| 1) Core items | ||
|---|---|---|
| Test code | Test name | Clinical description |
| S610 | Anti-cyclic citrullinated peptide (CCP) Ab | Antibody with high specificity for the diagnosis of rheumatoid arthritis |
| P775 | Anti-ENA and anti-DNA antibodies multiplex test | Simultaneous multi-autoantibody detection test for differential diagnosis of autoimmune diseases |
| P469 | Anti-ENA and anti-DNA antibodies screening test (Qualitative) | Screening panel test for multiple autoantibodies |
| Z977 | C-Reactive Protein (CRP, High sensitivity) | Assessment of autoimmune risk and low-grade (subclinical) inflammation |
| S449 | Fluorescent anti-nuclear Ab (FANA, Quantitative) | Quantitative screening test for autoimmune diseases |
| S112 | Rheumatoid factor (Quantitative) | Autoantibodies used for the diagnosis and differential diagnosis of rheumatoid arthritis |
| 2) Optional items | ||
| Test code | Test name | Clinical description |
| S981 | Anti-centromere Ab | Antibody associated with limited cutaneous systemic sclerosis |
| S451 | Anti-dsDNA Ab, IgG | Marker for assessment of SLE disease activity and diagnosis |
| E685 | Anti-dsDNA Ab, IgM | IgM antibody used for early diagnosis of systemic lupus erythematosus (SLE) |
| S125 | Anti-Jo-1 Ab | Antibodies associated with polymyositis / dermatomyositis |
| B342 | Anti-ribosomal P Ab | Antibody associated with neuropsychiatric SLE |
| S513 | Anti-RNP Ab | Diagnostic antibody for mixed connective tissue disease (MCTD) |
| S953 | Anti-Scl-70 Ab | Antibody associated with systemic sclerosis (scleroderma) |
| S516 | Anti-Sm Ab | SLE-specific antibody used for diagnosis |
| S514 | Anti-SS-A/Ro Ab | Antibodies associated with Sjogren’s syndrome and SLE |
| S515 | Anti-SS-B/La Ab | Antibody used for the diagnosis of Sjogren’s syndrome |
| 3) Supplementary items | ||
| Test code | Test name | Clinical description |
| S332 | Anti-cardiolipin Ab, IgA | Antibody used as an adjunct for the diagnosis of antiphospholipid syndrome (APS) |
| S494 | Anti-cardiolipin Ab, IgG | Key antibody for the diagnosis of antiphospholipid syndrome |
| S495 | Anti-cardiolipin Ab, IgM | Used for differential diagnosis of antiphospholipid syndrome or other autoimmune diseases |
| S488 | Anti-histone Ab | Antibody used for differential diagnosis of drug-induced lupus |
| S094 | Anti-β2-glycoprotein I, IgG | Major antibody associated with antiphospholipid syndrome |
| S095 | Anti-β2-glycoprotein I, IgM | Adjunctive antibody used for differential diagnosis of antiphospholipid syndrome |
| S460 | Ch (hematologic PB) | Antibody used for differentiation of drug-induced systemic lupus erythematosus |
| S442 | Complement C3 [S] | Assessment of complement activation in immune complex?mediated diseases |
| S443 | Complement C4 [S] | Evaluation of complement consumption in autoimmune diseases |
| H411 | DAT | Differential diagnostic test for autoimmune hemolytic anemia |
| H412 | IAT | Detection of unexpected antibodies; used for pre-transfusion testing and evaluation of hemolytic disorders |
| Z930 | Lupus A.coagulant (confirm) | Confirmatory test for antiphospholipid antibodies |
| H504 | Lupus A.coagulant (screen) | Screening test for the presence of antiphospholipid antibodies |
| 4) Diagnostic workflow | |||
|---|---|---|---|
| Disease | Step 1 – Screening tests | Step 3 – Monitoring | |
| Rheumatoid arthritis | ESR, CRP, Ra Factor | - | ESR, CRP, Ra Factor |
| Systemic lupus erythematosus (SLE) | ESR, CRP, FANA | - | Lupus A.coagulant (screen/confirm) |
| Anti Cardiolipin IgG/IgM | |||
|
Anti β2-GPI IgG/IgM (Evaluation for concomitant antiphospholipid syndrome) |
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|
Direct Coombs test (Performed when hemolytic anemia is suspected or present) |
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|
Anti-Histone Ab (Used for differentiation of drug-induced lupus) |
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| c3 | |||
| c4 | |||
| Sjögren’s syndrome (dry mouth and dry eyes) | ESR/CRP, FANA | - | ESR,CRP |
| Systemic sclerosis (scleroderma) | ESR/CRP, FANA | - | ESR,CRP |
| Suspected mixed connective tissue disease (MCTD) | FANA | - | ESR,CRP |
| Myositis / dermatomyositis (muscle weakness / myalgia) | ESR, CRP | - | ESR,CRP |
| CK | |||
| Antiphospholipid syndrome | Anti Cardiolipin IgG/IgM | - | ESR,CRP |
| Anti β2-GPI IgG/IgM, | |||
| Lupus A.coagulant (screen) | |||