Microbiologist nPOC Operational Feasibility Study
- Country
- India
- Type
- Independent Contractor
- Program (Division)
- Country Programs - India
- Additional Location Description
- Ahmedabad (Gujarat)
WJCF is an Indian non-profit organisation committed to saving lives by reducing the burden of disease and strengthening government-owned, high-quality health systems. Since 2007, WJCF has combined data-driven approaches and deep public health expertise with strong government partnerships to design, implement, and scale solutions across India’s national and state health programmes. We work for and at the service of governments — supporting the Ministry of Health & Family Welfare and State Departments of Health to build systems that are strong, sustainable, and led by Indian institutions.
As an Indian organisation, WJCF brings an unmatched depth of contextual understanding of India’s health system architecture, policy landscape, and implementation realities across diverse geographies and population groups. This local institutional credibility, combined with global technical rigour, is central to WJCF’s effectiveness as a partner to governments and donors.
Our work is built around four complementary roles: as a Trusted Government Partner, co-designing programmes and strengthening health system architecture; as an Operational Partner, translating strategies into effective on-the-ground delivery; as a Market Shaper, improving the availability and affordability of health commodities; and as an Ecosystem Catalyst, convening governments, development partners, academia, and the private sector to drive solutions at scale.
WJCF’s programme portfolio spans thematic areas like hepatitis, HIV/AIDS, tuberculosis, vector-borne diseases), syphilis, cervical cancer, diabetes, maternal and childhood anaemia, immunisation, under-5 diarrhoea and pneumonia, sexual and reproductive health, Ayushman Bharat Pradhan Mantri – Jan Arogya Yojana (AB PM-JAY), Ayushman Bharat Digital Mission (ABDM), hypoxemia and oxygen, safe drinking water, sickle cell disease, presbyopia, lead poisoning, and cross cutting thematic areas like AI and Health, integrated disease surveillance, and climate and health.
We currently support programmes across 19 states and union territories, with teams working at national, state, district, and sub-district levels.
Our people are our greatest asset. WJCF brings together a talented, diverse team of professionals from public health, analytics, consulting, healthcare, the development sector, and academia, all united by a shared commitment to improving health outcomes for the people of India. We are entrepreneurial, action-oriented, and deeply grounded in the communities and systems we work in. Our field teams collectively bring hundreds of years of experience managing public health programmes across the country.
WJCF collaborates with a range of international and domestic partners and donors to advance its mission, including an affiliation with the Clinton Health Access Initiative (CHAI), a global health organisation with which WJCF shares a common mission and values.
About the Program:
The National TB Elimination Programme (NTEP), led by the Central TB Division (CTD), MoHFW, is working towards TB elimination in line with the Sustainable Development Goals. WJCF has supported the CTD and more than fifteen state health departments on TB programming since 2012, with interventions across preventive therapies, case detection, diagnostics access, private-sector engagement, strategic planning, and service delivery
About the Project:
More than half of all people with TB in India first seek care from private providers, yet private-sector notifications account for only about one-third of total cases. A key driver of this gap is the limited availability of WHO-recommended rapid molecular diagnostics in private clinics. Existing platforms like GeneXpert and Truenat, though accurate, require dedicated infrastructure, stable power, and high per-test costs, making them unsuitable for routine point-of-care use. This leads to referrals and significant drop-outs along the diagnostic cascade.
The Huwel UniAmp NAT Device (Huwel Lifesciences, Telangana) is a palm-sized, battery-operated, isothermal amplification platform validated by ICMR for near point-of-care (nPOC) TB testing. Paired with the Quantiplus® MTB FAST cartridge, it delivers MTB-Detected/Not Detected results in 35–60 minutes. It is currently the only ICMR-validated indigenous nPOC NAT system, significantly more affordable than existing platforms, and works with both sputum and tongue swabs.
The nPOC Operational Feasibility Study, Ahmedabad, is a prospective, mixed-methods implementation study evaluating two deployment models in private clinics:
- Model 1 (Provider-Led): On-site testing in the clinic’s own laboratory with same-day results.
- Model 2 (Hub-and-Spoke): Samples from 4–5 spoke clinics are tested at a central hub, with results returned to the referring provider.
