Manufacturer Disclaimers

“The ARCHITECT HIV Ag/Ab Combo assay is a chemiluminescent microparticle immunoassay for the simultaneous qualitative detection of HIV p24 antigen and antibodies to human immunodeficiency virus type 1 and/or type 2 (HIV-1/HIV-2) in human serum or plasma. The ARCHITECT HIV Ag/Ab Combo assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection and as a screening test for donated blood and plasma…Specimens that are initially reactive in the ARCHITECT HIV Ag/Ab Combo assay should be retested in duplicate. Repeat reactivity is highly predictive of the presence of HIV p24 antigen and HIV-1/HIV-2 antibodies. However, as with all immunoassays the ARCHITECT HIV Ag/Ab Combo assay may yield non-specific reactions due to other causes, particularly when testing in low prevalence populations. A repeatedly reactive specimen should be investigated further with sensitive, supplemental HIV-specifi tests, such as immunoblots, antigen tests, and HIV nucleic acid tests. Supplemental testing of repeat-reactive specimens obtained from individuals at risk for HIV infection usually confirms the presence of HIV antibodies or HIV antigen and HIV nucleic acid. A full differential diagnostic work-up for the diagnosis of AIDS and AIDS-related conditions includes an examination of the patient’s immune status and a clinical history…If the assay results are inconsistent with clinical evidence, additional testing is suggested to confirm the result…Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunassays…The ARCHITECT HIV Ag/Ab Combo assay demonstrated a specificity of >99.5% in a study where specimens from a blood donor population with an assumed HIV infection prevalence of zero were tested [this population is the least likely to give false positive results but even so 7 people out of 6,365 were repeatedly reactive, slightly over 1/1000. In a population with a prevalence of HIV infection of 1/1000 this would mean that 50% of positive reactions were false positive]”

“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. Individuals may present incomplete banding patterns…A person who has antibodies to HIV-1 is presumed [!] to be infected with the virus…Do not use this kit as the sole basis of diagnosis of HIV-1 infection…[When tested on ‘Low Risk’ subjects 100 out of 495 people with a negative ELISA were indeterminate on the western blot and 0 out of 14 who had a positive ELISA were positive on the Western Blot (3 were indeterminate). One person with AIDS with a negative ELISA was indeterminate on the Western Blot and 5 out of 241 who had AIDS and were ELISA positive were indeterminate on the western blot. Of 1007 people who were HIV-negative by ELISA 207 were indeterminate on this test, of which 111 were negative by another test. Of the remaining 800 with negative ELISA and this Western Blot, 295 were indeterminate on another Western Blot]”

“This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients.…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.…Quantitative measurements of HIV viremia in the peripheral blood have shown that higher virus levels may [!] be correlated with increased risk of clinical progression of HIV disease, and that reductions in plasma virus levels may [!] be associated with decreased risk of clinical progression. Virus levels in the peripheral blood can be quantitated by measurement of the HIV p24 antigen in serum, by quantitative culture of HIV from plasma, or by direct measurement of viral RNA in plasma using nucleic acid amplification or signal amplification technologies. p24 antigen is the principal core protein of HIV and is found in serum either free or bound by anti-p24 antibody. Free p24 antigen can be measured with commercially available enzyme immunoassays (EIA), although the usefulness of p24 antigen as a marker of viral load is limited since the antigen is detectable in only 20% of asymptomatic patients and 40-50% of symptomatic patients…the viral protein remains undetectable in most asymptomatic patients.…Elevated levels of triglycerides, bilirubin, albumin, hemoglobin and human DNA in specimens as well as the presence of autoimmune diseases such as Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA) and Antinuclear Antibody (ANA) have been shown not to interfere with the quantitation of HIV-1 RNA or impact the specificity of the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test…”

“A Reactive result indicates that HIV-1 RNA was detected. For a specimen that is repeatedly reactive on an HIV-1 antibody test and reactive in the APTIMA HIV-1 RNA Qualitative Assay, the individual is considered confirmed infected with HIV-1…A specimen that is reactive in the APTIMA HIV-1 RNA Qualitative Assay but that has not been tested in an HIV-1 antibody test should be further tested using a licensed test for HIV-1 antibodies.”

