Laboratory Strengthening through partnership. C.N.Paramasivan

Transcription

1 Laboratory Strengthening through partnership C.N.Paramasivan

2 Background FIND was established s ed in 2003 To develop new affordable diagnostic test for TB To evaluate their efficacy To accelerate their appropriate use Malaria added to portfolio 2006, HAT in 2007 Our mission is to accelerate the development, evaluation, and appropriate use of high-quality yet affordable diagnostic tools for poverty related infectious diseases.

3 Objectives The goal: To improve the control of TB and the lives of people by making new diagnostics available that simplify and speed the diagnosis of TB The objectives toward this goal are: To advance the candidate diagnostic products in FIND s portfolio towards demonstration of their effectiveness in selected NTPs To address knowledge gaps that hinder the development of the types of technologies that can dramatically improve the diagnosis of TB among the world s poorest populations To ensure these technologies will be accessible and affordable in both the public and private health care sectors of these countries.

4 Lesotho & FIND model Demonstration ti WHO Implementation ti (Evidence) (Policy) (Practice) March June November Partners WHO Partners In Health MOH (Lesotho) 4

5 Background No. 8 out of 22 High-burden countries, with a population of 77 million Incidence rate of 341 cases/100,000 DOTS coverage of 90% and case detection of new SS+ at 33% Only 1 laboratory in public sector doing TB culture and DST Request from Ethiopian Health and Nutrition Research Institute to FIND/WHO for access to new TB diagnostic tools MOU signed 29 January 2008 FIND/EHNRI Action Plan for TB Laboratory Preparedness in Ethiopia 5

6 Sites identifed and assessed Six laboratories identified d Lab Assessment of ENHRI carried Addis Ababa out Jul -07 and Jan-08 EHNRI Comprehensive review of St Peter s Hospital Laboratory infrastructure, equipment, biosafety, Regional Centers human resources, QC and QA, Bahr Dar specimen handling, testing procedures and results Nazret Mekele Awasa Quality control and assurance 1. General quality assurance Cleaning, waste management Adequate Not adequate Preventive maintenance (e.g. microscopes, temperature Done Partly done Not done monitoring incubators & refrigerators) SOPs on file in local language, covering all required topics, Done Not done communicated to staff, and used Annual SOP training provided Done Not done Reagent bottles labeled with content, date of preparation, date of expiry Yes No Autoclave tape present across cap of new sterile bottles Yes No 2. Smear microscopy nternal quality control (IQC) Daily Weekly Monthly Never Whenever a fresh Read control slides batch of stains are prepared Reagent batch testing Always Frequently Rarely Not done Et External quality assurance (EQA) 2/year 1/year None Once. A set of panel slides of 7 Panel testing done numbers were sent to 14 regional centres and got feed back was obtained from 7 centres In 10% Done in > 5% Done in < 5% Not done Random blinded rechecking The regional centres undertake this for MCs On site evaluation Monthly Quarterly Other Not done 3. Culture Sterility tests LJ Done Not done QC of non-commercial media (batch) Done Not done QC procedures for commercial media on file Yes No Done Not done Process controls If yes, growth of MTB other mycobacteria Done Not done Marker strain containing sputum sample Growth checks with known positive and known Done Not done H37 Rv negative samples 4. DST Run qmonth Run qday Run q DST Control strains Own but don t run Don t own 2/year 1/year Never Carried out once by RIVM, Proficiency testing Netherlands during the DRS activity 5. PCR ( Not for routine diagnosis only as research studies) Negative control every run Done Not done Positive DNA control every run Done Not done Process controls Done Not done External DNA controls Done Not done 6

7 Background and Objectives FIND and Tanzania Ministry of Health and Social Welfare MoHSW has initiated actions to create a negative pressure lab within the CTRL, including installation of 2 bio-safety class II cabinets to introduce MGIT and DST FIND support requested to strengthen the Central TB Reference Laboratory (CTRL) MOU signed in June, 2007 FIND to provide technical assistance, help NTLP procure MGIT and reagents at FIND negotiated price Conduct demonstration projects of liquid culture & DST, HAIN MTBDR Plus, LED FM FIND Consultant posted from Oct 2007 Works closely with WHO/ TB CAP/ CDC 7

8 FIND/India Objectives have been defined 1. Prepare labs in public health sector for introduction of new diagnostic technologies developed by FIND and approved by WHO 2. Facilitate t the translation ti of WHO global l policy into national policy and implementation 8

9 Lab Preparedness in Public Sector FIND/India Upgrading identified all three DOTS Plus sites to BSL 3 level- Liquid culture/ DST/ Hain Assay Assistance to national programme in accreditation ti of culture facilities Assistance in EQA of RNTCP lab network On-Site Evaluations of RNTCP by FIND staff Manufacturing of sputum smears for panel testing Events sponsorship Developing research capacity and lab management SO Training on new diagnostic products via collaborating agencies/ partners 9

10 Other Countries / Programmes Uganda: Partner with NTP and other partners Cote d Ivor: Partner with ASM/ CDC/ PEPFAR Programmes UNITAID: GLI/ GDF/ FIND 10