1. Update Rapid HIV Testing in NJ
Eugene G. Martin, Ph.D.
Associate Professor of Pathology
and
Laboratory Medicine
UMDNJ – Robert Wood Johnson Medical School
Co-Director, NJ HIV

2. Rapid HIV Testing in New Jersey
The rapid HIV program in NJ is one of the largest, centralized rapid HIV testing programs in the country
Current locations (117) (2/2006):
County health departments
Sexually transmitted disease clinics,
Family planning programs,
Federally qualified healthcare centers,
TB clinics,
Hospital-based programs – 13 ERs (8 counties)
Prenatal clinics, and
Outreach through mobile vans.

3. Why do we need rapid HIV testing?
Effective HIV prevention, effective disease control requires reaching those at risk
Those unaware of their status
~ 25% of the 850, ,000 HIV + people in the United States
The newly infected ~ 40,000 new infections per year
Tested, but not told ~ 30% who test positive do not receive their results
HAART - another dimension to the utility of rapid HIV testing
Entry point to life-saving therapy, additional HIV-specific medical care, and other support services
Perinatal - women in labor
Occupationally exposed – Post-exposure prophylaxis
Improved outcomes: Rapid Testing in the ER
Shortened stays
Speeds entry into outpatient care

4. Why a Centralized Program (STEPS)
Specialized skills are centralized
Testing and processes are organized
Expenses are optimized
Problems are identified more quickly
Solutions are distributed to all

5. Concept of NJ HIV Build upon existing POCT program at medical school
Develop centralized QA process - standardized procedures, and centralized inventory and training
Use a single site to delineate a process development strategy, validate forms, communications, equipment and techniques.
Review activities at all sites monthly
Roll-out the program.

6. HIV Rapid Test Implementation NJ

7. AIDS Coalition of Southern New Jersey Atlantic City Health Department
UMDNJ-RWJMS/ NJ DHSS
AIDS PREVENTION GRANTEES
Primary Satellite fixed mobile
Pale colors indicate pending sites
AIDS Coalition of Southern New Jersey
Atlantic City Health Department
Bergen County Health Department
Burlington County Health Department
Camden AHEC
Camden County Health Department
East Orange Health Department
Eric B. Chandler Health Center
FamCare
Henry J. Austin Health Center
Horizon Health Center
Hunterdon County Health Department
Hyacinth Foundation
Martin Luther King Outreach
Morristown Counseling and Testing
Newark Community Health Center
NJCRI
Ocean County Health Department
Paterson Health Department
Plainfield Community Health Center
Proceed
Robert Wood Johnson Medical School
Trinitas Hospital
4/22/2018

8. HIV Testing in New Jersey
Rapid HIV Testing Introduced

9. Topics for discussion Rapid HIV Tests – Types and formats
Availability of rapid HIV testing in NJ
Brief analysis of NJ and US data from
Questions of interest:
Is DHAS going to offer OraSure again? 
There are reports of false positives in California and NY. Update.
Are we reaching those most-at-risk?

10. Current Options for HIV screening
Blood  LAB
Urine HIV test  LAB
Orasure HIV 1 test  LAB
EIA with Western Blot confirmation
Oraquick Rapid HIV 1/2 test
Blood
Fingerstick
OMT – Oral mucosal testing

11. Traditional HIV Testing
Testing technology driven by blood screening needs:
- Batched, high volume EIA testing
- Complex equipment
- Technically demanding
- Centralized
- Time-consuming

12. What is a rapid HIV test? RAPID HIV ASSAY–
Performed and interpreted at the site of care/counseling
Varying formats:
Venipuncture Blood
Fingerstick
Oral
Plasma
Varying complexity
CLIA-waived  Moderate complexity
From minutes
Oraquick Rapid HIV1/2

13. Rapid Diagnostic HIV Assays
ADVANTAGES:
Cost
No transportation expense or delay
Minimal equipment requirements
Whole blood, finger-stick or oral specimens
Easy to interpret
No additional laboratory personnel expense.
Negative results can be reported immediately
DISADVANTAGES:
Detects antibodies, not the virus
Must be performed according to manufacturer’s directions
Temperature limitation on storage and transport

