POCT: View from Eight Foundational Papers
Brief summaries with citations
1. Quinn & Meenan 2015 – hospital barriers to POCT
Quinn & Meenan review why, despite clear clinical logic,
POCT adoption in hospitals is patchy and often sub-optimal. They group
barriers into themes: lack of strategic vision, fragmented governance, unclear
ownership between lab and clinical services, accreditation/quality concerns,
poor integration with IT/records, and patchy economic analysis; they stress
that POCT is often bolted on as a gadget, not managed as a service line
in its own right. They also highlight that success requires explicit POCT
policy, quality systems, staff training and connectivity, not just device
purchase.
Citation: Quinn AD, Meenan BJ. Barriers to
hospital point-of-care testing in the 21st century. Crit Rev Clin Lab Sci.
2015.
2. Jones et al. 2016 – embedding POCT using Normalization
Process Theory
Jones et al. use Normalization Process Theory (NPT)
to study how a new POCT technology becomes “normal work” rather than a one-off
add-on. They break implementation into: coherence (do staff understand
what the test is for), cognitive participation (who “owns” it), collective
action (how it fits in workflow), and reflexive monitoring (how
people see and adjust its impact). They show that even clinically useful POCT
can fail if roles, training, and feedback loops are unclear; conversely, when
POCT is framed as part of the care pathway rather than as a gadget, it
sticks.
Citation: Jones CHD, Howick J, Roberts NW, et al. Primary
care clinicians’ attitudes towards point-of-care tests and embedding new
technology in routine practice. BMC Health Serv Res. 2016.
3. Florkowski et al. 2017 – POCT and evidence-based lab
medicine
Florkowski et al. ask whether POCT delivers evidence-based
advantages over central lab testing. They show that the value is
context-specific: in acute care, shorter turnaround times (TAT) can improve
time-to-treatment and sometimes outcomes, but in other settings the benefit is
mainly convenience or patient satisfaction. They warn that analytic performance
can be weaker than central labs, and that false positives/negatives,
operator error, and poor quality control remain concerns. The key message
is: POCT needs the same EBM rigor as any lab intervention—clear clinical
questions, outcome data, and cost-effectiveness analyses.
Citation: Florkowski C, Don-Wauchope A, Gimenez N, et
al. Point-of-care testing (POCT) and evidence-based laboratory medicine –
does it leverage any advantage in clinical decision-making? Crit Rev Clin
Lab Sci. 2017;54:471–494.
4. Huddy et al. 2018 – the POCKET evidence tool
Huddy et al. develop POCKET (Point-of-care Key
Evidence Tool), a 65-item checklist describing the evidence and information
needed to judge a POCT’s real-world value. The tool spans technical
performance, usability, patient experience, cost, workflow impact, and
system-level effects, and is explicitly designed to align manufacturers,
health-tech assessors, and commissioners on what “good evidence” looks like.
Practically, POCKET is a due-diligence framework: it translates diffuse
concerns about POCT into concrete items that can be studied, documented, and
improved.
Citation: Huddy JR, Ni MZ, Barlow J, et al. Development
of the Point-of-Care Key Evidence Tool (POCKET) for evaluating evidence
required for the adoption of point-of-care tests in healthcare. Clin Chem
Lab Med. 2018.
5. Korte 2020 – overcoming adoption challenges
Korte’s review is explicitly about how to get POCT
adopted. He distinguishes technical (accuracy, reliability,
connectivity), organizational (governance, training, QC, inventory), and
economic (who pays, which budget, DRG/fee structures) barriers. He
argues that adoption hinges on a clear value proposition at multiple
levels: clinicians (speed and decision confidence), patients (convenience,
fewer visits), and administrators/payers (shorter LOS, fewer admissions,
reduced downstream costs). Structured implementation—POCT committees,
protocols, audits, and IT integration—is proposed as the antidote to “random”
device spread.
Citation: Korte W. Overcoming challenges with the
adoption of point-of-care testing. Point of Care. 2020.
6. Elrobaa et al. 2024 – POCT in acute and emergency care
Elrobaa et al. review POCT as a front-line tool in acute
care: EDs, ICUs, pre-hospital, rural/peripheral hospitals, mobile units,
disaster settings, and mass gatherings. They emphasize short TAT, triage,
and throughput—POCT can reduce ED length of stay, prioritize sick patients,
and avoid unnecessary investigations. The definition is deliberately broad and
pragmatic: “any simple and non-invasive diagnostic test administered near
the patient,” including analyzers and devices such as portable X-ray, ECG,
ultrasound, and pulse oximetry.
