Nilai diagnostik pemeriksaan Antinuclear Antibody (ANA) secara kuantitatif dengan metode Chemiluminescent Immunoassay  (CLIA) pada pasien dengan penyakit autoimun

Indah Adhita Wulandari; Hani Susianti; Dian Sukma Hanggara; Kusworini Handono; Raymond Poeng; I Komang Adi Widana; Deasy Ayuningtyas Tandio

doi:10.15562/ism.v13i1.1223

Nilai diagnostik pemeriksaan Antinuclear Antibody (ANA) secara kuantitatif dengan metode Chemiluminescent Immunoassay (CLIA) pada pasien dengan penyakit autoimun

Indah Adhita Wulandari ,

Hani Susianti ,

Dian Sukma Hanggara ,

Kusworini Handono ,

Raymond Poeng ,

I Komang Adi Widana ,

Deasy Ayuningtyas Tandio ,

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DOI: https://doi.org/10.15562/ism.v13i1.1223 |
Published: 2022-02-18

Abstract

Background: Many serological examination methods have been developed to assist in diagnosing autoimmune diseases, one of which is the Chemiluminescent Immunoassay (CLIA) method. The CLIA method is an alternative method that is faster and estimated to have the same accuracy with IFA as the gold standard examination. It can help diagnose autoimmune diseases more quickly and easily. This study aims to determine the diagnostic value and conformity of the Anti-Nuclear Antibody (ANA) examination using the IFA method with the CLIA method in patients with autoimmune diseases.

Methods: The research design is a cross sectional study with consecutive sampling methods in autoimmune disease patients at Dr. Saiful Anwar Hospital Malang. ANA examination using the IFA method and the CLIA method. The data obtained by examining the IFA method is categorical, and the CLIA method is numerical. The diagnostic test uses the ROC curve and generates the AUC to determine the cut-off point. Furthermore, the suitability test was carried out using the Cohen's Kappa analysis technique. Data were analyzed using SPSS version 25 for Windows.

Results: The research sample collected was 110. Patients with positive ANA IFA results showed the same results with the CLIA method (58,18%). The diagnostic test using the cut-off value of serum ANA levels of 41.79 AU/mL showed a sensitivity value of 98.4%, specificity 95.5%, a positive predictive value of 95.63% and a negative predictive value of 98.35% with an AUC of 0.990. The suitability value of the ANA examination with the IFA and CLIA methods with the Cohen's Kappa test showed very good results, which was 0.908 (p=0.000).

Conclusion: There is a very good suitability value in examining the ANA parameters of the IFA method and the CLIA method. ANA CLIA examination has good diagnostic value.

Latar Belakang: Banyak metode pemeriksaan serologi yang berkembang untuk membantu penegakan diagnosis penyakit autoimun, salah satunya metode Chemiluminescent Immunoassay (CLIA). Metode CLIA merupakan alternatif metode yang lebih cepat dan diperkirakan memiliki keakuratan yang sama dengan pemeriksaan baku emas Immunofluorescence Assay (IFA), sehingga dapat membantu menegakkan diagnosa penyakit autoimun dengan lebih cepat dan mudah. Penelitian ini bertujuan untuk mengetahui nilai diagnostik dan kesesuaian hasil pemeriksaan Anti-Nuclear Antibody (ANA) metode IFA dengan metode CLIA pada pasien dengan penyakit autoimun.

Metode: Desain penelitian adalah studi potong lintang dengan metode consecutive sampling pada pasien penyakit autoimun di RSUD Dr. Saiful Anwar Malang. Pemeriksaan ANA menggunakan metode IFA dan metode CLIA. Data yang diperoleh dengan pemeriksaan metode IFA bersifat kategorikal, dan metode CLIA bersifat numerik. Uji diagnostik menggunakan kurva ROC dan menghasilkan AUC untuk menentukan cut-off-point. Selanjutnya dilakukan uji kesesuaian dengan teknik analisis Cohen’s Kappa. Data dianalisis dengan SPSS versi 25 untuk Windows.

Hasil: Sampel penelitian terkumpul 110. Pasien dengan hasil ANA IFA positif yang menunjukkan hasil yang sama dengan metode CLIA adalah (58,18%). Uji diagnostik menggunakan nilai cut-off kadar ANA serum 41,79 AU/mL menunjukkan nilai sensitivitas 98,4%, spesifisitas 95,5%, nilai ramal positif 95,63% dan nilai ramal negatif 98,35% dengan AUC 0,990. Nilai kesesuaian pemeriksaan ANA dengan metode IFA dan CLIA dengan uji Cohen’s Kappa menunjukkan hasil yang sangat baik secara bermakna yaitu sebesar 0,908 (p=0.000)

Kesimpulan: Terdapat nilai kesesuaian yang sangat baik pada pemeriksaan parameter ANA metode IFA dan metode CLIA. Pemeriksaan ANA CLIA memiliki nilai diagnostik yang bagus

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