14. Rapid HIV procedures Worldwide > 60 rapid diagnostic tests
US – 4 FDA approved rapid tests
2 Moderate complexity – lab only
MedMira HIV 1
Biorad HIV 1 & 2
2 CLIA-waived tests –
Oraquick HIV1 & 2
Unigold HIV 1

15. CLIA-waived Complexity
HIV Rapid Test Formats
HIV 1 Only
HIV 1 & 2
Moderate Complexity
MedMira Reveal
Bio-Rad Multispot
CLIA-waived Complexity
Trinity Uni-Gold
Oraquick Rapid
MedMira Reveal

16. Oraquick HIV-1/2 NJ CTS utilizes Oraquick Advanced HIV 1/2
CLIA-waived, BUT sale is restricted to clinical labs with an ADEQUATE QA PROGRAM
CLIA-waiver  eventually more than 180,000 additional US sites could test:
Outreach clinics,
Community-based organizations, and
Physicians’ offices.
Only agents of the clinical lab can test
State laws ultimately govern

17. New Jersey Lab Regulations
Being modified to expand the scope of testing in public health – not yet available for public comment
At the moment:
With the exception of small group practices(<4 physicians) -- Clinical Laboratories MUST have a Bioanalytical Laboratory Director (BLD)
Most BLDs are Pathologists (MDs)
A BLD can oversee a maximum of 3 labs
EXCEPTION!! – ‘Limited Purpose Laboratories’ - Rapid HIV testing paid for with New Jersey grant monies
A single BLD may oversee an unlimited number counseling and testing sites and serve as a resource to the remainder of CTS locations, as long as all facilities operate the same way.

18. Testing Personnel In order to test an individual needs:
HIV counselor training
Oraquick Training -
Oraquick Competency Assessment
Ongoing Proficiency Testing – CAP, CDC

19. Central Processes of QA
Development
Standard procedures
Quality control requirements
Temperature monitoring procedures
Forms
Training and operator certification requirements
Regulatory requirements/licensure
Reagent purchase and validation
Inventory control
Technical support
Follow-up of discordant results

20. NJ HIV Quality Assurance Program
Professional Oversight
Monthly site visits by core staff
Standardization of policies/procedures
Appropriate test procedures (client and QC)
Proficiency Testing

21. Oraquick Advanced HIV-1/2
Easy to use.
Untrained, first-time users report 98.6% of results correctly
CLIA Waived for Fingerstick and Oral specimens
Detects HIV1 and HIV2
Comparable to current EIAs in detecting low level reactive specimens
Specimen Type
Sensitivity
Test is + if patient is +
Specificity Test is – if patient is -
Fingerstick
99.6%
100%
Oral
99.3%
99.8%
Plasma
99.9%
Manufacturer’s Data

22. Performing the Oraquick Rapid HIV test

23. Oraquick Advanced -Specimen Types
Wholeblood
Fingerstick
Oral Mucosal Transudate

24. Loop collects 5 microliters of whole blood

25. Insert loop into vial and stir

26. Test develops in 20-40 minutes

27. Positive Negative Read results Reactive Control Positive HIV-1 C C T T
Test results are read directly from the device. The device contains an internal control that ensures that specimen was added and the test was run correctly. A single red band at the control “C” location – as on the right – indicates the specimen is negative. Two bands – one at the control location and one at the test or “T” location indicates the test is positive for HIV antibody. The intensity of the band does not matter. However, if no bands appear, if a band appears at the test location but not the control location, or if the bands do not coincide with the C and T locations, the test is invalid and must be repeated.
Positive
Negative
Read results

28. Non-reactive
Reactive

29. Invalid

30. Failure to return for results Failure to be placed for follow-up
THE MAJOR PROBLEM
Failure to return for results
Failure to be placed for follow-up

31. 2005 - Disposition of Confirmed HIV+
Problem
Preliminary Positive clients fail to return for results (25.2%)
NAP succeeds ONLY 20% of the time in locating these clients
Solution
Confirmatory testing on-site, same day
Not yet accepted by the FDA
In use, high prevalence areas worldwide

32. A Problem in San Francisco Or A Problem for All of Us?
DISCORDANTS
A Problem in San Francisco Or
A Problem for All of Us?