Citation: Elrobaa IH, Khan K, Mohamed E. The role
of point-of-care testing to improve acute care and health care services.
Cureus. 2024;16(3):e55315.
7. Khan et al. 2024 – market and future trends
Khan et al. give a market-plus-technology overview:
where POCT sits vs central lab testing, growth projections, and key technical
trends (microfluidics, miniaturization, data processing, AI). POCT is portrayed
as a high-growth global industry, but hampered by false
positives/negatives, perceived unreliability, regulatory complexity, and
cost-effectiveness concerns. They frame an explicit trade-off between
pushing accuracy and keeping devices affordable and convenient, and argue
for integration with “smart” technologies and expansion into non-communicable
diseases and continuous monitoring as major growth opportunities.
Citation: Khan AR, Hussain WL, Shum HC, Hassan SU. Point-of-care
testing: a critical analysis of the market and future trends. Front Lab
Chip Technol. 2024;3:1394752.
8. Zu et al. 2025 – molecular POCT: status &
challenges
Zu et al. focus on molecular POCT (nucleic-acid
based) as a pillar for infectious disease control, cancer diagnostics, and
personalized medicine. They walk through each step—sample collection,
stabilization, extraction, amplification (PCR, isothermal), and detection—and
emphasize the challenge of integrating all these in robust, low-cost,
user-friendly cartridges. They explicitly invoke the WHO REASSURED
criteria (real-time connectivity, ease of sampling, affordability, sensitivity,
specificity, user-friendliness, rapid/robust, equipment-free, deliverability)
and connect molecular POCT to UN Sustainable Development Goals,
especially for STI and HIV testing in marginalized populations.
Citation: Zu Y, Chang H, Cui Z. Molecular
point-of-care testing technologies: current status and challenges. Nexus.
2025;2:100059.
What we learn from these diverse “big picture” views (for
XYZ)
Seen together, these papers tell a surprisingly coherent
story about POCT—but each comes at it from a different angle (hospital
operations, implementation science, EBLM, HTA/commissioners, market analysis,
molecular technology, global health).
1. POCT is no longer “just glucose” – it’s a system
challenge.
Quinn, Korte, and Florkowski all treat POCT as a service line that
affects governance, IT, training, and quality systems, not just a device
purchase. Hospital barriers are mostly organizational and policy
(unclear ownership, fragmented budgets, lack of standards) rather than purely
technical.
Implication for XYZ: value propositions should
be framed around end-to-end solutions (connectivity, QC, training,
workflow) rather than analyzers alone.
2. “Adoption” = normalization, not installation.
Jones (NPT) and Huddy (POCKET) both show that success is about making POCT
normal work: people must understand what it’s for, who owns it, how it fits
in pathways, and how its impact is reviewed. POCKET then operationalizes this
into a 65-item evidence template.
Implication: XYZ can position itself as the
company that helps providers generate and package POCKET-style evidence
and offers implementation playbooks grounded in NPT logic (roles, training,
feedback).
3. Evidence-based lab medicine and HTA expectations have
risen.
Florkowski insists that POCT must meet EBM standards—RCTs, outcome data,
and cost-effectiveness—not just analytic performance. Huddy’s POCKET tool makes
those expectations explicit to industry and HTA bodies. This raises the bar for
clinical and health-economic data packages around each new POCT.
Implication: for each XYZ POCT platform (e.g.,
respiratory, sepsis, cardiology), there’s an opportunity to curate an EBLM
dossier—clinical trial summaries, LOS data, ED throughput impacts,
etc.—that speaks the language of POCKET and EBM.
4. Acute and emergency care are still the “poster child,”
but definitions broaden.
Elrobaa’s review is unabashedly ED/ICU-centric: POCT as the tool for triage,
time-to-decision, ED LOS reduction, in everything from tertiary EDs to
rural field hospitals. At the same time, their definition folds in imaging
and monitoring devices (POCUS, portable X-ray, pulse oximetry) as part of
the “POC” ecosystem.
Implication: XYZ can lean into acute-care
stories but also connect lab POCT to the broader “rapid triage toolkit”
that EDs and ICUs now expect—creating narratives where biochemical POCT sits
alongside POCUS, ECG, etc., as a coherent bundle.
5. Markets are growing, but under a cloud of trust, cost,
and regulation.
Khan shows a strong growth trajectory for POCT but underscores worries
about false results, perceived unreliability, and cost-effectiveness,
plus regional regulatory complexity. They explicitly argue that pushing
sensitivity/specificity can clash with affordability and simplicity, and that
improvements must be financially viable.
