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Evaluation of Youth Preferences for Rapid and Innovative Human Immunodeficiency Virus Antibody Tests
Ligia Peralta, MD;
Niel Constantine, PhD;
Bethany Griffin Deeds, MA;
Lee Martin, PhD;
Kareem Ghalib, BA
Arch Pediatr Adolesc Med. 2001;155:838-843.
ABSTRACT
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Objective To determine youth preferences for Food and Drug Administration (FDA)-approved
and investigational human immunodeficiency virus (HIV) antibody collection
and testing methods before and after subjects learned of test result response
times; to determine how influential test result response times are on participants'
preferences.
Design After health educators explained and demonstrated 6 different HIV antibody
collection and testing strategies (3 saliva, 1 urine, and 2 fingerstick methods),
participants completed a confidential survey about test method preference
and tried the different testing methods. The participants had an opportunity
to re-rank their test method preference after learning about each test's result
response time.
Setting Health education sessions in both clinical and community settings.
Participants Youths aged 12 to 24 years.
Results An oral collection device with a rapid saliva test was the most highly
preferred test method. The preference for this method and the rapid response
test methods via fingerstick procedures improved significantly after subjects
learned of the rapid result response time, while the other methods were given
significantly lower preference rankings after subjects learned of the longer
result response times. Shifts in preference rankings were not related to sex,
age, ethnic group, experience with HIV testing, or practice of risk behaviors.
Conclusions Our research supports the use of noninvasive and rapid HIV testing methods
with rapid response times for adolescents to assist in the early identification
of HIV status, while offering HIV prevention opportunities and immediate linkage
to care.
INTRODUCTION
ALTHOUGH the Centers for Disease Control and Prevention (CDC) estimates
that 50% of those newly infected with human immunodeficiency virus (HIV) in
the United States are younger than 25 years,1
youth remain underdiagnosed for HIV infection and are reluctant to seek HIV
counseling and testing services.2, 3, 4
These services may ensure that at-risk adolescents enter care early and receive
the maximum benefits from antiretroviral therapy, early opportunistic infection
prophylaxis, and perinatal transmission prevention interventions.2, 3, 4 Improving early identification
of HIV-infected youth remains a high priority for the public health system.5
The CDC recommends a client-centered approach to HIV counseling and
testing services in which HIV antibody testing is given during an initial
pretest counseling session followed by the delivery of results in a posttest
counseling session.6 This process takes approximately
2 weeks and requires the client to schedule and make 2 health care appointments.
Adolescents aged 13 to 19 years accepted receiving HIV testing at a much lower
rate than adult counterparts (fewer than half) with a posttest counseling
return rate of 60%.2 A report on metropolitan
adolescents has indicated a much lower posttest return rate (34%).7 To reduce this problem of low acceptance of receiving
HIV testing and posttest counseling return rates, existing research has focused
on predictors, motivators, and deterrents of HIV counseling and testing for
adolescents.3, 4, 8, 9, 10, 11
To date, there has been no investigation to our knowledge of adolescents'
preferences for HIV antibody testing techniques, particularly rapid testing
using alternative fluids. Currently, only 2 HIV screening strategies are available
in the United States: enzyme-linked immunosorbent assays (ELISAs) and 1 rapid
test, the Single-Use Diagnostic System (Abbott Laboratories, North Chicago,
Ill). The ELISA can be performed with serum, saliva, or urine samples, but
in each, at least 3 hours are required to confirm the results. The rapid test
can only be performed using serum or plasma but offers results within 15 minutes.12 However, numerous novel and rapid assays are available
internationally, some of which can be performed using oral fluid or fingerstick
blood13, 14 (Table 1). In this study, we investigated the acceptability to adolescents
of a variety of different collection methods and innovative testing devices
that varied in invasiveness and result response time. This study evaluated
youth preferences for Food and Drug Administration (FDA)-approved and investigational
HIV antibody testing methods and whether preferences would change after subjects
learned of the result response times of each test.
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Table 1. Description of HIV Testing Devices Presented to Subjects for
Preference Ranking*
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METHODS
Subjects aged 12 to 24 years were recruited for health education sessions
in 24 different locations throughout the state of Maryland, although most
of the participants were from Baltimore. All adolescents received pretest
counseling, a standardized health education intervention, and posttest counseling,
and they signed a consent form before participation. The study was approved
by the Institutional Review Board of the University of Maryland School of
Medicine, Baltimore. Most adolescents participated in health education groups
as part of the HIV education activities of the state-approved HIV counseling
and testing ambulatory unit. These health education groups ranged in size
from 5 to 10 adolescents per counselor and were conducted in community- and
clinic-based settings. The group sessions were held from January to July of
1999 in a variety of community settings, including public schools, youth recreation
centers, and sports programs. The study purpose, details of the informed consent,
and confidentiality information were explained to all subjects prior to voluntary
participation in the health education sessions.
