The Afinion HbA1c package insert is the essential technical reference for clinicians and laboratory staff using this point-of-care diagnostic test in UK healthcare settings. The Afinion HbA1c assay, manufactured by Abbott and used on the Afinion AS100 and Afinion 2 analysers, measures glycated haemoglobin in whole blood using boronate affinity chromatography, delivering results within minutes. Understanding the package insert — covering intended use, specimen requirements, performance data, quality control, and regulatory status — is critical for safe, accurate, and compliant use in GP surgeries, diabetes clinics, and community health services across the NHS.

What Is the Afinion HbA1c Test and How Does It Work?

The Afinion HbA1c test is a point-of-care assay using boronate affinity chromatography to measure glycated haemoglobin in whole blood on the Afinion AS100 or Afinion 2 analyser, returning results in 3–5 minutes.

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The Afinion HbA1c test is a point-of-care (POC) diagnostic assay designed to measure glycated haemoglobin (HbA1c) levels in whole blood. It is manufactured by Abbott (formerly Alere) and is intended for use on the Afinion AS100 and Afinion 2 analysers — compact benchtop devices commonly found in GP surgeries, diabetes clinics, and community health settings across the UK.

HbA1c reflects the average blood glucose concentration over the preceding two to three months, as glucose binds irreversibly to haemoglobin A in red blood cells. The Afinion system uses a boronate affinity chromatography method to separate glycated haemoglobin from non-glycated haemoglobin. A small capillary blood sample is applied to a reagent cartridge, which is then inserted into the analyser. The device processes the sample and delivers a result — typically within three to five minutes — expressed in both mmol/mol (IFCC units) and as a percentage (NGSP/DCCT units).

This rapid turnaround makes the Afinion HbA1c test particularly valuable in clinical settings where same-appointment decision-making is beneficial, such as during diabetes monitoring reviews or when adjusting treatment. The test holds NGSP certification, supporting its comparability with standard laboratory HbA1c assays.

It is worth noting that boronate affinity methods are generally less susceptible to interference from common haemoglobin variants than some other analytical approaches; however, interference is still method-specific. Clinicians should consult the current Abbott Afinion HbA1c Instructions for Use (IFU) and the NGSP method interference table for precise details on which variants and conditions may affect results. Understanding the principles behind the test helps clinicians appreciate both its utility and its limitations in everyday practice.

Key Information From the Afinion HbA1c Package Insert

The package insert specifies a measuring range of approximately 20–150 mmol/mol, within-run CVs typically below 3%, and lists interference sources including haemoglobin variants, lipaemia, and haemolysis.

The package insert (also referred to as the Instructions for Use, or IFU) is the primary technical document supplied with the Afinion HbA1c test cartridges. It provides essential information for operators regarding the test's intended purpose, methodology, performance characteristics, and safe use. Clinicians and laboratory staff should always consult the most current version of the IFU supplied with each lot of cartridges, as specifications may be updated following regulatory review.

Key data typically outlined in the Afinion HbA1c package insert includes:

• Measuring range: The assay is validated across a clinically relevant range. Published IFUs typically specify a range of approximately 20–150 mmol/mol (approximately 4.0–15.0% NGSP); the exact limits should be confirmed in the current IFU supplied with each cartridge lot.

• Precision and accuracy: The insert details within-run and between-run coefficients of variation (CVs), which are typically below 3%, indicating strong reproducibility.

• Interference data: The document lists substances and conditions known to potentially affect results — including specific haemoglobin variants, elevated bilirubin, lipaemia, and haemolysis — with defined tolerance limits. Operators should refer to the exact thresholds stated in the current IFU and the NGSP method interference table.

• Reporting units and traceability: Results are reported in mmol/mol (IFCC) and as a percentage (NGSP). Clinical decision thresholds are defined by NICE and WHO guidance, not by the analytical IFU itself.

The package insert also specifies that the test is intended for professional use only and should not be used for self-testing by patients at home. Operators are advised to complete appropriate training before using the device. Reviewing the IFU in full before first use — and whenever a new lot number of cartridges is introduced — is considered best practice and is consistent with MHRA guidance on in vitro diagnostic (IVD) devices.

