{"id":"bca226bc-a002-50ce-8905-a7364017ad38","stable_key":"33bef151-bdc7-5892-aff6-0345ab149739:immunoreactive-material-is-not-shown-to-be-active-enzyme","predicate":"does_not_establish","statement":"A polyclonal ELISA signal does not by itself distinguish intact catalytically active nattokinase from fragments, complexes or cross-reactive material.","claim_class":"mechanistic","status":"source_derived_draft","evidence_grade":"ungraded","direction":"neutral","is_public":true,"mechanism_event_id":"39f3905a-12cf-5270-a3b7-98f31315b529","mechanism_event_label":"A polyclonal ELISA signal does not by itself distinguish intact catalytically active nattokinase from fragments, complexes or cross-reactive material.","subject":{"id":"9d6038d5-8903-592d-9899-47ed9f3de183","slug":"nattokinase-immunoreactive-plasma-material","display_name":"Plasma nattokinase-immunoreactive material","entity_type_key":"cellular_process"},"object":{"id":"42b41a0d-c6d1-5147-83d8-b2e56a8bdab3","slug":"oral-active-nattokinase-plasma-exposure","display_name":"Systemic exposure to intact catalytically active nattokinase after oral dosing","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"39f3905a-12cf-5270-a3b7-98f31315b529","stable_key":"33bef151-bdc7-5892-aff6-0345ab149739:immunoreactive-material-is-not-shown-to-be-active-enzyme-event","event_type":"observed_intervention","label":"A polyclonal ELISA signal does not by itself distinguish intact catalytically active nattokinase from fragments, complexes or cross-reactive material.","description":"Serum","status":"provisional","compartment":null,"participants":[{"entity":{"id":"9d6038d5-8903-592d-9899-47ed9f3de183","slug":"nattokinase-immunoreactive-plasma-material","display_name":"Plasma nattokinase-immunoreactive material","entity_type_key":"cellular_process"},"role":"acting component","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"42b41a0d-c6d1-5147-83d8-b2e56a8bdab3","slug":"oral-active-nattokinase-plasma-exposure","display_name":"Systemic exposure to intact catalytically active nattokinase after oral dosing","entity_type_key":"cellular_process"},"role":"component the finding is about","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""}]},"contexts":[{"dimension":"duration","value_text":"Not stated here","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"evidence_access","value_text":"Primary PubMed abstract and indexed metadata reviewed. Full-text method details not stated here remain unresolved.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"Human","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"Anti-nattokinase polyclonal capture ELISA","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Recorded as an assay-scope limit, not as a negative finding. No study in the retrieved evidence immunocaptured the material and then measured catalytic activity on a substrate.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"organism","value_text":"Human","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"A polyclonal ELISA signal does not by itself distinguish intact catalytically active nattokinase from fragments, complexes or cross-reactive material.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"A pilot study on the serum pharmacokinetics of nattokinase in humans following a single, oral, daily dose. (2013) https://pubmed.ncbi.nlm.nih.gov/23709455/","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"route","value_text":"In vivo, oral","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue","value_text":"Serum","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"dd14bb2c-44d1-550a-94a8-b249a065bc9c","evidence_kind":"source_excerpt","locator":"Lines 829-829","start_line":829,"end_line":829,"excerpt":"A polyclonal ELISA signal does not by itself distinguish intact catalytically active nattokinase from fragments, complexes or cross-reactive material.","model_system":"Human","directness":"reported_statement","verification_status":"source_derived_draft","notes":"","relationship":"supports","weight":1.0,"link_notes":"","source":{"id":"41cb127c-1c23-53aa-b7d0-5ec7f6fa3c99","stable_key":"import-33bef151-bdc7-5892-aff6-0345ab149739","title":"Nattokinase: what the purified enzyme cleaves, what survives being eaten, and the gap between the two (2026-09-23)","document_type":"imported_text","citation_label":"Original AI-assisted curation built from a supplied entity-first document of 105 entities and 129 claims. Every reference in that document was resolved against live PubMed with its abstract read and its DOI cross-checked on 2026-09-23, and the EFSA novel-food opinion was retrieved and read in full. That check corrected two PMIDs that pointed at unrelated papers, two DOIs, and two papers recorded as carrying no erratum that do carry one; it also reversed three findings the supplied document had stated backwards. Two papers carry a published correction, recorded as such and not as a retraction. Three sources are not indexed in PubMed and are cited by what they have. Laboratory lineages are recorded, so the four papers from one group, the three from another and the two readings of a single applicant dossier cannot be counted as separate lines of support. Study-specific doses, units, populations and limitations retained; activity units are never converted between systems. Not publisher full text.","file_path":"","sha256":"34fc46e0e849d06bfa13cb099a79b50679dd6fd0de8a5a0575326afdde3259c1","revision_id":"efd063e6-e982-5f6e-a4b8-6f2ffe4185ce","review_status":"unverified_draft","notes":""}}],"relations":[{"id":"23f496c5-2651-5627-813b-5354b047c446","relation_type":"qualifies","notes":"What the assay detected is antibody-reactive material, which is not the same thing as intact active enzyme.","source_claim_id":"bca226bc-a002-50ce-8905-a7364017ad38","source_claim_key":"33bef151-bdc7-5892-aff6-0345ab149739:immunoreactive-material-is-not-shown-to-be-active-enzyme","source_statement":"A polyclonal ELISA signal does not by itself distinguish intact catalytically active nattokinase from fragments, complexes or cross-reactive material.","target_claim_id":"d5dcd9d3-e490-56a1-8b8d-5d4b8255eec4","target_claim_key":"33bef151-bdc7-5892-aff6-0345ab149739:a-single-oral-dose-produces-plasma-immunoreactivity","target_statement":"A single 2,000 FU oral NSK-SD dose produced anti-nattokinase immunoreactivity in serum that rose significantly from baseline between 2 and 24 h and peaked at about 13.3 +/- 2.5 h."}],"conflicts":[],"corrections":[],"research":null}