New HIV Test AlgorithmsNew HIV Test Algorithmsandand

Revised Adult HIV Case Report Revised Adult HIV Case Report Form Form (DCH #1355)(DCH #1355)

HIV SurveillanceHIV/STD/VH/TB Epidemiology Section

Bureau of EpidemiologyMichigan Department of Community Health

2013 Adult HIV Case Report Form, 2013 Adult HIV Case Report Form, DCH 1355DCH 1355

MDCH HIV-STD WebsiteMDCH HIV-STD Website

www.michigan.gov/hivstdwww.michigan.gov/hivstd

Click on “HIV/AIDS” for:– Downloadable forms and instructions–MDCH Surveillance Contact information– Statistics, reports, projects– Presentations and brochures– CD Rules and laws– Hotlines, links to other HIV websites– Prevention and care information

Reporting Cases to MDCHReporting Cases to MDCH Traditionally prefer US mail because unlawful

to open another’s mail Currently allow fax to MDCH secure fax with

caution:– Send test fax first– Program MDCH secure fax # into your fax to

avoid mis-dialing:

313-870-5257– Let your Surveillance Contact know that it

is coming–

2013 Adult HIV Case Report Form, 2013 Adult HIV Case Report Form, Sections I and IISections I and II

2013 Adult HIV Case Report Form, 2013 Adult HIV Case Report Form, Sections III, IV, VSections III, IV, V

Section VI: DemographicsSection VI: Demographics

SectionVII: SectionVII: Patient History – Risk FactorsPatient History – Risk Factors

Section VIII: Notify PartnersSection VIII: Notify Partners Section IX: Women Section IX: Women

Section XI: Opportunistic IllnessesSection XI: Opportunistic Illnesses

Stage 3 HIV Infection (AIDS):– CD4 count < 200 cells/microlitre– CD4 percent < 14%

2013 Adult HIV Case Report Form, 2013 Adult HIV Case Report Form, Section XII: Section XII:

Testing and Treatment History Testing and Treatment History

Changes:Changes:Ever had previous positive test?Ever had previous positive test?Number of negative HIV tests in Number of negative HIV tests in 24 months 24 months preceding first positivepreceding first positiveARV: If yes, and currently still using, date of most recent use ARV: If yes, and currently still using, date of most recent use

Testing/Treatment History Questionnaire Available

XIII: Comment SectionXIII: Comment Section

Note any additional information about …– Risk factors– Info helpful to Partner Services– Referrals– If client lived in other states while

infected– Lab testing information you don’t know

where or how to record elsewhere…

Section X: Documented Lab ResultsSection X: Documented Lab Results

Will review 2 tests:– 4th Generation Antigen/Antibody EIA–Multispot

Note:– Will use old term: “EIA, enzyme immunoassay”

but “IA, immunoassay” is more general, correct term

– Will use old terms: “screening” and “confirmatory” tests but correct terminology now is “initial” and “supplemental” tests

Section X: Documented Lab Results Section X: Documented Lab Results 44thth Generation Antigen/Antibody Test Generation Antigen/Antibody Test

New sensitive screening test run only in laboratories at present

Not available in the U.S. as a rapid test yet 4th Generation EIA detects both:– Antibody to HIV – P24 antigen, part of the HIV structure– So picks up infections earlier than

current 3rd generation EIA that detects antibody only

Section X: Documented Lab Results Section X: Documented Lab Results Type Differentiating: e.g. MultispotType Differentiating: e.g. Multispot

If Multispot negative: Need + NAAT to diagnose HIVIf Multispot negative: Need + NAAT to diagnose HIV

Section X: Documented Lab ResultsSection X: Documented Lab ResultsNew Testing AlgorithmsNew Testing Algorithms

New test combinations to make a diagnosis:– Now: EIA plus Western blot

– New: EIA plus Multispot (from laboratories)

(plus a positive NAT if Multispot negative)

– New: Dual Immunoassays: 2 positive EIAs from 2 different manufacturers • E.g. “Dual Rapids” (an option for testing sites)

Section X: Documented Lab ResultsSection X: Documented Lab ResultsNew Testing AlgorithmsNew Testing Algorithms

In the new laboratory algorithm, why replace one confirmatory antibody test (Western blot) with another (Multispot)…when either might be negative following a 4th generation antigen /antibody screen?– Western blots are complex tests that are run in

batches to cut down cost– Multispots are rapid tests that can be run

immediately following a positive “screen”

Section X: Documented Lab ResultsSection X: Documented Lab ResultsTesting ExampleTesting Example

Rapid reactive: serum sent to MDCH Lansing lab where Rapid reactive: serum sent to MDCH Lansing lab where 44thth generation EIA and Multispot are performed generation EIA and Multispot are performed

Section X: Documented Lab ResultsSection X: Documented Lab ResultsMultispot NegativeMultispot Negative

Since the Multispot was negative in this case, a positive NAT Since the Multispot was negative in this case, a positive NAT was required to make a diagnosis: either qualitative NAT, or was required to make a diagnosis: either qualitative NAT, or quantitative NAT (detectable viral load).quantitative NAT (detectable viral load).

Section X: Documented Lab ResultsSection X: Documented Lab Results

Dual Immunoassays – 2 positive EIAs from different

manufacturers make a diagnosis– Rapid or not– Collection dates may be different–Manufacturer names must be listed–May become popular at CTR sites– Do not know yet: impact on getting

patients into care

Section X: Documented Lab ResultsSection X: Documented Lab Results

Dual Immunoassays (EIAs)Example of two rapid reactive tests:

CD4 counts/% and MD DiagnosisCD4 counts/% and MD Diagnosis

Questions? Questions?

Contact your MDCH HIV Case Surveillance Liaison:

See jurisdiction site map and list of contacts under“Surveillance: Case Reporting and Projects” atwww.michigan.gov/hivstd (click on HIV/AIDS)

Or call:

HIV Surveillance in Southfield 248-424-7910

HIV Surveillance in Lansing517-335-8165