What is point of care testing? A plain guide for clinics and wards

A plain definition

Point of care testing (POCT) is diagnostic testing carried out at or near the place where the patient is being cared for, rather than in a central laboratory. The sample is usually taken and tested in the same room, by the nurse, doctor, pharmacist, healthcare assistant or paramedic who is looking after the patient, and the result is available within minutes. Other names for the same thing include near-patient testing, bedside testing, extra-laboratory testing and, in the United States, in-office or physician office testing.

Three features define it. First, location: the test happens outside the laboratory, in a clinic room, on a ward, in a pharmacy consultation room or in someone's home. Second, the operator: the person running the test is usually not a laboratory scientist and runs tests as a small part of a wider job. Third, timing: the result is intended to be used in the same episode of care, often in the same consultation.

The analyser itself can be anything from a single-use lateral flow cassette read by eye, to a handheld meter, to a bench-top instrument that would not look out of place in a laboratory. What makes it POCT is not the size of the device but where it is used and who uses it. ISO 15189:2022 describes POCT as testing performed near or at the site of the patient, and treats it as an activity the laboratory remains responsible for even when it does not run the tests itself.

Where point of care testing happens

POCT has moved well beyond the hospital. The common settings, with the tests you would expect to find in each:

• Wards, theatres and critical care. Blood gas, glucose, ketones, lactate, haemoglobin and activated clotting time, run by nurses and doctors on analysers kept on the ward.
• Emergency departments. Blood gas, troponin, D-dimer, urinalysis, pregnancy testing and, increasingly, molecular respiratory panels to decide on isolation.
• GP practices. HbA1c for diabetes reviews, CRP to support antibiotic decisions, INR for anticoagulation clinics, urinalysis and lipids.
• Community pharmacies. Blood pressure, cholesterol, glucose, HbA1c and, in some services, sore throat and urinary tract infection testing.
• Community diagnostic centres (CDCs). In England, CDCs bring imaging, physiological measurement and pathology closer to patients, and a share of that pathology is point of care.
• Patients' homes. Community nursing teams carrying INR and glucose meters, and self-testing that feeds back to a clinic.
• Occupational health. Drug and alcohol screening, lipids, glucose, HbA1c and haemoglobin for health surveillance and fitness-for-work assessments.
• Sports, wellness and longevity clinics. Lipid profiles, HbA1c, haematology and vitamin panels on bench-top analysers, often for members rather than patients.

Each setting shares the same problem: the analyser is far from the laboratory, the operator is not a laboratory scientist, and somebody still has to prove the result was good enough to act on.

The main types of test and the analysers that run them

Most POCT falls into a small number of categories. The named analysers are examples of the type, not recommendations.

• Blood gas and electrolytes. pH, oxygen, carbon dioxide, electrolytes, lactate and often co-oximetry, on cartridge-based analysers such as the Radiometer ABL90 FLEX, Werfen GEM Premier, Siemens epoc and Abbott i-STAT.
• Glucose and ketones. Handheld meters such as the Nova StatStrip, used on every ward and in most community services.
• HbA1c. Glycated haemoglobin for diabetes monitoring, on bench-top analysers such as the Abbott Afinion 2 and Siemens DCA Vantage.
• INR and coagulation. The international normalised ratio (INR) on handheld meters for anticoagulation clinics and home visits, and small bench-top coagulometers where more tests are needed.
• CRP and inflammation markers. C-reactive protein on cartridge or immunoassay analysers such as the Afinion 2, Boditech AFIAS 6 and Wondfo Finecare.
• Cardiac markers. Troponin, natriuretic peptides and D-dimer on analysers such as the Radiometer AQT90 FLEX, Quidel Triage MeterPro and Siemens Atellica VTLi, mostly in emergency and acute settings.
• Urinalysis. Dipstick readers such as the Siemens Clinitek Status+, Roche cobas u 411 and Arkray AUTION Micro, which remove the variation of reading strips by eye.
• Haematology. Compact full blood count analysers such as the HORIBA Yumizen H500, Sysmex XP-300 and Mindray BC-5380, typically in clinics and small hospitals.
• Molecular respiratory and infection panels. Polymerase chain reaction (PCR) and isothermal tests for influenza, respiratory syncytial virus (RSV), SARS-CoV-2, streptococcus and, on larger panels, many pathogens at once, on systems such as the Roche cobas Liat, Abbott ID NOW, Cepheid GeneXpert, bioMerieux SPOTFIRE and QIAGEN QIAstat-Dx.

Visually read lateral flow tests (pregnancy, strep A, HIV, drugs of abuse) are POCT too, but leave no electronic record unless a reader or an app captures the result. A fuller list of connected analyser types is on the supported devices page.

How POCT differs from laboratory testing

Three differences matter most.

