The Biohermes GlucoA1C HbA1c analyser is a point-of-care device designed to deliver rapid, quantitative glycated haemoglobin measurements in clinical settings such as GP surgeries, diabetes clinics, and community pharmacies. By providing results from a small capillary or venous blood sample without laboratory referral, it supports timely clinical decision-making during patient consultations. This article covers how the device works, its role in UK clinical practice, accuracy and regulatory requirements, NHS and NICE guidance on interpreting HbA1c results, and key considerations for practices evaluating point-of-care HbA1c testing.

What Is the Biohermes GlucoA1C HbA1c Analyser?

The Biohermes GlucoA1C is a compact, professional-use point-of-care IVD device that measures HbA1c rapidly from capillary or venous blood, intended for GP surgeries, diabetes clinics, and community pharmacies.

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The Biohermes GlucoA1C is a point-of-care (POC) HbA1c analyser designed to deliver rapid, quantitative measurement of glycated haemoglobin directly from a small capillary or venous blood sample. Manufactured by Biohermes, the device is intended for use in clinical settings such as GP surgeries, diabetes clinics, and community pharmacies, where timely results can directly inform patient management decisions without the delay associated with laboratory referral.

The analyser is classified as an in vitro diagnostic (IVD) medical device for professional use only. Devices placed on the UK market must carry a UKCA mark (or, during applicable transitional periods, a CE mark) in accordance with the UK Medical Devices Regulations 2002 (as amended) and MHRA requirements. Prospective users should confirm the current regulatory status of the specific UK model variant with the manufacturer or UK distributor before procurement.

The analytical method, sample volume, turnaround time, and sample handling requirements vary by model and cartridge lot. Users should refer to the manufacturer's instructions for use (IFU) for the specific UK-supplied variant for authoritative technical specifications, including:

• Measurement principle (e.g., immunoturbidimetric or boronate affinity chromatography)

• Required sample type and anticoagulant (typically EDTA whole blood)

• Sample volume and collection technique (capillary or venous)

• Cartridge storage conditions and lot-specific calibration requirements

• Steps to avoid pre-analytical errors such as haemolysis or inadequate mixing

Key features commonly associated with POC HbA1c analysers of this type include a compact, portable design suitable for desktop use in primary care, a digital display with printable or transferable results, and internal quality control functions to support consistent performance.

The device is not intended for patient self-testing at home and should be clearly distinguished from consumer glucose monitors. All operators must be trained healthcare professionals following the manufacturer's IFU and local standard operating procedures. Any suspected device malfunction or adverse incident should be reported to the MHRA via the Yellow Card scheme.

How HbA1c Testing Works and Why It Matters

HbA1c reflects average blood glucose over the preceding two to three months and is used to diagnose type 2 diabetes (≥48 mmol/mol), identify prediabetes (42–47 mmol/mol), and monitor glycaemic control in people with established diabetes.

HbA1c — glycated haemoglobin — is formed when glucose in the bloodstream binds irreversibly to haemoglobin within red blood cells. Because red blood cells have a lifespan of approximately 90 to 120 days, the HbA1c value reflects average blood glucose concentrations over the preceding two to three months. This makes it a far more informative marker of long-term glycaemic control than a single fasting or random blood glucose measurement.

In clinical practice, HbA1c testing serves several important purposes:

• Diagnosing type 2 diabetes — an HbA1c of 48 mmol/mol (6.5%) or above on two separate occasions is diagnostic in asymptomatic adults, in line with NICE guideline NG28 and WHO 2011 guidance

• Identifying non-diabetic hyperglycaemia (prediabetes) — values between 42 and 47 mmol/mol (6.0–6.4%) indicate elevated risk and warrant lifestyle intervention and annual monitoring

• Monitoring glycaemic control in people already diagnosed with diabetes, guiding treatment adjustments

The test is reported in mmol/mol in the UK, in line with International Federation of Clinical Chemistry (IFCC) standardisation adopted by NHS laboratories.

When HbA1c should not be used for diagnosis

HbA1c is not appropriate for diagnosing diabetes in a number of important clinical situations. In these circumstances, plasma glucose-based testing (fasting plasma glucose or oral glucose tolerance test) should be used instead, and specialist advice sought where appropriate. HbA1c should not be used for diagnosis in:

• Pregnancy (including gestational diabetes screening)

• Children and young people

• Suspected type 1 diabetes at any age

• Acute illness or following acute hyperglycaemia

• Recent blood transfusion (within approximately two to three months) or other conditions causing rapid red cell turnover

• Haemoglobinopathies (e.g., sickle cell trait or disease, thalassaemia) that affect HbA1c measurement

• Haemolytic anaemia or iron deficiency anaemia, which can falsely lower or raise results respectively

• Advanced chronic kidney disease (CKD stages 4–5/ESKD), where erythropoiesis is significantly altered

• Recent initiation of erythropoiesis-stimulating agents

In these situations, alternative markers such as fructosamine may be considered, and specialist input is advisable.

