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Pro-Health Community Care’s “4th Generation Combo Test” is a Dangerous Scam

We reported previously on the “4th Generation HIV testing” that is being promoted by an outfit known as Pro-Health Community Care. They want to convince the the adult production community to abandon PCR-RNA (viral load) testing in favor of the combo antigen/antibody test offered by them.

This is from one of their press releases, announcing a pitch scheduled for tomorrow afternoon in Chatsworth, CA:

 

FREE Information meeting about Pro-Health’s 4th generation HIV 1 & 2 COMBO Antigen/antibody test which can detect HIV within a few days of exposure.

Approved by the FDA, please consider this new test and our other STD testing panels.

. . .

WHY DOESN’T FREEDOM [sic] OF SPEECH COALITION want you to know about this BETTER, more accurate test? It can save your life — your business — and keep your clients safe and working.

-Joyce?Joyce L. Thomas, MHA, CPM, Administrator

 

Pro-Health Community Care

16101 Ventura Blvd. Suite #343

Encino, CA 91436

818.268.7397

Now, that reads like one of those scam flyers you find at a mini-mall laundromat, but performer testing is an important issue, so let’s dig a little deeper. What do we know about the relative merits of “4th generation combo” testing?

A 2009 study published by the American Society for Microbiology in its Journal of Clinical Microbiology assessed the 4th generation HIV Ag/Ab Combo test (interestingly, Jeffrey D. Klausner of UCLA, a friend of AHF and a Measure B supporter, was one of the study’s authors):

The performance of the 4th generation test “was evaluated on specimens from 64 recently infected individuals (tested in San Francisco, CA) identified based on an HIV-1 RNA testing algorithm (all specimens were HIV-1 RNA positive).”

Meaning: the study’s authors recognized RNA viral load testing as definitive. That’s how they determined they actually had HIV positive samples in hand to compare the “combo” test’s sensitivity.

The 4th generation test “was found to be capable of detecting the majority (89%) of infections, including 80% of those considered acute infections based on the presence of HIV RNA and the lack of detectable antibody to HIV.”

That means 20% of acute infections which WERE DETECTED BY RNA testing WERE MISSED BY THE 4th GEN TEST. TWENTY PERCENT! The detection of acute (new) infections is the main purpose of adult industry testing!

“57 of the 64 specimens from recently infected individuals were found to be reactive in the HIV [Ag/Ab] Combo assay,” the study reported.

These findings match what we reported previously on TRPWL, that the 4th generation HIV combo Ag/Ab EIA test may reduce the diagnostic window when compared to an 3rd generation screening assay, but the adult industry DOES NOT EMPLOY 3RD GENERATION TESTING. It uses PCR viral load testing.

It’s irrelevant that 4th generation testing is better than 3rd generation. A better version of the wrong test is still the wrong test.

4th generation tests detect 95% or more of infections or more at four weeks after exposure.

PCR viral load tests detect 95% or more of infections or more at 10 days after exposure.

[W]hile RNA PCR can screen for and confirm HIV infection, fourth generation EIA is not as specific and often requires an additional confirmatory assay for definitive diagnosis.

The study in the Journal of Clinical Microbiology found the 4th generation test was a less-expensive, easy substitute to RNA testing because RNA-based tests are “expensive, laborious” and in many cases it can take 1 to 2 weeks for test results to come back.

Well, adult industry (PASS-approved) RNA test results are received back the next day in most cases, so that’s not relevant, and as for cost — aren’t the lives of adult performers worth the added expense?

We think they are.

Pro-Health Community Care’s “4th Generation Combo Testing” is a dangerous scam – one which we’ll be exploring in more detail very soon.

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  • Also of note:

    Acute HIV infection can be challenging to diagnose, because 50% of acutely infected persons have no symptoms and because screening tests cannot detect HIV antibody or p24, the earliest HIV-1 antigen to appear, until 12-14 days after initial infection. Qualitative nucleic acid testing can detect HIV RNA as early as NINE days after initial infection. There is currently no commercially available assay that can detect HIV RNA in the peripheral blood between day 1 and day 8 after initial infection.

    4th Generation HIV Screening Tests

    Many laboratories in New York City currently perform “fourth generation” HIV testing. These tests detect HIV-1 p24 antigen and antibodies to HIV-1 and HIV-2. Such tests detect HIV infection 12-14 days after infection, but they do not report whether p24 antigen or antibody to HIV-1 or HIV-2 was detected. Supplemental antibody testing, e.g., with HIV-1 Western blot, will confirm if the patient has well-established HIV-1 infection. Nucleic acid [e.g., PCR-RNA] testing, however, is needed for an infection that has not yet generated sufficient antibody titers to be detected by Western blot, a process that can take up to five weeks.

    http://www.hivguidelines.org/wp-content/uploads/2012/10/missed-opportunity-to-detect-acute-hiv-infection-10-15-2012.pdf

    In other words PCR-RNA, the test currently required under PASS protocols IS THE BEST, MOST ACCURATE TEST AVAILABLE.

  • "When acute HIV infection is suspected, a plasma HIV RNA assay should be used, followed by confirmatory antibody testing 3 to 6 weeks later. Most HIV RNA tests will detect acute HIV infection 7 to 14 days after exposure to HIV. A qualitative [as opposed to quantitative] HIV RNA test is the approved method for such a diagnosis...."

    http://www.hivguidelines.org/clinical-guidelines/adults/diagnostic-monitoring-and-resistance-laboratory-tests-for-hiv/

    In other words PCR-RNA, the test currently required under PASS protocols IS THE BEST, MOST ACCURATE TEST AVAILABLE.

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