HIV Testing Section

Know your rights: You have a right to informed consent, a right to read and review all critical literature on a medical procedure before agreeing to undergo it.

Know your rights: You have a right to read and review all critical literature on HIV testing, before submitting to a test. You have a right to choose whether or not to take a test, based on your reading of the critical medical literature on testing. It is your legal right:

  • To review all critical literature on the tests and on testing.
  • To take or to not take a test.

Before you test, seek answers to the following questions:

  • How are the tests constructed? How do they work? What do they measure?
  • What are the specific mechanical components of the tests? Where are the parts made? Where do they come from?
  • What makes a test react? What makes a reaction positive or negative?
  • What is the difference between a positive and a negative reaction?
  • What standards are used to interpret a reaction?
  • What other factors are used to determine the meaning or interpretation of a test result?
  • Do the tests measure only one thing? Do they measure what they claim to measure? Do they cross-react, and if so, with what? Why do they cross-react?
  • Who are the tests used on? Where are they issued most often? What gives a test a higher versus a lower “predictive value“?

Exercise your right to informed consent, and make the decision according to a full understanding of the tests, their limitations and uses, as reviewed in twenty-five years of the medical literature.

More on testing below, and at ARAS.ab.ca/test

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Lo siguiente es un anuncio público:

Conoce tus derechos. Antes de someterte al test: Tienes derecho al consentimiento informado y el derecho a conocer todas las críticas al procedimiento médico publicadas en la literatura científica.

Conoce tus derechos: antes de someterte al test de VIH tienes el derecho a acceder a toda la literatura científica que critica el procedimiento.

Una vez que hayas leído las críticas publicadas, puedes elegir si quieres o no hacerte los tests del VIH. Es tu derecho legal:

  • El acceso a la literatura científica que critica las pruebas del VIH.
  • Hacerte o no los tests.

Antes de hacerte las pruebas, busca respuesta a las siguientes preguntas:

  • ¿En qué consisten los tests? ¿Cómo funcionan? ¿Qué detectan exactamente?
  • ¿Cuáles son los componentes mecánicos específicos de estos tests? ¿Dónde se fabrican los componentes? ¿De dónde proceden?
  • ¿Qué es lo que hace reaccionar los tests? ¿Qué es lo que produce una reacción positiva o negativa?
  • ¿Cuál es la diferencia entre una reacción positiva y otra negativa?
  • ¿Qué parámetros se siguen para interpretar una reacción?
  • ¿Qué otros factores se tienen en cuenta para determinar el sentido y la interpretación de los resultados de los tests?
  • Estos tests, ¿miden un sólo elemento?, ¿miden lo que afirman medir?, ¿pueden producirse reacciones cruzadas y, si es así, con qué? ¿Por qué se producen las reacciones cruzadas?
  • ¿A quién le hacen los tests del VIH? ¿Dónde son utilizados más a menudo? ¿Qué le da a un test un mayor o menor valor predictivo?

Ejercita tu derecho al consentimiento informado y decide tras entender completamente el funcionamiento de estas pruebas, sus usos y limitaciones, información que puedes encontrar en veinticinco años de literatura médica.

MÁS INFORMACIÓN SOBRE LOS TESTS: ARAS.ab.ca/test

Test Analysis:

1) Test Kits – Note that they all say something along the lines of:

  • “Suggest the presence of antibodies,”
  • “No standards,”
  • “More specific tests must be used to qualify this result,”
  • “AIDS is a clinical syndrome, and cannot be diagnosed with HIV testing / must be diagnosed clinically,”
  • “A negative may not be a negative,”
  • “A positive may not be a positive,”
  • “High-risk (black, gay, drug injecting) individuals are ‘high risk,’ meaning that they’re positive is more likely true, and their negative more likely false.”

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Abbot Labs 2006 HIV Test

Abbott Labs

“At present there is no recognized standard for establishing the presence or absence of antibodies to HIV-1 and HIV-2 in human blood.”

“The risk of an asymptomatic [not chronically ill] person with a repeatedly reactive [positive] serum sample developing AIDS or an AIDS-related condition is not known”

“Clinical studies continue to clarify and refine the interpretation and medical significance of the presence of antibodies to HIV.”

“AIDS and AIDS-related conditions are clinical syndromes and their diagnosis can only be established clinically. EIA testing [that’s this test] cannot be used to diagnose AIDS, even if the recommended investigation of reactive specimens suggest that the antibodies to HIV are present.”

“Sensitivity for HIV-1 antibodies was computed based on the clinical diagnosis of Aids.”

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Vironostika HIV Elisa Test (2003)

Vironostika-HIV-Test.pdf

“SUMMARY AND EXPLANATION OF THE TEST

Published data indicate a strong correlation between the acquired immunodeficiency syndrome (AIDS) and a retrovirus referred to as Human Immunodeficiency Virus (HIV).”

“Currently, two HIV serotypes, designated as HIV-1 and HIV-2, have been identified based on the results of serologic and molecular studies. Both HIV serotypes have been isolated from patients with AIDS and AIDS-related complex (ARC), as well as from apparently healthy individuals at high risk for AIDS.”