Intended Use, Specimen Requirements and Testing Procedure

The test is intended for monitoring long-term glycaemic control using K2-EDTA venous or fresh capillary blood; approximately 1.5 µL is required, and POC results must not be used alone to diagnose diabetes.

According to the Afinion HbA1c package insert, the test is intended for the quantitative determination of HbA1c in venous or capillary whole blood samples. It is designed as an aid in the monitoring of long-term glycaemic control in individuals with diabetes mellitus.

An important clinical note: NICE, WHO, and NHS guidance recommend that the diagnosis of diabetes using HbA1c should be made using a quality-assured, IFCC-standardised laboratory method — not a POC device. POC HbA1c results should not be used as the sole basis for diagnosing diabetes. Clinicians should follow local NHS protocols and refer to NICE NG28 and WHO 2011 guidance on this point.

Specimen requirements must be followed precisely to ensure result accuracy:

• Sample type: K2-EDTA anticoagulated venous whole blood or fresh capillary blood collected via fingerstick.

• Sample volume: Approximately 1.5 µL of whole blood is required per test.

• Sample stability: Refer to the current IFU for exact stability limits for both capillary and venous samples under specified storage conditions.

• Haemolysed, lipaemic, or icteric samples should be avoided, as these may affect result integrity.

The testing procedure involves loading the blood sample into the Afinion HbA1c cartridge using the supplied capillary tube or pipette, inserting the cartridge into the analyser, and awaiting the automated result. The analyser performs all processing steps internally, minimising operator variability.

The Afinion system uses lot-specific automatic calibration; there is no user calibration routine. Operators should ensure that lot information is correctly loaded into the analyser, that the device has been maintained in accordance with the manufacturer's instructions, and that quality control checks have been completed prior to patient testing. Staff should follow the manufacturer's step-by-step instructions as set out in the current IFU.

Interpreting HbA1c Results in Line With NHS and NICE Guidance

NICE NG28 defines 48 mmol/mol as the diagnostic threshold for type 2 diabetes (by laboratory method) and 42–47 mmol/mol as non-diabetic hyperglycaemia; targets for treated diabetes are individualised.

Interpreting Afinion HbA1c results correctly requires familiarity with both the test's output and the clinical thresholds recommended by NICE and the NHS. Results are reported in mmol/mol (IFCC), which is the standard unit used in the UK following harmonisation in 2011, though the percentage equivalent (NGSP) may also be displayed for reference.

NICE guidance (NG28) provides the following key thresholds for clinical decision-making in adults:

• HbA1c of 48 mmol/mol (6.5%) or above on two separate occasions is diagnostic of type 2 diabetes in asymptomatic individuals (once in those with symptoms), provided measurement is by a quality-assured laboratory method.

• HbA1c of 42–47 mmol/mol (6.0–6.4%) indicates non-diabetic hyperglycaemia (sometimes referred to as prediabetes), warranting lifestyle intervention and regular monitoring.

• HbA1c below 42 mmol/mol (6.0%) is generally considered within the normal range.

Important diagnostic cautions (NICE/WHO): HbA1c should not be used to diagnose diabetes in the following circumstances: suspected type 1 diabetes; children and young people; pregnancy or the postpartum period; acute illness; or where symptoms have developed within the preceding two months. In these situations, fasting plasma glucose or oral glucose tolerance testing should be used instead, and specialist advice sought as appropriate.

For people already diagnosed with diabetes, NICE recommends an individualised HbA1c target:

• 48 mmol/mol (6.5%) for those managed by lifestyle measures or metformin alone.

• 53 mmol/mol (7.0%) for those on any therapy that carries a risk of hypoglycaemia (e.g., sulphonylureas, insulin).

Targets should always be individualised, taking into account the person's circumstances, comorbidities, and risk of hypoglycaemia.

HbA1c may also be unreliable in conditions affecting red cell lifespan or haemoglobin structure, including haemolytic anaemia, iron deficiency anaemia, haemoglobin variants (e.g., sickle cell trait), recent blood transfusion, erythropoietin therapy, and advanced chronic kidney disease. Alternative diagnostic or monitoring methods should be considered in these circumstances. Clinicians should always interpret results within the broader clinical context and document findings in line with local NHS protocols.