33. Rapid HIV Testing 7/04 – 4/05 NJ 2004 RAPID HIV TESTING
97.3 % confirm
Western Blot Positive
Fingerstick ONLY
363
PRELIM POS
10 DISCORDANT
15,570
NEGATIVE
NJ 2004 RAPID HIV TESTING
363
PRELIM POS
10 DISCORDANT
15,570
NEGATIVE
NJ 2004 RAPID HIV TESTING
363
PRELIM POS
10 DISCORDANT
15,570
NEGATIVE
NJ 2004 RAPID HIV TESTING
363
PRELIM POS
10 DISCORDANT
15,570
NEGATIVE
NJ 2004 RAPID HIV TESTING

34. What are discordant results?
Rapid HIV – “Preliminary Positive”
EIA and/or Western Blot is negative
What causes a discordant?
Evolving infection – HIV ‘window’ – screen is positive prior to traditional EIA or Western Blot
Cross-reacting to patient’s non-specific antibodies
Over-reading by testing personnel

35. Recent Data from Rapid Testing
2005

36. NJ Rapid HIV Testing 2005 Compared to conventional testing in 2003
1/ /2005
Compared to conventional testing in 2003
7.2 % fewer tested in age group 20-29
More testing in higher age groups
Rapid HIV Testing Statewide at Publicly Funded Counseling and Testing Sites: A Successful Statewide Initiative in New Jersey
Sindy M. Paul, M.D., M.P.H. *, Evan Cadoff, M.D. **, Eugene Martin, Ph.D. **, Maureen Wolski*, Lorhetta Nichol*, Rhonda Williams*, Phil Bruccoleri*, Aye Maung Maung*, Rose Marie Martin, M.P.H. *, Linda Berezny RN*, Charles Taylor*
New Jersey Department of Health and Human Services * and UMDNJ – Robert Wood Johnson Medical School

37. NJ Rapid HIV Testing - 2005 Compared to conventional testing in 2003
1/ /2005
Compared to conventional testing in 2003
1.4 % Decline in testing among hispanics
Non-hispanic whites and blacks unchanged
Other races increases in testing
Rapid HIV Testing Statewide at Publicly Funded Counseling and Testing Sites: A Successful Statewide Initiative in New Jersey
Sindy M. Paul, M.D., M.P.H. *, Evan Cadoff, M.D. **, Eugene Martin, Ph.D. **, Maureen Wolski*, Lorhetta Nichol*, Rhonda Williams*, Phil Bruccoleri*, Aye Maung Maung*, Rose Marie Martin, M.P.H. *, Linda Berezny RN*, Charles Taylor*
New Jersey Department of Health and Human Services * and UMDNJ – Robert Wood Johnson Medical School

38. Switching from fingerstick to OMT
Managing the transition

39. 2005 - Shift in testing from Fingerstick to OMT
Rapid HIV Testing Statewide at Publicly Funded Counseling and Testing Sites: A Successful Statewide Initiative in New Jersey
Sindy M. Paul, M.D., M.P.H. *, Evan Cadoff, M.D. **, Eugene Martin, Ph.D. **, Maureen Wolski*, Lorhetta Nichol*, Rhonda Williams*, Phil Bruccoleri*, Aye Maung Maung*, Rose Marie Martin, M.P.H. *, Linda Berezny RN*, Charles Taylor*
New Jersey Department of Health and Human Services * and UMDNJ – Robert Wood Johnson Medical School

40. CDC PMS-2 Survey 2005 BLOOD 135,724 99.98% (range: 99.73% -100%)
TYPE of Rapid Test
Number Tested
Specificity
(Probability test – when patient -)
Positive Predictive Value (Probability patient + when test is +)
BLOOD
135,724
99.98% (range: 99.73% -100%)
99.24% (range: 66.27% - 100%)
ORAL
26,066
99.89% (range: 99.44% - 100%)
90.00% (range: 50.0% - 100%
Submitted data, February, 2006

