TROUBLESHOOTING REVIEW
A fixed-scope review for an assay problem that keeps coming back.
For R&D and operations teams with a recurring immunoassay or reagent problem and no specialist time to resolve it. The review turns the data you already hold into a ranked view of likely causes and a clear plan for what to test next.
Is this for you?
When this review is useful
- The same assay problem has returned across runs, lots or operators.
- The team has generated data but cannot agree on the most likely cause.
- Several variables could be responsible and the investigation needs narrowing.
- A transfer, supplier change, scale-up or process change has exposed performance problems.
- The team needs a clear investigation plan before spending more time in the lab.
Typical situations ORIVISE is brought in for
Your existing data in; ranked causes and a clear next test out.
Results drift between lots
An immunoassay passes in development but shifts between reagent lots in routine use. The review ranks the likely causes and sets the order of experiments that separates them fastest.
You get: ranked causes and the first test to run
A conjugate that won't stay stable
A labelled reagent loses signal in storage and shelf life keeps shrinking. The review examines conjugation history, storage and change records, and names the likely failure route.
You get: the likely failure route and a stability test plan
Weak or inconsistent signal on a lateral flow test
Faint test lines, high background or batch variation appear once the test is built in larger numbers. The review ranks membrane, conjugate, coating and drying causes.
You get: ranked causes and a build-level test sequence
Performance lost on scale-up
Sensitivity, precision or stability slips as reagent production or manufacturing volumes increase. The review compares small and large batches and prioritises what to align first.
You get: the differences most likely to matter, in order
What I need from you
Your data and your history.
- Results from affected and unaffected runs, lots or sites.
- Methods, SOPs and reagent or calibrator specifications.
- A history of recent changes: suppliers, materials, equipment, process.
- What has been investigated so far and what it showed.
- A named contact in your team for questions during the review.
A confidentiality agreement is in place before any data is shared.
What you receive
A clear route forward
- An assessment of the available evidence and the most likely causes, ranked.
- A prioritised investigation plan showing the key questions to resolve and the recommended order of work.
- A decision on what to test next.
- A debrief call with your team to walk through the findings.
How it runs
Five steps, agreed up front.
- 01Intro callA short, free conversation about the problem, timing and data available.
- 02Scope & feeConfidentiality agreement, written scope and agreed fee.
- 03ReviewData, methods and history examined, with questions to your team.
- 04Report & debriefRanked causes, investigation plan and next test, walked through together.
- 05Optional follow-onSupport while your team runs the plan, or a defined period of R&D leadership.
Working without a laboratory
I design and interpret. Your team runs the experiments.
ORIVISE does not run a laboratory. Your team, or a laboratory partner you agree, runs the experiments in the plan. That keeps the work in your quality system, on your equipment and with your materials, where the problem actually occurs.
The review focuses the investigation. Confirming a root cause normally requires the experiments it recommends, so no fixed-period guarantee of a root cause is given.
Every review is led personally by Dr Pompi Hazarika, drawing on 20+ years of immunoassay and diagnostics R&D leadership.
Typical problems
Immunoassays, ELISA, lateral flow, particle-based and other protein reagent systems.
Tell me what the assay is doing.
A short description of the problem and the data you have is enough for a free 30-minute intro call.