“A majority of patients who exhibit symptoms of AIDS or ARC have HIV specific antibodies in their blood. In addition, a significant proportion of apparently healthy individuals at increased risk for AIDS also contain HIV specific antibodies in their blood specimens.”

“The Vironostika HIV-1 Plus O Microelisa System assay was designed to be highly sensitive for a spectrum of HIV-1 serotypes, including group O virus. As a result, nonspecific reactions may occasionally be seen in specimens from people who have prior pregnancy, blood transfusion, or exposure to human cells or media containing cultured HIV antigen.”

“Because of these and other potential nonspecific reactions, specimens reactive with the Vironostika HIV-1 Plus O Microelisa System assay should be confirmed with a confirmatory test ,e.g., Western Blot.”

“Reactive specimens upon initial testing with the Vironostika HIV-1 Plus O Microelisa System assay should be re-tested in duplicate.”

“Reactivity in either or both of the duplicate tests indicates a potential for the presence of HIV-specific antibody.”

“In individuals at increased risk of infection, such as homosexual men, hemophiliacs, or intravenous drug users, repeatedly reactive specimens are usually found to contain antibodies to HIV by additional, more specific tests.”

“However, when the ELISA is used to screen populations with a low prevalence of HIV infections, nonspecific reactions may be more common than specific reaction.”

“Information about prevalence of HIV infections in persons in various categories of risk, as well as clinical and public health guidelines, are available in each CDC publication of Morbidity and Mortality Weekly Reports.”

“Although information about the degree of risk for HIV-1 infection and the degree of reactivity of the serum are of value in interpreting the test, a diagnosis should not be based only on this information.”

“Therefore, it is appropriate to investigate repeatedly reactive specimens by additional, more specific tests, such as Western Blot, immunofluorescence, radioimmunoprecipitation, viral antigen based immunoassays, peptide ELISAs, or nucleic acid amplification assays.”

“High-risk populations:

To assess the performance of the test with specimens collected from high-risk populations, fifteen hundred and fourteen (1,514) specimens were collected from four high-risk populations, which included prison inmates, STD (sexually transmitted diseases) clinic patients, inner city hospital emergency room patients, and HIV-1 outreach clinic patients.”

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OraQuick Rapid HIV Test Label

Oraquick-Rapid-Test.pdf

From the packet:

LIMITATIONS OF THE TEST

1. The OraQuick® Rapid HIV-1 Antibody Test must be used in accordance with the instructions in this package insert to obtain an accurate result.

2. Reading test results earlier than 20 minutes or later than 60 minutes may yield erroneous results.

3. This test is approved by FDA for use with fingerstick blood specimens only. Use of other types of specimens may not yield accurate results.

4. A Reactive result using the OraQuick® Rapid HIV-1 Antibody Test suggests the presence of anti-HIV-1 antibodies in the specimen. The OraQuick® Rapid HIV-1 Antibody Test is intended as an aid in the diagnosis of infection with HIV-1.

AIDS and AIDS-related conditions are clinical syndromes and their diagnosis can only be established clinically.

5. For a Reactive result, the intensity of the test line does not necessarily correlate with the titer of antibody in the specimen.

6. A Non-Reactive result does not preclude the possibility of exposure to HIV or infection with HIV. An antibody response to recent exposure may take several months to reach detectable levels.

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Reveal Rapid Test

Reveal-Rapid.pdf

[The Reveal Rapid Test – Another Rapid Test with the same contradictory warnings. You’re told to use this test and to not use this test to diagnose HIV infection. In the end, it is reiterated that AIDS is a clinical diagnosis, and can be made regardless of what the tests say.]

LIMITATIONS OF THE TEST

1. The Reveal™ Rapid HIV -1 Antibody Test must be used in accordance with this package insert to ensure accurate results.

2. The FDA has approved the Reveal™ Rapid HIV -1 Antibody Test for serum or plasma specimens only. Use of other types of specimens may not yield accurate results.

3. Test results are to be read and interpreted immediately following the final washing step with Universal Buffer. A delay in reading test results may yield inaccurate results.

4. Specimens that do not pass through the membrane within thirty (30) seconds after centrifugation (see Testing Procedure, step 2) are unsuitable for testing with the Reveal™ Rapid HIV -1 Antibody Test.

5. Lipemic samples or specimens contaminated with bacteria may not pass through the membrane within thirty (30) seconds, and therefore may be unsuitable for testing with the Reveal™ Rapid HIV -1 Antibody Test.

6. Limited studies were conducted to determine the potential effect of interfering substances and unrelated medical conditions on the performance of the Reveal™ Rapid HIV -1 Antibody Test.

7. The specificity of the Reveal™ Rapid HIV -1 Antibody Test for serum specimens in low -risk populations has not been evaluated.

8. Limited studies were conducted to determine the performance of the Reveal™ Rapid HIV -1 Antibody Test on fresh serum and plasma specimens.

9. A Reactive test result using the Reveal™ Rapid HIV -1 Antibody Test suggests the presence of anti-HIV-1 antibodies in the specimen.