Both models run alongside a control site using the standard referral pathway. GeneXpert MTB/RIF at STDC Ahmedabad serves as the reference standard. The study assesses diagnostic cascade completion, concordance with GeneXpert, operational performance, cost-effectiveness, and NTEP linkage outcomes. Findings will guide NTEP, the State TB Cell, and partners on the viability of nPOC molecular TB diagnostics in India’s private sector.
Objective of the Assignment:
WJCF seeks to engage an Independent Contractor with specialised microbiology expertise to provide scientific and technical inputs for the laboratory-side of the nPOC Operational Feasibility Study across all study sites in Ahmedabad. The Contractor will exercise independent professional judgement in their area of expertise to deliver the outputs set out in Section 5, in line with the study protocol, manufacturer’s instructions for use, ICMR guidance, and applicable biosafety and data-protection standards.
Scope of Work:
The Contractor will independently determine the manner, method, and sequencing of work required to deliver the outputs below, subject to the protocol, agreed timelines, and quality expectations defined in the ICA. The Contractor is not integrated into WJCF’s employee reporting structure and will not supervise WJCF employees, volunteers, or other WJCF independent contractors. Where training or competency assessments are delivered to third-party clinic and laboratory staff at private-sector study sites, this is in the Contractor’s capacity as an external technical expert engaged for the study.
1. Laboratory and device operations
- Provide technical oversight of specimen collection and processing of sputum-swab, tongue-swab, and sputum samples (for GeneXpert) across Hub A (Provider-Led), Hub B (Hub-and-Spoke), associated spoke clinics, and the control site.
- Provide technical oversight of the Huwel UniAmp NAT device operation at both intervention hubs, including correct cartridge handling, run setup, qualitative result interpretation (MTB Detected / Not Detected / Invalid) per the manufacturer’s instructions for use, and accurate recording in the Project MIS.
- Coordinate the parallel reference-standard pathway: collection, cold-chain storage, and same-day dispatch of sputum samples to STDC Ahmedabad for GeneXpert MTB/RIF testing, and timely retrieval of results.
- Ensure strict biosafety protocols appropriate for handling specimens potentially containing Mycobacterium tuberculosis, including spillage management, PPE compliance, and waste disposal in line with national biomedical waste rules.
- Design and oversee daily and weekly quality control procedures on the UniAmp device, track device uptime, document downtime causes, and lead troubleshooting in coordination with Huwel Lifesciences technical support.
- Implement the invalid result response protocol; monitor invalid and indeterminate rates separately for sputum-swab and tongue-swab samples and across sites, and escalate any deviation from expected performance
2. Training, SOPs, and competency
- Develop and finalise Standard Operating Procedures (SOPs) for sample collection, device operation, QC, sample transport (hub-and-spoke), invalid result management, and biosafety, aligned with the protocol and manufacturer guidance.
- Deliver structured pre-implementation training to clinic and laboratory staff at intervention sites (third-party private-sector personnel, not WJCF staff) covering TB clinical recognition, sample collection technique, UniAmp device operation, Project MIS data entry, and hub-and-spoke logistics.
- Conduct written and practical competency assessments for site personnel before the implementation phase, deliver remedial training where required, and maintain auditable training records.
- Provide ongoing refresher training and on-site mentoring throughout the implementation phase, particularly when staff turnover occurs at spoke clinics.
3. Data, analysis, and reporting
- Ensure complete and accurate capture of all laboratory data in the WJCF Project MIS, including sample collection logs, device operation logs, test results, and the daily device operational record.
- Lead the diagnostic concordance analysis comparing UniAmp results against GeneXpert MTB/RIF as the reference standard — calculating sensitivity, specificity, PPV, NPV, and kappa statistic separately for sputum swab and tongue swab.
- Compute and track operational performance indicators: device uptime, invalid test rate by sample type and site, sample adequacy rate, repeat-test rate, and turnaround time at each cascade step.
- Prepare structured weekly technical reports for the Project Manager and PI summarising enrolment, device performance, discordant results, invalid rates, and any quality issues requiring action.
- Support cost-data collection at site level for the cost-effectiveness analysis, particularly cartridge utilisation and laboratory staff time inputs.
- Contribute scientific and technical content to interim reports, IRB continuing-review submissions, donor reports, the final study report, conference abstracts, and manuscript drafts.
