Fifth Annual President’s Emergency Plan for AIDS Relief Track 1.0 ART Program Meeting September , 2007 Thomas J. Spira, M.D. International Laboratory Branch Global AIDS Program

Primary Health Center Essential Laboratory Services HIV Diagnostics HIV Diagnostics HIV rapid antibody tests HIV rapid antibody tests Infant diagnosis: preparation of DBS for send-out for virological testing Infant diagnosis: preparation of DBS for send-out for virological testing Hemoglobin or hematocrit Hemoglobin or hematocrit Blood collection and send-out for CD4 cell count and/or percentage Blood collection and send-out for CD4 cell count and/or percentage TB sputum collection and send-out for smear microscopy TB sputum collection and send-out for smear microscopy Malaria smear or rapid test (if endemic area) Malaria smear or rapid test (if endemic area) Syphilis rapid test Syphilis rapid test Pregnancy test Pregnancy test Urine dipstick for sugar and protein Urine dipstick for sugar and protein

District Hospital Minimum Tests Available HIV Antibody Test – screening, confirmatory, tie-breaker HIV Antibody Test – screening, confirmatory, tie-breaker Full blood count with differential Full blood count with differential AFB smear microscopy – sputum and other fluids AFB smear microscopy – sputum and other fluids Serum alanine aminotransferase (ALT) Serum alanine aminotransferase (ALT) Blood glucose Blood glucose Serum creatinine and blood urea nitrogen Serum creatinine and blood urea nitrogen Serum potassium Serum potassium Gram stain Gram stain Chest X-ray Chest X-ray Basic CSF and urine microscopy, including India ink Basic CSF and urine microscopy, including India ink Bilirubin determination for neonates Bilirubin determination for neonates Pulse oximetry Pulse oximetry Cryptococcal antigen testing Cryptococcal antigen testing CD4 testing may be available, but often need to be sent out CD4 testing may be available, but often need to be sent out Blood and sputum cultures may be available, but often need to be sent out Blood and sputum cultures may be available, but often need to be sent out

Primary Health Center Laboratory Services Operations Guide Infrastructure Infrastructure Human resources Human resources Quality assurance Quality assurance Sample collection methods Sample collection methods Venous blood Venous blood Fingerprick Fingerprick Urine Urine Standard Operating Procedures Standard Operating Procedures Rapid HIV antibody test Rapid HIV antibody test Hemoglobin Hemoglobin Rapid test for syphilis Rapid test for syphilis Malaria smear or rapid test Malaria smear or rapid test Pregnancy test Pregnancy test Urine dipstick for sugar and protein Urine dipstick for sugar and protein

Primary Health Center Essential Laboratory Services Specimen collection and shipment Specimen collection and shipment CD4 count CD4 count TB sputum TB sputum DBS DBS Chemistry Chemistry ALT ALT Creatinine Creatinine Potassium Potassium Hematology (CBC with differential) Hematology (CBC with differential) Laboratory safety Laboratory safety Training Training

Questions for Discussion Is the list of essential laboratory tests at the Primary Health Center complete? Is the list of essential laboratory tests at the Primary Health Center complete? If malaria smear microscopy is available, should TB smear microscopy also be available? If malaria smear microscopy is available, should TB smear microscopy also be available? Should pregnancy testing be available? Should pregnancy testing be available? What sensitivity of hemoglobin testing is required? Is a hematocrit adequate? What sensitivity of hemoglobin testing is required? Is a hematocrit adequate? Is the list of laboratory tests that should be available at the District Hospital level complete? Is the list of laboratory tests that should be available at the District Hospital level complete? What is the best way of doing quality assurance (QA) for testing? What is the best way of doing quality assurance (QA) for testing? Can district or higher level staff supervise QA? Is there staff, that with training and support, could do this? Can district or higher level staff supervise QA? Is there staff, that with training and support, could do this? Do testing staff need to go through training, including a certification process, prior to beginning testing with periodic refresher training? Do testing staff need to go through training, including a certification process, prior to beginning testing with periodic refresher training?

Questions for Discussion (cont.) Can a specimen transport system be organized to take specimens to a higher level site for testing and return results? Can a specimen transport system be organized to take specimens to a higher level site for testing and return results? What is the minimal packaging required to maintain specimen integrity and meet biosafety standards? What is the minimal packaging required to maintain specimen integrity and meet biosafety standards? How can specimens that need to be sent at room temperature (20-25 o C) be sent from laboratories without refrigeration? How can specimens that need to be sent at room temperature (20-25 o C) be sent from laboratories without refrigeration? What are the best ways of training testing staff at this level? What are the best ways of training testing staff at this level? Training at the district or higher level? Training at the district or higher level? In-service training on-site? In-service training on-site? Periodic training/supervision/mentoring as part of a QA process? Periodic training/supervision/mentoring as part of a QA process? What is the best way of assuring an adequate supply of reagents and laboratory commodities? What is the best way of assuring an adequate supply of reagents and laboratory commodities? Central supply? Central supply? Supply from the district or higher level? Supply from the district or higher level?