Turnaround. A laboratory result involves transport, booking in, analysis, validation and reporting, which takes hours in a hospital and a day or more from the community. A POCT result takes minutes and can be used in the same consultation. That is the whole reason POCT exists.

Who runs it. A laboratory has a small number of trained scientists running many tests each. POCT has a large number of clinical staff running a few tests each, sometimes months apart. Competence has to be built, recorded and refreshed across hundreds of people rather than dozens.

Governance. In a laboratory, quality control (QC), calibration, maintenance and result review are part of the daily routine and sit inside one department. At the point of care those same activities have to be organised across sites and shifts, usually by a POCT coordinator or POCT committee acting on behalf of the laboratory, and the evidence that they happened is spread across devices, paper logs and clinical records.

The quality framework: ISO 15189, MHRA and CLIA

Because the operator is not a laboratory scientist and the analyser is not in a laboratory, every serious health system has a framework that says who is responsible for POCT and what has to be in place. Three matter most to readers of this site.

ISO 15189:2022 Annex A

ISO 15189:2022 is the international standard for medical laboratory quality and competence. The 2022 edition absorbed the previous POCT standard, ISO 22870, into a normative annex, Annex A, so that a laboratory accredited to ISO 15189 is also assessed on the POCT it is responsible for. The annex expects the laboratory's management system to cover POCT, a named group or committee with authority over it, defined responsibilities for training and competence, quality control and external quality assessment (EQA) arrangements, and documented procedures for the whole process from sample to result. In the UK, accreditation is assessed by the United Kingdom Accreditation Service (UKAS). National accreditation bodies elsewhere, for example in Australia and across Europe, assess against the same standard. Our guide to ISO 15189:2022 and POCT works through what the annex means for software and records.

MHRA guidance in the UK

The Medicines and Healthcare products Regulatory Agency (MHRA) publishes Management and use of IVD point of care test devices. It is guidance rather than law, but it is what UK organisations are measured against. It asks for a POCT committee, a POCT coordinator, a policy, procurement that involves the laboratory, training and competence records, quality control and EQA, maintenance, incident reporting, a register of every device and where it is, and a way of recording results in the patient record.

CLIA in the United States

In the US, all clinical testing on human samples is regulated under the Clinical Laboratory Improvement Amendments (CLIA), codified at 42 CFR Part 493 and administered by the Centers for Medicare and Medicaid Services (CMS). Tests are categorised by complexity. Most POCT is "waived", which means the site holds a Certificate of Waiver and must follow the manufacturer's instructions, but is not subject to the personnel, proficiency testing and quality control rules that apply to moderate and high complexity testing. Sites that run non-waived POCT, and any site that chooses accreditation with the College of American Pathologists (CAP), COLA (an accreditor of physician office and community laboratories) or The Joint Commission, take on the fuller set of requirements.

Connectivity and middleware: how results reach the record

A POCT result that stays on the analyser, or on a printed strip stuck into the notes, is a clinical risk and a governance gap. It may be transcribed wrongly, it may never reach the record, and nobody can later show which operator, device, reagent lot and QC status stood behind it. Connectivity fixes this by moving the result electronically from the analyser into the laboratory information system (LIS or LIMS) or the electronic patient record (EPR in the UK, EHR in the US).

Analysers talk in a handful of standard protocols. HL7 v2 (Health Level Seven, version 2) is the common language of hospital systems. POCT1-A2, published by the Clinical and Laboratory Standards Institute (CLSI), was written specifically for point of care devices and carries operator, QC and device status alongside results. ASTM E1394 is an older laboratory protocol still used by many bench-top analysers. FHIR (Fast Healthcare Interoperability Resources) is the newer web-based standard that modern clinical systems increasingly accept. Most organisations end up with a mixture, which is where middleware comes in.

POCT middleware sits between the analysers and the clinical systems. It receives results in whatever protocol each device speaks, checks that the operator is authorised, matches the patient, applies the rules the POCT team has set (for example, hold a result if QC has failed), and forwards the result to the record in the format the record expects. It also keeps the QC data, the operator records and the device inventory in one place, which is the evidence base for ISO 15189, MHRA or CAP. See what is POCT connectivity and what is POCT middleware for the plain-English versions.

In community and home settings the analyser may be somewhere without a reliable network. Edge gateways that store results locally and forward them when the connection returns, and phone-based gateways that pair with the analyser, are how connectivity reaches those settings.

Common misconceptions

"It is a simple test, so it does not need the same governance." The analytical step is simple. Everything around it is not: patient identification, sample quality, operator technique, reagent storage, QC and recording the result. Most POCT errors happen before or after the analyser, not inside it.

"POCT replaces the laboratory." It does not. POCT answers a narrow question quickly. The laboratory confirms, extends and investigates. In ISO 15189 terms the laboratory remains responsible for POCT quality, which is the opposite of replacement.