HIV TEST METHODS AND DEVICES
During each group or individual health education session, a standardized
health education exercise was conducted by counselors with training in health
education who offered to try new HIV testing methods. A table was shown to
each participant that contained realistic printed drawings of 6 different
HIV testing devices, and above the drawings were displayed the actual respective
devices. Table 1 lists the 6 testing
systems that were offered to the participants. Three of these use oral fluid
(1 rapid), 1 uses urine, and 2 rapid tests use whole blood obtained by a fingerstick
method. All oral fluid test methods use mucosal transudate, which is collected
from cheek and gum tissue that contains high concentrations of serum-derived
immunoglobulin G to detect the presence of HIV type 1 (HIV-1). Throughout
this article, the term "saliva" will be used because it is the common usage
for HIV tests that use oral fluid.
The following is a brief description of the 6 tests used. (1) The SalivaStrip
(Saliva Diagnostics System [SDS], Vancouver, Wash) is a rapid chromatographic
strip test that uses a saliva sample collected by the Sampler (SDS) saliva
collection device (a pad on a stick). Although this test can be performed
within minutes, it requires that the sample be centrifuged prior to testing
(therefore, it is not considered to be a rapid test in our study). (2) The
SalivaCard (Trinity Biotech, Dublin, Ireland) is a rapid flow-through device
that uses saliva collected via Orapette (Trinity Biotech) (a rayon ball).
The test can be performed in less than 15 minutes and produces a blue dot
as a reactive result. (3) Oral Fluid Vironostika HIV-1 ELISA (Organon Teknika,
Durham, NC) is designed specifically for use with the OraSure (Epitope, Beaverton,
Ore) (a pad on a stick) saliva collection device. Although the sample is collected
rapidly, the test is a typical ELISA method requiring approximately 3 hours
for results; however, it is FDA approved. (4) The Sentinel HIV-1 Urine EIA
(Calypte BioMedical, Berkley, Calif) is an FDA-approved ELISA designed specifically
for urine samples. (5a) The Uni-Gold HIV (Trinity Biotech) is a rapid chromatographic
strip test that can be performed in minutes and uses whole blood collection
directly from a fingerstick; and (5b) the HemaStrip HIV (SDS) is a fingerstick
whole blood testing device. It is a chromatographic strip test in that the
fingerstick blood diffuses vertically into the device and then reacts with
buffer and immobilized antigens within minutes. For the purpose of this study,
both fingerstick methods were included in 1 preference option since the procedure
for collection of the whole blood was the same (ie, drop of blood by lancet).
However, the placement of the blood into the test varies. The HemaStrip HIV
device is applied to the drop of blood on the fingertip, while a blood drop
from the finger is applied by plastic pipette to the Uni-Gold HIV. All collections
and testing were performed as recommended by the manufacturers. Although the
testing devices for this study were supplied by the different manufacturers,
this study was not funded by the manufacturers.
The health educators demonstrated how each collection and testing device
is used and asked participants which ones they would like to try. Participants
were offered testing by the 6 different tests and were assisted by the health
educators and counselors when necessary. Participants were not required to
be tested by all methods if they declined. They were also informed that many
of these tests were investigational and nonapproved by the FDA. Therefore,
they would not receive the test results. If the participant wanted to obtain
the HIV test result with posttest counseling, the FDA-licensed OraSure HIV
test was performed.
HIV ANTIBODY TEST RANKING PROCEDURE
First Ranking (Collection Method Only)
After the participants were tested by the collection and testing methods,
they were asked to rank each according to how much they preferred each one
relative to the other methods. Participants were instructed to write in the
table, next to each drawing of the devices, a number from 1 to 5 (1, most
preferred; 5, least preferred). They were instructed to give each method a
different ranking value. However, if a participant chose not to use any particular
testing device, then they were instructed to omit the ranking for that method.
