{"hq_id":"hq-p-spe-000014","name":"Home Rapid Antigen Test Kit (COVID-19 / respiratory)","category":{"primary":"specialty","secondary":"medical_diagnostic","tags":["medical_device","diagnostic","sodium_azide","child_safety"]},"product_tier":"SPE","overall_risk_level":"low","description":"Over-the-counter rapid antigen test kits for COVID-19 and other respiratory viruses. Contains nasal swab, extraction buffer (surfactant + salt solution), and lateral flow test strip with colloidal gold nanoparticles conjugated to antibodies. Buffer solution contains sodium azide (biocide, toxic if ingested) and Triton X-100 or Tween-20 surfactants. Primary safety concern is sodium azide in extraction buffer — toxic at small doses, especially to children.","synthesis":{"derived_risk_level":"insufficient_data","synthesis_confidence":0,"synthesis_method":"none","context_source":null,"compounds_resolved":0,"compounds_total":0,"synthesis_date":"2026-05-09","synthesis_version":"1.2.0","methodology_note":"exposure_modifier and adjusted_magnitude are computed from ALETHEIA-calibrated heuristics (route × duration × frequency multipliers, clamped to [0.5, 1.4]). Multipliers are directionally informed by EPA Exposure Factors Handbook (2011) and CalEPA OEHHA but are not regulatory consensus. See /api/methodology for full disclosure."},"hazard_summary":{"overall_risk":"low","primary_concerns":["Sodium azide in buffer (toxic if ingested — child poisoning cases reported)","Nasal mucosal irritation from swab","False sense of security from negative results"],"sensitive_populations":"Children (sodium azide ingestion risk), individuals with nosebleeds or nasal conditions","exposure_routes":"Mucosal (nasal swab), dermal (buffer handling)"},"exposure":{"routes":["dermal","mucosal"],"contact_types":[],"users":[],"duration":"minutes per test","frequency":"occasional","scenarios":["Dermal contact during handling of Home Rapid Antigen Test Kit (COVID-19 / respiratory) (minutes per test contact)"],"notes":"Nasal swab contact; buffer handling; child poisoning risk from sodium azide"},"consumer_guidance":{"red_flags":["Buffer accessible to children","Using expired tests","Nasal bleeding during swab"],"green_flags":["FDA authorized","Child-resistant buffer tube","Clear instructions in multiple languages"],"what_to_ask":["Does the buffer contain sodium azide?","Is this FDA EUA authorized?"],"alternatives":["PCR testing (higher accuracy)","At-home PCR collection kits"],"notes":null},"regulatory":{"applicable_regulations":["FDA EUA / 510(k)","CE-IVD (EU)","TGA (Australia)","MHRA (UK)"],"certifications":[],"labeling":{},"recalls":[],"regulatory_gap":null,"notes":null},"lifecycle":{"recyclable":"no (biohazard)","disposal_guidance":"Seal in plastic bag after use; standard waste (household); biohazard waste (clinical)","hazardous_waste":false,"expected_lifespan":"12-24 months (check expiration)"},"formulation":{"form":"extraction_buffer","key_ingredients":[{"hq_id":null,"name":"Sodium azide","role":"preservative_biocide","concentration_pct":"0.01-0.1"},{"hq_id":null,"name":"Triton X-100 / Tween-20","role":"surfactant","concentration_pct":"0.5-2"},{"hq_id":null,"name":"Phosphate buffer","role":"pH_buffer","concentration_pct":"1-5"},{"hq_id":null,"name":"Colloidal gold nanoparticles","role":"detection_conjugate","concentration_pct":"trace"}],"certifications":["FDA EUA or 510(k)","CE-IVD (EU)"]},"materials":{"common":[],"concerning":[],"preferred":[]},"compound_composition":[],"identifiers":{"manufacturer":"","common_names":[],"aliases":[],"brands":[]},"brand_examples":[{"brand":"Generic Mass-Market Brand A","manufacturer":"Consumer Products Corporation","market_position":"mass_market","notable":"Widely available mass-market option"},{"brand":"Generic Mass-Market Brand B","manufacturer":"Consumer Goods Ltd","market_position":"mass_market","notable":"Popular budget alternative"},{"brand":"Premium Brand A","manufacturer":"Premium Consumer Inc","market_position":"premium","notable":"Upscale premium positioning"},{"brand":"Professional Brand","manufacturer":"Professional Products Co","market_position":"professional","notable":"Professional/salon-grade option"},{"brand":"Specialty Eco-Brand","manufacturer":"Natural Products Ltd","market_position":"premium","notable":"Sustainable/natural product line"}],"brand_examples_disclaimer":"Representative branded products of this category. Concerning ingredients listed in materials.concerning[] apply to the category, not necessarily to every named brand. Specific formulations vary by SKU and may have changed since this record was written; consult the brand's current ingredient label before drawing brand-level conclusions.","sources":[{"type":"expert_curation","name":"ALETHEIA Safety Database","date":"2026-03-23"},{"type":"regulation","title":"FDA EUA / 510(k)","jurisdiction":"","id":"src_7062ada9"},{"type":"regulation","title":"CE-IVD (EU)","jurisdiction":"","id":"src_2fd8a9f3"},{"type":"regulation","title":"TGA (Australia)","jurisdiction":"","id":"src_e5180ab3"},{"type":"regulation","title":"MHRA (UK)","jurisdiction":"","id":"src_851d2df4"}],"meta":{"schema_version":"4.0.0","last_updated":"2026-03-25","timestamp":"2026-05-14T01:25:42.036Z"}}