HbA1c is not a component of standard UK cardiovascular risk calculators such as QRISK, and clinicians should not rely on it as a standalone cardiovascular risk parameter.

Point-of-care devices like the GlucoA1C analyser bring this clinically valuable test closer to the patient, supporting faster clinical decisions and improving the efficiency of consultations.

Using the GlucoA1C Analyser in UK Clinical Settings

The analyser can be integrated into routine diabetes reviews and opportunistic screening, but POC results must be confirmed by laboratory testing before a formal diabetes diagnosis is made, per NICE NG28.

In UK primary care and community settings, the Biohermes GlucoA1C analyser can be integrated into routine diabetes reviews, new patient assessments, and opportunistic screening for at-risk individuals. Its rapid turnaround time allows clinicians to discuss results with patients during the same appointment, which may support more timely clinical decision-making and patient engagement, though practices should be aware that robust evidence specifically linking POC HbA1c testing to improved long-term outcomes remains limited.

For GP practices and pharmacies considering adoption, several operational factors are worth addressing:

• Staff training: All operators should receive formal training on device use, quality control procedures, and result interpretation before clinical deployment

• Standard operating procedures (SOPs): Local SOPs should be developed in line with the manufacturer's IFU and NHS laboratory medicine standards

• Quality assurance: Regular internal quality control (IQC) runs and participation in an accredited external quality assurance (EQA) scheme — such as those provided by UK NEQAS or WEQAS — are essential to maintain result reliability

• POCT governance: POC testing should operate within a local governance framework overseen by a designated POCT committee or lead, with quality management aligned to ISO 15189 (medical laboratories) and ISO 22870 (point-of-care testing). UKAS accreditation should be considered where applicable

• Data recording: Results should be documented in the patient's clinical record in accordance with local information governance policies and NHS Data Security and Protection Toolkit (DSPT) requirements

The analyser is particularly well-suited to settings where patients may face barriers to attending phlebotomy services, such as those with mobility difficulties, those in care homes, or those in underserved communities. Community pharmacies operating NHS diabetes prevention or management services may also find POC HbA1c testing a valuable addition to their clinical offering.

Clinicians must ensure that any POC result falling in a diagnostically significant range is confirmed by a laboratory-based test before a formal diagnosis of diabetes is made, in line with NICE guideline NG28. POC results should not be used in isolation to diagnose diabetes.

Accuracy, Validation and Regulatory Compliance

Devices must hold a UKCA or CE mark and ideally current NGSP certification with IFCC traceability; local NHS laboratory or POCT lead consultation and governance approval are required before procurement.

For any point-of-care HbA1c device used in UK clinical practice, accuracy and regulatory compliance are paramount. The MHRA classifies HbA1c analysers as IVD medical devices. Devices placed on the UK market must meet the requirements of the UK Medical Devices Regulations 2002 (as amended) and carry a UKCA mark (or, during applicable transitional periods, a CE mark), confirming conformity with applicable safety and performance standards. Prospective users should verify the current regulatory status of the specific device with the manufacturer.

Two key quality standards are relevant to POC HbA1c testing:

• ISO 15189 specifies requirements for quality and competence in medical laboratories, including those overseeing POC testing programmes

• ISO 22870 sets out specific requirements for point-of-care testing quality management and is the primary standard applicable to POC device governance

Neither standard defines analytical performance specifications for individual devices; these are addressed through method standardisation and certification schemes.

Analytical performance and standardisation

The internationally recognised framework for HbA1c method standardisation is IFCC traceability combined with NGSP (National Glycohaemoglobin Standardisation Program) certification. NGSP-certified methods are required to demonstrate mean bias within NGSP acceptance limits (typically ≤±0.75% HbA1c units versus the NGSP reference method) and acceptable imprecision (coefficient of variation generally ≤3%). Clinicians and procurement leads should verify that any device under consideration holds current NGSP certification and demonstrates IFCC traceability.

When evaluating the Biohermes GlucoA1C or any POC HbA1c device, healthcare organisations should look for:

• Published peer-reviewed validation studies comparing POC results against reference laboratory methods

• NGSP certification confirming traceability to international reference standards

• Manufacturer-provided precision and accuracy data across the clinically relevant measurement range

• Interference data documenting performance in the presence of common haemoglobin variants and other potential interferents

It is advisable for NHS trusts and GP practices to consult their local NHS laboratory or POCT lead before procuring any new POC device, as local validation and governance approval will typically be required. Suspected device malfunctions or adverse incidents should be reported to the MHRA via the Yellow Card scheme.

