{"schema":"https://ver.cy/schemas/card/1.0.0","id":"vr.tr.guthrie-test","code":"thing-q1531016","url":"https://ver.cy/models/thing/q1531016/","name":"Guthrie test","alternateNames":[],"kind":"thing","status":"published","version":"0.1.0-research.1","language":"en","classifiers":{"family":"Thing Registry","category":"Activities and processes","entryKind":"thing","plane":"ACT","domain":["ACT.ACT"],"industry":[],"navPath":"","tags":[],"facets":{}},"whatItIs":"In this sense, the Guthrie test is the newborn blood collection procedure, commonly involving a heel-prick sample collected on a filter paper card for dried blood spot screening, rather than the laboratory assay subsequently applied to the specimen.","purpose":"Enable an agent to identify newborn blood collection for dried blood spot screening, assess whether collection records and specimen acceptance information meet the screening programme's requirements, and recognise issues requiring qualified clinical review.","scope":{"in":["Identification of newborn blood collection for dried blood spot screening.","The relationship between the newborn, collection record and specimen identifier.","Consent or other applicable authorization within the screening programme.","Documented specimen suitability and acceptance requirements.","Collection-related discomfort, injury and concerns requiring clinical review.","Handover to the screening programme and requests for repeat collection."],"out":["Phenylketonuria pathophysiology, definitive diagnosis and treatment.","The complete newborn screening programme and its other target conditions.","Filter paper cards as manufactured physical products.","Bacterial inhibition, fluorometric and tandem mass spectrometry assays as independent laboratory methods.","Analytical interpretation of screening results and confirmatory investigations.","Secondary research uses of stored newborn blood spots."],"boundaries":[]},"distinguishingFeatures":["The defining activity is collecting a newborn's blood for dried blood spot screening, rather than measuring a substance in the laboratory.","A heel-prick sample supports this identification only when its documented purpose is newborn dried blood spot screening.","A Guthrie card is the specimen carrier, while this sense of Guthrie test denotes the collection activity.","Collection does not itself produce a screening result or establish a diagnosis.","The laboratory may use different analytical methods without changing the identity of the preceding collection activity."],"structure":{"bundles":[{"id":"assay-identity-and-boundaries","name":"Assay identity and boundaries","description":"Establish what activity a Guthrie-labelled record actually represents.","layers":[{"id":"name-resolution","name":"Name resolution","description":"Resolve the local meaning before interpreting results.","findings":[{"id":"documented-method-identity","name":"Documented method identity","description":"Require evidence of the analytical method independently of the recorded test name.","questions":[{"text":"Does Guthrie test mean the bacterial inhibition assay or a broader newborn blood spot screen in this record?","id":"documented-method-identity-q01","kind":"definition"},{"text":"Which laboratory report or procedure establishes the method actually performed?","id":"documented-method-identity-q02","kind":"provenance"}]}]},{"id":"screening-purpose","name":"Screening purpose","description":"Identify the assay's intended use and the limits of its conclusion.","findings":[{"id":"phenylalanine-screening-target","name":"Phenylalanine screening target","description":"Distinguish detection of elevated phenylalanine from confirmation of its cause.","questions":[{"text":"Is this instance newborn screening, a documented monitoring use or another application?","id":"phenylalanine-screening-target-q01","kind":"definition"},{"text":"Which conclusions about phenylketonuria require evidence beyond this assay?","id":"phenylalanine-screening-target-q02","kind":"boundary"}]}]}]},{"id":"blood-spot-and-collection-context","name":"Blood spot and collection context","description":"Represent the specimen and collection circumstances needed to judge assay suitability.","layers":[{"id":"collection-timing-and-context","name":"Collection timing and context","description":"Connect the specimen to the infant and the applicable collection window.","findings":[{"id":"collection-context-adequacy","name":"Collection context adequacy","description":"Record timing and relevant clinical circumstances without inventing a universal collection schedule.","questions":[{"text":"What was the infant's age when the specimen was collected, and does it meet the programme's collection rule?","id":"collection-context-adequacy-q01","kind":"measurement"},{"text":"Which feeding, prematurity, illness or treatment circumstances does the applicable protocol require