Comparison. Specify which test or service is being assessed and which activities the calculation covers.

Reagents. Distinguish transport conditions from storage conditions and conditions of use after opening.

Materials. Assess any reductions alongside the risk of contamination and the instructions for use.

Verification. Check both the measured impact and whether diagnostic performance is maintained.

A laboratory seeking to reduce its consumption can start with what staff see every day, such as opened packs, expired reagents or equipment left running. EFLM guidance also covers building services and transport, which often fall under different teams’ responsibilities [1]. The assessment therefore calls for discussion between the laboratory, facilities managers and procurement staff.

Decisions should be examined in the setting where they will take effect. Consider ordering larger packs to reduce packaging material. At a site that carries out few tests, some of the contents could expire after opening. This possibility can be checked by recording actual use. The calculation must also include unused material and apply the same criterion to the alternatives [2].

Life cycle assessment (LCA) examines the impacts associated with the stages in the life of a product or service. The European Product Environmental Footprint (PEF) method requires a description of the function provided, the quantity required, the expected quality and the reference duration. Together, these define the functional unit. The calculation also requires explicit boundaries and data appropriate to the system under study [2].

For a diagnostic comparison, one might choose, for example, a test that delivers a valid result within a specified time. The definition should be tailored to the clinical question.

If two methods yield different information, the first step is to clarify which results are needed and verify the required performance. A difference in emissions cannot establish equivalence.

The type of impact must also be specified. A carbon footprint expressed in carbon dioxide equivalents (CO₂e) measures the contribution to climate change. The PEF method also considers other categories, including water and resource use. An assessment confined to emissions must state that choice [2].

A study published in 2020 examined five common tests at two hospitals in Melbourne. It assessed the additional impact of a single test, including sample collection materials and resources used in the analysis. For several tests, sample collection and the associated materials accounted for the largest share of the carbon footprint [3]. The authors treated the C-reactive protein assay differently. As it was ordered alongside other tests, they attributed only the additional energy and reagents to the assay, with no additional blood draw. They also excluded long-lived infrastructure. The study examined tests other than PCR and illustrates how choices made in the calculation affect the result. Its estimates cannot be used as the footprint of a molecular test [3].

In practice, when several tests share one sample, an explicit allocation rule is needed. Attributing the entire collection to each test would count the same activity several times. Omitting collection from every analysis would leave it out altogether. A comparison between a central laboratory and a local site likewise needs to account for the activities actually carried out.

The EFLM includes the appropriate use of tests among its measures for more sustainable laboratory management [1]. Decisions about which tests to perform remain clinical. An environmental assessment can then record how much material is used to meet that request, including any subsequent analyses.

For qPCR, MIQE 2.0 calls for sample documentation, assay verification and the controls needed to interpret the results. These recommendations cover research and the reporting of results and help make experiments reproducible [4]. One practical approach to studying waste in a service is to supplement these checks with a record of repeat analyses and their causes.

Repeating a test because a sample has deteriorated is different from running a control required by the protocol. The two should be counted separately. The same principle applies when comparing a multiplex panel, which looks for several targets in one analysis, with separate tests. The assessment needs to establish which reactions are actually avoided and which investigations are still necessary. MIQE requires validation of the multiplex reaction. Any environmental advantage requires a separate calculation [4].

When assessing supplies for sites that are difficult to reach, it is necessary to know the conditions under which the reagents retain their stated performance. The WHO technical guidance document TGS–2 distinguishes stability during transport from shelf life in storage and from stability after opening or reconstitution [5].

For example, a reagent’s ability to withstand high temperatures in transit does not establish how long it remains usable after opening. Temperature and humidity must be assessed in relation to the intended route. The guidance also calls for verification that transport does not compromise performance over the remaining shelf life [5].

To assess a freeze-dried formulation from an environmental perspective, the comparison should document production and packaging as well as the resources used for storage under each alternative. The quantities discarded in both configurations should also be considered. This is an application of life cycle comparison. Stability data alone do not quantify any emissions savings [2,5].

The laboratory may also need to make decisions about stock management. It helps to distinguish a batch that expired unopened from a pack discarded with reagent left over after opening. The two records point to different options to discuss with the service manager, such as changing the order frequency or the pack size. Any change to ordering must still respect the storage and use conditions specified for the product.

Waste segregation depends on risk. WHO distinguishes general healthcare waste from infectious, chemical and other hazardous waste and stresses the need for safe management [6]. In the laboratory, a clean outer box and a contaminated item require different assessments. Local procedures must help staff identify the correct waste stream even at busy times.