The Reveal™ Rapid HIV -1 Antibody Test is intended to be used as an aid in the diagnosis of infection with HIV -1.

AIDS and AIDS-related conditions are clinical syndromes and their diagnosis can only be established clinically.

Results of the MedMira Reveal™ Rapid HIV -1 Antibody Test should not be used in isolation, but in conjunction with the clinical status, history, and risk factors of the individual being tested.

10. The intensity of the red dot (Reactive test result) does not necessarily correlate with the antibody titre of the specimen.

11. A Non-Reactive test result with the Reveal™ Rapid HIV -1 Antibody Test indicates the absence of detectable antibodies to HIV in the specimen. However, a Non-Reactive test result does not exclude the possibility of exposure to, or infection with HIV.

Following a recent exposure to HIV, it may take several months for the antibody response to reach detectable levels, during which time testing for antibodies to HIV will not be indicative of true infection status. A comprehensive risk history and clinical judgement should be considered before concluding that an individual is not infected with HIV.

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2) Interpretation / Risk Assessment / Testing Algorithms:

HIV test results are not HIV test results.

There are so many different kinds of tests, all giving different results, that laboratories and countries have to define and re-define ‘algorithms’ to create the illusion that there really is any standard at all in testing.

Individual tests also must be interpreted for risk group, and against expectation of positivity or negativity for each group (called “low” or “high risk,” and separated by race/ethnicity and sexual orientation).

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Guidelines for Interpreting HIV Test Results – National and State Reference Laboratories Australia.
A PDF Presentation on multiple strategies for interpreting HIV test results

Australia-Guidelines-for-Interpretting-HIV-Test-Results.pdf

[Goals] “To reach consensus on: Interpretation of HIV test results. Reporting WB Indeterminate Results”

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HIV Test Interpretation Strategy Paper -Brasil

Testing-and-Confirmation-Brasil.pdf

“The signal/cut-off ratio in any assay has no predictive value for the signal/cut-off ratio in any other assay, since the signal/cut-off ratios do not correlate for any of the investigated ELISA pairs (Figure 1).

On the other hand, all sera with a signal/cut-off ratio greater than 2.0 for all ELISA pairs were also positive in Western blot. This fact was used to develop a simplified confirmation strategy for HIV testing (Figure 2).”

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Coming to your clinic: Candidates for rapid tests
Aids Alert – March 1998

http://reducetheburden.org/?p=149

“[The test’s] error rate won’t matter much in areas with a high prevalence of HIV, because in all probability the people testing false-positive will have the disease. But if the same test was performed on 1,000 white, affluent suburban housewives – a low-prevalence population – in all likelihood all positive results will be false, and positive predictive values plummet to zero.”

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UK test Guidelines

UK-Interpretation-Guidelines.pdf

The official interpretation guidelines for the UK. [with notes in brackets]

“Specimens from HIV-infected individuals typically give rise to strong, and often maximum, signals in most commercial screening assays whereas falsely reactive specimens infrequently do.”

–[What makes it a false reaction? The strength of the reaction? ….Nope]

“However, this is not a reliable basis on which to make a diagnosis of HIV infection, and further testing is essential, employing several different tests carefully selected to minimise the possibility of each additional test being prone to the same false-positive effect as gave rise to the false reaction in the initial screening test.”

–[So, how do they know which is a false reaction and which is a true reaction? — “Expectation“]

“Other pitfalls arise from the use of fourth generation tests (where, as noted above, both components need to be checked) and the application of screening tests to populations where the strong expectation is of a negative result. Reactivity on these specimens needs very careful scrutiny, unhurried by inappropriate ‘turn-around’ targets.”

–[But – if they think you’ve got it, then, well, you’ve got it.]

“Clearly, waiting for six months to test is untenable, and an approach should be adopted that strikes a balance between certainty that transmission has not happened and the need to be able to reassure the patient as soon as possible.”

“A nucleic acid test (see below) may hasten a positive finding after exposure to HIV, but it is not a substitute for anti-HIV testing after a ‘safe’ interval.”

–[Here the ELISA test is considered more accurate than the PCR. This is the opposite of the standard line (That PCR is more accurate than the ELISA).]


–[But the ELISA antibody tests (what they delightfully call “anti-HIV”) are not virologic tests, they’re non-specific antibody tests, hence the call for PCR (“nucleic acid test”, which they’ll say, is more specific than ELISA (except that it’s actually not)… Clear?]

“We would suggest testing using a sensitive fourth (or third) generation screening test immediately after the exposure and then: at one to two months, at three to four months, and six months.”

“Should suspicious clinical signs and symptoms develop, ie almost anything occuring in persons in the pre-designated “risk groups” – cold, allergy, fever, etc an immediate test, including for HIV RNA, is indicated.”

“Some time and care will be needed to explain the reasons underlying the need for follow-up testing and to communicate without undue alarm an appropriate level of residual risk of infection, despite negative results, prior to completing the six-months follow up.”

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From the Max Planck Institute, Germany, 1998.

