V. Habiyambere (WHO), J. Perriëns (WHO), Ekaterina Milgotina (GSSHealth) and P. Fernandes (GSSHealth) WHO AMDS, April 2015

Transcription

1 V. Habiyambere (WHO), J. Perriëns (WHO), Ekaterina Milgotina (GSSHealth) and P. Fernandes (GSSHealth) WHO AMDS, April 2015

2 Maputo 2008 Defined tests for each tiered network level Recognized importance of standardization Geneva 2008 (AMDS/EHT meeting) TWG 1 Goal: Standardization and case studies TWG 2 Goal: Specifications to facilitate (a) procurement HIV diagnostic tests in adults and children (b) monitor treatment outcomes in patients on ART Geneva 2012 (AMDS/EHT meeting) Revised tool from meeting outcomes Released Jan 2014

3 Support procurement for lab technology Enable purchasers and suppliers to understand end user requirements Provide detailed specifications to improve procurement Support the production of test results by listing and quantifying all items needed to complete a test run: all commodities required and optional accessories other relevant data e.g. shelf life, installation

4 Buyers, logisticians and national program officers Develop correct specifications List required accessories List optional accessories Identify installation and training requirements Identify quality standards Staff responsible for laboratory logistics, supply chain management, service planning and scale-up Determine appropriate laboratory network level Identify required additional equipment Determine required quantities Identify shipping and storage conditions Approximate shelf-life Laboratory managers, supervisors and technical staff Identify suitable equipment for the laboratory network level Determine need for equipment installation, training, calibration and regular servicing Understand equipment operating conditions Recognize required quality standards Identify items required by test to assist in work flow planning

5 Technologies included or removed from WHO, GF, USAID lists Additional information as it becomes available Optimization of tool structure and format

6 Updated list of technologies (PQ & partner lists) 31 added 26 deleted Separated RDTs, EIAs, and supplemental assays Revised test tables Added short description of the assay Added Specimen type, Eligibility Criteria, Regulatory Status Deleted No. of tests, UN hazard code Revised specification tables Added columns Manufacturer, Price range

7 Arranged in alphabetical order by technology Updated: catalog nos., shelf life, storage conditions, accessories, items required to perform test Improved tool navigation (tables now accessible from table of content)

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10 Test Tables Commodities by Test 2015 ed. HIV RDT: HIV 1/2 STAT-PAK DIPSTICK, CHEMBIO DIAGNOSTIC SYSTEMS, INC. HIV 1/2 STAT-PAK DIPSTICK assay is a single use, immunochromatographic screening test which uses a cocktail of antigens to detect antibodies to HIV 1 and 2 in serum, plasma or whole blood. Reactive results are supportive evidence of exposure to HIV 1/2 and can be used to support a clinical diagnosis of HIV 1 or HIV 2. Nonreactive results, however, should not be used to exclude infection with HIV 1 or 2. Time to result 15 to 20 minutes. Sensitivity 100%, specificity 99.7%. Item no. Item name Catalogue no. 1 Required kit or equipment Commodity code Unit of measure (UoM) No. of tests/uom No. of tests No. of UoM units required Specimen type Shelf-life Temperatur e requirement Docume nt/packa ge/link Eligibility criteria Regulat ory status Comment 206 HIV 1/2 STAT-PAK Dipstick 2 Test run HIV303 B 30 tests/kit Serum, plasma, venous or fingerstick whole blood 24 months Store at 8-30 o C o.gl/ja2y je WHO, GF, USAID ROW, WHO PQ 534 Blood collection consumable s 505 Gloves multiple sizes, powder-free 385, 386, 387 Biohazard waste container 46 Timer, digital 3 Control C 1000 Fingerstick, venous whole blood Generic C 100 gloves /box 1000 Generic D 1 unit 1000 Generic E 1 unit 1000 For venous blood or plasma specimens, use tubes with EDTA, citrate, or heparin. 562 Rapid HIV 1/2 Antibody Test Kit Controls HIV104 R 50 tests/each control/pac kage 50 tests/contro l Store at 2-8 o C ROW Available from manufacturer as accessory; non-who PQ; Contains 1 HIV-1 Reactive Control 0.25mL, 1 HIV-2 Reactive Control 0.25mL, 1 HIV Nonreactive Control 0.5mL

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13 Training of laboratory, program and logistics managers approx. 60 All 5 ROs and Country Offices Inclusion in PSMToolbox.org

14 Produce online version Dissemination through workshops and field visit Inclusion on partner websites and training workshops

15 ASLM, CDC, CHAI, Crown Agents, ESTHER, FIND, Global Fund, GSSHealth, MSF, SCMS, The Murtagh Group, UNAIDS, UNDP, UNICEF, USAID, USAID/Deliver, JSI, USAID/SIAPS, MSH, Representatives from Argentina, Thailand, and Senegal, i+solutions lab workshop participants COMPANIES WHICH PROVIDED COMMENTS ON THE USE OF THEIR TECHNOLOGIES AND CONTENT OF THE TOOL