By Alyx Arnett
For many years, the scientific lab’s contribution to diabetes care adopted a well-known script: A affected person confirmed up with signs, a clinician ordered an A1C or fasting glucose check, and the lab returned a quantity confirming the analysis.
That mannequin is beginning to shift. The 2026 American Diabetes Affiliation Requirements of Care place better emphasis on earlier identification and extra exact classification of diabetes, together with using islet autoantibody testing in folks at elevated threat for sort 1 diabetes.1
“Ten years in the past, the lab’s function in sort 1 diabetes was predominantly to substantiate illness,” says Jeanie Chiu, MD, medical director at Beckman Coulter Diagnostics. “Immediately, the paradigm has shifted towards presymptomatic detection and staging.”
That shift is prompting labs to rethink how they manage testing, which assays they provide, and the way outcomes are reported to clinicians.
A1C Stays Central, however Context Issues Extra
A1C testing isn’t going wherever. The 2026 requirements reaffirm it as a cornerstone of diabetes screening and monitoring, with continued emphasis on Nationwide Glycohemoglobin Standardization Program-certified strategies traceable to the Diabetes Management and Issues Trial reference assay.1 However the requirements additionally underscore that A1C has limits and spotlight the significance of recognizing when outcomes could also be unreliable.
Situations reminiscent of anemia, altered crimson blood cell turnover, being pregnant, persistent kidney illness, and up to date transfusion can all skew A1C outcomes. “A1C is a robust marker, however it displays glycation over erythrocyte lifespan,” says Michael O’Bryan, MD, MHA, headquarters director of medical science liaisons for diagnostics at Siemens Healthineers. “When that lifespan modifications, interpretation should be adjusted accordingly.”
Chiu factors to fructosamine as a sensible various when A1C reliability is in query. “Fructosamine serves instead for sufferers whose HbA1c could also be unreliable as a consequence of situations the place crimson blood cells have shortened lifespans,” she says. “In these instances, fructosamine supplies a two- to three-week snapshot of glycemic management.”
On the analytical facet, Chiu says fashionable A1C assays have made significant beneficial properties. Older strategies required guide pattern lysis or advanced pretreatment steps, creating bottlenecks and errors in busy labs. Present enzymatic and immunoturbidimetric designs embody on-board automated lysis, permitting labs to load the first tube with out further preparation steps.
“As well as, the trade has made unimaginable strides in analytical specificity,” she says. “We will now report correct HbA1c ends in the presence of widespread hemoglobin variants like hemoglobin S, hemoglobin C, or hemoglobin D. It is a big win for well being fairness.”
Past A1C: The Cardiometabolic Panel Takes Form
O’Bryan says many labs are shifting away from standalone A1C orders towards broader cardiometabolic panels. “A very powerful shift underway is conceptual,” says O’Bryan. “Diabetes testing is evolving from remoted glucose or A1C measurement towards built-in cardiometabolic threat evaluation.”
Labs are more and more operating A1C alongside lipid profiles, renal markers reminiscent of creatinine and eGFR, urinary albumin-to-creatinine ratio, insulin, and C-peptide—all from a single pattern on a consolidated platform, he says.
O’Bryan describes this as a shift “from volume-driven A1C testing towards built-in cardiometabolic panels and automation methods.” That shift aligns with how typically diabetes happens alongside situations reminiscent of weight problems, heart problems, persistent kidney illness, and metabolic dysfunction–related steatotic liver illness, as famous within the 2026 requirements.1
Consolidating these assays onto core chemistry or built-in immunoassay/chemistry programs gives a number of operational benefits. O’Bryan cites workflow consolidation, diminished footprint and upkeep from eliminating standalone analyzers, improved turnaround instances, and the power to help holistic diabetes evaluation from screening by means of complication monitoring.
Chiu says the benefit of consolidation turns into clear in routine pattern dealing with. “Each time a secondary tube is poured off or a pattern is moved between ‘islands’ of automation, the chance of labeling errors and specimen degradation will increase,” she says. “A single platform additionally considerably improves turnaround time. If a clinician wants a C-peptide to make clear a analysis, operating it on the identical observe because the routine chemistry panel means the result’s delivered in minutes or hours, not days.”
