Standardization and Harmonization ofLaboratory Equipment: Selected Country

Case StudiesWHO Geneva AMDS Partners and Stakeholders Meeting

March 22-24, 2010

Sherry OrloffLead Public Health Advisor

International Laboratory BranchGlobal AIDS Program

CDC-Atlanta

2008 Tanzania Experience Assessment of laboratories Review of Guidelines Development of the Operational Plan

for the National Laboratory System tosupport HIV/AIDS Care and Treatment

Test Harmonization Equipment Standardization Implementation

Testing at tiered levels Health Center

Manual, low throughput equipment run by laboratorypersonnel with minimum certificate level of training.

District and Regional Medium throughput laboratory equipment run by at a

minimum diploma holding laboratory personnel. Referral

Automated high throughput equipment run by(technicians, technologist and scientists) with at leastadvanced diploma level of training.

2008 Tiered distribution of labequipment

Equipment Referral Region District

ELISA Multiscan Multscan -Axysm

RNA PCR. Taqman - -

DNA PCR Cobas amplicor - -

Flow Cyto FACS Callibur FACSCount FACSCount

Chem Cobas Integra Fully Screen MasterMicro Lab 200

Hem ACT5 DIFF Pentra 80 Micro 60

OI BSC II/Inc/Microsc Incub/Microsc Incub/Microscopy

2010 Tiered distribution of labequipment

Equipment Referral Region District

ELISA Multiscan Multscan -Axysm

RNA PCR. Taqman - -

DNA PCR Cobas amplicor - -

Flow Cyto FACS Calibur FACSCalibur FACSCount

Chem Fully Science Master Screen Master3000 Micro Lab 200

Hem CellDyne 3700 CellDyne1700 Micro 60

OI BSC II/Inc/Microsc BSC II/Incub/ Incub/MicroscopyMicrosc

Tanzania 2008

• Meetings with stakeholders• Training of Biomedical Engineers and

technicians• Database of all equipment procured in

country – date of procurement, by whom,reagent procurement support, vendor,manufacturer

• Tender for maintenance contract floated

2010 Tanzania Updates onStandardization

• Have budgeted for construction orrenovation for 15 district labs which willinclude BSC level II

• B-D has had a monopoly for CD4 testingwhich has not shown any cost savings.TZ is eager to begin point-of-care testingfor CD4

Cote d’Ivoire Experience Post Maputo

Harmonization in 2008

• In 2008, harmonization was occurringwithin PEPFAR supported laboratories,but the MOH had not committed to theprocess

2008 Harmonization of laboratory equipmentat PEPFAR supported sites - Cote d’Ivoire

ReferenceLabs

Regional &District Labs

Peripheral Labs

Immunology FACSCaliburFACSCountGuava

FACScountGuava

FACSCount if>100 CD4 a week

Hematology Sysmex 200 i,ACT Diff III

KX 21 N,ACT Diff II

Sysmex KX 21 N,CoulterACT Diff II

Biochemistry Cobas Integra400

Cobas C 111,Fully

Biolabo Kenzamax,Humalyser

2008 Harmonization of lab equipment atPEPFAR

supported sites - Level ITests Instruments Models

Immunology CD4 Flow Cytometer FACSCount

Hematology WBC Count Automated mach.18 parameters

Sysmex KX 21 N,CoulterACT Diff II

Biochemistry ASTALTCreat., Gluc.

Spectrophometer Biolabo Kenzamax,

Humalyser

2008 Harmonization of lab equipment atPEPFAR

supported sites - Level II

Tests Instruments Models

Immunology CD4 Flow Cytometer FACSCountGuava

Hematology WBC Count Automated mach.18 parameters

KX 21 N,ACT Diff II

Biochemistry ASTALTCreat., Gluc.

Automated mach.100 tests/hour

Cobas C 111,Fully

2008 Harmonization of lab equipment atPEPFAR

supported sites- Level IIITests Instruments Models

Immunology CD4 Flow Cytometer FacsCaliburFACScountGuava

Hematology WBC Count Automatedmachine (23parameters)

Sysmex 200iACT Diff III

Biochemistry ASTALTCreat., Gluc.

Automatedmachine (300tests/hour)

Cobas Integra 400

Distribution of Equipment

Source : Données Partenaires

CD4 Biochemistry Hematology Viral load

FACSCOUNT FULLY ACT DIFF TAQMAN 48

FACSCALIBUR COBAS INTEGRA 400 ACT 5 DIFF ABI PRISM 7000

GUAVA COBAS C111 SYSMEX XT2000I NUCLISENS

HITACHI 902 SYSMEX KX21N

REFLOTRON PLUS (3) MEDONIC CA620 (5)

KONELAB 20 (11)

KENZA MAX

HUMALYSER

Domain Equipment Level 3Labs

Level 2Labs

Level 1Labs

CD4 BD FACScaliburBD FACScountGuava Easy

Hematology AcT5 DiffAcT Diff 2Sysmex Xt 200iSysmex kx21

Biochemistry Cobas Integra 400FullyCobas C111Spectro Kenza Max

Others Centrifuge Eppendorf 5804Refrigerators/ freezersMicroscope Olympus cx21Water distillatory 4l/h & 7L/hOnduleur 2KVAWater reservoir 20LMicropipettes Eppendorf (20, 200,1000)

Furniture Split 1,5 CVOffice furniture (desk, chair, tabouret, etc.)