41. 2005 CDC PMS-2 Survey 87 - True False Pos. TESTS PERFORMED DISCORDANTTP FP
Indeterminant
135,724 BLOOD
68 (.05%)
13 (19.1%) True Pos
40 (58.8%) False Pos
15 (22.1%) Indeterm
26,066
ORAL
56 (.22%)
4 (7.1%) True Pos
47 (83.9%) False Pos
5 (8.9%) Indeterm
TOTAL
124
Evolving infections
87 - True False Pos. 20

42. The Future of Orasure Testing

43. OraSure ® HIV-1 – OMT
Specially treated cotton fiber pad attached to a nylon stick
Placed between the lower cheek and gum and left for 2-5 minutes.
Pad draws IgG antibodies out of the tissues of the cheek and gum.
OMT- oral mucosal transudate,
Fewer contaminants than saliva.
If present, antibodies to the HIV-1 virus will be collected in this sample.

44. Orasure Testing
Disadvantages:
HIV-1 ONLY
Vironostika HIV-1 assay is an older, less sensitive EIA – false negatives
Orasure false positives are common and expensive!!
Logistical delays:
Couriers
Batched testing
Second Visits are req’d.
With very, limited exceptions - Switch to Oraquick ASAP
96 %
~50 % confirm

45. Counseling a Rapid Test Result

46. Preliminary Positive Result
Client to return for confirmatory results
~ 2-3 in a 100 will fail to confirm
Phrases such as
- “a good chance of being infected” or
- “very likely infected” to communicate probability + positive rapid test result reflects infection with HIV
HIV prevalence & assessment of each patient’s individual risk should be discussed

47. Confirmed Positive Result
As always, emphasize risk reduction plan to prevent transmission to partner(s)
Try to elicit needle-sharing &/or sexual contacts
Refer needle-sharing &/or sexual contacts to NAP
Refer for treatment, social services, etc.

48. Clinical Response to Rapid Testing Preliminary Positive Results
Occupational Exposure
Women in labor with unknown HIV status
Why? Because tested person benefits
Post Exposure Prophylaxis reduces risk of occupational transmission
Short course therapy reduces risk of mother-to-child HIV transmission

49. Discordant Result A discordant result is a rare event
NJ HIV is a resource for managing the discordant result
Discordants can represent evolving infections or be a true false positive
We can counsel your client with you or advise you
Follow-up testing is free and includes qualitative PCR to look for HIV

50. Ongoing Projects within NJ HIV

51. Projects
Can a statewide network of rapid HIV test sites be established to provide quality service to high-risk clients?
How many false positive and invalid results are there in practice?
How much quality control/quality assurance is needed in practice?
How does Oral Mucosal Transudate testing really compare to whole blood fingerstick testing?
Can a second rapid test perform as well as a conventional Western Blot for confirmation of positives?

52. Projects - 2
Can rapid testing be implemented quickly when there is a nationwide shortage of OMT reagents?
Can we reduce quality control costs without reducing quality?
Modify system so that non-traditional sites can perform rapid HIV testing, such as outreach workers (NAP) and low volume test sites.
Assess impact in New Jersey of quality issues related to rapid HIV testing, such as:
Shortening of expiration dating
False positive OMT results, as reported in San Francisco and New York

53. Summary Rapid testing will be helpful for prevention
More people will know their HIV status  prevent progression and transmission
Ideally, testing and confirmation should occur at time of initial visit
An approach that will allow this is under investigation in the US
Available internationally in high prevalence locations, not in US
Counseling completed same day so resources spent on getting people to return for posttest counseling can be directed to other prevention efforts

54. THE END

55. RESPECT-2 Multi-site study: Newark, Denver, Long Beach
Randomized trial of rapid testing +/- booster session compared with traditional blood or oral mucosal test
Outcome measures = incident STD’s and self-reported risk behaviors
Sample size = 3297

56. Preliminary Findings from RESPECT-2
Overall there were no differences in risk behavior or incident STDs between the standard and rapid test group or between the booster and no booster groups.
Men who had sex with women in the rapid test group had a higher cumulative rate of incident STDs than their standard group counterparts at 6 months, but the difference disappeared by 12 months.