reviewers to consider?","id":"collection-context-adequacy-q02","kind":"boundary"}]}]},{"id":"spot-integrity-and-traceability","name":"Spot integrity and traceability","description":"Establish whether the tested disc represents an acceptable, correctly identified blood specimen.","findings":[{"id":"testable-blood-spot","name":"Testable blood spot","description":"Capture specimen acceptance, handling history and the link between card, punched disc and assay position.","questions":[{"text":"Do spot saturation, drying, contamination and transport history meet the assay's acceptance criteria?","id":"testable-blood-spot-q01","kind":"measurement"},{"text":"Can the tested disc and its plate position be traced unambiguously to the infant's specimen?","id":"testable-blood-spot-q02","kind":"provenance"},{"text":"Which observed defects require another disc, recollection or rejection under the procedure?","id":"testable-blood-spot-q03","kind":"action"}]}]}]},{"id":"bacterial-inhibition-and-run-validity","name":"Bacterial inhibition and run validity","description":"Represent the biological response and the evidence needed to accept an assay run.","layers":[{"id":"growth-response-system","name":"Growth response system","description":"Identify the biological reagents and conditions defining the implemented assay.","findings":[{"id":"phenylalanine-responsive-inhibition","name":"Phenylalanine-responsive inhibition","description":"Document how the procedure establishes an inhibited bacterial background and a phenylalanine-responsive growth signal.","questions":[{"text":"Which bacterial strain, inhibitor and medium does the documented Guthrie procedure specify?","id":"phenylalanine-responsive-inhibition-q01","kind":"definition"},{"text":"Which protocol or validation record supports the selected incubation and reading conditions?","id":"phenylalanine-responsive-inhibition-q02","kind":"provenance"}]}]},{"id":"standards-controls-and-interference","name":"Standards, controls and interference","description":"Determine whether growth can support phenylalanine estimation in this run.","findings":[{"id":"interpretable-assay-run","name":"Interpretable assay run","description":"Require acceptable standard responses and control performance before classifying patient specimens.","questions":[{"text":"Did the phenylalanine standards and controls satisfy the procedure's acceptance criteria?","id":"interpretable-assay-run-q01","kind":"measurement"},{"text":"What evidence addresses possible antimicrobial interference, contamination or abnormal background growth?","id":"interpretable-assay-run-q02","kind":"measurement"},{"text":"When must the laboratory invalidate the run or investigate a specimen-specific growth anomaly?","id":"interpretable-assay-run-q03","kind":"action"}]}]}]},{"id":"growth-reading-and-screening-classification","name":"Growth reading and screening classification","description":"Connect the observed growth pattern to a qualified phenylalanine estimate and screening decision.","layers":[{"id":"signal-to-estimate","name":"Signal to estimate","description":"Retain the original reading and its comparison with standards.","findings":[{"id":"semiquantitative-phenylalanine-estimate","name":"Semiquantitative phenylalanine estimate","description":"Represent the reported value or interval at the resolution supported by the growth comparison.","questions":[{"text":"Which standard growth zones bracket or match the specimen's observed growth?","id":"semiquantitative-phenylalanine-estimate-q01","kind":"measurement"},{"text":"What original units, interval and reading uncertainty accompany the phenylalanine estimate?","id":"semiquantitative-phenylalanine-estimate-q02","kind":"measurement"}]}]},{"id":"decision-rule-application","name":"Decision rule application","description":"Apply the appropriate interpretation rule without conflating screening with diagnosis.","findings":[{"id":"protocol-specific-screening-category","name":"Protocol-specific screening category","description":"Record the applicable cutoff or interval rule, its version and the resulting screening category.","questions":[{"text":"Which laboratory and programme rule governed classification on the test date?","id":"protocol-specific-screening-category-q01","kind":"provenance"},{"text":"Does the valid estimate fall below the action threshold, in a borderline interval or in a screen-positive category?","id":"protocol-specific-screening-category-q02","kind":"measurement"},{"text":"What limitations prevent this category from independently confirming or excluding a clinical diagnosis?","id":"protocol-specific-screening-category-q03","kind":"boundary"}]}]}]},{"id":"repeat-testing-and-clinical-handoff","name":"Repeat testing and clinical handoff","description":"Make the next screening action and its completion traceable.","layers":[{"id":"result-dependent-next-action","name":"Result-dependent