Max-Planck-Institute-HIV-Counseling-for-Low-Risk-Clients.pdf

HIV Testing for Low-Risk Clients

Abstract. This study addresses the counselling of heterosexual men with low-risk behaviour who, voluntarily or involuntarily, take a HIV test. If such a man tests positive, the chance that he is infected can be as low as 50%. We study what information counsellors communicate to clients concerning the meaning of a positive test and whether they communicate this information in a way the client can understand.

To get realistic data, one of us visited as a client 20 public health centres in Germany to take 20 counselling sessions and HIV tests. A majority of the counsellors explained that false positives do not occur, and half of the counsellors told the client that if he tests positive, it is 100% certain that he is infected with the virus. Counsellors communicated numerical information in terms of probabilities rather than absolute frequencies, became confused, and were inconsistent.

Recall that under the currently available estimates, only some 50% of heterosexual German men with low-risk behaviour actually have HIV if they test positive. The information provided by the counsellors was quite different. Half of the counsellors (ten of 18; two repeatedly ignored this question) told the client that if he tested positive it was absolutely certain (100%) that he has HIV (Table 1 and Session 1). Five told him that the probability is 99.9% or higher (e.g., Session 3). Thus, if the client had tested positive and trusted the information provided by these 15 counsellors, (Stine, 1996).

Counseling people at low risk requires paying particular attention to false positives, that is, to the possibility that the client has a positive HIV test even though he or she is not infected with the virus….If clients are not informed about this fact, they tend to believe that a positive test means that they are infected with absolute certainty….Emotional pain and lives can be saved if counselors inform the clients about the possibility of false positives…

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CDC MMWR – 1985 Elisa tests

http://reducetheburden.org/?p=181

http://wonder.cdc.gov/wonder/prevguid/p0000335/p0000335.asp

CDC-PCR-Review.pdf

“HTLV-III antibody was found to range from 68% to 100% of patients with AIDS, and in 84%-100% of persons with related conditions, such as unexplained generalized lymphadenopathy (5-7).

“Serologic surveys have yielded variable seropositivity rates in groups at increased risk for AIDS:

22%-65% of homosexual men (8-11), 87% of intravenous-drug abusers admitted to a detoxification program in New York City (12), 56%-72% of persons with hemophilia A (13,14), and 35% of women who were sexual partners of men with AIDS (15). In contrast to the above groups, HTLV-III antibody has been detected in fewer than 1% of persons with no known risks for AIDS (4-10).”

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CDC instruction/quiz for HIV test interpretation

CDC-Instruction-for-Test-Interpretation.pdf

“Establishing the cutoff value to define a positive test result from a negative one is somewhat arbitrary. Suppose that the test manufacturer initially considered that optical density ratios greater than “A” on the above figure would be called positive.

Where might the blood bank director and the head of drug treatment want the cutoff point to be for each program? Who would probably want a lower cutoff value?”

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3) False-Positives:

HIV Test proteins and genetic material react with a wide variety of proteins and genetic material, and are not in the least specific.

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Report of a False-Positive HIV Test Result and the Potential Use of Additional Tests in Establishing HIV Serostatus

http://archinte.ama-assn.org/cgi/content/abstract/160/15/2386

FalsePositiveHIVTest.pdf

Arch Intern Med. 2000;160:2386-2388.

Considering the lifelong implications of a positive human immunodeficiency virus (HIV) test result, physicians should be aware of the limitations of tests for HIV.

A 43-year-old man had a reactive enzyme-linked immunosorbent assay [HIV test] and an indeterminate result on Western blot analysis.

The results of subsequent enzyme-linked immunosorbent assay and Western blot tests were interpreted as positive, and the patient was informed that he had HIV infection.

Persistently undetectable plasma HIV-1 RNA, combined with normal physical examination findings, CD4+ cell count, and CD4/CD8 ratio, prompted further testing, which revealed that the patient was not infected with HIV.

False-positive HIV test results are uncommon, but they can occur. In the appropriate clinical setting, follow-up and the use of other laboratory tests, such as determination of plasma viral load, may help identify such cases.

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Mice Test HIV Positive – Science 1991

Mice-Test-Positive.pdf

“Alloimmune mice (mice that have been exposed to cells from another murine [mouse] strain) were shown to make antibodies against gp 120 and p24 of human immunodeficiency virus (HIV), and mice of the autoimmune strains MRL-_tpr/lpr_ and MRL-+/+ made antibodies against gp120.

This is surprising because the mice were not exposed to HIV.”

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Cows, Goats, Babies Test Positive

Cows-Goats-Babies-Test-Positive.pdf

Heterophile antibodies are a well-recognized cause of erroneous results in immunoassays. We describe here a 22-month-old child with heterophile antibodies reactive with bovine [Cow] serum albumin and caprine [Goat] proteins causing false-positive results to human immunodeficiency virus type 1 and other infectious serology testing.

Two-site immunoassays are susceptible to interference when heterophile antibodies bridge the capture and detection antibodies, as can occur with HAMA (2).

HAMA and other heterophile antibodies may be present in as many as 40% of individuals, especially in patients treated with monoclonal antibody immunotherapy (6, 7).