Second Ranking (Collection Method and Result Response Time)
Following testing, the health educators collected all of the testing
devices and proceeded to show each participant another graphic containing
drawings of the test devices, except that it also listed the time required
to get results from each method. The health educators explained how the results
are derived for each procedure and pointed out that the SalivaCard with Orapette
collection method and the fingerstick method using either the Uni-Gold HIV
or HemaStrip devices produce results in approximately 10 minutes compared
with the other 3 test methods, which require considerably longer times (a
few days to 2 weeks). After participants asked questions, they again ranked
the test methods they had used in order of preference as during the first
set of rankings.
Participants were also requested to complete a brief self-administered
questionnaire as part of their health education session that included information
on age, sex, ethnic group status, and whether they had ever been tested for
HIV prior to this study. The ethnic group categories included African American
(n = 237), white (n = 27), Hispanic (n = 7), Native American (n = 4), and
other (n = 2). Results are presented with a collapsed variable that compares
minority subjects with white subjects. The questionnaire also contained a
checklist for risk exposure to HIV that listed having sex with a man, with
a woman, with a person with HIV or acquired immunodeficiency syndrome, using
drugs, having sex for drug money, or having been a victim of sexual assault.
A dichotomous variable was developed so that responses to any of these items
were coded in 1 category compared with a category for no risk factors indicated.
Analyses were conducted with independent sample t tests and  2 analysis for sex comparisons. We conducted
the same set of paired-sample t tests comparing mean
rankings for each test method before and after the educational intervention
when controlling for the demographic and other characteristics listed in Table 2. For the reanalyses of the paired-sample t tests by test methods, we divided the sample by sex,
ethnic group, age (12-14 years vs 15-24 years), setting (community vs clinic-based),
whether the participants were ever tested for HIV, and whether they ever experienced
HIV risk behaviors. An illustration of 95% confidence intervals for these
comparisons was constructed to demonstrate graphically the relative shifts
and positions of the preference rankings before and after the intervention.
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Table 2. Demographic Characteristics and Other Variables for 278 Subjects*
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The paired-sample t tests showed high levels
of power for all the test method comparisons, including the urine and fingerstick
HIV testing methods. We conducted a separate power analysis for each test.
Effect sizes ranged from a low of f = 0.36 for the OraSure rank difference,
to a high of f = 0.65 for the SalivaCard rank difference. The power for the
SalivaStrip, SalivaCard, and fingerstick preference-change tests were nearly
100%, the OraSure test power was 91%, and the Sentinel HIV-1 Urine EIA test
power was 82%.
Multiple analysis of variance and ordinary least squares models using
the 5 rating differences as the dependent variables with the demographics,
HIV status tested previously, and experienced HIV risk behaviors present or
not present were conducted. No analyses results were significant; therefore,
no specified individual characteristic could predict a change in preference
for the 5 testing methods.
RESULTS
Of the 278 total participants, approximately half were female and half
were male, with an average age of 15 years (Table 2). Most subjects were minorities, predominantly African American,
and participated in this study at a community setting. None of these characteristics
was significantly different by sex. Slightly more than one quarter of the
sample reported having ever been tested for HIV (also not statistically significant
by sex) and this was similar to findings from a self-report study of subjects
aged 15 to 17 years.15 Males were more likely
than females to report experience with any of the 6 HIV risk behaviors (P<.001), primarily owing to relatively more males reporting
having sex with females than females reporting having sex with males. Participants
attended health education sessions in community (69.4%) and clinical (25.2%)
settings.
Results from the paired-sample t tests given
in Table 3 clearly indicate that
the second set of preference rankings (combination of collection method and
result response time) shifted significantly from the first set of preference
rankings (collection method only). After participants learned of the time
to receive results, the preferences for the 2 rapid result test methods improved
as choices for HIV test method, whereas the other 3 test methods were ranked
lower in preference than they were during the first set of rankings. Table 4 indicates that the shifts toward
more favorable preference rankings for the SalivaCard and fingerstick methods
were substantial, resulting from the fact that it did not require days to
weeks to receive test results.
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Table 3. Descriptive Statistics and Paired t
Test Results for Preference Rankings of 6 HIV* Test Methods Before and After
Educational Intervention on Rapid Results
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Table 4. Percentages of Subject's Preference Rankings for 6 HIV* Test
Methods After Educational Intervention on Rapid Results Compared With Initial
Rankings
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Figure 1 shows sets of confidence
rankings for each HIV test method before and after the educational intervention
introducing test response time. When confidence intervals do not overlap,
they are significantly different from one another. The most highly preferred
HIV test method was the SalivaCard (with Orapette) when participants ranked
the procedures the second time, displacing the SalivaStrip (with Sampler)
as the most preferred test. However, all 3 of the saliva test methods were
preferred as much as or more than the urine and fingerstick test methods in
both ranking conditions. Even though preference for the fingerstick method
improved significantly after subjects learned of the rapid result response
time, the less invasive yet slightly longer response time of the SalivaStrip
method remained more highly preferred in general. Since the urine (47.8%)
and fingerstick (40.3%) HIV testing methods were used relatively less frequently,
there are correspondingly fewer rankings for these procedures.