4. Stakeholder engagement
- Serve as the principal technical liaison with Huwel Lifesciences on device performance, software updates, cartridge supply, warranty, and any field-reported technical anomalies.
- Coordinate operationally with STDC Ahmedabad to ensure timely processing and reporting of GeneXpert MTB/RIF results for all enrolled patients.
- Engage private-sector physicians, laboratory technicians, and clinic management at intervention and control sites to support protocol adherence and address operational concerns.
- Support the WJCF Project Coordinator and PI in engagement with the State TB Cell, the District TB Officer, and NTEP-designated microscopy and CBNAAT facilities for patient linkage.
- Provide technical inputs to the qualitative team in framing content for provider semi-structured interviews and patient exit interviews where laboratory or device-related themes are explored.
5. Ethics, regulatory, and protocol fidelity
- Maintain protocol fidelity across all study sites and document and escalate any protocol deviations to the Project Manager and PI in a timely manner.
- Support preparation and submission of IRB amendments, continuing-review submissions, and serious adverse event reports, where these relate to laboratory procedures, sample handling, or device performance.
- Ensure communication of clinically actionable findings — including rifampicin resistance detected on GeneXpert in UniAmp-positive patients — to treating clinicians and the relevant NTEP facility, in line with the protocol’s pre-specified ethical obligations.
- Uphold patient confidentiality and data protection requirements under the Digital Personal Data Protection Act, 2023 across all study data handling.
Deliverables and Indicative Milestones:
Final deliverable definitions, acceptance criteria, payment values, and dates will be set out in the ICA. Indicative deliverable categories, mapped to study phases, are as follows:
- Preparation Phase: Finalised SOPs (sample collection, device operation, QC, transport, invalid result handling, biosafety); training curriculum and assessment instruments; UniAmp device commissioning and baseline QC records; biosafety readiness verification across sites.
- Baseline Phase: Site-readiness assessment report covering all intervention and control sites; pre-implementation competency assessment records for all site personnel.
- Training Phase: Training delivery report with attendance, assessment outcomes, and remedial-training records.
- Implementation Phase-1 (50% of sample testing): Weekly technical reports covering enrolment, device performance, invalid rates, discordant results, and quality issues; ongoing mentoring and refresher-training records; documented device QC, downtime, and troubleshooting logs.
- Implementation Phase-2 (100% of sample testing): Weekly technical reports covering enrolment, device performance, invalid rates, discordant results, and quality issues; ongoing mentoring and refresher-training records; documented device QC, downtime, and troubleshooting logs.
- First draft Manuscript: Diagnostic concordance analysis (sensitivity, specificity, PPV, NPV, kappa) separately for sputum swab and tongue swab; operational performance indicator analysis; contribution to interim, donor, and final study reports; contribution to abstracts and manuscript drafts as agreed.
- D. in Medical Microbiology, Molecular Biology, Biotechnology, or a related field, with at least three (3) years of hands-on laboratory experience specifically in Tuberculosis diagnostics; or
- Sc. in Medical Microbiology, Molecular Biology, Biotechnology, or a related field, with at least five (5) years of hands-on laboratory experience specifically in Tuberculosis diagnostics.
- Experience in evaluating in-vitro diagnostic (IVD) medical devices or molecular assays.
- Expertise in conventional TB diagnostics including smear microscopy, culture (LJ/MGIT), and drug susceptibility testing (DST).
- Proficiency in molecular platforms such as GeneXpert, Truenat, and line probe assays (LPA).
- Strong understanding of Good Clinical Laboratory Practice (GCLP) guidelines.
- Familiarity with digital tools and connectivity solutions for point-of-care devices.
Desirable Skills:
- Experience working with the private sector or Public-Private Mix (PPM) TB initiatives.
- Prior experience supporting implementation research or operational studies under NTEP.
Professional Skills:
- Demonstrated ability to work independently, set own work plan, prioritise effectively, and manage multiple workstreams in parallel.
- Strong interpersonal skills and the ability to engage credibly with private-sector physicians, laboratory staff, NTEP officials, and study stakeholders.
- Excellent written and oral communication skills in English and Hindi.
Last Date to Apply: 10th August, 2026