58. Potential Impact of Rapid Testing on Prevention
More people know their HIV status
Increase number of HIV + people who know their status therefore can prevent progression & transmission
Counseling completed same day so resources spent on getting people to return for posttest counseling can be directed to other prevention efforts

59. Confirmatory test results
8 Western Blot negative
(False Positive OraQuick)
355 Western Blot positive
(True Positive OraQuick)
OraSure OraQuick
7 positive
1 negative
355 positive
Trinity Uni-Gold
8 negative
BioRad Multispot
7 negative
1 positive
354 positive
1 QNS
MedMira Reveal
340 positive
15 sample interference
Follow-up of >2 months
6/6 negative Western Blot
6/6 negative viral load

60. NJ 2004 – Discordant Follow-up
Rapid HIV Testing Statewide at Publicly Funded Counseling and Testing Sites: A Successful Statewide Initiative in New Jersey
Sindy M. Paul, M.D., M.P.H. *, Evan Cadoff, M.D. **, Eugene Martin, Ph.D. **, Maureen Wolski*, Lorhetta Nichol*, Rhonda Williams*, Phil Bruccoleri*, Aye Maung Maung*, Rose Marie Martin, M.P.H. *, Linda Berezny RN*, Charles Taylor*
New Jersey Department of Health and Human Services * and UMDNJ – Robert Wood Johnson Medical School

61. Results with counseling HIV + HIV - Newly Identified
Total tests
Results with counseling
HIV +
HIV -
Newly Identified
32,463
32,300 (99.5%)
626 (1.9%)
31,837 (98.1%)
419
(67% of HIV+)
Rapid HIV Testing Statewide at Publicly Funded Counseling and Testing Sites: A Successful Statewide Initiative in New Jersey
Sindy M. Paul, M.D., M.P.H. *, Evan Cadoff, M.D. **, Eugene Martin, Ph.D. **, Maureen Wolski*, Lorhetta Nichol*, Rhonda Williams*, Phil Bruccoleri*, Aye Maung Maung*, Rose Marie Martin, M.P.H. *, Linda Berezny RN*, Charles Taylor*
New Jersey Department of Health and Human Services * and UMDNJ – Robert Wood Johnson Medical School

62. State of the Union
The President proposed >$90 million initiative to
Purchase and distribute rapid HIV test kits
Distribution - areas with the highest rates of
Newly discovered HIV cases
Highest suspected rates of undetected cases.
Programs
Testing of Prisoners ~ $20 million
Testing of IV Drug Users ~ $25 million

63. Obtain finger stick specimen…

64. The study was conducted before the OraQuick test was approved
The study was conducted before the OraQuick test was approved. The test is currently approved for use only with finger stick whole blood specimens. However, it is also designed to be used with serum or whole blood specimens obtained by venipuncture. To conduct the test, a specimen is obtained from the vial or tube with a plastic specimen loop.
Or whole blood

65. Why use HIV Rapid Tests?
Rapid HIV testing - effective in screening high-volume, high-prevalence settings
With conventional HIV testing many do not return for results
Approximately 30% fail to return in CTS locations
Need for immediate test results
Perinatal - women in labor
Occupational exposure

66. Judging an assay Sensitivity Probability test is + if patient is +
Specificity
Probability test is - if patient is -
Predictive value
PPV - Probability patient is + if test is +
NPV - Probability patient is - if test is -

67. Positive Predictive Value
Example: Test 1,000 persons
(4/1000)
Test Specificity = 99.6%
HIV prevalence = 10%
True positive:
100
False positive: 4
Positive predictive value:
100/104 = 96%
Positive Predictive Value tells us how likely a patient is + with a + test result

68. Why Prevalence Matters!
Example: Test 1,000 persons
Test Specificity = 99.6% (4/1000)
HIV prevalence = 10%
True positive: 100
False positive: 4
Positive predictive value: 100/104 = 96%
HIV prevalence = 0.4% 4
True positive:
False positive: 4
Positive predictive value:
4/8 = 50%