Guthrie test

Documented method identity

Require evidence of the analytical method independently of the recorded test name.

1. Does Guthrie test mean the bacterial inhibition assay or a broader newborn blood spot screen in this record? definition
2. Which laboratory report or procedure establishes the method actually performed? provenance

Phenylalanine screening target

Distinguish detection of elevated phenylalanine from confirmation of its cause.

1. Is this instance newborn screening, a documented monitoring use or another application? definition
2. Which conclusions about phenylketonuria require evidence beyond this assay? boundary

Collection context adequacy

Record timing and relevant clinical circumstances without inventing a universal collection schedule.

1. What was the infant's age when the specimen was collected, and does it meet the programme's collection rule? measurement
2. Which feeding, prematurity, illness or treatment circumstances does the applicable protocol require reviewers to consider? boundary

Testable blood spot

Capture specimen acceptance, handling history and the link between card, punched disc and assay position.

1. Do spot saturation, drying, contamination and transport history meet the assay's acceptance criteria? measurement
2. Can the tested disc and its plate position be traced unambiguously to the infant's specimen? provenance
3. Which observed defects require another disc, recollection or rejection under the procedure? action

Phenylalanine-responsive inhibition

Document how the procedure establishes an inhibited bacterial background and a phenylalanine-responsive growth signal.

1. Which bacterial strain, inhibitor and medium does the documented Guthrie procedure specify? definition
2. Which protocol or validation record supports the selected incubation and reading conditions? provenance

Interpretable assay run

Require acceptable standard responses and control performance before classifying patient specimens.

1. Did the phenylalanine standards and controls satisfy the procedure's acceptance criteria? measurement
2. What evidence addresses possible antimicrobial interference, contamination or abnormal background growth? measurement
3. When must the laboratory invalidate the run or investigate a specimen-specific growth anomaly? action

Semiquantitative phenylalanine estimate

Represent the reported value or interval at the resolution supported by the growth comparison.

1. Which standard growth zones bracket or match the specimen's observed growth? measurement
2. What original units, interval and reading uncertainty accompany the phenylalanine estimate? measurement

Protocol-specific screening category

Record the applicable cutoff or interval rule, its version and the resulting screening category.

1. Which laboratory and programme rule governed classification on the test date? provenance
2. Does the valid estimate fall below the action threshold, in a borderline interval or in a screen-positive category? measurement
3. What limitations prevent this category from independently confirming or excluding a clinical diagnosis? boundary

Appropriate repeat or referral

Link each disposition to the next step specified by the responsible programme.

1. Does this result require repeat analysis, a new specimen or clinical referral under the applicable pathway? action
2. Which role owns the next action, and what documented deadline applies? action

Acknowledged follow-up outcome

Keep receipt, follow-up completion and diagnostic outcome distinct from the original screening result.

1. Was the result acknowledged by the responsible clinical service, and what follow-up remains outstanding? action
2. Which linked confirmatory investigation or clinical assessment resolves the screening episode? provenance
3. Which diagnostic and treatment decisions belong to the linked phenylketonuria or hyperphenylalaninaemia model? boundary

Check these first

Recalled without web access and unsourced; every item is a lead to verify.

1. Which of these check these first hold for the sense of Guthrie test this model covers, and on what evidence? provenance

Real-world use

Recalled without web access and unsourced; every item is a lead to verify.

1. Which of these real-world use hold for the sense of Guthrie test this model covers, and on what evidence? provenance

Typical measurements

Recalled without web access and unsourced; every item is a lead to verify.

1. Which of these typical measurements hold for the sense of Guthrie test this model covers, and on what evidence? provenance

Failure modes and hazards

Recalled without web access and unsourced; every item is a lead to verify.

1. Which of these failure modes and hazards hold for the sense of Guthrie test this model covers, and on what evidence? provenance

Regional variation

Recalled without web access and unsourced; every item is a lead to verify.

1. Which of these regional variation hold for the sense of Guthrie test this model covers, and on what evidence? provenance

Neighbouring kinds and how to tell them apart

Recalled without web access and unsourced; every item is a lead to verify.

1. 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? provenance