drugs for healthy people so he could “sell to everyone.” With 35 years of so-called HIV-medicine, Gadsden’s dream has come through. The consequences of a positive HIV test are uniformly bad: criminal prosecution, limitation of travel, mistreatment by health professionals, public health surveillance, breakup of family relationships, suicide, and social stigma. Moreover, the tests are used as a weapon of terror and discrimination against traditionally marginalized people.

People are far too trusting of their doctors and of the predatory health establishment. Doctors are far too trusting of medical authorities. AIDS Service Organizations work for their Big Pharma funders and Fauci, not for the people they claim to serve. And just by putting this word, “AIDS” and that word “HIV” out there, I’ve been forced to devote many days and hours of my life researching predatory medical minutiae as an act of self defense when I really have better things to do and more to contribute to society.