1 LABNET CURRENT HIV TESTING ACTIVITIES IN PACIFIC JURISDICTIONS

2 HIV SCREEN TESTING Using HIV rapid screening test kits that have been recommended by WHO and further evaluated by Lab Net partner, NRL-Melbourne, on specimens from Fiji Some labs use an ELISA test for initial screening test (e.g. Abbott HIV 1 / 2, Vidas) Two kits that were evaluated: Serodia-Fujirebio and Determine-Abbott Initial recommendation from NRL  Either test could be used for first-line screening  A positive Serodia result confirmed with Determine, but not positive Determine with Serodia  NRL would look at y possibly evaluating additional screen tests (UniGold, Capillus), on specimens from the Pacific region All current screen testing is performed in lab-based settings Using HIV rapid screening test kits that have been recommended by WHO and further evaluated by Lab Net partner, NRL-Melbourne, on specimens from Fiji Some labs use an ELISA test for initial screening test (e.g. Abbott HIV 1 / 2, Vidas) Two kits that were evaluated: Serodia-Fujirebio and Determine-Abbott Initial recommendation from NRL  Either test could be used for first-line screening  A positive Serodia result confirmed with Determine, but not positive Determine with Serodia  NRL would look at y possibly evaluating additional screen tests (UniGold, Capillus), on specimens from the Pacific region All current screen testing is performed in lab-based settings

3 HIV SCREEN TESTING EQA is available for Serodia and Determine, provided by PPTC-New Zealand Training for kit usage: workshops at off-site facilities (NRL, PPTC, etc), training sessions in-country (e.g. WHO, Mataika House), on-the-job training by lab staff Test kits procurement: in-country procurement mechanisms, from UN/WHO direct procurements, from SPC-Global Fund-Fiji Pharmaceutical arrangement, NGO’s and other donor groups Negative results are reported to requesting site Positive results: reported as pending confirmation and sent to reference lab for confirmation EQA is available for Serodia and Determine, provided by PPTC-New Zealand Training for kit usage: workshops at off-site facilities (NRL, PPTC, etc), training sessions in-country (e.g. WHO, Mataika House), on-the-job training by lab staff Test kits procurement: in-country procurement mechanisms, from UN/WHO direct procurements, from SPC-Global Fund-Fiji Pharmaceutical arrangement, NGO’s and other donor groups Negative results are reported to requesting site Positive results: reported as pending confirmation and sent to reference lab for confirmation

4 HIV CONFIRMATION TESTING US affiliated jurisdictions must follow CDC requirement and have a Western Blot Non-US jurisdictions can utilize the recommendation of a 2 ELISA test confirm (e.g. Enzygnost-Dade Behring and Vironostika-Biomeriuex at Mataika House) Labs refer positive screen samples to the most appropriate reference lab Current confirmation labs: US affiliated jurisdictions must follow CDC requirement and have a Western Blot Non-US jurisdictions can utilize the recommendation of a 2 ELISA test confirm (e.g. Enzygnost-Dade Behring and Vironostika-Biomeriuex at Mataika House) Labs refer positive screen samples to the most appropriate reference lab Current confirmation labs:

5 Country / TerritoryReference Lab / Location US Affiliated IslandsDiagnostic Lab Services or Hawaii State Lab: Honolulu, Hawaii Cook Islands, Samoa, TongaLabPlus: Auckland, New Zealand Fiji-all sites in-countryMataika House (Public Health) Lab: Suva, Fiji KiribatiMataika House Lab: Suva, Fiji NauruQueensland Medical Lab: Brisbane, Australia Solomon IslandsRoyal Brisbane Hospital: Brisbane, Australia VanuatuInstitute Pasteur: New Caledonia Wallis & FutunaInstitute Pasteur: New Caledonia

6 MAJOR ISSUES WITH CURRENT SCREEN AND CONFIRMATION TESTING Delay in HIV results to requesting sites (hospitals, clinics, etc) Inconsistent performance and maintenance of test competency and EQA performance for all performing lab techs Poor and non-user friendly procurement practices  Lab staff, government procurement systems, donor agencies  Many kits expire; kits are frequently out of stock Delay in shipping specimens to reference labs  Inadequate resources and arrangements for courier or shipper  Inconsistent availability of trained personnel to process shipments Delay in HIV results to requesting sites (hospitals, clinics, etc) Inconsistent performance and maintenance of test competency and EQA performance for all performing lab techs Poor and non-user friendly procurement practices  Lab staff, government procurement systems, donor agencies  Many kits expire; kits are frequently out of stock Delay in shipping specimens to reference labs  Inadequate resources and arrangements for courier or shipper  Inconsistent availability of trained personnel to process shipments