next action","description":"Separate specimen failure, analytical uncertainty and abnormal screening findings.","findings":[{"id":"appropriate-repeat-or-referral","name":"Appropriate repeat or referral","description":"Link each disposition to the next step specified by the responsible programme.","questions":[{"text":"Does this result require repeat analysis, a new specimen or clinical referral under the applicable pathway?","id":"appropriate-repeat-or-referral-q01","kind":"action"},{"text":"Which role owns the next action, and what documented deadline applies?","id":"appropriate-repeat-or-referral-q02","kind":"action"}]}]},{"id":"confirmation-and-closure","name":"Confirmation and closure","description":"Connect the screening episode to subsequent assessment without absorbing diagnosis or treatment.","findings":[{"id":"acknowledged-follow-up-outcome","name":"Acknowledged follow-up outcome","description":"Keep receipt, follow-up completion and diagnostic outcome distinct from the original screening result.","questions":[{"text":"Was the result acknowledged by the responsible clinical service, and what follow-up remains outstanding?","id":"acknowledged-follow-up-outcome-q01","kind":"action"},{"text":"Which linked confirmatory investigation or clinical assessment resolves the screening episode?","id":"acknowledged-follow-up-outcome-q02","kind":"provenance"},{"text":"Which diagnostic and treatment decisions belong to the linked phenylketonuria or hyperphenylalaninaemia model?","id":"acknowledged-follow-up-outcome-q03","kind":"boundary"}]}]}]},{"id":"evidence-and-external-alignment","name":"Evidence and external alignment","description":"What the world already says about this thing, gathered so the model can be checked against it.","layers":[{"id":"reported-evidence","name":"Reported evidence","description":"Findings from the breadth pass, kept separate from the structural claims.","findings":[{"id":"evidence-confidence-notes","name":"Check these first","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these check these first hold for the sense of Guthrie test this model covers, and on what evidence?","id":"evidence-confidence-notes-q01","kind":"provenance"}]},{"id":"evidence-real-world-use","name":"Real-world use","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these real-world use hold for the sense of Guthrie test this model covers, and on what evidence?","id":"evidence-real-world-use-q01","kind":"provenance"}]},{"id":"evidence-measurements","name":"Typical measurements","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these typical measurements hold for the sense of Guthrie test this model covers, and on what evidence?","id":"evidence-measurements-q01","kind":"provenance"}]},{"id":"evidence-failure-modes-and-hazards","name":"Failure modes and hazards","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these failure modes and hazards hold for the sense of Guthrie test this model covers, and on what evidence?","id":"evidence-failure-modes-and-hazards-q01","kind":"provenance"}]},{"id":"evidence-regional-variation","name":"Regional variation","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these regional variation hold for the sense of Guthrie test this model covers, and on what evidence?","id":"evidence-regional-variation-q01","kind":"provenance"}]},{"id":"evidence-neighbours","name":"Neighbouring kinds and how to tell them apart","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these neighbouring kinds and how to tell them apart hold for the sense of Guthrie test this model covers, and on what evidence?","id":"evidence-neighbours-q01","kind":"provenance"}]}]}]}]},"agentConduct":{"may":["Explain the Guthrie test and the history of newborn screening.","Point parents to the screening programme or their doctor for questions about results."],"mustNot":["Interpret a specific infant's screening result for parents.","Discourage parents from newborn screening without medical basis.","Use or share stored newborn blood spots or results beyond the purposes parents consented to or law allows."],"requiresHuman":["Any decision on diet or treatment after a positive screen."]