Utility of various commercially available human immunodeficiency virus (HIV) antibody diagnostic kits for use in conjunction with efficacy trials of HIV-1 vaccines

Schwartz, David H.; Mazumdar, Abhijit; Winston, Stuart; Harkonen, Scott

doi:10.1128/cdli.2.3.268-271.1995

Cited by 13 publications

(1 citation statement)

References 11 publications

(10 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This mechanism of HIV false positivity may become increasingly significant if experimental HIV vaccination programs become more widespread. 20 If HIV vaccination programs become routine, it will be important to develop HIV donor screening strategies that discriminate between HIV-infected persons and HIV-vaccinated, uninfected persons. Until such assay development occurs, it is important that HIV vaccine recipients be advised not to donate blood.…”

Section: Resultsmentioning

confidence: 99%

False-Positive HIV-1 Test Results in a Low-Risk Screening Setting of Voluntary Blood Donation

Kleinman

Busch²,

Hall³

et al. 1998

JAMA

105

View full text Add to dashboard Cite

Context.-Persons at risk of human immunodeficiency virus 1 (HIV-1) infection have been classified incorrectly as HIV infected because of Western blot results, but the frequency of false-positive Western blot results is unknown. Objectives.-To determine the frequency of false-positive HIV-1 Western blot results in US blood donors and to make projections to other screened populations. Secondarily, to validate an algorithm for evaluating possible false-positive cases. Design.-A retrospective cohort study of HIV-1 enzyme immunoassay (EIA) and Western blot results from large blood donor screening programs in which donors with suspected false-positive Western blot results underwent HIV-1 RNA polymerase chain reaction (PCR) testing and follow-up HIV-1 serology. Setting.-Five US blood centers participating in the Retrovirus Epidemiology Donor Study. Participants.-More than 5 million allogeneic and autologous blood donors who successfully donated blood at 1 of the 5 participating centers from 1991 through 1995. Main Outcome Measures.-Rate of false positivity by Western blot and true HIV-1 infection status as determined by HIV-1 RNA PCR and by serologic followup of blood donors more than 5 weeks after donation. Results.-Of 421 donors who were positive for HIV-1 by Western blot, 39 (9.3%) met the criteria of possible false positivity because they lacked reactivity to p31. Of these, 20 (51.3%) were proven by PCR not to be infected with HIV-1. The falsepositive prevalence was 4.8% of Western blot-positive donors and 0.0004% (1 in 251 000) of all donors (95% confidence interval, 1 in 173 000 to 1 in 379 000 donors). Conclusions.-A false diagnosis of HIV-1 infection can result from the combination of EIA and Western blot testing in blood donor and other HIV-1 screening programs. Individuals with a positive Western blot result lacking the p31 band should be counseled that, although they may be HIV infected, there is uncertainty about this conclusion. These individuals should be further evaluated by RNA PCR testing (if feasible) and HIV serologic analysis on a follow-up sample.

show abstract

Section: Resultsmentioning

confidence: 99%

False-Positive HIV-1 Test Results in a Low-Risk Screening Setting of Voluntary Blood Donation

Kleinman

Busch²,

Hall³

et al. 1998

JAMA

105

View full text Add to dashboard Cite

show abstract

Vaccine-Induced HIV Seropositivity/Reactivity in Noninfected HIV Vaccine Recipients

Cooper

Metch

Dragavon

et al. 2010

JAMA

View full text Add to dashboard Cite

Context Induction of protective anti-HIV immune responses is the goal of an HIV vaccine. However, this may cause a reactive result by routine HIV testing in the absence of HIV infection. Objective This study evaluated the frequency of vaccine-induced seropositivity/reactivity (VISP) in HIV vaccine trial participants. Design, Setting, and Participants A routine diagnostic HIV algorithm was used for participants who completed 25 phase 1 and two phase 2 vaccine trials from 2000–2010 conducted in the United States, South America, Thailand, and Africa. Main Outcome Measures Three common FDA-approved enzyme immunoassay (EIA) HIV antibody kits were used to determine VISP. VISP was defined as being reactive on ≥ 1 EIA test, HIV-1 negative by nucleic acid testing, and Western blot negative, indeterminate, or atypical positive (profile consistent with vaccine product). Results Among 2176 HIV uninfected participants who received a vaccine product, 908 (41.7%; 95% confidence interval [CI], 39.6–43.8%) had VISP, but the occurrence of VISP varied substantially across different HIV vaccine product types: 399 of 460 (86.7%; 95% CI, 83.3–89.7%) adenovirus 5 product recipients, 295 of 552 (53.4%; 95% CI, 49.2–57.7%) recipients of poxvirus alone or as a boost, and 35 of 555 (6.3%; 95% CI, 4.4–8.7%) of DNA alone product recipients developed VISP. Overall, the highest proportion of VISP (40.9%; 891 of 2176 tested) occurred with the HIV 1/2 (rDNA) EIA compared to the rLAV EIA (21.4%; 150 of 700 tested), HIV-1 Plus O Microelisa System (14.7%; 193 of 1309 tested), and HIV 1/2 Peptide and HIV 1/2 Plus O (8.8%; 189 of 2150 tested) kits. Only 17 (1.9%) of the 908 participants with VISP tested nonreactive using the HIV 1/2 (rDNA) kit. All recipients of a gp140 vaccine (n= 70) had VISP, with 94.3% tested reactive to all three EIA kits tested. Among 901 participants with VISP and a Western blot result, 92 (10.2%) had a positive Western blot (displaying an atypical pattern consistent with vaccine product) and 592 (65.7%) had an indeterminate result. Only 8 participants with VISP received a vaccine not containing an env insert. Conclusions The induction of VISP in HIV vaccine recipients is common especially with vaccines containing both the HIV-1 envelope and gag proteins. Development and detection of VISP appear to be associated with the immunogenicity of the vaccine and the EIA assay used.

show abstract

Capillary Electrophoresis of Proteins and Glycoproteins

Trout

Muza

Landers

2000

Encyclopedia of Analytical Chemistry

View full text Add to dashboard Cite

As a result of their complex nature, the separation of proteins and glycoproteins by capillary electrophoresis (CE) is a challenge. Fortunately, a number of approaches allow for effective analysis of these biomolecules. Of particular concern is the proclivity of proteins and their glycoconjugates to adsorb to the capillary wall. Various covalent and dynamic capillary coatings are described which minimize this effect. We also address general concerns including electrode polarity, capillary conditioning and method development that are important for achieving optimal separation. Finally, each separation mode, including capillary zone electrophoresis (CZE), capillary gel electrophoresis (CGE), and capillary isoelectric focusing (CIEF), is discussed with particular attention to its niche in the realm of protein and glycoprotein analysis.

show abstract

Utility of various commercially available human immunodeficiency virus (HIV) antibody diagnostic kits for use in conjunction with efficacy trials of HIV-1 vaccines

Cited by 13 publications

References 11 publications

False-Positive HIV-1 Test Results in a Low-Risk Screening Setting of Voluntary Blood Donation

False-Positive HIV-1 Test Results in a Low-Risk Screening Setting of Voluntary Blood Donation

Vaccine-Induced HIV Seropositivity/Reactivity in Noninfected HIV Vaccine Recipients

Capillary Electrophoresis of Proteins and Glycoproteins

Contact Info

Product

Resources

About