CHAI Indonesia is looking for a consultant to conduct assessment to determine the opportunities, conditions, and pathways for the use of distributable PCR for TB screening in Indonesia.

Introduction

Objectives

The consultant is expected to conduct rapid assessment of to evaluate the opportunity for distributable PCR to play a role in scaling up molecular TB screening in Indonesia.

Scope of Work

The rapid assessment that the consultant will undertake should at least cover three areas of woks:

1. Instrument footprint and feasibility assessment.

Consultant will conduct assessment to determine the distribution of open PCR footprint and machine in Indonesia three time zones provinces.

Consultant will analyze key conditions and drivers for uptake, including quality requirements, commercial offering (i.e. placements, supplies, service), supportive systems required to enable scale (i.e. infrastructure, HR, supply chain), technical offerings (i.e. drug resistance testing capabilities).

This analysis will be done with the aim of establishing a generalizable set of information on the feasibility and interest in distributable PCR -based TB screening in order to engage key stakeholders and decision-makers of governments, distributors and other entities regarding normative guidance for this class of TB testing.

1. Use cases and deployment pathways

Consultant will conduct analyses in the selected provinces to develop a more and nuanced detailed understanding of current footprint (i.e. source and mechanism of procurement), feasible introduction and scale-up pathways and the likelihood and modalities of adoption (optimal use cases and testing workflows) in a set of high TB burden countries that would be influential to establishing the market for these test kits.

Consultant will conduct map current testing networks and laboratory workflows and explore options to simplify these and will capture how current testing applications came to market (i.e. funders, procurement mechanisms) and were deployed. Consultant will also define what is needed in terms of  training and sample transportation to extend the use of these platforms.

Based on this analysis and on discussions with suppliers, established high volume laboratories, and with laboratory experts we will develop a set of feasible recommendations on level of simplicity required in workflow to access the bulk of instruments and available testing capacity, and how to achieve these.

1. Regulatory pathways

Consultant will conduct assessment:

• To define the regulatory pathway in key markets that have a lower dependency on WHO approval.

• Better understand the requirement for WHO endorsement by GDG and/or PQ for uptake, and consultation with WHO on pathway to establish a class.

Deliverables

The appointed consultant should provide written deliverables across the three objectives:

1. Instrument footprint and feasibility assessment:

• A database of open PCR machines across provinces of Indonesia three time zone, including details of instrument location, ownership, current use, and accessibility for TB testing
• A report capturing qualitative feedback from provinces stakeholders on the feasibility and interest in deploying distributable PCR for TB screening, as well as a high-level assessment of viewpoints on how a generic near POC TB test could fit within screening programs.

2. Use-cases and deployment pathways:

In depth case study reports on distributable PCR for each of provinces representing three time

zone, covering the following:

• Current use, workflow, and test deployment experience
• Recommendations for simplification of workflow
• Potential use cases
• Viewpoints on acceptable levels of test complexity
• Pathways for scalable adoption of distributable PCR across regulators, donors, and partners

These will also include assessments of the opportunities, conditions and pahways for generic

near POC TB technology and the NEXAR technology.

3. Regulatory pathways:

Reports on the following:

• National regulatory requirements
• Pathways and requirements for WHO/PQ establishment of a new product class

Timeline & area of work

The work should be completed in up to three months from June – Augut 2024, covering representative time zone of West, Central, East Indonesia

Budget Ceiling

Proposal up to maximum 300,000,000 IDR (inclusive of professional fee, & expense reimbursement for delivering result such as travel, meal, lodging)

Consultant qualifications

The consultant is expected to have:

1. Minimum five years’ experience working in areas of clinical laboratory field particularly TB Screening
2. Experience working with MOH on clinical laboratory field, especially molecular TB testing, and has laboratory networking both public and private sectors
3. Understanding of Indonesia clinical laboratory structure both in government and private sectors
4. Understanding of molecular testing especially open and close PCR testing.
5. Proven skills & capacity to conduct analysis with both qualitative & quantitative methods.
6. Experience in collecting data/information from many resources.
7. Strong communication skills both written and spoken.

Review & selection process

Please submit your CV and proposal in English (with detailed data collection methodology & analysis, budget, timeline) in a single pdf file online through email [email protected].  Proposals will be reviewed and selected by a team, evaluating the rationale of the proposal to attain the objectives as well as profile/track records of the applicant. Submission will be closed at 26 May 2024; only selected candidate will be contacted for further interview.