Quality Control, Limitations and Contraindications

External liquid QC and EQA participation are mandatory; key limitations include potential interference from haemoglobin variants, conditions affecting red cell lifespan, and operator error.

Robust quality control (QC) is a fundamental requirement for any point-of-care testing programme, and the Afinion HbA1c system is no exception. The package insert specifies that both internal and external quality control procedures must be performed regularly. The Afinion analyser incorporates internal electronic and optical checks with each test run, but external liquid QC materials — supplied separately — should be run in accordance with the current IFU, local standard operating procedures (SOPs), and risk assessment (for example, when opening a new lot of cartridges, following maintenance, and when results appear clinically discordant).

External quality assurance (EQA) participation is strongly recommended and is a requirement under UKAS accreditation to ISO 15189 and ISO 22870 (the international standard for POCT quality management) for POC testing services. Organisations such as WEQAS and UK NEQAS offer HbA1c EQA schemes suitable for POC devices including the Afinion system. MHRA guidance on point-of-care testing should also be consulted when establishing or reviewing a POC service.

Known limitations of the Afinion HbA1c test, as outlined in the package insert, include:

• Haemoglobin variants: Boronate affinity methods are generally less susceptible to interference from common haemoglobin variants (e.g., HbS, HbC, HbE) than some other methods; however, specific tolerance limits are method-dependent. Operators should consult the current IFU and the NGSP method interference table for precise information. Conditions affecting red cell lifespan (e.g., haemolytic anaemia, iron deficiency, recent transfusion) can still falsely lower or raise HbA1c values regardless of method.

• Operator error: Incorrect sample application, use of expired cartridges, failure to load correct lot information, or inadequate device maintenance can compromise results.

• Samples outside specification: Haemolysed, lipaemic, or icteric samples, and samples outside the validated measuring range, should not be tested.

Contraindications include use outside the validated measuring range and use with sample types not specified in the IFU. Regarding use in children and young people: whilst there may not be an absolute analytical contraindication in the IFU, the clinical use of POC HbA1c for diagnosis in paediatric populations is subject to separate clinical and governance considerations; local protocols and specialist guidance should be followed.

Storage, Handling and Regulatory Status in the UK

Cartridges must be stored at 2–8°C and not frozen; the device is regulated by the MHRA as an IVD under UK Medical Devices Regulations 2002, with adverse incidents reportable via the Yellow Card scheme.

Correct storage and handling of Afinion HbA1c cartridges is essential to maintain reagent integrity and ensure accurate results. According to the package insert, cartridges should be stored at 2–8°C (refrigerated) and must not be frozen. Before use, cartridges should be allowed to equilibrate to room temperature for the period specified in the current IFU (operators should refer to the exact IFU requirement rather than an approximate duration), to prevent condensation affecting the reagent chemistry.

Additional handling guidance includes:

• Do not use cartridges beyond their stated expiry date, as reagent degradation may lead to inaccurate results.

• Protect cartridges from direct sunlight and humidity, which can compromise the boronate affinity matrix.

• Each cartridge is for single use only and must be disposed of in accordance with local clinical waste regulations.

• The analyser itself should be stored and operated within the temperature and humidity ranges specified in the device manual.

• Any allowable room-temperature storage periods for cartridges (once removed from refrigeration) should be confirmed in the current IFU.

In terms of regulatory status, the Afinion HbA1c test is classified as an in vitro diagnostic (IVD) medical device. In the UK, IVD devices are regulated by the MHRA under the UK Medical Devices Regulations 2002 (as amended). The device previously held CE marking under the EU IVD Directive (98/79/EC). MHRA transitional arrangements currently allow continued recognition of CE marking for a defined period; healthcare organisations should confirm the current regulatory status of the device with their medical devices lead or procurement team and check the MHRA device register for the latest position.

If a suspected safety issue or adverse incident involving the Afinion device is identified, this should be reported to the MHRA via the Yellow Card scheme for medical device incidents (available at yellowcard.mhra.gov.uk).

For the most up-to-date technical specifications, always refer to the current package insert supplied with each lot of cartridges, and consult the Abbott technical support team or the MHRA device register if regulatory queries arise.

Frequently Asked Questions