retrospective application of the proposed cdc/aphl rapid testing algorithms in new jersey 2004-7
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Retrospective Application of the Proposed CDC/APHL Rapid Testing Algorithms in New Jersey 2004-7. Cadoff EM, Cadoff RA, Salaru G, Paul SM, Martin EG. Evan M. Cadoff, MD Robert Wood Johnson Medical School New Brunswick, NJ. NJHIV Rapid Testing Program. Under direction of RWJMS - PowerPoint PPT PresentationTRANSCRIPT
Retrospective Application of the Proposed CDC/APHL Rapid Testing Algorithms in New Jersey 2004-7
Evan M. Cadoff, MDRobert Wood Johnson Medical
SchoolNew Brunswick, NJ
Cadoff EM, Cadoff RA, Salaru G, Paul SM, Martin EG
NJHIV Rapid Testing Program
Under direction of RWJMS OraQuick started
November 1, 2003 Oversees about 2/3 of NJ
CTS HIV testing Confirmatory testing at
PHEL in Trenton NJHIV oversees followup
of all discordant NJHIV does not evaluate
linkage to care
AIDS Coalition of Southern New JerseyAtlantic City Health DepartmentBergen County Health DepartmentBurlington County Health DepartmentCamden AHECCamden County Health DepartmentCheck-MateEast Orange Health DepartmentEric B. Chandler Health CenterFamCareHenry J. Austin Health CenterHope HouseHorizon Health CenterHunterdon County Health DepartmentHyacinth FoundationInstitute For Human DevelopmentJersey Shore Addiction ServicesLennard ClinicMartin Luther King OutreachNewark Community Health CenterNew Horizon Treatment ServicesNJCRIOcean County Health DepartmentPaterson Health DepartmentPlainfield Community Health CenterProceedRobert Wood Johnson Medical SchoolWilliam Paterson College
12/2/2007
UMDNJ-RWJMS/ NJ DHSS AIDS PREVENTION GRANTEES
Primary Satellite fixed mobile
Pale colors indicate pending sites
AIDS Coalition of Southern New JerseyAtlantic City Health DepartmentBergen County Health DepartmentBurlington County Health DepartmentCamden AHECCamden County Health DepartmentCheck-MateEast Orange Health DepartmentEric B. Chandler Health CenterFamCareHenry J. Austin Health CenterHope HouseHorizon Health CenterHunterdon County Health DepartmentHyacinth FoundationInstitute For Human DevelopmentJersey Shore Addiction ServicesLennard ClinicMartin Luther King OutreachNewark Community Health CenterNew Horizon Treatment ServicesNJCRIOcean County Health DepartmentPaterson Health DepartmentPlainfield Community Health CenterProceedRobert Wood Johnson Medical SchoolWilliam Paterson College
12/2/2007
UMDNJ-RWJMS/ NJ DHSS AIDS PREVENTION GRANTEES
Primary Satellite fixed mobile
Pale colors indicate pending sites
UMDNJ-RWJMS/ NJ DHSS AIDS PREVENTION GRANTEES
Primary Satellite fixed mobile
Pale colors indicate pending sites
Preliminary Positive Followup
7.1% refused blood draw for confirmation 25.8% of those drawn did not return for
results 70.1% of confirmed positives got their
results and post-test counseling Rapid confirmation could improve
effectiveness of prevention and referral/entry to care and treatment services
Data Needs for Proposed Testing Strategies
1. Are there false negative screening tests?2. Can true positive screening tests be confirmed by a
second rapid test, rather than WB/IFA/NAT?3. Can false positive screening tests (ie discordants)
be detected by a second rapid test, rather than waiting for WB/IFA/NAT?
4. Impact on linkage to care?5. How well can inconclusive “second-round” test
results (eg, WB vs a second rapid test) be resolved?
Two NJHIV Datasets
Confirm true positives Evaluate confirmed false positives Resolve discordants and
indeterminate confirmatory test results
Nov 2003 – April 2005 data
Rapid testing by blood only using OraQuick
Western Blot specimens sent to PHEL All avialable WB specimens evaluated by:
Repeat OraQuick on blood Trinity Uni-Gold MedMira Reveal BioRad Multispot
Followup of clients with discordant results
Nov 2003 – April 2005 data
15,923 OraQuick tests statewide 363 preliminary postive samples
to state lab for Western Blot 355 Western Blot positive confirmed by other rapids
8 Western Blot negative discordants
all repeat OraQuick positive one reactive Multispot by one readerothers all negative6 preliminary positive is false positive25% with no clinical followup
Negative Discordant WB Pos
15,923
355
8
Strategy 1, Data Need 3
Discordant followup
Four visits:1. Rapid test. If prelim pos, draw blood
and send to Trenton for Western Blot.2. Return in a week, and get discordant
confirmatory test result.3. Return at a month to have more blood
drawn (repeat antibody; and NAAT).4. Come back a week later for definitive
result.
