Real-time 4th Generation HIV Algorithm Implementation in the · 2019. 8. 6. · Diagnostic Testing...
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2012 2013 2014 2015 February March2012: MHDL begins mee-ng with AbboH Laboratories & city architects to plan for HIV Architect instrument at Keenan Health Center (KHC) STD Clinic Lab Early 2013: MHD Lab staff considers several remodeling op-ons from city architects to accommodate the Architect instrument at KHC Summer 2013: MHDL works with Wisconsin Department of Health Services AIDS/HIV Program to discuss an-cipated test volume and funding for startup costs and tes-ng services December 2013: STD Lab is relocated to basement of KHC in prepara-on for remodel JanuaryMarch 2014: KHC STD Lab remodel March 2014: STD Lab opera-ons return to newly remodeled 2 nd floor space at KHC Summer 2014: Lab conducts several mee-ngs with KHC clinic & lab staff & state AIDS/HIV Program head to discuss 4 th Gen HIV Algorithm implementa-on logis-cs; CDC releases 4 th Gen HIV tes-ng recommenda-ons. May 2014: WDPH releases 2014 Budget & con-nued support for KHC HIV December 2014: HIV Architect installa-on & valida-on at KHC STD Lab January 2015: Architect training for KHC & main lab staff completed. Mul-spot valida-on at MHD. February 2015: Architect & Mul-spot use for HIV rapid tes-ng at KHC officially launches November 2014: Contract executed between city & AbboH Laboratories Real-me 4 th Generaon HIV Algorithm Implementaon in the STD Clinic at the City of Milwaukee Health Department Steve Gradus 1 , Jose Navidad 1 , Manjeet Khubbar 1 , Kathleen Krchnavek 2 , Willie Genous 3 , Eze Osuala 3 , Bill Borzon 3 , Irmine Reitl 3 , Paul Hunter 3,4 , Kwadwo Owusu-Ofori 1 , Sanjib Bhaacharyya 1 1 City of Milwaukee Health Department Laboratory, Milwaukee, WI, 2 Wisconsin Division of Public Health – AIDS/HIV Program, Madison, WI, 3 City of Milwaukee Health Department STD Clinic, Milwaukee, WI, 4 University of Wisconsin School of Medicine and Public Health, Madison, WI MATERIALS AND METHODS 4 th GENERATION HIV TESTING Tesng includes (Figure 1): HIV Angen/Anbody enzyme immune assay (EIA) on the Architect 1000i system (Abbo, IL) to screen blood samples (serum/plasma) for p24 angen and HIV 1/2 anbodies; Mulspot assay (Bio-Rad, CA) for differenaon of HIV 1& 2 anbodies from reacve samples at MHDL; HIV 1-Proviral DNA PCR referral to the Wisconsin State Laboratory of Hygiene. COLLABORATION Over two years the MHDL worked with the WDPH to convert state support for the manual HIV rapid screening into support for the automated 4 th Gen HIV tesng (Figure 2). RENOVATION MHDL implemented several remodeling opons for the KHC STD Lab in order to accommodate the Architect instrument. The KHC STD Lab was temporarily relocated during renovaon. CLINIC WORKFLOW OPTIMIZATION Numerous planning and logiscs meeng among local, state, clinic, lab and adminsitave staff resulted in detailed workflow analysis using LEAN tools (Figure 3.) VALIDATION 326 serum or plasma specimens were analyzed to validate assay sensivity and specificity (Tables 1 & 2). ACKNOWLEDGEMENTS: We acknowledge the staff of the City of Milwaukee Health Department Laboratory and of the City of Milwaukee Keenan Health Center. Special thanks to Julie Becker for her assistance in eding and poster producon. Special thanks to Olio Oyervideo of the STD Clinic Outreach Program. REFERENCES: 1. hp://www.cdc.gov/hiv/pdf/HIVtesngAlgorithmRecommendaon- Final.pdf 2. hp://www.cdc.gov/hiv/pdf/guidelines_tesng_ recommendedLabTesngAlgorithm.pdf 3. APHL Suggested Reporng Language for the HIV Laboratory Diagnosc Tesng Algorithm Contact: [email protected] Presented at the 2015 APHL Annual Meeng, Indianapolis, IN CONCLUSIONS • Manual HIV rapid screening was replaced with the CDC 4 th Gen HIV tesng algorithm at the KHC STD Clinic for same day screening, typing, and confirmaon. • Turn-around-mes for HIV screening , typing, and confirmaon were improved from 1-2 weeks via outsourcing to the WSLH, to 1 day via in-house 4 th Gen HIV tesng. • 4 th Gen HIV tesng improved and enhanced Milwaukee’s local public health system’s capacity for early detecon and follow up of HIV cases. This