Xpert/Rif country rollout in the Philippines: impact and lessons - - PowerPoint PPT Presentation

Xpert/Rif country rollout in the Philippines: impact and lessons learned

Celia Carlos, MD Chief, Laboratory Research Division Research Institute for Tropical Medicine In behalf of the National TB Reference Laboratory

Outline

 Strategy and algorithms used  Achievements and evidence of

impact

 Challenges encountered  Future plans

National GeneXpert Strategy

 Rapid roll-out of GX from Metro

Manila to regions (within the last Q

• f 2011)

 GX positioned with or close to

existing PMDT treatment and culture centers

 National and sub-national/regional

levels

Suspects, diagnostic algorithms

 Suspect Selection Criteria:

• all DR-TB patients:

 retreatment cases with (+) DSSM results from quality assured MC  retreatment cases with (-) DSSM results from quality assured MC and active TB dx by RHU MD or TB dxtic committee  HIV TB suspect – newly started and only in 2 centers (RITM and SLH)*  symptomatic household contacts of any of the above 3 cases

*HIV prevalence in Philippines = 1% of population

 Guidelines and

SOPs developed

 Revision of

request, results forms, laboratory registers (NTRL revised the lab request forms and registers to include Gx results)

Suspects, diagnostic algorithms

Diagnostic Algorithm with Xpert for MDR- TB (old)

MDR-TB suspects (Sm + or X-ray +) Smear + TB, RIF (+) Xpert MTB/RIF DOTS or Private Sector TB, RIF (-) Smear (-), but X-ray (+) No TB (+ or -) S-ReTx for MDR-TB Tx for TB (Cat II) Retest/Further clinical Obs DST for FLD & SLD Individualized Tx

Slide courtesy

• f Dr. WJ Lew

• Govt. DOTS facilities
• Pvt. facilities/ referring

health providers

• Hospitals
• Treatment Sites (Peripheral

Health Centers)

Treatment Center or Satellite Treatment Center Identification and referral

• f suspects

Quality Assured Laboratory

Screening, assessment, sputum collection

GeneXpert, DSSM, TB Culture, DST

Case Finding Strategy in the Philippines National Gx Strategy

R-res GX/Confirmed DRTB

Category IV treatment

Treatment centers

Site selection for GeneXpert placement

 Based on existing network of treatment

and culture centers

 At or near point-of-care  Treatment Center or Culture Center with:

 adequate space: secure, ambient temperature  stable electrical power supply  continuous water supply  storage space for the cartridges  available staff (either organic or contractual)

 16 Gx centers all

• ver the country

(20 machines)

 44 Treatment

Centers/STC

Nationwide Distribution of Gx for PMDT

PhilPACT Performance Target as

• f June 2012

2010 2011 2012 2013 2014 2015 2016 PhilPACT target cases to detect and treat 1174 3546 5918 8290 10662 13034 15406 Cases detected 522 1670 2694 Enrolled 601 1786 2690

2000 4000 6000 8000 10000 12000 14000 16000 18000

Number of MDR - TB patients

PhilPACT target cases to detect and treat Cases detected Enrolled

Cumulative cases detected Cumulative Enrolled

200 400 600 800 1000 1200 1400

2011-2012 Monthly cartridge consumption

Total monthly consumption per cartridge

DSSM RESULT POSITIVE NEGATIV E RESULT NOT AVAILAB LE GRAND TOTAL

Number of DR-TB suspect tested

1544 2905 8441 12,890 Mtb Detected

Rif Resistant 679 (44%) 142(4.8%)

1263 2,084 (16%)

Rif Susceptible

759 339 2131 3,229 (25%)

Indetermina te

2 16 30 48 (0.37%) Mtb not Detected 75 2371 4816 7,262 (56%) Error 28 32 192 252 (2%) Invalid 3 9 12(0.09%) Sub Total 1,543 2,903 8,441 12,887 GeneXpert results, 2012

Number of DR-TB suspect tested (N=12,890), 2012

252 (1.96%) 12 (0.09%)

Number of DR-TB suspect tested, 2012 (N=12,890)

48 (0.37%)