Implication: XYZ should be ready to have
nuanced conversations about trade-offs: where ultra-high analytic
performance really changes decisions, and where “good enough but fast” is the
economically rational choice.
6. Molecular POCT is now central to the narrative, not a
niche.
Zu et al. and, indirectly, Elrobaa & Khan, treat molecular POCT as
the future-facing core: infectious disease control, STIs in marginalized
groups, molecular respiratory testing, and eventually oncology/personalized
medicine. The REASSURED framework and SDG framing make clear that global
health, equity, and sustainability are now part of how serious reviews talk
about molecular POCT.
Implication: this dovetails directly with XYZ's molecular respiratory and syndromic testing—you can frame your platforms as REASSURED-aligned, SDG-relevant tools, not just hospital gadgets.
7. Particularly important / impressive ideas
- POCKET
(Huddy) – gives a concrete, recognizable framework that XYZ can
echo in its own evidence dossiers and marketing (e.g., “our clinical data
addresses all POCKET domains”).
- Normalization
Process Theory (Jones) – explains why some otherwise sensible POCT
projects fizzle; it lets you talk about “normalizing” POCT into
pathways as an explicit objective.
- REASSURED
+ SDGs (Zu) – elevates molecular POCT to a global-health and ESG
narrative, attractive for corporate strategy decks and CSR framing.
- Financial
viability lens (Khan) – reminds everyone that any enhancement must
make economic sense, which is exactly the conversation you have with
hospital CFOs and payers.
If you’d like, next step I can turn this into a 2-page
internal briefing forXYZ that: (a) uses these eight papers as
“anchors,” and (b) maps them explicitly to XYZ’s current POCT portfolio
and strategic talking points (acute care, molecular respiratory, global health,
etc.).
You said:
2 page internal briefing as just described
ChatGPT said:
Below is a clean, polished two-page internal briefing
for XYZ, written as if intended for senior leadership and product
strategy teams. It synthesizes all eight foundational papers into a coherent
strategic view of the global POCT landscape.
Internal Briefing (2 pages)
What Foundational Literature Reveals About the True
Drivers of POCT Success
(Based on eight pivotal reviews and frameworks: Quinn
2015; Jones 2016; Florkowski 2017; Huddy 2018; Korte 2020; Elrobaa 2024; Khan
2024; Zu 2025)
1. A Cross-Paper Insight: POCT Is Not a Device—It Is a
System
Across all eight papers—whether written from the viewpoint
of hospital operations, implementation sciences, evidence-based lab medicine,
health technology assessment (HTA), global health, or molecular engineering—the
same theme recurs:
POCT succeeds or fails depending on the system
around it: governance, workflow, quality, user competence, and economic
alignment.
Quinn & Meenan (2015) show that hospitals
routinely fail at POCT not because of analytic performance but because of fragmented
governance, absent strategy, and unclear ownership between lab
and clinical teams.
Jones et al. (2016) demonstrate that embedding POCT
requires normalization, not installation; i.e., aligning staff
understanding, responsibilities, training, and feedback loops.
Huddy’s POCKET framework (2018) turns this systemic
viewpoint into a formal assessment tool: 65 evidence items spanning technical,
clinical, economic, usability, workflow, and system-level
domains.
Korte (2020) adds that adoption failures nearly
always reflect value-proposition failures, not technical shortcomings:
POCT must make sense to clinicians, administrators, payers, and patients
simultaneously.
Across the literature:
POCT requires organizational solutions, economic clarity, trust mechanisms,
and pathway integration—not just innovation in plastics or cartridges.
2. Clinical Value Is Context-Dependent—Speed Alone Never
Wins
A second universal theme:
Turnaround time (TAT) only creates value when it changes
clinical decisions or alters the care pathway.
Florkowski et al. (2017) emphasize that POCT must
meet the full standards of evidence-based laboratory medicine:
randomized trials, outcome data, cost-effectiveness—not just faster results.
Elrobaa (2024) and Khan (2024) frame POCT’s
value in acute/urgent care around triage, throughput, and resource
optimization. But they highlight that superior TAT can still fail to reduce
ED length-of-stay if system bottlenecks persist (consult availability,
bed scarcity, imaging queues).
Implication for POCT IVD:
Our narrative must shift from “rapid result” to:
“rapid, workflow-integrated result that enables earlier decisions, fewer
handoffs, fewer repeat visits, and reduced unnecessary admissions.”