improves clinician case management capabilies, and holds the promise of decreasing morbidity and mortality locally and statewide. FUTURE DIRECTIONS • 4 th Gen HIV screening, typing and confirmaon at the KHC STD Lab prior to client departure. • Enhanced community capacity directed to KHC STD Lab. • HIV 1 & 2 real-me PCR at MHDL. Figure 1. Recommended Laboratory HIV Tesng Algorithm for Serum or Plasma Specimens (MMWR 2014) Table 1 (Serum specimens) Table 2 (Plasma specimens) Figure 3. Value Steam Mapping for KHC Workflow for HIV Client Services Figure 4. Overall Impact on Process Improvement INTRODUCTION The City of Milwaukee Health Department Laboratory (MHDL), Keenan Health Center STD Clinic (KHC), and the Wisconsin Division of Public Health AIDS/HIV Program (WDPH) implemented the CDC 4 th generaon (4 th Gen) HIV tesng algorithm (Figure 1). This will soon provide same-day confirmatory results and counseling for HIV posive paents. RESULTS • In late 2014 HIV Architect instrumentaon and methodology was installed and validated at KHC STD Lab (Figure 2). • Sensivity and specificity was based on a 95 confidence internal (CI 95) (Tables 1 & 2). • Several workflow inefficiencies were defined and removed in order to save 15 minutes from each paent’s wait me, as a result of LEAN workflow analysis. • As of May 2015, four HIV posive screened paents were confirmed within 24 hours of examinaon. This is compared to the 1-2 week turn- around-me associated with the prior system (Figure 4). Figure 2. Timeline for implemenng 4 th Gen HIV Tesng Algorithm at MHD laboratory PPV 100% (78 -100%); NPV 99.5% (96 - 100%) PPV 100% (5 -100%); NPV 100% (95.6 - 100%) Real-time 4 th Generation HIV Algorithm Implementation Timeline
Transcript of Real-time 4th Generation HIV Algorithm Implementation in the · 2019. 8. 6. · Diagnostic Testing...
2012 2013 2014 2015
Real-‐-me 4th Genera-on HIV Algorithm Implementa-on Timeline
February -‐March2012: MHDL begins mee-ng with AbboH Laboratories & city architects to plan for HIV Architect instrument at Keenan Health Center (KHC) STD Clinic Lab
Early 2013: MHD Lab staff considers several remodeling op-ons from city architects to accommodate the Architect instrument at KHC
Summer 2013: MHDL works with Wisconsin Department of Health Services AIDS/HIV Program to discuss an-cipated test volume and funding for start-‐up costs and tes-ng services
December 2013: STD Lab is relocated to basement of KHC in prepara-on for remodel
January-‐March 2014: KHC STD Lab remodel
March 2014: STD Lab opera-ons return to newly remodeled 2nd floor space at KHC
Summer 2014: Lab conducts several mee-ngs with KHC clinic & lab staff & state AIDS/HIV Program head to discuss 4th Gen HIV Algorithm implementa-on logis-cs; CDC releases 4th Gen HIV tes-ng recommenda-ons.
May 2014: WDPH releases 2014 Budget & con-nued support for KHC HIV
December 2014: HIV Architect installa-on & valida-on at KHC STD
Lab
January 2015: Architect training for KHC & main lab staff completed. Mul-spot valida-on at MHD.
February 2015: Architect & Mul-spot use for HIV rapid tes-ng at KHC officially launches
November 2014: Contract executed between city & AbboH Laboratories
Real-time 4th Generation HIV Algorithm Implementation in the STD Clinic at the City of Milwaukee Health Department
Steve Gradus1, Jose Navidad1, Manjeet Khubbar1, Kathleen Krchnavek2, Willie Genous3, Eze Osuala3, Bill Borzon3, Irmine Reitl3, Paul Hunter3,4, Kwadwo Owusu-Ofori1, Sanjib Bhattacharyya1
1City of Milwaukee Health Department Laboratory, Milwaukee, WI, 2Wisconsin Division of Public Health – AIDS/HIV Program, Madison, WI, 3City of Milwaukee Health Department STD Clinic, Milwaukee, WI, 4University of Wisconsin School of Medicine and Public Health, Madison, WI
MATERIALS AND METHODS4th GENERATION HIV TESTINGTesting includes (Figure 1): HIV Antigen/Antibody enzyme immune assay (EIA) on the Architect 1000i system (Abbott, IL) to screen blood samples (serum/plasma) for p24 antigen and HIV 1/2 antibodies; Multispot assay (Bio-Rad, CA) for differentiation of HIV 1& 2 antibodies from reactive samples at MHDL; HIV 1-Proviral DNA PCR referral to the Wisconsin State Laboratory of Hygiene.