MDG TARGETS: Prevalence rate of 502/100,000; death rate of 24/100,000

2012

29 484

Lessons learned

 Using old algorithm, too many patients (26%) were started

unnecessarily on Cat IV treatments without confirmation of drug resistance due to wide use of empiric treatment regimen

 Using old algorithm resulted in too many backlogs for DST;

• > molecular triaging to determine whether FL-DST only is

required or FL and SL-DST needs to be implemented urgently

 With Xpert, treatment delays decreased  Need to provide recalculations of PMDT enrolment targets

according to 2nd DRS results, existing epidemiological data, results of current experience in PMDT case finding data

 importance of results of QA microscopy and GX in clinical

decision-making

Challenges

 National GeneXpert Strategy

– bringing GX closer to patients (point-of-care) – sustaining the financial costs (courier) – High cost of calibration & annual calibration overdue – It is taking a long time for the coordination of the calibration between Cepheid and the local service provider – Macare

 Clinical & Laboratory Algorithm:

– need continuous review and analysis of data

 Site Selection

─

criteria for geographical expansion being developed through planned operational research on cost-effective diagnostic tests

 Human Resources

• 80% of staff working in NTRL, culture centers, and

GeneXpert sites are supported via Global Fund

 Procurement, importation & registration

– Currently no problem & being done by GF principal recipient but DOH needs to be able to carry out its own supply & logistics plan prior to end of GF funding

• Infrastructure and quality of laboratories
• cost of transport system
• optimum procedure for quality assurance
• Linking of diagnostic and clinical services
• improving TAT to 24-48 hrs; results to be

released by email followed by a hard copy

• Training and Supervision:
• to develop a monitoring plan for sites outside

Metro Manila

Challenges cont’d.

Next Steps

 Clinical & Laboratory Algorithm:

– revise testing algorithm based on data gathered – establish molecular ‘triaging’ with only rifampicin-resistant isolates to receive SL-DST – operational research planned on cost- effective tests – Implementing treatment of MDR-TB

• nly to confirmed MDR-TB cases

Xpert Test Results

(January to December 2012)

(4.8%) (44.0%)

Diagnostic Algorithm with Xpert for MDR- TB (New)

MDR-TB suspects (Sm+ or X-ray +) Smear + TB, RIF (+) Xpert MTB/RIF DOTS Private Sector TB, RIF (-) Smear (-), but X-ray (+) No TB S-ReTx for MDR-TB Tx for TB (Cat II) Further clinical Obs DST for FLD & SLD Individualized Tx Re test RIF+

Slide courtesy

• f Dr. WJ Lew

Diagnostic Algorithm with Xpert for MDR- TB (old)

MDR-TB suspects (Sm + or X-ray +) Smear + TB, RIF (+) Xpert MTB/RIF DOTS or Private Sector TB, RIF (-) Smear (-), but X-ray (+) No TB (+ or -) S-ReTx for MDR-TB Tx for TB (Cat II) Retest/Further clinical Obs DST for FLD & SLD Individualized Tx

Slide courtesy

• f Dr. WJ Lew

Next Steps

 Implement new diagnostic algorithm with Xpert

for MDR-TB starting April 2013

 Rollout: 1) around 10 Xpert machines for

diagnosis of TB in pedia patients & extrapulmonary TB and other special situations (UNITAID) 2) 50 sites under NTP (external to PMDT program) in provinces and districts

 Site Performance

– review reason for low workload and potential for increasing workload in a sustained manner

 Procurement, importation & registration

– logistics for module replacement will need to be in place – need to strengthen supplies management to avoid stock out

Next Steps cont’d

• Infrastructure and quality of laboratories
• ensuring proper transport of specimens
• Linking of diagnostic and clinical services

– evaluate reasons for long TAT and how to reduce this – ensure quality of microscopy

• Training and Supervision:

– Integrate monitoring & evaluation in the Lab Subplan – Continuous proficiency of lab workers

 NTRL: Dr. Noel Macalalad, Dr. Cecilia

Ama

 WHO: Dr. Woojin Lew  NTP: Dr. Rosalind Vianzon, Dr. Anna

Celina Garfin

Acknowledgments