TOTAL/site 350,000$ 113,000$ 98,000$

2010 Cote d’Ivoire Update

• A meeting sponsored by the National Care andTreatment MOH program and SCMS isscheduled for May 2010 to develop a nationaldocument for standardized equipment

• Lab accreditation: 20 Labs will be included in theprocess the first year ( with a focus on 3 centrallabs already engaged in the ISO15189accreditation). A TWG has been put in place andhave developed a draft national policy and theCOP10 work-plan

Nigeria HarmonizationExperience 2010

• Nigeria PEPFAR program works with 17laboratory partners in COP2010

• Harmonization of laboratory equipmenthas been done within implementingpartner programs

• At this time, Nigeria PEPFAR program isusing a phased approach to standardizeequipment across the country

Harvard Nigeria Program

Harvard Nigeria Major LaboratoryEquipment(Tertiary Level)

LEVELS(TERTIARY)

EQUIPMENT (Model) NUMBERINSTALLED

NUMBER INOPERATION

DRM AB 3130 Autosequencer 2 2

Viral Load 1. Roche (manual)2. Cobas/Roche (semi-

automated)

84

84

CD4 Count 1.Cyflow counter 1&22.Cyflow SL-3

615

615

Chemistry 1.Hitachi 902 2 2

Hematology 1.Sysmex KX-21N2.Mindray 3200

77

77

LEVELS(SECONDARY)

EQUIPMENT (Model) NUMBERINSTALLED

NUMBER INOPERATION

Viral Load - - -

CD4 Count 1.Cyflow counter 1&22.Cyflow SL-3

-21

-21

Chemistry Cobas-C111 18 18

Hematology 1.Sysmex KX-21N2.Mindray 3200

-17

-17

Harvard Nigeria Major LaboratoryEquipment (Secondary Level)

Institute Of Human VirologyNigeria

EXISTING LABORATORY MAJOR EQUIPMENT/ LABLEVEL-COP 09LEVELS EQUIPMENT

(Model)NUMBERINSTALLED

NUMBER INOPERATION

TERTIARY Vitros DT60Vitros 250Vitros 350ReflotronCyflow SLCyflow New CounterFACS CountFACS CaliburSysmex KX21NABI 9700 (PCR)PCR (MDRTB)ABI Genetic Analyzer 3130EIABiosafety CabinetsMGIT

2646921251132811

9183

2616921251132811

9183

EXISTING LABORATORY MAJOR EQUIPMENT/LAB LEVEL-COP 09

SECONDARY Vitros DT60ReflotronCyflow CounterSysmex KX21 NHemocue

332535

332535

PRIMARY Hemocue 25 25

TB PCR (MDRTB)ABI GeneticAnalyzer 3130EIABiosafety CabinetsMGIT

11

9183

11

9183

ICAP-Nigeria

EXISTING LABORATORY MAJOREQUIPMENT/ LAB LEVEL-COP 09

LEVELSLEVELS EQUIPMENTEQUIPMENT(Model)(Model)

NUMBERNUMBERINSTALLEDINSTALLED

NUMBER INNUMBER INOPERATIONOPERATION

SECONDARYSECONDARY Cyflow SL_3,Cyflow SL_3,Cyflow CounterCyflow CounterV250V250DT60DT60ReflotronReflotronSysmexSysmexAbacus JuniorAbacus Junior

44303055191944222244

44303055191944222244

PRIMARYPRIMARY Point Care nowPoint Care nowReflotronReflotron

1111

1111

TBTB Partec CyscopePartec CyscopeFlorescence MicrocopeFlorescence MicrocopeRegular MicroscopesRegular Microscopes

22 22

Family Health InternationalGlobal HIV/AIDS Initiative

Nigeria

EXISTING LABORATORY MAJOREQUIPMENT/ LAB LEVEL

LEVELSLEVELS EQUIPMENT (Model)EQUIPMENT (Model) NUMBERNUMBERINSTALLEDINSTALLED

NUMBER INNUMBER INOPERATIONOPERATION

TERTIARYTERTIARY CyFlow counterCyFlow counterFacscountFacscountSysmex KN-21XSysmex KN-21XSelectra JuniorSelectra Junior

8199

all

SECONDARYSECONDARY Facscount/Facscount/CyFlowCyFlowSysmex KN-21XSysmex KN-21XQBCQBCReflotronReflotronSelectra JuniorSelectra Junior

89166733103 1

all

PRIMARYPRIMARY Microscope (OlympusMicroscope (Olympusbinocular)binocular)

4 all

TBTB BACTEC MGIT 960BACTEC MGIT 960 1

Zambia Experience

• Zambia began to standardize equipmentprior to Maputo Meeting

• Activities have complimented work ofSCMS in terms of provision of laboratorysupplies and avoiding stock outs

PEPFAR Updates

• New laboratory indicators in COP 20101. Number of laboratories supportedby PEPFAR2. Number of accredited laboratoriessupported by PEPFAR

• Point of care equipment evaluations

What have we learned?

• Country needs and technology change, flexibilityis a must

• Process of standardization happens at varyingrates, will the accreditation process improveprogress?

• Need to share our experience with otherprograms, i. e., what has to happen to receivebuy in from MOH?

• If standardization creates a monopoly, what canwe do to lower costs?

Acknowledgments

• Luciana Kohatsu, PhD CDC-Tanzania• Christiane Adje, PhD CDC-Cote d’Ivoire• Isatta Wurie, PhD CDC-Nigeria• Rachanee Cheingsong, PhD CDC-Zambia• John Nkengasong, PhD CDC-Atlanta