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95% Confidence intervals (CIs) for preference rankings of 5 human
immunodeficiency virus (HIV) testing devices in which the first ranking is
collection method only and the second ranking is collection method and test
result response time. For manufacturer information, see Table 1.
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Paired-sample t tests comparing mean rankings
for each test method before and after the educational intervention when controlling
for the demographic and other characteristics given in Table 2 were significant (P<.001). For
the reanalyses, the paired-sample t tests were analyzed
by test methods when the sample was divided by sex, ethnic group, age (12-14
years vs 15-24 years), whether or not the participants were ever tested for
HIV, whether they ever experienced HIV risk behaviors, and whether the health
education setting was conducted in clinical or community settings. The only
exception was that white subjects did not significantly change their preference
ranking for the urine test. Essentially, the improvement in preference for
2 rapid result response test methods did not seem to be a function of major
demographic characteristics, setting, HIV test history, or HIV risk behavior
experience.
COMMENT
This study clearly provides support for the use of noninvasive and rapid
HIV antibody testing methods for adolescents. Adolescents have shown distinct
preferences for innovative HIV antibody testing technologies (rapid saliva
and rapid fingerstick testing) regardless of age, sex, ethnic group status,
setting (community vs clinic-based), whether they have been previously tested
for HIV, or self-reported HIV risk experience. Despite the belief that adolescents
would not undergo fingerstick testing owing to fear of pain, 60% of teenagers
accepted the fingerstick testing method with only a few describing the experience
as painful. The fact that HIV antibody test results could be received in 10
minutes was a powerful indicator in determining adolescent preferences (Figure 1). Preference ranking of the rapid-result
testing methods (1 saliva, 2 fingerstick) significantly improved after adolescents
learned about the result response time (10 minutes), whereas the other 3 test
methods (OraSure, SalivaStrip, and Sentinel HIV-1 Urine EIA) were ranked lower
in preference (Table 3). Furthermore,
43.4% of youth rated the SalivaCard and 35.6% of youth rated the fingerstick
method more favorably after they learned about the rapid result times of these
test methods (Table 4).
Although the preference for the fingerstick methods greatly improved
after the adolescents knew the availability of rapid test results, adolescents
generally preferred oral testing methods, both before and after the result
response time education intervention (Figure
1). We have shown that the most preferred HIV antibody testing method
for subjects age 12 to 24 years was a rapid test (SalivaCard) that uses oral
fluid as a testing medium (Table 3 and Figure 1). When given the option,
adolescents would clearly prefer both a noninvasive and an HIV antibody test
with a rapid result response time.
As with all screening tests for HIV, repeatedly reactive results must
be confirmed using a more specific supplemental assay such as the Western
blot or indirect fluorescence assay. As with venipuncture specimens, saliva
and urine samples can be used for screening and confirmation; there are currently
FDA-licensed Western blot tests that can be used with saliva and urine matrices.
Although confirmation using these specimens does require sending these to
a laboratory, the total time for confirmed results is less than with venipuncture
specimens, since repeatedly reactive screening test results are obtained in
less than 1 hour with rapid tests compared with 1 to 5 days when specimens
are sent to a laboratory for initial ELISA testing. Furthermore, for most
patients who are tested, results are nonreactive, thereby completing the testing
process. For reactive results using a fingerstick specimen, another fingerstick
specimen can be obtained on filter paper and sent to a laboratory for testing
using a specific ELISA. Although the time for this testing is identical to
that of the ELISA and Western blot for venipuncture specimens, the collection
is much simpler, does not require a phlebotomist, and is less costly. Finally,
our group has reported on the use of a prototype rapid confirmatory HIV assay
that has produced an excellent correlation with Western blot results16 and which may become available in the near future.
This would allow for the screening and confirmation of HIV infection in less
than one-half hour.
