Implications for the Public Health Laboratories from

Expansion of Rapid Testing

Arthur KazianisArthur Kazianis

Massachusetts Department of Public HealthMassachusetts Department of Public Health

State Laboratory InstituteState Laboratory Institute

HIV LaboratoryHIV Laboratory

Background

HIV LaboratoryHIV Laboratory

Existing RelationshipsExisting Relationships

HIV Laboratory

Has provided HIV antibody screening and Has provided HIV antibody screening and confirmatory testing since 1985 for DPH confirmatory testing since 1985 for DPH and CDC funded clinics.and CDC funded clinics.

Algorithm: EIA screening followed by Algorithm: EIA screening followed by Western blot confirmationWestern blot confirmation

Laboratory staff:Laboratory staff: Skilled techniciansSkilled technicians epidemiologistsepidemiologists

Laboratory Staff

Perform all testing (screening and Perform all testing (screening and confirmatory)confirmatory)

ReportingReporting Technical support of Counseling and Technical support of Counseling and

Testing staffTesting staff Perform QA/QC functionsPerform QA/QC functions

Laboratory Epidemiologists

Daily contact with HIV lab staffDaily contact with HIV lab staff Liaison between the HIV lab andLiaison between the HIV lab and

AIDS Bureau program staffAIDS Bureau program staff Surveillance staffSurveillance staff C & T staffC & T staff

Incidence and Resistance Coordinators for Incidence and Resistance Coordinators for MassachusettsMassachusetts

HIV Laboratory Provides:

Daily contact via telephone for reporting Daily contact via telephone for reporting and consultation to C & T personneland consultation to C & T personnel

Laboratory toursLaboratory tours Input at monthly meetings with C & T Input at monthly meetings with C & T

supervisorssupervisors

Specimens Processed by YearSpecimens Processed by Year

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

90,000

100,000

Year

OMT

Serum

Initial Concerns for the Laboratory

Clinical and C & T Staff not Experienced with Performing Screening

C & T staff are C & T staff are notnot laboratorians laboratorians Counselors have misunderstood reactive Counselors have misunderstood reactive

screening results despite trainingscreening results despite training MakeMake nono assumptionsassumptions: Clinical staff, not : Clinical staff, not

only lay counselors, require clarification only lay counselors, require clarification about these laboratory tests.about these laboratory tests.

Purpose of “Screening” and “Confirmation” not Completely Understood

All screening tests: EIAs and OraQuick All screening tests: EIAs and OraQuick reactives require confirmationreactives require confirmation

Significance of OraQuick reactive as Significance of OraQuick reactive as screening screening vs.vs. Western blot as confirmation Western blot as confirmation

Some Perceptions of Reactive OraQuick Results

OraQuick reactive OraQuick reactive ≠ Western blot positive≠ Western blot positive ““Preliminary positive “ language can be Preliminary positive “ language can be

misleadingmisleading OraQuick testing is always rapid for a OraQuick testing is always rapid for a

negative interpretation.negative interpretation.

Rapid Testing in MA 2004(from PMS-1 Sites Only)

Total OraQuick tests performed:Total OraQuick tests performed: 99809980 OraQuick reactive:OraQuick reactive: 114 114 Confirmed + (Wb):Confirmed + (Wb): 94 94 Confirmed – (Wb):Confirmed – (Wb): 7 7 Indeterminate:Indeterminate: 6 6 No serum follow-up received:No serum follow-up received: 7 7

Positive Predictive Value (PPV)

Calculated if the total tested (denominator) Calculated if the total tested (denominator) is knownis known If your laboratory no longer receives If your laboratory no longer receives

samples for screening, how do you samples for screening, how do you determine the denominator associated determine the denominator associated with those sent to the lab for with those sent to the lab for confirmation?confirmation?

PPV During OraQuick Post-marketing Phase (PMS-1 only) for Massachusetts

PPV = 88 % PPV = 88 % GoodGood NewsNews::

More reactive and/or positive clients More reactive and/or positive clients received their resultsreceived their results

BadBad NewsNews:: Increased number of false reactive Increased number of false reactive

results reportedresults reported

Lab Issues

Reduced Testing Volume Affects Lab Infrastructure Significant reduction in serum submissionsSignificant reduction in serum submissions

Lack of specimens for other requested or Lack of specimens for other requested or approved testingapproved testing

Reduced screening performedReduced screening performed Smaller pool for negative controlsSmaller pool for negative controls Equipment not used as frequently- maintenance Equipment not used as frequently- maintenance

issuesissues Tasks normally done daily may require less frequent Tasks normally done daily may require less frequent

scheduling. Lab staff will have less familiarity with scheduling. Lab staff will have less familiarity with such tasks.such tasks.

