Slide 1: From Research to Policy to Implementation: The TB-LAMP Experience in the Philippines
FROM RESEARCH TO POLICY TO IMPLEMENTATION: THE TB-LAMP EXPERIENCE IN THE PHILIPPINES Rosarie Villabito Gabuya, MHSS, RN DEPARTMENT OF HEALTH RESEARCH INSTITUTE FOR TROPICAL MEDICINE NATIONAL TUBERCULOSIS REFERENCE LABORATORY 1
Slide 2: Presentation Outline
PRESENTATION OUTLINE ❶ ❷ ❸ ❹ ❺ ❻ ❼
Slide 3: Estimates of TB burden, 2018
Estimates of TB burden’, 2018 Number (thousands) _ (per 100 000 population) Mortality (excludes HIV+TB) 28 (22-30) 24 (20-28) Mortality (HIV#TB only) 6 (0-4.1) 057 (0-38) Incidence (includes Hiv+TB) 591 (332-924) 564 (311-866) Incidence (HIV+TB only) 96 (39-18) 9 (37-17) Incidence (MDR/RR-TB)* 48 (7
Slide 4: High prevalence-to-notification ratio, missed cases
HIGH PREVALENCE-TO-NOTIFICATION RATIO = HIGH NUMBER OF MISSED CASES = IMPROVEMENT IN CASEFINDING NEEDED SOURCE: National TB Prevalence Survey 2016, Philippines
Slide 5: TB laboratory network in the Philippines
2,872 TB Microscopy Laboratories (TMLs) • 12 Regions with TML using LED-FM 403 Rapid TB Diagnostic Laboratories (RTDLs) • 107 sites to be added this year 29 TB Culture Laboratories • 6 labs with Non functional MGIT (liquid culture) 9 Drug Susceptibility Testing Laboratories 2 Line Probe Assay Sites
Slide 6: Xpert coverage and usage statistics, 2018
Xpert coverage and usage statistics, 2018 Indicator Data Total no. of Xpert machines in the country 323 Xpert machines linked with diagnostic connectivity network 41 Total no. of Xpert tests done in 2018 480,666 Proportion of Xpert tests with Invalid/ Error/ No results 3.5% (17,094) Use ULTRA cartri
Slide 7: Evaluation process as done for TB LAMP
EVALUATION PROCESS AS DONE FOR TB LAMP Two-Phased Evaluation: Policy Formulation Based Pilot Implementation 1. Central Level Evaluation from Evaluation Studies and Operational 2. Peripheral Level Evaluation Done Assessment
Slide 8: Timeline of activities involving the TB-LAMP evaluation
TIMELINE OF ACTIVITIES INVOLVING THE TB-LAMP EVALUATION PHASE I EXTENSION/PHASE III INDIVIDUAL EVALUATION TB LAMP OF TB LAMP AND DEPLOYMENT AT GENOSCHOLAR LPA AT SELECT SITES AND CENTRAL LEVEL OPERATIONAL ASSESSMENT 2017 2019 2016 2018 RESEARCH PHASE II COLLABORATION SIMULTANEOUS AGREEMENT EVALUATIO
Slide 9: Phase 1 and Phase 2 evaluation design
PHASE 1 PHASE 2 • TB-LAMP performed at central level • TB-LAMP performed at peripheral laboratory level laboratories (n=5) • Diagnostic performance evaluation • Diagnostic performance evaluation and end-user appraisal and end-user appraisal • Total participants = 279 • Total participants = 507
Slide 10: Phase 1 findings: sensitivity and specificity
PHASE 1 FINDINGS • TB-LAMP performed at central level SENSITIVITY SPECIFICITY laboratory • Diagnostic performance evaluation 86.1 (78.7-93.4, 95% CI) 95.7 (92.9-98.6, 95%CI) and end-user appraisal • Total participants = 279 • More sensitive than smear microscopy (66.3, p=0.001) • Similar sensitivity
Slide 11: Phase 2 findings: sensitivity and specificity
FINDINGS PHASE 2 SENSITIVITY • TB-LAMP performed at peripheral SPECIFICITY level laboratories (n=5) 73.5 (66.1-80.0, 95% CI) 97.1 (94.7-98.6, 95%CI) • Diagnostic performance evaluation and end-user appraisal • Total participants = 507 • More sensitive than smear microscopy (66.1, p=0.0013) • Similar
Slide 12: Conclusions and Recommendations
CONCLUSIONS AND RECOMMENDATIONS • TB-LAMP has good diagnostic performance both in a central laboratory setting and local field conditions • Intended users gave positive feedback on the test and found it easy to use • The technology could be integrated into the country diagnostic algorithm following
Slide 13: TB Laboratory Network Strategic Plan 2018-2022
$ Ce trol Program Local Ev alia tine: gra ioni lace tic Philippines TB LABORATORY NETWORK STRATEGIC PLAN 2018-2022 A Sub-Plan of PhilSTEP-1 Strategy 1.1: Increase availability and accessibility of WRD, LPA, and culture/DST services Performance targets and outputs: 1.1.1 100% of presumptive TB cases
Slide 14: TB-LAMP proposed in revised TB diagnostic algorithm
TB-LAMP proposed to be included in the revised TB diagnostic algorithm as an alternative primary diagnostic test in settings where access to Xpert is limited* *Subject to change depending on the policies to be adopted by the Philippine NTP SOURCE: National Tuberculosis Control Program – Manual of Pr
