Transcript Evaluation of a Three Rapid Test Algorithm for the

Evaluation of a Three Rapid Test Algorithm for the
Diagnosis of HIV Infection at Point-of-Care Rapid
Testing Facilities: Strategy 4 Data Needs.
R. Boromisa1, J. Schwendemann1, M. Parker1, T.
Sullivan1, M. San Antonio-Gaddy2, A. RichardsonMoore2
NEW YORK STATE DEPARTMENT OF HEALTH
WADSWORTH CENTER 1
AIDS INSTITUTE 2
ALBANY, NY
Description of test data for 11 A1+/A2+ Western blot indeterminate
specimens.
Specimen
number
EIA
s/co
Multispot
result (A2)
WB Band pattern
HIV-1 RNA
061086002
QNS
4,1,0,0
p24,p51,*gp160
Positive
061806001
9.92
4,4,2,0
p24,p51,p66,*gp160
Positive
061816003
9.92
4,4,2,0
gp41,gp 120/160
Positive
062656003
9.92
4,4,3,0
p17,p24,p31,p51,p66,*gp120/160
Positive
063356003
9.92
4,4,2,0
p17,p24,p66,*gp120/160
Positive
072606003
10.07
4,2,4,0
p24,p51
Positive
072116003
10.89
4,0,2,0
*p17,p24
Positive
071866006
10.10
4,0,3,0
p24,p31,p51,p55,p66,*gp160
Positive
071986003
9.45
4,0,4,0
p24,p31,*gp41,p51,p66,*gp160
Invalid
063496002
9.27
4,4,2,0
p17,p24,p66,*gp120/160
Invalid
072396003
10.04
4,4,0,0
p24,p55,*gp120/160
QNS
* Weakly reactive WB band
Description of test data for 3 A1+/A2+ Western blot
negative specimens.
Specimen
number
EIA
s/co
Multispot
result (A2)
072156004
070226001
072706001
10.27 4,1,1,0
<1
4,0,3,0
<1
4,0,1,0
WB band
pattern
HIV-1
RNA
No bands Positive
No bands Negative
No bands Negative
Description of test data for 3 A1+/A2-/A3+ specimens.
Specimen
number
072196004
EIA
s/co
<1
Multispot WB band
result
pattern
4,0,0,0
No bands
HIV-1
RNA
Negative
070386001
<1
4,0,0,0
No bands
Negative
070876001
1.015 4,0,0,0
No bands
Negative
Details of 6 A1+/A2-/A3- specimens that were EIA reactive.
Specimen
Number
EIA
s/co
WB
result
HIV-1
RNA
060816005
8.629 Negative Negative
062296001
2.957 Negative Negative
062796003
1.718 Negative Negative
062916003
2.172 Negative Negative
070226002
3.802 Negative Negative
063496003
9.924 Negative Invalid
Data Needs for Strategy 4: Questions 1 - 6
1) Number and percentage of false positive A1+/A2+
results in truly uninfected persons, as detected by
laboratory-based supplemental testing.
Only 2 of 11 A1+/A2+ WB indeterminate or negative
specimens that produced valid HIV-1 RNA results
were negative (2/136, 1.5%).
Data Needs for Strategy 4: (continued)
2) Number and percentage of persons referred to
medical care on presumptive positive rapid test
results who are actually in medical care within six
months of receiving the results.
In 2006-2007, there were a total of 148 confirmed
positive clients. There were 106 clients (71.6%) that
accepted referrals for medical care but only 77
(72.6%) reached their referrals.
Data Needs for Strategy 4: (continued)
3) Number and percentage of specimens with negative
rapid tests (A1-) that were determined to be false
negative results by acute infection screening; and
the impact of using risk-based criteria for acute
infection screening.
This study did not test A1- specimens for acute HIV
infection screening. The impact of using risk-based
criteria for acute infection screening has not been
determined.
Data Needs for Strategy 4: (continued)
4) Number and percentage of specimens with
presumptive positive rapid tests results that have
false negative results on the A2 test as determined
by further clinical evaluation.
None of the 38 A2- specimens were false negative.
The 3 A2- specimens (7.9%) that were weekly
reactive on the A3 rapid test were HIV-1 RNA
negative.
Data Needs for Strategy 4: (continued)
5) Number and percentage of specimens with
inconclusive rapid test results for one or more of the
following:
• False positive A1 results
There were 40 false positive A1+ specimens (40/174,
23.0%) identified in this study: 35 A2-/A3-/WB-, 3 A2/A3+/WB-/RNA-, and 2 A2+/WB-/RNA-.
• False negative A2 and A3 results
None of the 35 A2-/A3- specimens were thought to be
false negatives even though HIV-1 RNA was not
performed on EIA- specimens. All 35 specimens
were WB negative.
Data Needs for Strategy 4: (continued)
6) For persons with inconclusive rapid test results (A1+/A2/A3-)
• Number and percentage of clients that are uninfected
There were 40 clients that were determined to be
uninfected: 35 A2-/A3-/WB-, 3 A2-/A3+/WB-/RNA- and 2
A2+/WB-/RNA- (40/174, 23.0%).
• Rates of receipt of laboratory results
In 2006-2007, 110 of 148 clients (74.3%) received their
confirmed test result.
Data Needs for Strategy 4: (continued)
6) For persons with inconclusive rapid test results
(A1+/A2-/A3-) (continued)
•Whether a change in the message a client
receives from a counselor influences client return
rates to receive their laboratory test results
We cannot say with confidence whether a
counseling message changes the return rate for
clients since so many other variables, including
whether they already knew their HIV positive
status or they went directly to a medical provider
instead of returning to the program site.
Description of Multispot (BioRad) HIV-1/HIV-2 Reactive Control
Spot and Test Spots.
1. Procedural control: Anti-human IgG (goat)
2. HIV-2 Peptide: Peptide representing the HIV-2 virus gp36
3. Recombinant HIV-1: Recombinant gp41 (gp41rDNA)
4. HIV-1 Peptide: Peptide representing the HIV-1 virus gp41