Interpreting HbA1c Results Using NHS and NICE Guidelines

NICE NG28 defines three diagnostic categories: below 42 mmol/mol (normal), 42–47 mmol/mol (prediabetes requiring lifestyle intervention), and ≥48 mmol/mol (diabetes, requiring confirmatory repeat testing).

Correct interpretation of HbA1c results is as important as the accuracy of the measurement itself. In the UK, NICE guideline NG28 (Type 2 diabetes in adults: management) and NICE guideline NG17 (Type 1 diabetes in adults) provide the primary framework for clinical decision-making based on HbA1c values.

Diagnostic thresholds (NICE/NHS, for eligible adults only — see exclusions below):

• Below 42 mmol/mol: Normal — no evidence of diabetes or non-diabetic hyperglycaemia

• 42–47 mmol/mol: Non-diabetic hyperglycaemia (prediabetes) — lifestyle intervention recommended; annual monitoring advised; referral to the NHS Diabetes Prevention Programme (NDPP) should be considered

• 48 mmol/mol or above: Indicative of diabetes — requires confirmation with a repeat test on a separate day (unless symptomatic hyperglycaemia is present with an unequivocal result)

When not to rely on HbA1c for diagnosis

As noted in the section on HbA1c testing, the test is not appropriate for diagnosis in pregnancy, children and young people, suspected type 1 diabetes, acute illness, recent transfusion, haemoglobinopathies, significant anaemia, or advanced CKD. In these situations, plasma glucose-based testing and/or specialist input is required.

Monitoring targets for people with established diabetes (NICE NG28 and NG17):

• For most adults with type 2 diabetes managed with lifestyle or non-hypoglycaemic agents: target HbA1c of 48 mmol/mol (6.5%)

• For those on insulin or sulfonylureas (where hypoglycaemia risk is higher): target of 53 mmol/mol (7.0%)

• For adults with type 1 diabetes: an individualised target, typically 48–58 mmol/mol, agreed with the patient

• Individualised targets should be agreed with the patient, taking into account age, comorbidities, frailty, and patient preference

Clinicians should communicate results clearly to patients, explaining what the value means in practical terms and what action — if any — is required. A result in the non-diabetic hyperglycaemia range represents an important opportunity for preventive intervention; eligible patients should be offered referral to the NHS Diabetes Prevention Programme (NDPP) and provided with appropriate lifestyle advice. Patients with a new result of 48 mmol/mol or above, once confirmed, should be referred promptly for structured diabetes education (such as the DESMOND programme for type 2 diabetes) and further assessment, and should not be left without a clear management plan.

Choosing a Point-of-Care HbA1c Device for Your Practice

Prioritise NGSP-certified, IFCC-traceable devices with published validation data, valid UKCA or CE marking, and compatibility with local POCT governance frameworks and accredited EQA schemes such as UK NEQAS or WEQAS.

Selecting the right POC HbA1c analyser for a clinical setting involves balancing analytical performance, practical usability, regulatory compliance, and cost-effectiveness. The Biohermes GlucoA1C is one of several devices available in the UK market, and a structured evaluation process is recommended before procurement.

Key considerations when choosing a POC HbA1c device:

• Analytical performance: Prioritise devices with current NGSP certification and IFCC traceability. Review published peer-reviewed validation data comparing the device against reference laboratory methods. Look for imprecision (CV) of ≤3% and mean bias within NGSP acceptance limits (typically ≤±0.75% HbA1c units versus the NGSP reference method)

• Regulatory status: Confirm the device holds a valid UKCA or CE mark and meets current UK IVD regulations (UK MDR 2002, as amended)

• Ease of use: Consider the complexity of the testing procedure, the training burden for staff, and the risk of operator error

• Throughput and turnaround time: Assess whether the device can meet the volume demands of your setting without compromising quality

• Consumable costs and supply chain: Factor in the ongoing cost of reagents, cartridges, and quality control materials

• Technical support and maintenance: Ensure the manufacturer or UK distributor offers adequate after-sales support, including troubleshooting and calibration services

• Integration with clinical systems: Check whether results can be exported securely to your clinical record system (e.g., EMIS, SystmOne) in compliance with NHS DSPT and local information governance policies

• POCT governance alignment: Device selection should be compatible with local POCT governance frameworks, quality management systems aligned to ISO 22870 and ISO 15189, and participation in an accredited EQA scheme (e.g., UK NEQAS or WEQAS)

It is strongly recommended that practices consult their NHS pathology network or POCT coordinator before finalising any device selection. Many NHS regions have approved device lists or preferred supplier agreements that can simplify procurement and ensure governance requirements are met. Ultimately, the best device is one that delivers reliable, NGSP-certified, IFCC-traceable results in the hands of well-trained staff, within a robust quality management framework.

Frequently Asked Questions