COLLABORATIONOver two years the MHDL worked with the WDPH to convert state support for the manual HIV rapid screening into support for the automated 4th Gen HIV testing (Figure 2).
RENOVATIONMHDL implemented several remodeling options for the KHC STD Lab in order to accommodate the Architect instrument. The KHC STD Lab was temporarily relocated during renovation.
CLINIC WORKFLOW OPTIMIZATIONNumerous planning and logistics meeting among local, state, clinic, lab and adminsitative staff resulted in detailed workflow analysis using LEAN tools (Figure 3.)
VALIDATION326 serum or plasma specimens were analyzed to validate assay sensitivity and specificity (Tables 1 & 2).
ACKNOWLEDGEMENTS:We acknowledge the staff of the City of Milwaukee Health Department Laboratory and of the City of Milwaukee Keenan Health Center. Special thanks to Julie Becker for her assistance in editing and poster production. Special thanks to Otilio Oyervideo of the STD Clinic Outreach Program.
REFERENCES:1. http://www.cdc.gov/hiv/pdf/HIVtestingAlgorithmRecommendation-
Final.pdf2. http://www.cdc.gov/hiv/pdf/guidelines_testing_
recommendedLabTestingAlgorithm.pdf3. APHL Suggested Reporting Language for the HIV Laboratory
Diagnostic Testing Algorithm
Contact: [email protected]
Presented at the 2015 APHL Annual Meeting, Indianapolis, IN
CONCLUSIONS• Manual HIV rapid screening was replaced with
the CDC 4th Gen HIV testing algorithm at the KHC STD Clinic for same day screening, typing, and confirmation.
• Turn-around-times for HIV screening , typing, and confirmation were improved from 1-2 weeks via outsourcing to the WSLH, to 1 day via in-house 4th Gen HIV testing.
• 4th Gen HIV testing improved and enhanced Milwaukee’s local public health system’s capacity for early detection and follow up of HIV cases. This improves clinician case management capabilities, and holds the promise of decreasing morbidity and mortality locally and statewide.
FUTURE DIRECTIONS• 4th Gen HIV screening, typing and confirmation at
the KHC STD Lab prior to client departure.
• Enhanced community capacity directed to KHC STD Lab.
• HIV 1 & 2 real-time PCR at MHDL.
Figure 1. Recommended Laboratory HIV Testing Algorithm for Serum or Plasma Specimens (MMWR 2014)
Table 1 (Serum specimens)
Table 2 (Plasma specimens)
Figure 3. Value Steam Mapping for KHC Workflow for HIV Client Services Figure 4. Overall Impact on Process Improvement
INTRODUCTIONThe City of Milwaukee Health Department Laboratory (MHDL), Keenan Health Center STD Clinic (KHC), and the Wisconsin Division of Public Health AIDS/HIV Program (WDPH) implemented the CDC 4th generation (4th Gen) HIV testing algorithm (Figure 1). This will soon provide same-day confirmatory results and counseling for HIV positive patients.
RESULTS• In late 2014 HIV Architect instrumentation and methodology was
installed and validated at KHC STD Lab (Figure 2).
• Sensitivity and specificity was based on a 95 confidence internal (CI 95) (Tables 1 & 2).
• Several workflow inefficiencies were defined and removed in order to save 15 minutes from each patient’s wait time, as a result of LEAN workflow analysis.
• As of May 2015, four HIV positive screened patients were confirmed within 24 hours of examination. This is compared to the 1-2 week turn-around-time associated with the prior system (Figure 4).
Figure 2. Timeline for implementing 4th Gen HIV Testing Algorithm at MHD laboratory
PPV 100% (78 -100%); NPV 99.5% (96 - 100%)
PPV 100% (5 -100%); NPV 100% (95.6 - 100%)
Tom Barrett, MayorBevan K. Baker,Commissioner of Health
www.milwaukee.gov/health
Real-time 4th Generation HIV Algorithm Implementation Timeline