Reusing consumables requires further checks. A 2026 study examined five reuse cycles for reconditioned materials in research applications with a low biological risk. The tests covered five types of consumable, but the environmental model covered only 50 mL tubes. The authors reported comparable performance in the selected tests and lower impacts in the simplified LCA. They did not test sterility directly or quantify endotoxins, and the LCA included neither an uncertainty analysis nor a sensitivity analysis. The authors disclosed industry funding and reported that two authors held equity in the reconditioning company [7].

These findings have a limited experimental scope and do not establish suitability for reuse in clinical diagnostics [7]. For in vitro diagnostic devices, the intended purpose and the manufacturer’s instructions matter, including single-use designations and any specified procedures for reusable products [8].

Maintenance should be considered from the point at which equipment is selected. WHO training material on equipment management covers the availability of support, staff training and procedures for dealing with faults. A maintenance programme helps extend the life of an instrument and limit interruptions [9]. This provides a basis for organising the service. It does not measure the emissions avoided.

For the environmental analysis, consumption can be recorded during operation and while instruments are idle, and related to the work actually performed. A site that handles few samples may have a different profile from one that operates continuously. The EFLM suggests identifying which devices can be switched off and which must remain in operation, and agreeing the rules with those responsible [1]. Changes must maintain the safety and performance specified for the device [8].

Distributing testing across local sites requires a comparison of the service arrangements as a whole. Some journeys might be avoided, while more sites might need equipment and supplies. The overall effect needs to be measured at the sites involved, taking the additional activities into account. Distance from the patient matters for access to the service and must be assessed separately from the environmental footprint.

In its 2025 report Energy and AI, the IEA estimates that data centres consumed around 415 TWh of electricity in 2024, or 1.5% of the global total. This estimate covers data centres as a whole and does not identify the consumption attributable to diagnostics or to a particular artificial intelligence application. It includes infrastructure for processing, storage and cooling [10].

In a diagnostic project, the comparison can start with a specific task. If software is proposed to avoid duplicate tests, the assessment needs to document how many duplications occurred beforehand and how many still occur. Any additional computing resources should be considered alongside the observed benefit. This is an example of an assessment that could be designed, rather than a result attributed to an existing platform.

When setting a data storage policy, the data needed to verify a result and reanalyse it must remain available. MIQE 2.0 also highlights this requirement for qPCR research [4].

Suppliers can provide data that the laboratory does not generate itself. For example, the laboratory can request packaging weights and transport conditions, specifying the configuration to which they apply. Comparing offers also requires information on where the data came from and which assumptions were made. The PEF method distinguishes data quality from representativeness. Using the same final indicator is only one part of the comparison [2].

Regulation (EU) 2025/40 on packaging generally applies from 12 August 2026, with specific deadlines for different obligations. Articles 6 and 7 provide exclusions for certain types of contact-sensitive packaging for in vitro diagnostic devices, concerning recyclability and recycled content respectively [11]. Applicability therefore needs to be assessed for each type of packaging and each provision. There is no general exemption for the diagnostics sector.

The contents still need protection. Under the IVDR, stability studies cover shelf life, use after opening and transport, with documented criteria [8]. Changes to packaging must be assessed against these conditions. When a comparison based on the PEF method is presented publicly, the method’s verification and validation requirements must also be met [2].

An initial local assessment can focus on a specific problem, such as reagent discarded after opening. Before the intervention, record the quantities purchased and used, and the reasons for disposal. Apply the same criteria in the following period and note changes in the number and type of tests performed. This is a proposed operational assessment to be agreed with the person responsible for the service.

Quality data must remain visible. If the new pack size reduces waste but leads to more preparation errors or repeat analyses, the comparison must include them. It is also necessary to distinguish an absolute reduction in consumption from lower consumption per test. The two measures can diverge if the volume of testing changes.

A full environmental comparison also requires data on the stages outside the laboratory and on the activities included in the calculation [2]. The report should identify any estimates. For example, the laboratory can check whether a different delivery frequency would change the conclusion. The manager can then identify which local measurements are sufficient and what information still needs to be requested from the supplier.

Choosing an environmental intervention in molecular diagnostics requires identifying the activities affected and obtaining the data needed to compare them. Checks on reagents and materials safeguard the analytical result. Measurements taken within the service show what changes in day-to-day work. Findings should be reported for the configuration studied.

A laboratory can start with a documented problem and involve suppliers to obtain missing information. Readers of the report should be able to trace the improvement back to the supporting data and understand how far the conclusion depends on the assumptions made. The evidence discussed here does not establish the environmental performance of any specific Helyx Industries S.p.A. product.