Widana, I Komang Adi and Dr. dr. Hani Susianti,, Sp.PK(K) and Prof. Dr. dr. Kusworini,, SpPK(K) (2022) Performa Diagnostik Anti-dsDNA dan Anti-Sm, serta uji kesesuaian ANA metode Indirect Immunofluorescence Assay (IIFA) (Cytobead ANA 2) dan Chemiluminescence Immunoassay (CLIA) Pada Penyakit Reumatik Autoimun. Magister thesis, Universitas Brawijaya.
Abstract
Latar belakang: Penyakit Reumatik Autoimun (PRA) muncul dengan gejala klinis yang hampir mirip antara satu dengan yang lainnya. Penegakan diagnosisnya sendiri adalah dengan sistem skoring yang melibatkan pemeriksaan antibodi di laboratorium sebagai salah satu parameter. Pemeriksaan antibodi untuk diagnosis PRA dapat dikerjakan dengan berbagai macam metode, namun baku emas ditegakkan dengan pemeriksaan Indirect Immunofluorescence Assay (IIFA). Teknik pemeriksaan IIFA memiliki tingkat kesulitan yang cukup tinggi serta memerlukan keahlian/pelatihan khusus. Seiring berkembangnya kemajuan teknologi, pemeriksaan PRA dapat dikerjakan dengan metode lain seperti Enzyme Linked Immunosorbant Assay (ELISA) dan Chemiluminescenct Assay (CLIA). Penelitian ini bertujuan untuk menilai kesesuaian hasil pemeriksaan ANA, Anti-dsDNA, Anti-Sm, serta menilai uji diagnostik dari Anti-dsDNA dan Anti-Sm pada PRA. Metode: Penelitian cross sectional dengan melibatkan 110 pasien terdiagnosis PRA dan 20 pasien kontrol sehat. Diagnosis PRA ditegakkan dengan sistem skoring. Pemeriksaan ANA, Anti-dsDNA dan Anti-Sm dikerjakan dengan metode IIFA (Cytobead ANA 2) dan CLIA (Maglumi). Analisis uji kesesuaian dengan Kappa Cohen dan uji diagnostik menggunakan kurva Receiver Operating Characteristic (ROC) dan menilai Area Under Curve (AUC) untuk menilai sensitivitas dan spesifitasnya. Hasil penelitian: dari 130 subjek penelitian, pasien terbanyak dengan terdiagnosis LES (52 subjek). Didapatkan hasil ANA positif metode IIFA sebesar 50,77%, negatif sebesar 49,23%. ANA dengan metode CLIA baik positif maupun negatif sebesar 50%. Kesesuaian ANA metode IIFA dan CLIA adalah 0,908 (p=0,000). Parameter Anti-dsDNA metode IIFA positif sebesar 26,92%; negatif 73,08%. Kesesuaian metode IIFA dan CLIA untuk Anti-dsDNA sebesar 0,962 (p=0,000). Nilai cut-off Anti-dsDNA adalah29,28 IU/mL dengan sensitivitas 100%, spesifisitas 98,9%, dan AUC sebesar 0,955. Parameter Anti-Sm dengan metode IIFA positif sebesar 18,46%; negatif 81,54%; metode CLIA positif 20%, negatif 80%, dengan kesesuaian 0,950 (p=0,000). Nilai cut-off Anti-Sm adalah 18,99 AU/mL dengan sensitivitas 100%, spesifisitas 98,1% dengan AUC 0,994. Simpulan dan Saran: Hasil uji kesesuaian didapatkan cukup baik antara metode IIFA dan CLIA dibuktikan dengan nilai uji yang cukup tinggi. Uji diagnostik dengan kurva ROC pada parameter Anti-dsDNA dan Anti-Sm juga memberikan nilai sensitivitas dan spesifisitas yang baik dalam membantu menegakkan diagnosis dari PRA.
English Abstract
Background: Autoimmune Rheumatic Disease (ARD) appears with clinical symptoms that are almost similar to the others. Enforcement of the diagnosis itself is by a scoring system which involves examination of antibodies in the laboratory as one of the parameters. Antibody examination for the diagnosis of ARD can be done by various methods, but the gold standard is established by the Indirect Immunofluorescence Assay (IIFA). The IIFA examination technique has a fairly high level of difficulty and requires special skills/training. As technology advances, ARD examination can be carried out using other methods such as Enzyme Linked Immunosorbant Assay (ELISA) and Chemiluminescenct Assay (CLIA). This study aims to assess the results of the examination of ANA, Anti-dsDNA, Anti-Sm, as well as assess the diagnostic test of Anti-dsDNA and Anti-Sm in ARD. Methods: Cross sectional study involving 110 patients diagnosed with PRA and 20 healthy controls. The diagnosis of ARD is made by a scoring system. The examination of ANA, Anti-dsDNA and Anti-Sm was performed using the IIFA (Cytobead ANA 2) and CLIA (Maglumi) methods. Test analysis with Kappa Cohen and diagnostic test using Receiver Operating Characteristic (ROC) curve and assessing Area Under Curve (AUC) to assess sensitivity and specificity. Results: from 130 research subjects, most patients were diagnosed with SLE (52 subjects). The positive ANA results for the IIFA method were 50.77%, and the negative was 49.23%. The ANA with the CLIA method is both positive and negative by 50%. The ANA concordance between IIFA and CLIA methods was 0.908 (p=0.000). Anti-dsDNA parameter IIFA method was positive 26.92%; negative 73.08%. The suitability of the IIFA and CLIA methods for Anti-dsDNA was 0.962 (p=0.000). Anti-dsDNA cut-off value was 29.28 IU/mL with 100% sensitivity, 98.9% specificity, and 0.955 AUC. Anti-Sm parameter with positive IIFA method of 18.46%; negative 81.54%; CLIA method positive 20%, negative 80%, with a concordance of 0.950 (p=0.000). Anti-Sm cut-off value was 18.99 AU/mL with 100% sensitivity, 98.1% specificity with 0.994 AUC. Conclusions and Suggestions: The test results obtained are quite good between the IIFA and CLIA methods as evidenced by a fairly high-test value. Diagnostic tests with ROC curves on Anti-dsDNA and Anti-Sm parameters also provide good sensitivity and specificity values in helping to confirm the diagnosis of ARD.
| Item Type: | Thesis (Magister) |
|---|---|
| Identification Number: | 042206 |
| Uncontrolled Keywords: | Autoantibodi, PRA, IIFA, CLIA-Autoantibody, ARD, IIFA, CLIA |
| Divisions: | Profesi Kedokteran > Spesialis Patologi Klinik, Fakultas Kedokteran |
| Depositing User: | Sugeng Moelyono |
| Date Deposited: | 18 Jan 2024 02:11 |
| Last Modified: | 18 Jan 2024 02:11 |
| URI: | http://repository.ub.ac.id/id/eprint/211812 |
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