"The result is as good as the laboratory's." Sometimes it is, sometimes it is close enough for the decision in hand, and sometimes it is not. Verification studies before go-live (see how to verify a new POCT analyser) are how you find out for your own devices and operators.

"Waived means unregulated." In the US, a Certificate of Waiver still requires following the manufacturer's instructions and allows CMS inspection. In the UK there is no waived category at all; MHRA guidance and ISO 15189 apply to all POCT.

"Anyone can run it." Anyone can be trained to run it. Untrained use is a recurring theme in incident reports, and every framework above requires documented training and competence for named operators.

"Connectivity is an IT project." It is a governance project with an IT component. The reason to connect a device is to get the operator, lot, QC and patient details into the record with the result. The cabling is the easy part.

Where software helps

POCT software exists to close the gap between a result on a device and a result the organisation can stand behind. The features worth asking about are the ones that map directly onto the frameworks above.

1. Connectivity to every analyser you own, over HL7 v2, POCT1-A2, ASTM or the manufacturer's own interface, with a store-and-forward gateway for sites where the network is unreliable.
2. Delivery into the record you already use, whether a hospital LIS, a GP clinical system or a clinic EHR, with the patient positively matched before anything is filed.
3. Operator management: who is trained on which device, when competence expires, and a lockout so that an untrained person cannot produce a result.
4. QC captured as it happens, with Levey-Jennings charts, Westgard rules and a link between a failed QC run and the patient results that followed it.
5. Device and inventory records: which analyser is where, its maintenance history, and reagent lots and expiry dates for recall tracing.
6. An audit trail and reporting that can produce the evidence an assessor or inspector asks for without a week of collecting paper.

Catenix is one example of this category: POCT middleware that has grown into a connected diagnostics platform, designed and ready to connect analysers over open standards and to deliver results into hospital, GP and clinic systems, with QC, operator competency, inventory and an ISO 15189-aligned quality module in the same place. The device connectivity page describes how the gateway and the protocols work. It records and routes results; it does not interpret them.

Questions people ask

What does point of care testing mean?

Point of care testing means diagnostic tests performed at or near the patient, outside a central laboratory, with the result available quickly enough to be used in the same episode of care. The operator is usually a nurse, doctor, pharmacist or healthcare assistant rather than a laboratory scientist. Common examples are blood glucose meters, blood gas analysers, HbA1c and CRP analysers, urine dipstick readers and rapid molecular tests for respiratory infections.

What is the difference between point of care testing and laboratory testing?

The main differences are turnaround, operator and governance. A laboratory result takes hours or days and is produced by trained scientists inside an accredited quality system. A point of care result takes minutes and is produced by clinical staff wherever the patient is. Both need quality control, training and a record of the result, but at the point of care those have to be organised across many sites and operators, usually by a POCT coordinator on behalf of the laboratory.

Who can perform point of care testing?

Anyone who has been trained and assessed as competent on the specific device, under the organisation's POCT policy. In the UK, MHRA guidance and ISO 15189:2022 Annex A expect documented training and competency for every operator. In the US, CLIA sets no personnel qualifications for waived tests but does for moderate and high complexity tests, and accreditors such as CAP expect competency records for all point of care operators.

Is point of care testing as accurate as laboratory testing?

It depends on the test, the device and how it is used. Manufacturers publish performance claims, and a POCT service verifies those claims with its own operators before go-live, using protocols such as CLSI EP15. Some point of care methods match the laboratory closely; others are designed to be good enough for a specific decision rather than to replace the laboratory. Poor sample collection and untrained operators cause more errors than the analytical method itself.

Is point of care testing regulated?

Yes. In the UK, devices must carry the conformity marking the medical devices regulations require (UKCA or CE in Great Britain, CE under EU rules in Northern Ireland), and services are expected to follow MHRA guidance and, where the laboratory is accredited, ISO 15189:2022 Annex A assessed by UKAS. In the US, all clinical testing is regulated under CLIA (42 CFR Part 493), with a Certificate of Waiver for simple tests and fuller requirements for moderate and high complexity testing. Most other countries apply ISO 15189 through their national accreditation body.

What is POCT connectivity?

POCT connectivity is the electronic link between a point of care analyser and the clinical systems that hold the patient record, so that results, operator identity, device details, reagent lot and QC status are transferred automatically rather than transcribed. It uses standards such as HL7 v2, POCT1-A2, ASTM E1394 and FHIR, usually through middleware that receives from every device and forwards to the laboratory system or patient record.

Sources and further reading

• ISO 15189:2022 Medical laboratories: requirements for quality and competence (Annex A, point-of-care testing)
• MHRA, Management and use of IVD point of care test devices
• CMS, Clinical Laboratory Improvement Amendments (CLIA)
• 42 CFR Part 493, Laboratory Requirements
• CLSI POCT1-A2, Point-of-Care Connectivity