Heterophile antibodies reactive with other molecules used in immunoassays have not been well characterized but can also cause false assay results (4).

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Dogs Test HIV Positive

Dogs-Test-Positive.pdf

“Retroviruses have been isolated from a wide variety of species including humans…Immunoblotting (Western blot) is routinely used for detection of antibodies in human sera against HIV proteins.”

“A total of 144 dog sera were tested on Chiron Western blot strips. Of these, 72 sera (50%) reacted with one or more HIV recombinant proteins.”

“Some canine sera contain antibodies that cross-react with different HIV structural proteins and to a limited degree with SIV (mac) core protein.”

“The majority of the sera reacted with the HIV core protein, although some sera reacted with more than one protein, which indicates a specific rather than a nonspecific reaction.”

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False Positive HIV Tests in Pregnant Women

Pregant-Women-Test-Positive.pdf

http://archfami.ama-assn.org/cgi/content/full/9/9/924

“A strongly reactive ELISA result is more likely to indicate that the person is infected (true-positive result) than a weakly reactive result.16-17

The ELISA screening test is inexpensive and is designed with a low threshold so that few infected individuals will be missed. However, like other screening tests, it will also capture some uninfected individuals.

“This is especially a problem when testing is expanded from a high-risk population to a large low-risk population.18”

“The PPV* of the ELISA test has been reported to be as low as 2% for a weakly reactive ELISA result in a low-risk population and as high as 99% for a strongly positive ELISA result in a high-risk population.14”

“Expanding the test population to include more low-risk people can be expected to result in a proportionate increase in false-positive test results and to decrease the PPV.”

“False-positive ELISA test results can be caused by alloantibodies resulting from transfusions, transplantation, or pregnancy,13, 19-20 autoimmune disorders,13, 15, 20 malignancies,15, 19 alcoholic liver disease,15, 19, 21 or for reasons that are unclear.”

*[Note – PPV – positive predictive value – ‘is positive positive?’]

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High False-positive Rate of Human Immunodeficiency Virus Rapid Serum Screening in a Predominantly Hispanic Prenatal Population

False-Positives-in-Pregnancy-Hispanic.pdf

A total of 69 patients had a positive rapid HIV-ELISA out of 9,781 deliveries. Of those, 26 were confirmed as HIV infected by Western blot (overall HIV prevalence: 0.27%, ELISA-positive predictive value: 37.7%).

The subgroup prevalence of HIV and positive predictive value of ELISA were 1.53 and 75% among Caucasians; 2.43 and 82.6% among African- Americans; and 0.05 and 9.8% among Hispanics, respectively (p <0.05 for the comparisons between Hispanics and non-Hispanics only). A history of multiple (Z5 lifetime) sexual partners was elicited in the majority of HIV-infected patients.

In conclusion, our findings underscore the fact that not all patients are at the same risk for HIV infection. Any screening program must consider the characteristics of the target population;29 health providers should keep in mind the effect of population prevalence on the predictive value of a given test. In fact, the CDC states that informed refusal of intrapartum HIV screening is a reasonable option for the parturient without historical risk factors for HIV infection.4 Finally, release of preliminary test results and counseling for the HIV ELISA-positive mother and her family must consider her a priori risk status, particularly in low-risk women, such as immigrants from Mexico and Central America.

CONCLUSIONS:

The positive predictive value of rapid HIV-ELISA during pregnancy varies widely, depending on maternal race/ethnicity and sexual behavior. The routine disclosure of rapid intrapartum HIV serum screening results prior to Western blot confirmation should be avoided in very low-risk populations.

Journal of Perinatology (2004) 24, 743 – 747. doi:10.1038/sj.jp.7211184 Published online 19 August 2004

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HIV Screening In Russia – False Positives

HIV Screening in Russia

Sir, In the May 9 issue of The Lancet, Round the World correspondents discussed AIDS-associated problems in former Eastern bloc countries…I would like to emphasize another alarming concern – namely, the rapid growth in false-positive HIV tests in the former USSR, and in Russia especially.

In 1990, of 20.2 million HIV tests done in Russia only 12 were confirmed and about 20,000 were false positives.
1991 saw some 30,000 false positives out of 29.4 million tests, with only 66 confirmations.

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Flu Vaccine Causes HIV Positivity
Flu-Vaccine-Tests-Positive.pdf

New England Journal of Medicine – March 30, 2006

From the New England Journal of Medicine, March, 2006:

A case–control study of 101 blood donors who had been vaccinated against influenza and 191 matched controls showed that recent inoculation with any brand of influenza vaccine was significantly associated with a false positive screening assay for HIV antibodies. Guidelines of both Johns Hopkins and the New York State Department of Health list influenza vaccination as a known cause of indeterminate results on Western blotting for HIV antibodies.

Given the escalating international awareness of various influenza strains, it is very important to remind patients and clinicians that influenza vaccination may cause cross-reactivity with HIV antibody assays. The time course for such cross-reactivity remains uncertain. Moreover, if the screening algorithm for acute HIV infection had called for the use of a nucleic acid amplification test instead of the Western blot assay to confirm the enzyme immunoassay, the index patient would not have received an indeterminate result.