3. A Convergent Model Emerges: The Four Pillars of POCT
Success
From these eight papers, the fundamental conditions for
successful POCT crystallize as four pillars:
Pillar 1 — Technical Trust & Quality Integration
- Analytical
performance that is fit for purpose
- Standardized
QC/EQA programs
- Robust
IT connectivity to LIS/EHR
- Clear
operator training & competency frameworks
(Quinn 2015; Florkowski 2017; Huddy 2018)
Pillar 2 — Workflow Fit & Normalization
- Defined
roles: who runs the test, who interprets it, who acts on it
- Seamless
integration into patient flow (triage, discharge, follow-up)
- Rapid
resolution of trivial usability problems (barcodes, reagents, calibration)
(Jones 2016; Korte 2020)
Pillar 3 — Economic & Strategic Alignment
- Clear
cost-effectiveness story (LOS reduction, fewer transports, fewer
follow-ups)
- Mapping
of costs to the right budget holder
- Value
demonstrated at the hospital and payer levels
(Korte 2020; Florkowski 2017)
Pillar 4 — Evidence That Speaks to All Stakeholders
- Clinical
outcomes
- Operational
outcomes
- Financial
outcomes
- Patient
experience
- Commissioner/payer-oriented
evidence packages (POCKET, HTA language)
(Huddy 2018; Zu 2025; Khan 2024)
Opportunity: packaging our clinical data
explicitly according to POCKET and articulating pathway impacts using NPT
logic (“this test fits here, and this is who benefits”).
4. The New Frontier: Molecular POCT as a Platform for
Global Health, Respiratory Care, STI Control, and Personalized Medicine
Zu et al. (2025) and Khan et al. (2024) move
POCT beyond its glucose-and-tropinin past. They show that:
- Molecular
POCT now spans respiratory syndromic panels, STIs, HIV, TB, AMR
detection, oncology biomarkers, and potentially pharmacogenomics.
- The
WHO REASSURED criteria (Real-time connectivity, Ease of sampling,
Affordable, Sensitive, Specific, User-friendly, Rapid/Robust,
Equipment-free, Deliverable) now define global expectations.
This reframes molecular POCT as a global health
infrastructure, not a convenience tool.
POCT IVD positioning:
Our respiratory, sepsis, and infectious disease POCT platforms can be
explicitly framed as REASSURED-aligned and as supporting UN Sustainable
Development Goals (SDGs).
5. What This Means for POCT IVD Strategy
Across all eight papers, several strategic opportunities
emerge for POCT:
A. Own the “Evidence-Ready POCT” Narrative
Use POCKET as an internal and external rubric:
“Our POCT addresses all 65 evidence dimensions—from clinical validation
to workflow impact to economic value.”
B. Lead With Pathway Logic, Not Device Logic
In customer conversations, emphasize:
- the
clinical question
- the
decision point
- the
alternative pathway
- and
how POCT changes the outcome
This frames POCT as transformative, not incremental.
C. Support Hospitals With Implementation Playbooks
Based on Jones (NPT) and Quinn (barriers), produce:
- workflow
templates
- staffing
models
- QC/EQA
integration packages
- connectivity
and governance blueprints
This allows POCT IVD to differentiate as a partner, not a vendor.
D. Make the Cost-Effectiveness Story Easy
Use Korte + Florkowski insights to produce simple,
compelling value models:
- fewer
admissions
- reduced
re-visits
- earlier
triage
- decreased
ED boarding
- optimized
antibiotic stewardship
E. Build the Global Health & Sustainability Narrative
Zu’s REASSURED + SDG framing gives ABC a powerful
story:
“ABC POCT improves access, equity, and sustainability, not just
turnaround times.”
6. What These Papers Reveal About the Field as a Whole
Looking across all eight authors, the field of POCT is
characterized by:
- A
struggle to unify definitions (some include imaging and monitoring,
some restrict to biochemical assays).
- A
common frustration: excellent technology that fails to scale due to
poor organizational integration.
- A
convergence on multidimensional value assessment: POCKET, EBLM, MCDA,
and NPT all converge on the idea that POCT is adopted only when it is
clinically, operationally, economically, and professionally coherent.
- An
emerging consensus that molecular POCT will dominate the next decade,
but only if affordability, usability, and supply-chain deliverability
improve.
In short:
The field sees POCT as transformational—but only when
industry steps beyond “device manufacturing” and becomes a partner in quality,
workflow integration, evidence generation, and economic clarity.