“Testing for the presence of antibodies to HIV in bodily fluids is an accurate aid in the diagnosis of HIV infection. However, the implications of seropositivity must be considered in a clinical context…absence of antibody to HIV cannot be taken as absolute proof that an inidividual is free of HIV infection or incapable of transmitting the virus…[After a positive OraSure rapid test result] With blood specimens, enzyme immunoassay (EIA) screening tests prior to the Western blot or IFA confirmatory test are optional. If an EIA is performed, even if it is non-reactive, the specimen must proceed to Western blot or IFA testing (reactive EIA specimens will automatically be tested by Western blot or IFA). For oral fluid testing, both EIA and Western blot testing should be performed to confirm results.Clinical data has not been collected to demonstrate the performance of the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test in persons under 12 years of age. A reactive test…suggests the presence of HIV-1 and/or HIV-2 antibodies…[this test] is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2. AIDS and AIDS-related conditions are clinical syndromes and their diagnosis can only be established clinically. For a reactive result, the intensity of the test line does not necessarily correlate with the titer [amount] of antibody in the specimen…A person who has antibodies to HIV-1 or HIV-2 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…[Table 10 shows that false positives occurred with 1/14 multiparous women (multiple births), 1/17 people with rheumatoid factor, 1/14 with Epstein-Barr Virus, 3/17 with Hepatitis A and 1/16 with Hepatitis B]”

“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 possibly additional testing to decide whether a diagnosis of HIV infection is accurate…Reactivity at or only slightly above the Cutoff Value is more frequently nonspecific, especially in samples obtained from persons at low risk for HIV infection…At present, there is no recognized standard for establishing the presence or absence of antibodies to HIV-1 and HIV-2 in human blood…Specificity is based on assay of blood donations from random donors [under the assumption that any positive result would be a false positive, yet when this test is used under normal circumstances such a positive would be treated as a true positive]…Specificity based on an assumed zero prevalence of antibody to HIV-1 and/or HIV-2 in random donors (17037 out of 17054) is estimated to be 99.90%…[but] in these calculations, one sample of the eighteen total repeatedly reactive specimens was confirmed by Western Blot and has been excluded.”

“A reactive result by Uni-Gold Recombigen HIV [test] suggests the presence of anti-HIV-1 antibodies in the specimen. Uni-Gold Recombigen HIV is intended as an aid in the diagnosis of infection with HIV-1. AIDS and AIDS-related conditions are clinical symptoms and their diagnosis can only be established clinically.”

“Uni-Gold™ Recombigen® HIV is a single use rapid test, for the detection of antibodies to HIV-1 in plasma, serum and whole blood (venipuncture). Uni-Gold™ Recombigen® HIV is intended for use in point of care settings as an aid in diagnosis of infection with HIV-1…Immunosuppressed or immunocompromised indiv iduals infected with HIV-1 may not produce antibodies to the virus…A Reactive result by Uni-Gold Recombigen® HIV suggests[!] the presence of anti-HIV- 1 antibodies in the specimen. Uni-Gold Recombigen® HIV is intended as an aid in the diagnosis of infection with HIV-1. AIDS and AIDS-related conditions are clinical symptoms and their diagnosis can only be established clinically…”

“Antibody detection tests for HIV -1/HIV -2 antibodies provide a means to aid in the diagnosis of HIV -infected individuals. However, when utilizing HIV antibodies to diagnose HIV infection, corresponding clinical factors must also be considered…The overall specificity of the Reveal™ Rapid HIV -1 Antibody Test for serum specimens in these studies was calculated to be 3608/3639 = 99.1%, combining the number of Reveal™ Rapid HIV -1 Antibody Test Non-Reactive results obtained from the study of previously screened HIV -1 antibody negative serum specimens with the number of Reveal™ Rapid HIV-1 Antibody Test Non-Reactive results obtained from the studies of high-risk populations [i.e. 1% false positives if we can assume that other antibody tests (ELISA and Western Blot) are 100% accurate and also completely independent from this rapid test]…The overall specificity of the Reveal™ Rapid HIV -1 Antibody Test for plasma [i.e. blood] specimens in these studies was calculated to be 2970/3011 = 98.6% [i.e. 1.4% of tests false positive] combining the number of Reveal™ Rapid HIV -1 Antibody Test Non-Reactive results obtained from the study of previously screened HIV -1 antibody negative plasma specimens with the number of Reveal™ Non-Reactive results obtained from the studies of low -risk populations [with the same caveats]…LIMITATIONS OF THE 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 [amount] of the specimen.”

“The VERSANT HIV-1 RNA 3.0 Assay (bDNA) is not intended for use as a screening assay for HIV infection or as a diagnostic test to confirm the diagnosis of HIV infection”

“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 testing…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…Specimens found repeatedly reactive by ELISA and positive by additional, more specific tests are considered positive for antibodies to HIV-1. Clinical correlation is indicated with appropriate counseling, medical evaluation and possibly additional testing to decide whether a diagnosis of HIV infection is accurate.”