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HIGH FREQUENCY OF FALSE POSITIVE RESULTS IN HIV SCREENING IN BLOOD BANKS
Ayub Medical College Pakistan
http://www.ayubmed.edu.pk/JAMC/PAST/16-1/Aqleem.htm

“[B]efore we screen low-risk groups for antibody to the human immunodeficiency virus (HIV), we should consider what the results would mean. Serologic tests for HIV antibodies appear to be characterized by extra-ordinarily high false–positive results in a low risk screening setting of voluntary blood donation.

“Furthermore, any increase in false positive rate could turn a screening program into a social catastrophe. A false positive result may label an infant, born to HIV positive mother, as HIV positive where as the same infant may actually be HIV negative.2 The false positive result regarding HIV in a neonate can lead to very serious problems.”

“If we want to test each other, we should make a deliberate choice of the threshold probability of infection above which we will screen. We should make explicit the trade-offs implicit in any testing program. How many engagements should end to prevent one infection? How many jobs should be lost? How many insurance policies should be cancelled or denied? How many fetuses should be aborted and how many couples should remain childless to avert the birth of one child with AIDS?”

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4) Viral Load Tests – are as non-specific as antibody tests:

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Misdiagnosis of HIV Infection by HIV-1 Plasma Viral Load Testing: A Case Series

http://reducetheburden.org/wp-content/uploads/2009/03/316-misdiagnosis-by-vl.pdf

FalsePositiveHIVTest.pdf
CASE 1.

A previously healthy 12-year-old boy, whose HIV-infected mother is cared for at one of our institutions, presented for evaluation of a positive plasma viral load (PCR) of 1254 copies per/mL determined by using the branched-chain DNA assay (Chrion) for HIV-1 RNA.

The patients’ mother had received a diagnosis of HIV infect around the time of his birth, and the patient had tested negative for HIV-1 by enzyme-linked immunosorbent assay (ELISA) several times in the years after his birth.

Although the patient reported no risk factors for HIV infection, he underwent plasma viral load testing after his primary care physician noted a skiing lesion that was interpreted as herpes zoster. At our institution, the patient subsequently had a negative result on HIV-1 ELISA, a normal CD4 cell count and a CD4:CD8 ration, and a negative plasma viral load…His skin lesion was diagnosed as impetigo, and he remains in excellent health 3 months after his initial presentation.

The patient tested negative for HIV-1 antibody on (an) HIV-1 oral specimen collection device..

CASE 2.

A previously healthy, pregnant 40-year-old woman presented for an HIV test. Her male sexual partner, with whom she had recently had repeated unprotected vaginal intercourse, had been given a diagnosis of HIV infection 1 week before her office visit.

The patient tested negative for HIV-1 antibody on (an oral test)…but continued to be concerned about her HIV status.

One week after her initial presentation, she underwent a plasma viral load test… that yielded a positive value of 1574 copies/mL. The patient was told shat she was probably infected with HIV.

During the next 3 months, she had a negative result on an HIV-1 ELISA, a normal CD4 cell count…and three HIV-1 plasma viral load tests …that showed an undetectable viral load. When the patient delivered a healthy baby 7 months after her initial presentation, another HIV-1 ELISA yielded negative results.

CASE 3

A 20-year-old healthy woman…had a positive result on HIV-1 ELISA and an indeterminate result on a Western blot test.

During a 4-month period after her indeterminate result on the WB test, she had a positive result on ELISA and an indeterminate result on a Western blot test on separate occasions.

Five months later, both ELISA and a Western blot test yielded negative results, but the patient had a plasma viral load of 1300 copies/mL. (Roche PCR test).

She was subsequently counseled that she was probably infected with HIV. Nearly 6 months after her initial indeterminate HIV test result, she was tested by a third laboratory and was negative for HIV-1 antibodies on both ELISA and Western blot test.

She had a normal CD4 cell count.. and a plasma load that was undetectable on RT-PCR (Roche Viral Load tees).

She remains healthy 8 months after her initial presentation.

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Failure to Quantify Viral Load with Two of the Three Commercial Methods in a Pregnant Woman Harboring an HIV Type 1 Subtype G Strain

FailureToQuantifyViralLoadPregnantWoman.pdf

AIDS RESEARCH AND HUMAN RETROVIRUSES Volume 14, Number 5, 1998 Mary Ann Liebert, Inc.

ABSTRACT

The level of HIV-1 RNA in plasma has become one of the most important markers in the follow-up of HIV- infected patients. Three techniques are commercially available: both the Amplicor HIV Monitor and the NASBA HIV-1 RNA QT are target amplification methods, whereas the Quantiplex HIV RNA assay is a branched DNA signal amplification technique. Detection in both target amplification techniques is based on a single primer pair and a single probe in the gag region, whereas multiple probes capture the pol region of the viral RNA in the branched DNA assay.

