ART in Pregnancy, Breastfeeding and Beyond

June 18-20, 2012

Enhanced Strategies to Improve the

Quality of HIV Testing

Mireille Kalou, CGH/ILBKeisha Jackson, CGH/ILB

Omotayo Bolu, CDC, Cameroon

First step to HIV prevention, care and treatment, and surveillance (ALL PROGRAMS)

Several reports of testing errors

>40 million people tested by RT in 2011 1% error = 400,000 wrong diagnosis 5% error = 2 million wrong diagnosis 10% error = 4 million wrong diagnosis

Impact of false HIV diagnosis at the individual and program level

Why Enhanced Focus on the Quality of

HIV Rapid Testing?

False negative diagnosis Not referred to care and

treatment Result in prevention failure

(counseling and prophylaxis)

Can lead to more transmission to infant

False sense of security (negative HIV status)

Social/ Individual Implications of False HIV Diagnosis

False positive diagnosis Individual/family stress Stigma, discrimination Personal and program cost Side effects of ART Loss of confidence in

testing Adverse impact on the

program

Huge Financial implications, when you have discordant, indeterminate test results

Anecdotal Reports: Rates of up 30 -50% false HIV negative/ positive results have been reported by some countries. Investigations are on going, but this reflects the need for improved quality improvement.

Boreas et al, JAIDS, 2012 (from Rwanda & Zambia):

Three step algorithm &

DiagnosisInitial

DiagnosisFinal Resolution

 

Unresolved/ Did not

return for retesting

  Total Uninfected Infected  Two Negative & one Indeterminate (NEGATIVE) 410 265 4 141

    65% 1% 34%Two Positive & one Indeterminate (POSITIVE) 37 17 17 3

    46% 46% 8%Two of Three Other 214 136 10 68

    64% 5% 32%

Use of sub-optimal test kits Control specimens not used Procedures not followed Use of expired test kits Deviation from country’s testing algorithm Testing personnel not trained or under trained Test results improperly recorded

Factors Impacting the Quality of HIV Testing

Multi-step Approach: Ten Indicators of Quality Assurance

Parekh, et al., Am J Clin Pathol. 2010 (134) 573-584

Testing Algorithm

Hands-on training of

trainers

Standardized Logbook and Dried Tube Specimen (DTS)

Proficiency Testing (PT)

Use of Local Partners for Scale-Up

Data collection and analysis

Annual Refresher Training

Use of validated test kits (USAID-CDC validation)

Corrective Actions

Certification

New Kit Lot Verification and Post-market surveillance

Approaches used for Improving Quality of RT

Proficiency testing using Dried Tube Specimen (DTS)

Standardized Log Book Training Curriculum on

Improving the Quality of RT

I. Proficiency Testing Program Using Dried Tube Specimens

Dried tube specimens (DTS) concept Developed in the Serology laboratory, CDC/DGHA/ILB Cost effective and practical alternative for proficiency testing programs Easy to prepare and stable at room temperature for at least 4 weeks compared

with traditional approach of shipping PT panels that require a cold chain system

Objectives Panels of coded specimens sent to multiple test sites by reference laboratory Test sites perform tests and report results Results indicate quality of personnel performance and test site operations

Country Experience: DTS-PT Survey 2010 Performance Rate at PMTCT Sites (N=200)

Staff turnover, Limited supervision

II. Standardized Log Book

Critical Variables to Add

HIV Test 1, 2, 3: kit name, lot number, expiration date

Operator doing the test Final QA Results

Example of Uganda Standardized Logbook

Implementation of Standardized logbook at Testing Sites

Revision of existing logbooks to include key QA elements

Training of supervisors and end-users Monthly review of logbook data Monthly supervision and corrective actions, if

any Feedback to MOH, CDC HQ and in Country

programs, key stakeholder

Agreement Rates Between Test 1 and Test (2011), using the Log book

Corrective Actions

Percentage of Invalid Results by Test Kit (2010), Using the Log Book

Percentage of Kit Stock-out Overtime, Using the Log Book , 2011

III. RT Quality Improvement Training Curriculum

Requires some adaptation Country Experiences (Katy Yao et al, AJCP,

2010): Uganda, Botswana:

All lab and non lab staff performed RT well For non-lab staff regular supervision was critical Staff not conducting test regularly did not do so well on

proficiency test

DTS PT program Lack of buy-in from PMTCT stakeholders and testing facilities Staff not trained due to attrition or transfers of trained staffs Logistics for PT panel distribution and result data collection

Standardized logbook Multiple registers being used at PMTCT sites Misplaced logbooks or only used by trained staff Cost of printing registers and monthly supervision Logistics for data collection When used, logbook QA data not used for decision making

Training Need for continuous training and retraining

Challenges in implementing the QA activities for HIV testing

Advocacy to allocate resources to national and regional level to implement EQA approaches

Use of a combination of indigenous NGOs and a decentralized approach for the EQA program

National Reference Laboratory to provide oversight , coordinate supervisory visits and corrective actions

Involvement of in-country USG PMTCT team and national key stakeholders

Development of strategies for corrective actions i.e. Standardized site visit tools which include testing QA elements Decision tree for correctives Include as part of other supportive supervisory visit (clinical/ lab related visits)

Considerations for National Scale up

We need to have both lab and program teams working together to achieve

better results

PMTCT Cascade is achieved, when we work together as a team

PMTCT Cascade is NOT achieved

Participation rate of PMTCT Sites in 2011 (N=200)