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. Richardson-Moore2 NEW - PowerPoint PPT Presentation

Title: 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. Richardson-Moore2 NEW


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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.
Richardson-Moore2NEW YORK STATE DEPARTMENT OF
HEALTHWADSWORTH CENTER 1AIDS INSTITUTE
2ALBANY, NY
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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
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Description of test data for 3 A1/A2 Western
blot negative specimens.
Specimen number EIA s/co Multispot result (A2) WB band pattern HIV-1 RNA
072156004 10.27 4,1,1,0 No bands Positive
070226001 lt1 4,0,3,0 No bands Negative
072706001 lt1 4,0,1,0 No bands Negative
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Description of test data for 3 A1/A2-/A3
specimens.
Specimen number EIA s/co Multispot result WB band pattern HIV-1 RNA
072196004 lt1 4,0,0,0 No bands Negative
070386001 lt1 4,0,0,0 No bands Negative
070876001 1.015 4,0,0,0 No bands Negative
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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
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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).

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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.

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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.

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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.

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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.

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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.

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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.

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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