We investigated the discrepant observation of an undetectable viral load in an immunodeficient pregnant HIV-l-infected patient of African origin with no prior antiretroviral treatment. Although clinical progression was present in this patient with tuberculosis and a low CD4 cell count, viral load determinations with both the Amplicor Monitor and NASBA assays revealed no detectable RNA levels. The presence of HIV-1 RNA in the plasma of the patient was demonstrated by an in-house RNA-PCR. Subsequent HIV-1 RNA quantification with the branched DNA method revealed a high viremia (460,000 copies/ml).

DNA sequence analysis of the gag gene identified a subtype G HIV-1 strain (HIV-Ibl)- To our knowledge this is the first report of a patient harboring an HIV-1 genotype of the main group with a high viral load as quantified by the branched DNA assay, but undetectable with the two commercial HIV RNA amplification techniques because of genetic divergence. In the case of discrepant low viral loads determined by one amplification technique in patients with advanced clinical stage one should use an alternative quantification technique for confirmation.

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False-positive HIV Diagnosis by HIV-1 Plasma Viral Load Testing

pcr-false.pdf

A 59-year-old man known to have type 2 diabetes mellitus, alcoholism, hypertension, and chronic obstructive lung disease was hospitalized for headache and confusion.

The result on enzyme-liked immunosorbent assay for serum HIV was negative, whereas the result on testing for serum HIV-1 RNA by using reverse-transcriptase PCR was positive.

[that is, he was negative on an antibody (protein) test, and positive on a genetic test]

[Results of repeated subsequent tests “were all negative”]

The HIV-1 PCR assay was designed to monitor HIV therapy, not to diagnose HIV infection. For diagnostic tests, prior probability of a positive test result needs to be considered. in patients (like ours) with a low prior probability of ideas, almost all positive test results are false positive.

Our urge to confirm the cause of acute encephalopathy rather than accept a diagnosis of exclusion resulted in inappropriate use of HIV-1 PCR.

This case confirms the importance of prior probability in diagnostic assays. We concur with Rich and colleagues that low-level positive results on HIV-1 PCR must be interpreted within the context of the patient’s entire picture.

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Viral Load does not correlate with AIDS

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=17003398

http://www.aidsmap.com/en/news/796E5C58-223A-48E2-AE15-B2C6EB1130D4.asp

“Plasma HIV RNA (viral load) measurements predict no more than 9% of the rate of CD4 cell loss in untreated HIV-positive individuals….viral load measurements [should] play a diminishing role in informing decisions regarding when to start antiretroviral therapy.”

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MMWR 2001 – Variation among Major Brand

CDC-PCR-Review.pdf

Your ‘Viral Load’ is either 3,849 … or 118,000 … or 259,018 – depending on the lab which is running your test – with the same sample.

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5) News Items:

Occaisonally the mainstream press is forced to report on the failure of HIV testing and AIDS diagnosing technology. They usually try to make it look like a one-of-a-kind event. But it ain’t so.

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Viral Load Creates False Epidemic – NYTImes

Faith in Quick Test Leads to Epidemic That Wasn’t

http://query.nytimes.com/gst/fullpage.html?res=9501E7DB1F30F931A15752C0A9619C8B63

“At Dartmouth the decision was to use a test, P.C.R., for polymerase chain reaction. It is a molecular test that, until recently, was confined to molecular biology laboratories.” [ed – for “diagnosing” Aids, Bird Flu, Sars, etc.]

“[E]ach laboratory may do them [the tests] in its own way … their very sensitivity makes false positives likely, and when hundreds or thousands of people are tested, as occurred at Dartmouth, false positives can make it seem like there is an epidemic.”

“Now, as they look back on the episode, epidemiologists and infectious disease specialists say the problem was that they placed too much faith in a quick and highly sensitive molecular test that led them astray.”

“There are no national data on pseudo-epidemics caused by an overreliance on such molecular tests, said Dr. Trish M. Perl, an epidemiologist at Johns Hopkins and past president of the Society of Health Care Epidemiologists of America. But, she said, pseudo-epidemics happen all the time.”

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Four Chicago transplant recipients contract HIV
(Four organ recipients in Chicago test.. (Negative, Negative), Positive)

http://www.reuters.com/article/middleeastCrisis/idUSN13630047

“Kuehnert said the organs came from a high-risk donor, meaning from someone who fit under one of several criteria that would increase the chances that the person might have be infected with HIV. Those include men who have had sex with another man in the preceding five years, intravenous drug users, prisoners, and people who have had sex for money or drugs.”

[but not heterosexuals who have sex]

“Dave Bosch of the Gift of Hope Organ and Tissue Donation, the regional organ procurement agency that handled the donor organs, said the donor’s high-risk status was confirmed on a questionnaire. “We were aware of that from the beginning,” he said.

“But standard testing using the enzyme-linked immunosorbent assay or ELISA antibody screening test was negative.”

[Negative! Oh good! Because these tests are so accurate and reliable and predictable.. oh…]

“When Gift of Hope was notified of the infections, it sent samples from the donor to an outside lab, Bosch said. A second ELISA test turned up negative,”

[Negative! Oh good! Because these tests are so accurate and reliable and predictable.. oh….]