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

“The ImmunoComb® II HIV 1 & 2 BiSpot kit is a screening test. Reactivity for antibodies to HIV-1/HIV-2 must not be considered a diagnosis of Acquired Immunodeficiency Syndrome (AIDS) or of infection with HIV[!]. Since the production of antibodies to HIV may be delayed following initial exposure, non-reactivity with this test must not be considered conclusive evidence that the patient has not been exposed to or infected by HIV…The following performance characteristics were calculated [on people of African origin] Sensitivity–100%; Specificity–98.4% [Meaning that when used in a low risk population with 1/1000 HIV infected there would be 1 true positive out of 1000 people and 6 false positives for a Positive Predictive Value of 14%]”

“Limitations: The ImmunoComb® II HIV 1 & 2 CombFirm is a supplementary assay aimed at confirming the presence of antibodies to HIV antigens in initially reactive specimens. In the absence of uniformly accepted criteria for the interpretation of HIV antibody profiles, the above-described interpretation should be considered as a recommended guideline[!]. Yet, reactivity for antibodies to HIV-1/HIV-2 must not be considered a sole criterion for the diagnosis of Acquired Immunodeficiency Syndrome (AIDS) or of infection with HIV[!]. Since the production of antibodies may be delayed following initial exposure to HIV, or be suppressed due to the immunocompromised condition of a patient, a negative result with this test must not be considered conclusive evidence that the patient has not been exposed to or infected by HIV.”

“The NucliSens 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.”

“The AMPLICOR HIV-1 MONITOR Test is an in vitro nucleic acid amplification test for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma...[It] is not intended to be used as a screening test for HIV or as a diagnostic test to confirm the presence of HIV infection…Quantitative culture has limited utility for monitoring virus levels in infected individuals since only a small fraction of virus particles is infectious in vitro. Infectious virus is often undetectable in asymptomatic individuals…The clinical specificity of the…test was determined by analysis of 495 anti-HIV-1 negative blood donors. None of these specimens was reactive…Assuming[!] a zero prevalence of HIV-1 infection in the seronegative blood donors, the specificity of the test was 100%”

“Although nonspecific reactvity [false positives] may sometimes be attributed to autoantibodies, it is possible that in some cases the pattern may represent a cross-reaction with another human retrovirus...POSITIVE blot results using any specimen type (serum, plama, or urine) should be followed with additional testing. Such testing may rely on alternative test methods or specimen types. [yet this is a 'confirmatory test'!]...[Table P shows that 1 out of 63 tests on pregnant women who were HIV ELISA negative was positive on western blot]

[Table A of this test kit label shows that 168 out of 364 people (75%) classified as low risk had at least one of 8 bands positive, but only 126 people were eventually classified as positive. Out of the 75% with at least one positive band only 54% had a p17 band while 79% had gp120/160. Amongst people with AIDS while 100% had a gp41 band and 98% had a gp120/160 band, only 21% had p17 and only 42% had p55]

[Table B of this test kit label shows that of 278 Low Risk people with a positive ELISA antibody test, 123 had negative Western Blots (44%), 29 indeterminate (11%) and 126 positive (45%). Of 86 people classified as low risk with consistently negative ELISA tests 73 (85%) were western blot negative, 13 (15%) were indeterminate and 0 were positive.]

Persons demonstrating antibodies to HIV-1 should be referred for medical evaluation, which may include testing by other techniques...Accurate diagnosis of HIV-1 infection is important in determining an individual’s risk for developing AIDS. Accuracy is complicated by false-positive and false-negative (EIA) results...Slight ambiguities exist in the designation of the molecular weights of the HIV-1 antigens [used in this test]...Although a [Western] blot POSITIVE for antibodies to HIV-1 indicates infection with the virus, a diagnosis of Acquired Immundeficiency Syndrome or AIDS can only be made clinically if a person meets the case definition of AIDS established by the CDC. POSITIVE blot results using any specimen type (serum, plasma, or urine) should be followed with additional testing [even though the Western Blot test is usually claimed to be a 'confirmatory' test]...The clinical implications of antibodies to HIV-1 in an asymptomatic person are not known. However, a larger proportion of such persons have virus detectable in their peripheral blood and some will develop immunodeficiency. INDETERMINATE blots should not be used as the basis for diagnosis of HIV-1 infection...A negative blot does not exclude the possibility of infection with HIV-1.”

“In order to afford maximum protection of the blood supply, the Genetic Systems rLAV EIA [ELISA] was designed to be extremely sensitive. As a result, non-specific reactions may be seen in samples form some people who, due to prior pregnancy, blood transfusion, or other exposure, have antibodies to the human cells or media in which the HIV-1 virus used for the manufacture of the Genetic Systems rLAV EIA is grown…when the EIA is used to screen population in which the prevalence of infection with HIV-1 is low (e.g., blood donors), nonspecific reactions may be more common.”

