Sensitivitas pemeriksaan cepat NS1 metode Lateral Flow Immunoassay (LFIA)  untuk diagnosis infeksi dengue

Lulu Harida Rofi, Prof. Dr. dr. Osman Sianipar, DMM., M.Sc., Sp.PK., Subsp.PI(K)., Subsp. Onk.K(K); Prof. Dr. drh. Wayan Tunas Artama

2026 | Tesis | S2 Ilmu Kedokteran Tropis

Latar Belakang: Dengue merupakan penyakit infeksi yang ditularkan oleh nyamuk  Aedes aegypti atau Aedes albopictus, dengue menjadi beban kesehatan global, terutama di wilayah tropis. Peningkatan kasus secara signifikan dalam beberapa dekade terakhir, termasuk di Indonesia yang bersifat endemik-epidemik, menuntut adanya deteksi dini yang cepat dan akurat untuk mencegah komplikasi berat seperti Dengue Hemorrhagic Fever (DHF) dan Dengue Shock Syndrome (DSS). Metode diagnostik standar seperti RT-PCR memiliki sensitivitas tinggi namun kurang praktis untuk fasilitas kesehatan primer karena biaya dan kebutuhan peralatan khusus. Protein non-struktural 1 (NS1) yang bersirkulasi sejak fase awal infeksi menjadi target ideal untuk diagnosis infeksi virus dengue.

Tujuan: Penelitian ini bertujuan untuk mengevaluasi akurasi pemeriksaan cepat NS1 berbasis Lateral Flow Immunoassay (LFIA) sebagai alat diagnosis infeksi dengue.

Metode: Penelitian ini menggunakan sampel serum pasien probable dengue dan membandingkan hasil pemeriksaan cepat NS1 berbasis Lateral Flow Immunoassay (LFIA) komersil dengan standar emas RT-PCR. Analisis perhitungan meliputi sensitivitas, spesifisitas, NPV, PPPV serta akurasi.

Hasil: Dari 100 sampel yang diperiksa, pemeriksaan cepat NS1 metode Lateral Flow Immunoassay (LFIA)  mendeteksi 63% kasus positif, sedangkan RT-PCR sebagai gold standard menunjukkan 68% kasus positif. Pemeriksaan cepat NS1 metode Lateral Flow Immunoassay (LFIA) memiliki sensitivitas 92,65%, spesifisitas 100%, PPV 100%, NPV 86,49%, dan akurasi 95%. Deteksi NS1 paling tinggi pada hari demam ke-2 hingga ke-4 dan menurun setelah hari ke-5, sedangkan RT-PCR mencapai puncak positif pada hari ke-4 hingga ke-5. Pemeriksaan serologi menunjukkan distribusi infeksi primer sebesar 44?n infeksi sekunder sebesar 43%. Mayoritas pasien menunjukkan gejala khas dengue seperti demam (100%), sakit kepala (95%) dan mual/muntah atau nyeri perut (89%), serta 72 % mengalami trombositopenia derajat ringan hingga sedang.

Kesimpulan: Hasil penelitian ini dapat disimpulkan bahwa pemeriksaan cepat NS1 metode Lateral Flow Immunoassay (LFIA) memiliki sensitivitas 92,65%, spesifisitas 100%, PPV 100%, NPV 86,49%, dan akurasi 95%. 

 

Background: Dengue is an infectious disease transmitted by  Aedes aegypti or Aedes albopictus mosquitoes, dengue represents a major global health burden, particularly in tropical regions. The significant increase in cases over recent decades, including in Indonesia where dengue is endemic–epidemic, underscores the need for rapid and accurate early detection to prevent severe complications such as Dengue Hemorrhagic Fever (DHF) and Dengue Shock Syndrome (DSS). Standard diagnostic methods such as RT-PCR have high sensitivity but are less practical for primary healthcare facilities due to high costs and the need for specialized equipment. Non-structural protein 1 (NS1), which circulates from the early phase of infection, is an ideal target for diagnosis of dengue infection.

Objective: This study aimed to evaluate the accuracy of an NS1-based Rapid Diagnostic Test using the Lateral Flow Immunoassay (LFIA) method as a diagnostic tool for dengue infection.

Methods: This study used serum samples from patients with probable dengue and compared the results of a commercial NS1-based Rapid Diagnostic Test using the Lateral Flow Immunoassay (LFIA) with RT-PCR as the gold standard. Diagnostic performance was assessed by calculating sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and accuracy.

Results: Among the 100 samples analyzed, the NS1 rapid diagnostic test identified dengue infection in 63% of cases, while RT-PCR, used as the gold standard, detected 68% positivity. The NS1 RDT demonstrated high diagnostic performance, with a sensitivity of 92.65%, specificity of 100%, positive predictive value (PPV) of 100%, negative predictive value (NPV) of 86.49%, and an overall accuracy of 95%. NS1 antigen detection was most prominent during the early febrile phase (days 2–4) and declined after day 5, whereas RT-PCR positivity peaked between days 4 and 5 of illness. Serological analysis showed that 44% of patients had primary dengue infection and 43% had secondary infection. Clinically, all patients presented with fever (100%), followed by headache (95%) and nausea/vomiting or abdominal pain (89%). Laboratory findings revealed that 72% of patients developed mild to moderate thrombocytopenia.

Conclusion: The results of this study indicate that the NS1-based Rapid Diagnostic Test using the Lateral Flow Immunoassay (LFIA) has a sensitivity of 92.65%, specificity of 100%, PPV of 100%, NPV of 86.49%, and an accuracy of 95%.

Kata Kunci : Dengue, NS1 Rapid Diagnostic Test, Sensitivitas,  RT-PCR.