Challenges in Capacity in SA for diagnosing DR-TB

Transcription

1 National Tuberculosis Reference Laboratory Challenges in Capacity in SA for diagnosing DR-TB March 2010 Gerrit Coetzee

2 Rapid response to XDR-TB WHO Global Task Force on XDR-TB, October 2006 Accelerate access to rapid tests for rifampicin resistance Adherence to WHO Drug Resistance Guidelines; improve programme management; access to MDR-TB drugs including DOT; HIV+ cases adequately treated and started on ART Implementation of IC measures, especially among HIV+ Strengthen laboratory capacity to diagnose, manage and survey DR; rapid survey to determine size of XDR-TB problem Initiate information sharing strategies that promote prevention, treatment and control of XDR-TB

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4 Challenges in TB control Health systems weaknesses one of the greatest challenges in TB control Laboratory services one of the weakest links Lack of diagnostic capacity a crucial barrier preventing an effective response to the challenges of HIV-associated TB and drug-resistant TB 500,000 new MDR-TB cases estimated annually 10% of MDR-TB cases XDR-TB and present in more than 50 countries SA: 4 th highest total number MDR reported % of MDR-TB cases projected to be treated in 2009 and 3% only under GLC standards

5 Why laboratory performance is unsatisfactory Inadequate human resources Biosafety concerns Lack of recognition of laboratory importance in TB control Weak communication between NTP and laboratory services Insufficient financial resources Problems of laboratory availability and accessibility Delay in technology transfer to resource-limited settings

6 TB CULTURES PER PROVINCE PER YEAR (excl KZN) PROVINCE Grand Total EC 35,132 47,866 69,229 96, , , ,882 FS 18,240 22,434 29,288 37,072 36,629 31, ,232 GP 79, , , , , , ,096 LP 4,128 5,315 8,407 13,504 16,884 19,550 67,788 MP 13,246 13,813 15,616 21,047 34,880 46, ,839 NW 14,312 17,864 24,036 36,134 44,388 41, ,576 NC 20,016 25,062 31,949 35,133 41,362 44, ,772 WS 115, , , , , ,228 1,028,830 Total 299, , , , , ,165 3,319,015

7 Number of NEW MDR-TB patients diagnosed by the NHLS by province per year PROVINCE Total EC ,092 1,501 1,858 6,211 FS ,278 GP ,028 1,307 5,266 KZN 583 1,024 2,200 2,208 1,573 1,773 9,361 LP MP ,044 NW ,838 NC ,631 WC 1,085 1,192 1,179 1,771 2,220 2,078 9,525 Total 3,219 4,120 5,774 7,429 8,198 9,070 37,810

8 Number of NEW XDR-TB patients diagnosed by the NHLS by province per year PROVINCE Total EC FS GP KZN ,298 LP MP NW NC WC Total ,387

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11 Genome of M. tuberculosis H37Rv 4,411,529 bp 4000 genes

12 Line probe technologies endorsed by WHO in 2008 for the rapid detection of MDR-TB katg RMP INH # CC AC TUB WT1 WT2 WT3 WT4 WT5 WT6 WT7 WT8 MUT1 MUT2A MUT2B MUT3 WT MUT1 MUT2 katg katg katg katg WT1 WT2 MUT1 MUT2 MUT3A MUT3B inha inha inha inha inha inha inha TUB MUT katg WT katg MUT inha WT inha MUT sensitive resistant sensitive resistant Detects resistance to both rifampicin and isoniazid Licenced for use on AFB smear positive processed sputum specimens and positive cultures inha

13 South African LPA roll out DNA STRIP Technology HAIN LIFESCIENCE

14 NHLS LPA Roll out LPA endorsed by WHO, will be part of National TB Control Programme Roll out over 2 years ~20 additional regional sites Now have LPA for 2 nd line anti-tb drugs Other systems eg gene Xpert also developing

15 LPA Roll out: Objectives Provide rapid diagnosis of MDR-TB Timeously effect appropriate treatment Prevent further development of resistance to antituberculosis drugs Prevent further transmission of tuberculosis Cut down on the cost of diagnosing TB by screening drug-susceptible TB out of conventional drug susceptibility testing (DST) using the LPA Decrease the cost of treating TB by reducing unnecessary transmission through early diagnosis, as well as preventing development of drug-resistant TB which is more expensive to treat

16 Project goals roll the assay out to additional 20 laboratories by December 2010 implement the assay with as little disruption to the normal flow as possible standardize the performance, reading, interpretation and reporting of results across laboratories

17 Project Approach Phase I: Secure laboratory space (renovate existing labs or erect mobile labs) Phase II:Order and install equipment Phase III:Recruit staff (technicians/medical scientists) Phase IV: Train staff Phase V: Implement the assay Phase VI: Review success of initial roll out and start the procedure for the next cycle

18 Laboratory name Dr George Mukhari Completed 18August 2009 Edendale Completed 7 August 2009 PE Completed 5 August 2009 Status of laboratory renovations / mobile lab construction Mafikeng Completed 14 September 2009 Baragwanath Ngwelezane (M- PROJECTS) Helen Joseph Paarl Worcester Welkom Madadeni (M-PROJECTS) Ermelo No. 1 (M-PROJECTS) Ermelo No. 2 (M-PROJECTS) Polokwane (PARK HOMES) East London Tshepong (PARK HOMES) George Letaba Nelspruit Rustenburg Kokstad PCR labs completed; DNA extraction room renovations to go on tender Completed to sign off Awaiting Hospital approval Awaiting Hospital approval Ready for tender, on hold pending DOH Contractor busy, estimated to finish by end of October Ground work quote finalized, Park Home Lab ready for delivery Ground work quote finalized, Park Home Lab ready for delivery Park Home Lab ready for delivery, to be adapted as a culture lab Awaiting ground work quote, busy manufacturing Park Home Lab Awaiting Hospital approval for Park home Awaiting ground work quote, busy manufacturing Park Home Lab Awaiting Hospital approval Awaiting Hospital approval. Business manager is following up Space for mobile lab verbally allocated, though no formal letter. Concern is that space is about 200m from the lab & next to a crèche. Space to be renegotiated. Two rooms at Rustenburg lab previously ear marked for viral loads, could be used as an alternative. Approval for placing a mobile lab will first be requested. Space for mobile lab identified. Awaiting hospital approval

19 LPA inter-laboratory comparison 10 DNA samples Include fully susceptible, INH/Rifampicin mono-resistance, MDR, MOTTS Excellent performance 4x pa.

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21 Development of an Algorithm Simplify current algorithms Capacity of laboratories to inactivate sputum to PCR friendly state Cost to NTP should not increase Laboratory capacity/physical structure for LPA PCR Available technical skills At least provisionally confirm MDR phenotypically Technical problems eg amplicon contamination

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23 THANK YOU