figure 1 a case series of discordant laboratory results with statewide rapid hiv testing in new...
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Figure 1
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A Case Series of Discordant Laboratory Results with A Case Series of Discordant Laboratory Results with Statewide Rapid HIV Testing in New JerseyStatewide Rapid HIV Testing in New Jersey
Eugene G Martin, PhD1, Gratian Salaru , MD1, Sindy M Paul, MD, MPH2, Rose Marie Martin, MPH2, Maureen Wolski,BA2, Linda Berezny, BSN2, Evan M Cadoff1, MD1UMDNJ – Robert Wood Johnson Medical School and 2New Jersey Department of Health and Senior Services
AbstractBackground: A statewide case series of patients with discordant rapid HIV results at
publicly funded counseling and testing sites is described.Methods: Initial fingerstick testing by either OraQuick or OraQuick Advance was
confirmed with Vironostika HIV-1 (BioMerieux) enzyme immunoassay (EIA) and HIV-1 Western blot (Biorad). Discordant results (Oraquick positive/Western blot negative) were followed by repeat Oraquick screening at 4-6 weeks, confirmation of the original
EIA and Western blot results, collection of additional serum for hepatitis A (HAV), hepatitis B (HBV), hepatitis C (HCV), HIV by standard enzyme immunoassay, Epstein-Barr virus (EBV), and Rheumatoid factor (RF); collection of additional plasma for ultrasensitive, quantitative RNA determination of HIV. Demographic data were collected using the standard CDC form.
Results: Rapid testing began at a single New Jersey site on 11/1/03. Through 10/5/05, 125 sites were conducting rapid testing with 32,463 tests completed. Twenty (0.06%) patients were discordant with a preliminary positive Oraquick rapid test and a negative Western blot. Two patients refused follow-up testing. Three other patients were lost to follow-up. Nine of 10 patients tested were Oraquick positive upon re-examination 4-6 weeks later, but continued to test HIV negative by traditional EIA and Western blot. Other testing included: 12 of 12 tested were negative by ultrasensitive RNA analysis. Eight of 12 (67%) were HAV polyvalent antibody positive, 1 of 12 (8%) had acute HBV, 2 of 9 (22%) had HCV infection, 1 of 12 (8%) had RF, 12 of 12 (100%) had evidence of a distant EBV infection. No instances of an evolving HIV infection were identified.
Conclusion: Rapid testing is a reliable, reproducible screening test in publicly funded counseling and testing sites. The 0.06% observed false positive rate in sites with a rigorous QA program is acceptable.
Background – Discordant HIV Result
DEFINITION: A reactive OraQuick® rapid HIV test followed by a negative or indeterminate Western blot (WB) or immunofluorescent assay (IFA) result.
TWO TYPES OF DISCORDANTS TYPE I Positive Oraquick ®, NEGATIVE Western Blot No bands present Client is considered HIV negative and not likely to be in an HIV window. TYPE II Positive Oraquick ®, INDETERMINATE Western Blot Some bands not meeting the criteria to be declared positive are present Possibility the client is in the process of seroconverting.
What Causes Discordants?• An evolving infection – HIV screen is positive prior to traditional EIA or
Western Blot • Cross-reacting non-specific antibodies• Over-reading by testing personnel
TOTAL TESTS 11/1/03 – 10/5/05 HIV PRELIM POSITIVE WESTERN BLOT – Discordant
32,463 554 (1.7 %) 20 (3.6 % of Prelim Pos. – 0.06% Overall)
Negative Discordant WB Pos
554
PRELIM POS
20 DISCORDANT
15,570
NEGATIVE
NJ 2004 R
APID
HIV TESTIN
G
Negative Discordant WB Pos
PRELIM POS
32,463
NEGATIVE
NJ R
APID
HIV TESTIN
G
0%10%20%30%40%50%60%70%80%90%
100%
Posit
ive H
IV N
ATHAV
Poly
valen
t Abs
Acute
Hep
. BHCV
Infe
ction
Rheum
atoid
Fac
tor
Distan
t EBV
Infec
tion
Oraqu
ick S
pecif
icity
NJHIV Discordant Series11/2003 --> 10/2005
Frequency of Discordants – NJ (2003-5)
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 FoundationMartin Luther King OutreachMorristown Memorial HospitalNewark Community Health CenterNJCRIOcean County Health DepartmentPaterson Health DepartmentPlainfield Community Health CenterProceedRobert Wood Johnson Medical SchoolTrinitas Hospital
6/5/2006
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 FoundationMartin Luther King OutreachMorristown Memorial HospitalNewark Community Health CenterNJCRIOcean County Health DepartmentPaterson Health DepartmentPlainfield Community Health CenterProceedRobert Wood Johnson Medical SchoolTrinitas Hospital
6/5/2006
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
Rapid Testing in New Jersey – NJ HIV
METHODS:• The NJ Rapid HIV Program is a large, centralized QA effort (Fig.
1)• After an initial positive Oraquick result and negative
confirmationoccurs at any site NJ HIV technical support is contacted (http://www.njhiv.org)
• At 4-6 WEEKS:– Repeat HIV by Oraquick– Venipuncture. Collect SST, white top, & purple top tube. Centrifuge
and prepare ASAP (< 4 hrs). – Ship to reference laboratory (ARUP)
• Repeat HIV1/2 EIA Qualitative HIV PCR• HIV1 Western blot Ultrasenstive Quantitative RNA
PCR• HAV (Polyvalent) Hepatitis B surf. Ag, Ab, HBcAb• HCV Ab EBV, RF,
– 4-6 weeks Independent confirmation of the original negative Western blot,
• Demographic data were collected using the standard Centers for Disease Control and Prevention counseling and testing form
CONCLUSIONS:• Between 2003-5, 20 discordant rapid HIV tests were identified
(Fig. 2). • A discordant occurs when a + Rapid HIV test fails to confirm by
confirmatory Western blot.• While evidence of distant EBV and HAV infection exist in more
than half of individuals with discordant HIV results, the frequency is similar to that in the US population (Fig. 3)
• With the growth of NJ statewide program, additional discordant results have been identified. Through September 2006, 58 additional discordants have been identified. Of these, 78% were associated with oral specimens, while 20% were associated with fingerstick specimens. A slightly lower degree of specificity is reported by the manufacturer when using oral specimen types and is apparent in NJ.
• The possibility of seasonal variation is suggested by monthly data, but remains within the manufacturer’s specificity claims.
• With the exception of a single NJ case, discordant results in 2006 have not been associated with an evolving infection as demonstrated by > 1 month follow-up utilizing qualitative DNA and quantitative RNA HIV testing, as well as HIV1/2 EIA testing.
Sp
ecim
en
Typ
e
Correlations with Disease States – NJ (2003-5)
Figure 1
Figure 2
Figure 3
NEW JERSEY DISCORDANTS - 2006
0
10
20
30
40
50
60
Jan Feb Mar Apr May Jun Jul Aug Sep YTDTotal
ORAL FINGERSTICK Venipuncture
0
2
4
6
8
10
12
14
Jan-06 Feb-06 Mar-06 Apr-06 May-06 Jun-06 Jul-06 Aug-06 Sep-06
DISCORDANTS
Mon
th t
o
Mon
th
Figure 4
Ou
tcom
e
Figure 5
0
10
20
30
40
50
60
Jan-06 Feb-06 Mar-06 Apr-06 May-06 Jun-06 Jul-06 Aug-06 Sep-06 YTDTotal
False Pos True Pos No FollowupFigure 6