Discordant followup
AIDSAcute Infection Silent Infection
1-3 yearsWeeks after infection 5-10 years
Symptoms
Antibody by 3rd gen EIA
Antigen
Antibody by Western Blot
Antibody by 1st gen EIA
RNA / NAAT
AIDSAcute Infection Silent Infection
1-3 yearsWeeks after infection 5-10 years
AIDSAcute Infection Silent Infection
1-3 yearsWeeks after infection 5-10 years
Symptoms
Antibody by 3rd gen EIA
Antigen
Antibody by Western Blot
Antibody by 1st gen EIA
RNA / NAAT
SymptomsSymptoms
Antibody by 3rd gen EIAAntibody by 3rd gen EIA
AntigenAntigen
Antibody by Western BlotAntibody by Western Blot
Antibody by 1st gen EIAAntibody by 1st gen EIA
RNA / NAATRNA / NAAT
Revised discordant followup
Three Visits1. If rapid test is reactive, draw Western Blot.2. Return in a week. Get discordant
confirmatory test result and draw NAAT.3. Third visit for NAAT result.
orTwo Visits1. If rapid test is reactive, draw both Western
Blot and NAAT.2. NAAT is run if WB is discordant, and both
results are available at second visit.
Revised discordant followup
Three Visits1. If rapid test is reactive, draw Western Blot.2. Return in a week. Get discordant confirmatory
test result and draw NAAT.3. Third visit for NAAT result.
orTwo Visits1. If rapid test is reactive, draw both Western Blot
and NAAT.2. NAAT is run if WB is discordant, and both results
are available at second visit. or
One visit with rapid confirmation would be better!
Jan 2006 – Oct 2007 data
Retained specimens from followup testing for discordant Western Blot results.
Cannot confirm true positives. Can evaluate discordants and
indeterminates (if they had followup).
Jan 2006 – Oct 2007 data
Samples are not from the same time as screening OraQuick.
Used CLIA-waived tests: Repeat OraQuick on blood Trinity Uni-Gold Clearview StatPak
Jan 2006 – Oct 2007 data
Total tests, NJ 2006-2007
119794
1535
72
41
67
Total tests
Confirmed positive
No followup
No blood available
Other rapids tested
180 discordant
108 false positive; 72 without followup may be false positive [Strategy 1, Data need 3; Strategy 4, Data need 5a]
No false positive strategy results [Strategy 4,Data need 1];
No false negative A2 or A3 [Strategy 4, Data need 4, 5b]
Jan 2006 – Oct 2007 data
No false positive strategy results [Strategy 3, Data need 1]
1 false positive A1-blood result [Strategy 3, Data need 4a,5]
91 false positive A1-oral results [Strategy 3, Data need 5]
No false negative A2 results [Strategy 3, Data need 4b]
Oral screening, NJ 2006-2007
56
35
65
892
77592
Total tests
Confirmed positive
No followup
No blood available
Other rapids tested
156 discordant
Jan 2006 – Oct 2007 data
Blood screening, NJ 2006-2007
11
6
7
643
42202
Total tests
Confirmed positive
No followup
No blood available
Other rapids tested
24 discordant
No false positive strategy results [Strategy 2, Data need 1]
17 Inconclusive results with false positive A1 [Strategy 2, Data need 4]
Data Needs for Proposed Testing Strategies
All followups on negative Western Blot were NAAT negative (OraQuick false positive).
All were "second rapid" negative.
Oral OraQuick followed by blood OraQuick: 3 tested at CTS site on False Positives:
2 blood negative; 1 blood positive 56 tested on followup blood specimen
all blood negative
OraQuick blood discordant 11 tested on followup blood specimen
7 negative 4 repeat positive
Observations
Indeterminate Western Blot: 12 total:
4 no followup; 3 QNS 3 NAAT negative were "second rapid" negative 2 NAAT positive were "second rapid" positive
Rapid Confirmation Is Needed
Rapid confirmation of preliminary positive results is necessary: 30-40% without followup would have
benefited from rapid confirmatory testing.
Rapid Confirmation Works
All 355 true positives confirmed using a second rapid test (from a pool of about 16,000 clients tested)
All 65 false positives with followup available were negative using a second rapid test (from a pool of about 120,000 clients tested)
Indeterminate Western Blots were resolved by a second rapid
Conclusions
Rapid confirmation of preliminary positive results is necessary.
Rapid confirmation of preliminary positive results works at least as well as Western Blot testing.