But also…

Less screening could also provide greater Less screening could also provide greater opportunities to participate in opportunities to participate in incidence/resistance and other laboratory incidence/resistance and other laboratory initiatives. initiatives.

Some Lab Activities will Always Remain

Screening and confirmatory testing Screening and confirmatory testing continue but at reduced levelscontinue but at reduced levels

QA/QC Activities continueQA/QC Activities continue Use of controlsUse of controls Equipment maintenanceEquipment maintenance Proficiency testingProficiency testing Competency assessmentCompetency assessment

Request from C & T for Faster Confirmation

Should an OraQuick reactive serum follow-Should an OraQuick reactive serum follow-up sample be tested by “rapid” Western blot up sample be tested by “rapid” Western blot confirmation?confirmation?

Counseling and Testing Issues

Significant changes in counseling strategySignificant changes in counseling strategy Scheduling issuesScheduling issues Preparation time to deliver positive resultPreparation time to deliver positive result Counselors have limited or no experience in Counselors have limited or no experience in

reporting reactive screening resultsreporting reactive screening results How does an OraQuick reactive screening How does an OraQuick reactive screening

result differ from a “final” result obtained from result differ from a “final” result obtained from the lab? the lab?

Public Health Lab’s Role in Oversight

Components of Testing Unfamiliar to Counseling and Testing Staff

ScreeningScreening ConfirmationConfirmation Quality Assurance / Quality ControlQuality Assurance / Quality Control CLIACLIA

Training Counseling Staff in the Use of OraQuick Pre-analytical concernsPre-analytical concerns Analytical processesAnalytical processes Interpretation of resultsInterpretation of results Post-analytical activitiesPost-analytical activities

ReportingReporting Required documentationRequired documentation

Continuous QA/QC Support

Regular maintenance and support from the Regular maintenance and support from the lab to clinics on QA/QC issues:lab to clinics on QA/QC issues: Assist with lab documentsAssist with lab documents Training new employees Training new employees Competency AssessmentCompetency Assessment Proficiency testingProficiency testing

Public Health Lab’s Role in Transition

Take the Lead in Education

What is screening and confirmation?What is screening and confirmation? What is a Control?What is a Control? What is QA and QC?What is QA and QC? State regulations regarding HIV testing and State regulations regarding HIV testing and

reportingreporting CLIA licensureCLIA licensure FDA approvalFDA approval

Provide Continuous Support

Answering questions – a daily activityAnswering questions – a daily activity QA / QCQA / QC Records managementRecords management Maintaining required lab documents for Maintaining required lab documents for

testing, equipment maintenance, testing, equipment maintenance, temperature charts, etc.temperature charts, etc.

Provide QA/QC documentation that mimics Provide QA/QC documentation that mimics that of traditional laboratory setting. that of traditional laboratory setting.

Support Continued…

Some counselors have refused to perform Some counselors have refused to perform rapid test. rapid test.

Laboratory safety: new concept for most Laboratory safety: new concept for most counselorscounselors

Handling inactivated controls as infectiousHandling inactivated controls as infectious Maintaining supply inventoryMaintaining supply inventory Control and kit expiration datesControl and kit expiration dates Consistent labelingConsistent labeling

Laboratory’s Role in Rapid Testing QA/ QC Program

Lab Staff May Visit Clinics for:

Initial rapid testing orientationInitial rapid testing orientation Practical trainingPractical training Visit sites when problems ariseVisit sites when problems arise

Determine Acceptability of Site for Testing

Appropriate lab spaceAppropriate lab space LightingLighting Location for test developmentLocation for test development Waiting area for clientsWaiting area for clients

Provide with Training:

Written testWritten test Test panel (practical assay performance)Test panel (practical assay performance) Mandatory competency assessmentMandatory competency assessment

Provide QA/QC Documents

Log sheetsLog sheets Temperature chartsTemperature charts Follow-up documentationFollow-up documentation

Concluding Remarks

Laboratory’s Role in Support of Rapid Testing Continue to provide Western blot confirmationContinue to provide Western blot confirmation Provide mechanism for continuing educationProvide mechanism for continuing education

New employees will always need training: lab New employees will always need training: lab staff as well as counselors at clinicsstaff as well as counselors at clinics

Epidemiologists with lab experience and other Epidemiologists with lab experience and other members of the lab can assist with ongoing QA members of the lab can assist with ongoing QA efforts.efforts.

Changes for the Laboratory

New testing environment: fewer screening New testing environment: fewer screening performed while Western blot confirmation performed while Western blot confirmation continuescontinues

Greater role for handling specimens for Greater role for handling specimens for incidence & resistanceincidence & resistance

Gain familiarity with rapid testsGain familiarity with rapid tests Participation in OraQuick training as an Participation in OraQuick training as an

expanded laboratory activity expanded laboratory activity