C-peptide itself has gained new relevance. Chiu describes “fairly a resurgence” in its use, significantly for differentiating sort 1 from sort 2 diabetes in adults, the place scientific presentation will be ambiguous. It additionally performs a task in assessing residual beta-cell perform to information insulin remedy selections.
Autoantibody Testing Steps Out of the Analysis Lab
One space drawing elevated consideration is islet autoantibody testing, which might establish presymptomatic sort 1 diabetes in folks at elevated threat. The requirements talk about testing for autoantibodies towards insulin, GAD, IA-2, and ZnT8 in people with a household historical past of sort 1 diabetes or elevated genetic threat, and description a three-stage mannequin of illness development that permits clinicians to establish the illness earlier than signs seem.1
As consciousness grows, Lisa-Jean Clifford, president of Gestalt Diagnostics, says laboratories which have by no means provided autoantibody panels are starting to see requests for them.
Chiu provides that early identification reduces the chance of diabetic ketoacidosis, permits affected person schooling, and helps well timed use of disease-modifying therapies reminiscent of teplizumab.
However early detection isn’t nearly timing; it’s additionally about accuracy. Misclassification stays a problem, significantly in adults whose signs can resemble sort 2 diabetes. Clifford says the issue is widespread. “A major variety of adults who’re initially identified with sort 2 diabetes are literally sort 1,” she says. “And conversely, numerous adults who’re identified with sort 1 diabetes are literally not.”
The ADA requirements word that as much as 40% of adults with new-onset sort 1 diabetes could initially be misclassified.1 Autoantibody testing on the level of early analysis can appropriate that. “Utilizing autoantibody testing in early analysis not solely supplies an accurate classification however is important, as identification means degrades in long-standing illness,” Clifford says.
For labs implementing these panels, Jessica Dunne, MD, sort 1 diabetes medical director at Sanofi, factors to a number of concerns. “Scientific cutoffs should be predefined and validated per established steering previous to scientific deployment, and [quality control] should cowl every of the 4 autoantibodies,” she says. “Labs will want clear protocols for decoding two impartial plate studies, dealing with invalid plate eventualities, and figuring out when follow-up confirmatory testing or reflex metabolic testing for staging is clinically acceptable.”
Multiplex Assays and Dried Blood Spots Broaden Testing Choices
Increasing autoantibody testing would require assays designed to deal with larger volumes. A number of producers are growing multiplex platforms that may check for a number of autoantibodies from a single specimen.
Madhuri Hegde, PhD, senior vice chairman and chief scientific officer at Revvity, describes the corporate’s 4-plex assay, which delivers a mixed outcome for GAD, IA-2, and ZnT8 plus a separate insulin autoantibody outcome from one specimen. “When a mixed constructive result’s detected, the system helps a transparent reflex testing protocol that guides laboratories by means of confirmatory particular person antibody testing,” Hegde says. “This two-tier strategy balances effectivity in preliminary screening with diagnostic precision in affirmation.”
A key function of Revvity’s strategy is specimen flexibility. The assay works with dried blood spot playing cards—each capillary and venous blood on filter paper—which stay steady at room temperature and get rid of chilly chain necessities. “This permits dwelling assortment the place people mail samples to laboratories, extends entry to distant areas the place refrigerated transport is impractical, and reduces complexity and value,” Hegde says. For labs already operating genetic screening processor platforms for new child screening, including sort 1 diabetes screening requires no new capital funding, Hegde says.
However scaling these approaches past particular person labs can even rely on regulatory approval and standardization, says Dunne. “In vitro diagnostics (IVD) standing is important for population-scale screening as a result of it ensures standardized, validated scientific efficiency and high quality merchandise manufactured beneath GMP throughout all deploying laboratories,” she says. “IVD clearance additionally facilitates reimbursement, permits broad deployment throughout industrial lab networks, and helps the multi-jurisdictional regulatory technique wanted to advance sort 1 diabetes screening globally.”