“"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"

"the EIA [this test] 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 manufacturer of the EIA. The risk of an asymptomatic person with a repeatably reactive serum sample developing AIDS or an AIDS-related condition is not known."

"At present there is no recognized standard for establishing the presence and absence of HIV-1 antibody in human blood."”

“Not all persons infected with HIV-1 will test positive; not all persons testing positive are infected with HIV-1…inaccurate results may occur and a positive test result alone does not mean I have AIDS or will ever develop AIDS…an indeterminate result means the result is neither negative nor positive”

“The possibility of exposure to or infection with HIV cannot be excluded by a negative [Coulter HIV-1 antigen] test result.”

“AIDS and AIDS-related conditions are syndromes that can only be established by clinical diagnosis…The possibility of exposure to or infection with HIV cannot be excluded by a negative [Coulter HIV-1 antigen] test result…False positive results may occur due to non-specific binding to assay materials and not from infection with HIV-1…Based on an assumed 100% prevalence [of HIV] in antibody positive individuals, the sensitivity of the neutralization test was 99.5% (855/859) for repeatedly reactive specimens with a valid neutralization test and 100% (855/855) for specimens that were stored and tested according to recommendations.”

“HIV-1 p24 antigen is present only transiently prior to seroconversion and later can be complexed by specific antibodies. HIV-1 p24 antigen testing should not be used in lieu of HIV-1 antibody testing as a screen for HIV-1 infection…The predictive value of a positive test is strongly influenced by the prevalence of HIV-1 infection in the population tested. For example, in low prevalence populations the predictive value was 11.1% (1/9) while in populations with known HIV-1 infection, the predictive value was 97.1% (395/407).”

“False positive results [with this HIV-1 antigen test kit] may occur due to non-specific binding to assay materials, and not from infection with HIV-1”

“When the EIA [enzyme immunoassay antibody test] 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…Reactivity at only slightly above the cut-off value is more frequently nonspecific…A person who has antibodies to HIV-1 is presumed to be infected with the virus…The risk of an asymptomatic person with a repeatedly reactive serum sample developing AIDS or an AIDS-defining condition is not known.”

“In comparison with antibody testing, antigen testing will only detect approximately 50% of AIDS, 30% of ARC [AIDS Related Complex] and 10% of asymptomatic HIV infections…the predictive value of a positive test is strongly influenced by the prevalence of the condition in the population tested. In low risk populations, where the rate of HIV-1 infection may not exceed 0.1%, the rate of antigen positivity could be as low as 0.01%. Assuming a test sensitivity of 100%, the positive predictive value of a repeatably reactive test would be only 5.9%, i.e. only 6 tests per 100 would be true positives…The sensitivity and specificity of the HIVAG-1 blocking antibody procedure are not known…In clinical studies performed in low risk populations, the neutralization test was negative for 137/137 repeatedly reactive (presumed false reactive) samples giving a 95% confidence range for specificity of 97.8% to 100%…in known infected individuals [assuming the accuracy of antibody tests], the HIVAG-1 blocking antibody test was positive in 67/67 repeatedly reactive (presumed true positive) samples giving a 95% confidence range for sensitivity of 95.9% to 100%”

“Manufacturers claim impressive levels of accuracy [of HIV tests] - usually well in excess of 99% - but much depends on the context in which the assays are being used, and any overall figure is likely to be misleading.”

“Clinical samples have also been described have…been described that are reactive in the screening assays but do not contain HIV-1 antibody. Some of these samples possess antibody to certain Class II HLA histocompatibility antigens that are found in some cell lines used to produce the virus. Other persons, who have had no known exposure to HIV-1, produce reactive results in the screening test for still unknown reasons. Such nonspecific results are found commonly when screening tests are used in large populations. Since the psychosocial and medical implications of a positive antibody test may be devastating, it has been recommended that additional testing be performed on such samples [such as this test]…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…Sensitivity and specificity of the HIV-1 Western Blot Kit was determined in comparative studies with a previously licensed HIV-1 Western blot using EIA repeatedly reactive samples from high AIDS risk and low risk populations respectively [i.e. without a ‘gold standard’ such as virus purification] [Specificity can only be tested with EIA negative specimens, of which there were none].”

“The Chembio HIV 1/2 STAT-PAK™ Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, serum or plasma specimens. The Chembio HIV 1/2 STAT-PAK™ assay is intended for use as a point of- care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results…A Reactive Test Result using the Chembio HIV 1/2 STAT-PAK™ test suggests the presence of antibodies to HIV-1 and/or HIV-2 in the specimen. The Chembio HIV 1/2 STAT-PAK™ Assay is intended as an aid in the diagnosis of infection with HIV-1/2. AIDS and AIDS-related conditions are clinical syndromes and their diagnosis can only be established clinically.”