“but a more sensitive test called the nucleic acid-amplification test or NAT was positive.”

[Hmm. More “senstive.” That means, “more likely to ‘react’ for any reason whatsoever.” The difference between “sensitive, and accurate.” Good to know.]

“Bosch said it is possible the HIV infection in the donor occurred within three weeks of donation — too recent for the ELISA test to detect.

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Jilin HIV carrier claims tests show disappearance of virus

If the negative test results are verified, Mr Wen would be the first person in China to become free of HIV after contracting it. -Reuters
Wen Congcheng [hljnews.cn]

BEIJING – A CHINESE farmer has been given the all clear from HIV six years after testing HIV-positive, Xinhua news agency said on Monday.

Mr Wen Congcheng, from the Chuanying district of northeastern Jilin, first tested HIV positive in 2001 at the Chuanying Disease Prevention and Control Centre when it was screening blood-plasma donors.

‘Late in 2003, he was re-confirmed to have HIV/AIDS as a result of another test, this one by the disease prevention and control authorities of Jilin province,’ Xinhua said.

‘After learning of the negative test result in July, Wen went to the First Hospital of China Medical University and (another) three hospitals for HIV tests, which all proved to be negative.’ The results could not be immediately confirmed independently. Xinhua said experts at Chuanying were not clear why Mr Wen tested negative, and further research was needed.

‘I do not think that any drug has helped Wen to become clear of the virus,’ Xinhua quoted an expert as saying.

If the negative test results are verified, Mr Wen would be the first person in China to become free of HIV after contracting it.

China has become increasingly open about Aids in recent years, after initially denying the spread of the disease. But in some areas the epidemic is still stigmatised and civil society groups engaged in Aids prevention work are periodically harassed.

In 2003, Andrew Stimpson, a 25-year-old Briton, tested HIV-negative 14 months after testing positive, sparking a media frenzy of speculation in late 2005 when the case came to light.

Source: http://news.asiaone.com/News/AsiaOne%2BNews/Asia/Story/A1Story20071203-39411.html

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BOSTON – A jury awarded $2.5 million in damages Wednesday to a woman who received HIV treatments for almost nine years before discovering she never actually had the virus that causes AIDS.

In her lawsuit against a doctor who treated her, Audrey Serrano said the powerful combination of drugs she took triggered a string of ailments, including depression, chronic fatigue, loss of weight and appetite and inflammation of the intestine.

Serrano, 45, said she cried after hearing the verdict in Worcester Superior Court and was gratified that the jury believed her.

“I’m going to finish my school and I am going to continue to help others,” Serrano said in a telephone interview from her Fitchburg home. “I am going to find another doctor that will help me.”

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Briton claims to have beaten HIV virus

http://www.intensemuscle.com/archive/index.php/t-12692.html

LONDON (Reuters) – A British man claimed on Sunday to be the first person to become clear of the HIV virus, which can lead to AIDS , after earlier testing positive for it.

If true, the case of 25-year-old Andrew Stimpson — reported in two British newspapers — could reveal more about the virus and possibly even provide a breakthrough in the search for a cure for HIV/AIDS.

A spokeswoman for Chelsea and Westminster Heathcare Trust in London confirmed that one of its patients had tested negative for HIV about 14 months after testing positive in May 2002.

“He did test positive and then later negative, but in terms of curing himself, we don’t know because he hasn’t been back for further tests,” said the spokeswoman.

“We very much want him to return so we can try to find out what exactly has happened,” she added.

There is no known cure for HIV/AIDS, responsible for the deaths of millions of people and especially virulent in parts of Africa. Some experts say there are nearly 35 million sufferers around the world.

Scientists cite anecdotal accounts from Africa of people shaking off HIV but say they have never seen firm evidence.

“I feel truly special and lucky,” Stimpson, who is a sandwich maker, told the News of the World. “All the doctors have told me it is a medial miracle that I am clear.”

Patrick Dixon, a doctor and HIV expert, told Sky News this was the first time someone had kicked the virus out of their body.

“(AIDS) is a hugely significant problem which at moment we have no cure for,” said Dixon.

“It’s just possible inside this man’s body is a biological key. If we can find an antibody that he’s produced that has enabled him to kick this virus out, we could in theory find a way of engineering that antibody and giving it as some sort of treatment,” he said.

The hospital spokeswoman said subsequent DNA checks had proven there had been no mix-up in the identity of the patient and the HIV tests, but said she did not know whether there could have been any other error in the original test.

One thought on “HIV Testing Section

  1. is it ever possible to clear a nightmare of a family? I know a young african muslim lady 30 yrs, who was diagnosed as hiv positive after 3 month of giving birth to twin by c/s, she has no history of suspicious behaviors, she was wasted then but now she is very wasted and depressed since then, both babies tested negative on hiv screening repeatedly and her husband also was found to be negative. she had chronc history of generlized reactive lymphadenopathy for more than 7 years before that. she was tested with both elisa and westernblott. what are the chances of her being negative if there is ever a chance???????????

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