Tesis

Perbandingan Nilai Diagnostik Ketuban Pecah Dini antara Tes Immunoassay IGFBP-1 (Actim PROM) dengan Tes Nitrazin = Comparing Immunoassay IGFBP-1 (ACTIM PROM) with Nitrazine Test to Diagnose Premature Rupture of Membrane.

Latar belakang: Ketuban Pecah Dini (KPD) didefinisikan sebagai pecahnya selaput ketuban sebelum onset persalinan. Sampai saat ini, tidak ada tes diagnostik KPD non invasif yang terstandard. Salah satu tes non invasif yang sedang dikembangkan adalah Actim Prom dengan cara mendeteksi IGFBP-1, protein yang disintesis di desidua dan sel liver fetus dan dapat dideteksi di cairan amnion selama kehamilan. Penelitian ini bertujuan untuk membandingkan akurasi dari tes cepat IGFBP-1 dengan tes konvensional Nitrazin dalam mendiagnosis KPD. Metode: Studi diagnostik potong lintang dilakukan di RSCM selama Desember 2022 Maret 2023. Subjek meliputi pasien kehamilan preterm yagn dicurigai KPD. Kehamilan dengan riwayat perdarahan antepartum yang diakibatkan plasenta previa dan riwayat infeksi dieksklusikan dalam penelitian ini. Data kemudian dianalisis menggunakan tabel 2x2 untuk mendapatkan nilai sensitifitas, spesifisitas, PPV, NPV dan akurasi Actim PROM dibandingkan tes nitrazin. Hasil: Dari 4 subjek dengan kecurigaan KPD, dilakukan pemeriksaan Actim PROM dan nitrazin, dengan sensitifitas tes cepat Actim PROM 97.37%, spesifisitas 73.08%, 84% PPV, 95% NPV, an akurasi 87.5%. Pada subjek dengan Indek Cairan Amnion (ICA < 5), Actim PROM menunjukkan nilai sensitivitas 100%, spesifisitas 100%, 100% PPV, 100% NPV, dan akurasi 100%. Sementara pada subjek dengan ICA >5, nilai sensitivitasnya 100%, spesifisitas 76.47%, PPV 80.95%, NPV 100%, dan akurasi 88.24%. Pada subjek dengan KPD < 12 jam, Actim PROM memiliki nilai sensitifitas 100%, spesifisitas of 50%, PPV 92.86%, NPV 100%, dan akurasi 93.3%. Sementara pada KPD > 12 jam, sensitifitasnya 86%, spesifisitas 14.2%, PPV of 80%, NPV of 50%, dan akurasinya 78.1%. Kesimpulan: Actim PROM memiliki nilai senstifitas 97.37%, spesifisitas 73.08%, 84% PPV, 95% NPV, dan akurasi 87.5% dalam mendeteksi KPD. Namun pada kasus KPD > 12 jam, Actim PROM dapat menunjukkan negatif palsu dalam mendeteksi KPD.
Kata Kunci : IGFBP 1, ACTIMPROM, Nitrazine, PROM


Introduction: Premature rupture of membranes (PROM), is defined as the rupture of the membranes before the onset of labor. Until now, there is no standard non-invasive test to diagnose premature rupture of membrane. One of the non-invasive tests being developed is the Actim PROM which is designed to detect IGFBP-1, a protein synthesized in fetal decidual and liver cells and detected in amniotic fluid during pregnancy. This study aims to compare the accuracy of the IGFBP-1 rapid immunoassay test with the conventional nitrazine test in diagnosing PROM. Methods: A cross-sectional diagnostic test study, carried out at Cipto Mangunkusumo General Hospital from December 2022 - March 2023. Subjects included preterm mothers who were suspected of PROM. Pregnancy with a history of antepartum bleeding due to placenta previa and a history of/with infection were excluded. Data were analyzed using a 2x2 table to calculate the sensitivity, specificity, PPV, NPV, and accuracy of Actim PROM compared to nitrazine. Results: 64 research subjects came with suspicion of PROM. In general, the Actim PROM examination, compared to Nitrazine, has a sensitivity value of 97.37%, a specificity of 73.08%, 84% PPV, 95% NPV, and 87.5% accuracy. In subjects with AFI (Amniotic Fluid Index) < 5, the Actim PROM assay had 100% sensitivity, 100% specificity, 100% PPV, 100% NPV, and 100% accuracy. Meanwhile, the sensitivity value was 100%, specificity 76.47%, PPV 80.95%, NPV 100%, and accuracy 88.24% in subjects with AFI ≥ 5. In subjects with PROM events < 12 hours, Actim PROM had a sensitivity of 100%, specificity of 50%, PPV of 92.86%, NPV of 100%, and accuracy of 93.3%. Meanwhile, Actim PROM had a sensitivity of 86%, specificity of 14.2%, PPV of 80%, NPV of 50%, and accuracy of 78.1% in patients with PROM > 12 hours. Conclusion: Actim PROM has a sensitivity value of 97.37%, a specificity of 73.08%, 84% PPV, 95% NPV, and 87.5% accuracy. Premature rupture of membrane for more than 12 hours could produce false negative result for Actim PROM.
Keywords : IGFBP 1, ACTIMPROM, Nitrazine, PROM