Serving to Clinicians Interpret Outcomes
As autoantibody testing expands, laboratories and clinicians might have extra assist decoding the outcomes, in line with Dunne. She says constructive findings have to be positioned in the precise scientific context, together with confirmatory testing, metabolic staging, and referral pathways. She additionally notes that main care and pediatric clinicians will want clear steering on learn how to act on outcomes.
Clifford says labs ought to present greater than uncooked numbers, together with “standardized reporting templates that embody clear scientific explanations of each the testing that was performed and the outcomes.” She provides, “There might be informational or academic phrases, definitions, and explanations of the completely different autoantibody assays which can be used and the way they differ within the means to offer early and extra correct analysis versus earlier testing strategies.”
Based on Dunne, a constructive display is simply the start line, and labs want clear pathways for what comes subsequent. “We want the convergence of validated IVD-approved assays, clear scientific pathways defining what occurs after a constructive display—confirmatory testing, metabolic staging, referral—and reimbursement that helps the total screening-to-intervention continuum,” Dunne says. “Equally vital are scientific and nationwide pointers, in addition to supplier schooling in order that main care and pediatrics can act on outcomes.”
Level of Care and Core Lab: Complementary, Not Competing
Diabetes testing is happening throughout each point-of-care and core laboratory settings, with diagnostics leaders pointing to distinct roles for every.
Level-of-care A1C testing, when carried out on US Meals and Drug Administration-approved units in CLIA-certified settings, allows clinicians to make quick selections in outpatient and decentralized settings. O’Bryan describes a tiered strategy, with “point-of-care testing in outpatient and non-traditional settings, together with pharmacies, to increase entry and allow quick decision-making, complemented by core laboratory integration for high-throughput, complete cardiometabolic analysis.”
Clifford anticipates that point-of-care diabetes testing “will evolve to incorporate extra complete testing, permitting for extra constant monitoring of a affected person’s illness state, and supply clinicians with data that they can act upon sooner.”
On the similar time, laboratory testing stays central to analysis and interpretation. Chiu notes that steady glucose monitoring (CGM), whereas more and more widespread, enhances fairly than replaces lab testing. “Prognosis nonetheless requires lab-confirmed A1C or glucose. CGM-derived glucose administration indicator is supportive however not standalone,” she says. When clinicians see discrepancies between CGM knowledge and lab-based A1C, “the lab is the primary place they flip for an evidence,” she says.
What Comes Subsequent
The near-term outlook for scientific labs in diabetes testing factors to rising volumes, increasing check menus, and stress to do extra with restricted employees. Chiu predicts that essentially the most quick change laboratorians will discover is “a fast rise in check orders for islet autoantibody panels for T1D threat screening because of the up to date 2026 ADA requirements of care.”
Hegde says the shift will prolong past preliminary testing into what occurs after a result’s returned, together with “confirmatory testing and longitudinal monitoring workflows tied to early-stage illness identification and therapy eligibility.”
As testing expands, laboratories are additionally dealing with sensible challenges round entry, availability, and clinician consciousness. Clifford says one of many largest gaps is not only capability, however making certain suppliers know when and the place to order these assessments.
“The gaps are extra in clinician entry to present data concerning the testing that’s accessible and to find out who and when to order it for,” Clifford says. “Not all laboratories could have the assays accessible on their check menus, and clinicians could have to seek out labs that do provide autoantibody testing which can be outdoors their current community.”
Finally, the shift towards earlier detection is driving these modifications. “A considerable proportion of people with diabetes stay undiagnosed, underscoring the necessity for earlier identification methods,” O’Bryan says.
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Reference
- American Diabetes Affiliation Skilled Observe Committee for Diabetes. Prognosis and classification of diabetes: Requirements of Care in Diabetes—2026. Diabetes Care. 2026;49(Suppl 1):S27-S49.
Alyx Arnett is chief editor of CLP. Query or feedback? E mail [email protected].