Currently, the Single-Use Diagnostic System is the only rapid HIV antibody
test approved by the FDA.12 Although a negative
result can be given in less than 1 hour during a counseling and testing session,
an invasive venipuncture is required, and the sample must be centrifuged before
testing. Although the test indices of rapid tests were questionable in the
late 1980s when they were developed, manufacturers have addressed the issues,
and these tests are now considered to have the same sensitivities, specificities,
and predicative values as ELISAs.12, 13, 14, 17, 18
Even the analytical sensitivity of rapid assays, as assessed by seroconversion
panels, to detect early infection has proven to be comparable to other licensed
methods.19 Furthermore, the ability for rapid
assays to detect viral variants, such as HIV-1 group O and HIV-2, is excellent.20 Other publications using the newer lateral flow rapid
tests have also indicated excellent test indices, including the use of salvia,
urine, and whole blood via fingerstick.14, 21, 22, 23
In our study, the purpose was not to compare results between the methods
but to offer clients a variety of tests that use sample media other than blood
collected via venipuncture to determine their preferences. Although each of
the 3 saliva collection systems was simple, results indicate that not all
were equally desirable by participants. Some participants commented to the
health educators that some testing methods were uncomfortable, salty, "felt
dry," or had a "funny taste." Regardless, it was obvious that the ability
to perform HIV antibody testing on samples other than via venipuncture blood
collection (ie, saliva, urine, fingerstick) was desirable to participants.
At present, at least 1 of the fingerstick rapid HIV antibody testing devices
used in this study is pending approval by the FDA (Table 1). A urine test is currently available in many clinical settings,
but it is not rapid, and our adolescents preferred this collection method
least of all. This seems to be owing to the need to visit a restroom and carry
back the sample to the health education area. Also, some adolescent girls
mentioned they felt uncomfortable giving a urine specimen because they were
menstruating. Finally, as OraSure HIV antibody testing gains popularity at
youth-specific HIV counseling and testing sites because of its simple saliva
collection method, in our study, adolescents preferred it the least compared
with the other 2 saliva testing devices (Table 3). Two reasons included the salty taste and the longer response
time for results. Additionally, the fingerstick rapid tests were also preferred
over the FDA-approved OraSure test.
Our interpretation is tempered by several limitations. First, there
are fewer rankings for the urine (47.8%) and fingerstick (40.3%) HIV testing
methods. Each participant was instructed to omit a ranking value if they did
not use the device. A participant may have refused to take the test owing
to their comfort level or to time constraints when multiple collection and
testing systems were requested. Second, most of our adolescent population
is representative of one metropolitan city. Our study may not address whether
adolescents in different geographic locations or from a differing socioeconomic
status had different HIV antibody testing preferences. Although this may be
viewed as a limitation, our sample predominantly includes minority subjects,
the population that continues to be disproportionately affected by HIV and
AIDS.
As further information becomes available that describes the impact of
HIV testing devices and sampling media on the acceptance of HIV counseling
and testing services, public health professionals need to advocate the development,
approval, and use of innovative HIV antibody testing technologies. Our study
is the first to show which sample collection methods are preferred and the
importance of rapidly obtained results. The goal of this ongoing research
is to increase the number of adolescents accepting HIV counseling and testing
services while increasing opportunities for HIV prevention, early identification,
and linkage to care. Recent studies by the CDC17
have shown the importance of rapid HIV testing, such that rapid results can
have a major impact on counseling to change behavior, eliminating the need
for return visits, and for providing antiretroviral treatment in a clinically
relevant time frame.
AUTHOR INFORMATION
Accepted for publication March 6, 2001.
We thank Rebecca Saville, MS, Daniel Edelman, MS, and Fassil Ketema,
MS, for their assistance in the laboratory and data management. We also thank
Mary Beth Raven, Pat Caldwell, Sue Miller, PhD, Celia Ryder, CPNP, and Tay
Croxton for assistance in data collection and organization.
Presented in part at the XIII International AIDS Conference, July 9-14,
2000, Durban, South Africa.
From the Departments of Pediatrics (Drs Peralta and Martin, Ms Deeds,
and Mr Ghalib) and Pathology (Dr Constantine), University of Maryland School
of Medicine, Baltimore. The testing devices for this study were supplied by
the different manufacturers; however, this study was not funded by the manufacturers,
and the authors have no financial interest in these devices.
Corresponding author and reprints: Ligia Peralta, MD, University
of Maryland School of Medicine, Department of Pediatrics, Division of Adolescent
Medicine, 655 W Lombard St, Suite 311, Baltimore, MD 21201 (e-mail: lperalta{at}peds.umaryland.edu).
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