},"ethics":{"considerations":["Early screening prevents severe disability; delay can harm a child.","Stored newborn blood spots hold genetic information about whole families."],"affectedParties":["Newborns","Parents","Screening laboratories"]},"owners":{"steward":"The public health newborn screening programme of each jurisdiction.","roles":[],"masterSystems":[]},"relations":[{"target":"Q5307389","type":"parent","note":"registry parent class"}],"interaction":{"identity":{"applicability":"required","items":["Vercy registry: vr.tr.guthrie-test","Wikidata: Q1531016 (https://www.wikidata.org/wiki/Q1531016)"]},"properties":{"applicability":"not-applicable","items":["Recorded meaning of Guthrie test: Bacterial inhibition assay; broader blood spot screening usage; unresolved","Assay protocol: Laboratory procedure identifier, version and effective dates","Age at collection: Hours after birth","Blood spot suitability: Accepted; conditionally accepted; rejected; unassessed, with reasons","Bacterial growth zone: Diameter in millimetres or recorded comparison with standard discs","Estimated phenylalanine: Reported concentration or interval in mg/dL or µmol/L, with original units and method resolution","Assay run validity: Valid; invalid; pending review","Screening disposition: Below action threshold; borderline; screen positive; uninterpretable; pending","Follow-up linkage: Repeat specimen, referral and confirmatory investigation records"]},"recognition":{"applicability":"not-applicable","items":[]},"capabilities":{"applicability":"required","items":["Disambiguate a Guthrie-labelled record using its actual laboratory method.","Assess blood spot acceptance against the linked procedure.","Compare growth observations with standards while retaining measurement uncertainty.","Apply a documented screening decision rule only to a valid result.","Flag recollection or referral requirements and track their acknowledgement.","Reassess historical results using the protocol and method in force when testing occurred."]},"hazards":{"applicability":"required","items":["Incorrect specimen identification can assign screening findings to the wrong newborn.","An inadequate or contaminated specimen can produce unreliable findings or require repeat collection.","Delayed collection, transport or follow-up can postpone recognition of a screened disorder.","Collection can cause pain, bruising or local injury."]},"interfaces":{"applicability":"required","items":["CLSI NBS01, issued by the Clinical and Laboratory Standards Institute, addresses dried blood spot specimen collection for newborn screening.","ISO 15189, issued by the International Organization for Standardization, specifies quality and competence requirements for medical laboratories analyzing screening specimens."]},"context":{"applicability":"required","items":["In the supplied procedural sense, this term refers to collecting newborn blood spots for screening programs.","The collected specimen supports laboratory screening for selected disorders, with the screening panel determined by the responsible program.","The name also denotes a historical phenylalanine assay, so records should distinguish specimen collection from laboratory testing."]}},"sources":[{"title":"Wikidata item Q1531016: Guthrie test","url":"https://www.wikidata.org/wiki/Q1531016","note":"identity and sense of the item"},{"title":"Wikipedia: Neonatal heel prick","url":"https://en.wikipedia.org/wiki/Neonatal_heel_prick","note":"general description of the item"}],"openQuestions":["Does the registry's intended referent exclusively denote the original bacterial inhibition assay, or also regional uses of Guthrie test for an entire newborn blood spot screen?","Which original and subsequently validated protocols establish the assay variants, reagent identities and interference limitations that this model must distinguish?","Which jurisdictions and laboratories still perform the bacterial assay, and which retain the Guthrie name while using another analytical method?","What collection windows, reporting intervals, action thresholds and follow-up deadlines are supported by each applicable programme rather than historical examples?","Should documented uses for dietary monitoring remain variants within this entry, and what additional validation would those uses require?"],"resources":{"spec":"/models/things/publications/thing-q1531016/spec.json"},"provenance":{"origin":"thing registry research (pass 2)","builtFrom":["models/things/publications/thing-q1531016/spec.json"],"providers":["Codex"],"researchStatus":"unreviewed","generatedAt":"2026-09-12T10:08:29Z","builder":"tools/build_cards.py@1.0.0"},"completeness":{"sections":{"classifiers":"filled","whatItIs":"filled","purpose":"filled","distinguishingFeatures":"filled","structure":"filled","agentConduct":"filled","ethics":"filled","owners":"filled","relations":"filled","interaction.identity":"filled","interaction.properties":"not-applicable","interaction.recognition":"not-applicable","interaction.capabilities":"filled","interaction.hazards":"filled","interaction.interfaces":"filled","interaction.context":"filled","sources":"filled"},"notes":{"_gate":"Published through the thing publication gate 1.0 on 2026-10-07T12:16:29+00:00: completeness 1.00; sense: Wikidata description; 2 live sources; review by codex: pass","interaction.properties":"Plane ACT: no invented physical properties.","interaction.recognition":"A collection procedure has no intrinsic visual identity, and its purpose must be established from the clinical protocol and documentation."},"score":1.0}}