Slide 15: Systematic screening for PTB in adults
SYSTEMATIC SCREENING FOR PTB IN ADULTS >15 YEARS OLD WITH UNKNOWN HIV INFECTION STATUS FINDINGS SUGGESTIVE OF PTB If CXR is not accessible, in the presence of cough of any RISK FACTORS duration with or without other Age >60 years old TB S/S in high risk group, collect Diabetes sputum sample on t
Slide 16: Systematic screening for active pulmonary TB for PLHIV
SYSTEMATIC SCREENING FOR ACTIVE PULMONARY TB FOR PLHIV AT TIME OF DIAGNOSIS OF HIV AND EVERY VISIT ANNUALLY (IF NOT ON TB TREATMENT) + YES IF >1 CRITERIA FINDINGS PRESENT SUGGESTIVE OF PTB
Slide 17: Interim Guidelines on the Use of TB LAMP
SUBJECT: Interim Guidelines on the Use of the Loop-Mediated Amplification Test for Tuberculosis (TB LAMP) as Rapid Diagnostic Tool in Selected Sites Under the National TB Control Program
Slide 18: Integration into the TB Control Program
@) integration into the TB Control Program USE OF TB LAMP AS INITIAL DIAGNOSTIC TOOL FOR TB Presumptive pulmonary ‘TB in adults* v Yes Risk group for drug resistance** p—————»| No ¥ a | TB LAMP | Indeterminate Xpert MTB/RIF J I | Re-collect MTB 7 ; Negative MTB MTB MTB Indeterminate sample 4 detecte
Slide 19: About the pilot implementation
ABOUT THE PILOT IMPLEMENTATION • TB-LAMP deployed as primary diagnostic tool in selected health facilities for presumptive TB patients with low risk for drug resistant TB • TB-LAMP positives tested with Xpert to screen for RIF resistance Sites: 1. San Lazaro Hospital 2. Commonwealth Health Center 3.
Slide 20: Findings
FINDINGS – Average Positivity Rate for TB-LAMP in Pilot Implementation – Country Average Positivity Rate for Smear Microscopy 93.43% AVERAGE CONCORDANCE WITH XPERT 2X POSITIVITY RATE VS SMEAR MICROSCOPY
Slide 21: Experiences of pilot sites
EXPERIENCES OF PILOT SITES • Smearing, staining, and microscopy entail a lot of time and effort. While, in using TB LAMP, the procedure is simple and user-friendly. • TB LAMP alleviates heavy workload from Xpert MTB/Rif assay. • The number of tests done using TB LAMP is greater than Xpert in the sam
Slide 22: Challenges encountered
CHALLENGES ENCOUNTERED • Unable to maximize the use of detection reagents when few specimens are processed. • Challenging to perform in the beginning due to the number of steps
Slide 23: Improving casefinding in urban hospitals
IMPROVING CASEFINDING IN URBAN HOSPITALS • Part of the TB Innovations and Health Systems Strengthening Project of the FHI360 • Selected large private and public hospitals (n=3) in urban areas were installed with equipment and their staff capacitated for conduct of TB-LAMP in settings where workload
Slide 24: Mass screening in prisons
MASS SCREENING IN PRISONS • Part of the ACCESS TB (Advancing Client-centered Care and Expanding Sustainable Services for TB) Project under the Global Fund grant in the Philippines • TB-LAMP to be deployed in selected prisons for use in mass screening among PHOTO COURTESY OF ICRC detainees • To be co
Slide 25: Cost effectiveness and usage beyond the program evaluation
Cost Effe( @ Usage Beyond the Program Evaluation IS 5205611 wstirore Fon morica. mins @ @ @ @ @
Slide 26: Summary
SUMMARY • Philippines is a high TB burden country and based on estimates, we are not finding enough bacteriologically confirmed cases to curb the TB epidemic • We need more testing and TB-LAMP is a viable option to the country based from evidence gathered through our research and pilot implementatio
Slide 27: Acknowledgments
ACKNOWLEDGMENTS • Eiken Chemical Co., Ltd., • Japan International Cooperating Agency • Department of Health, Philippines • Research Institute for Tropical Medicine- National Tuberculosis Reference Laboratory 27
Slide 28: Thank you for your attention
THANK YOU FOR YOUR ATTENTION. 28
Slide 29: NS 52056: wstirure ron morica. meine @ @ @ @ @
NS 52056: wstirure ron morica. meine @ @ @ @ @
Slide 30: The TB-LAMP Experience in the Philippines
FROM RESEARCH TO POLICY TO IMPLEMENTATION: THE TB-LAMP EXPERIENCE IN THE PHILIPPINES Rosarie Villabito Gabuya, MHSS, RN DEPARTMENT OF HEALTH RESEARCH INSTITUTE FOR TROPICAL MEDICINE NATIONAL TUBERCULOSIS REFERENCE LABORATORY 30