The comparison of amnisure ™ and altest ™ in the detection of the premature rupture of membranes

Abstract

Objectives: Amnisure™ (based on the existense of PAMG-1 in vaginal fluid) and Altest™ (based on the nitrasin test) were compared to detect a reliable, sensitive and quick test for the detection of the premature rupture of membranes in pregnancy. Material and Methods: Fifty pregnant patients between 21-38 weeks who has a suspicion for the fluid leakage were enrolled to the study. Altest™ and then Amnisure™ were applied. A sterile speculum examination and pooling were evaluated for the positive results. Amniotic volumes were calculatedfour quadrent with obstetric ultrasound. Results: The sensitivity and spesifisity for Altest™ were 83.3% and 65.9% respectively. Altest™ had 25% truepositivity and 75% false positivity rate. However, Altest™ had 96.7% true negativity and %0.3 false negativity rates. The sensitivity and spesifisity for Amnisure™ were 83.4% and 97.8% respectively. Amnisure™ had 83% true positivity and 0.2% false positivity rate. However, Amnisure™ had 97.7% true negativity and %0.2 false negativity rates. Conclusions: Amnisure™ is more reliable in the detection of the premature rupture of membranes in pregnancy.

Keywords

• Fetal Membranes, Premature Rupture,Comparative Study,Pregnancy Complications,Sensitivity and Specificity

Erken membran rüptürü tanısında altest ™ ve amnisure™ adlı tanı kitlerinin karşılaştınlması

Öz

Amaçlar: EMR şüphesi olan vakalarda hızlı, güvenilir bir metot saptayabilmek için; vajinal sıvıdaki PAMG-1 tayinine dayanan Amnisure™ kiti ile nitrazin testi esasına dayanan Altest™ kiti karşılaştırılmıştır. Gereç ve Yöntem: Çalışmaya kadın doğum bölümüne su gelmesi şüphesi ile başvuran 21-38 hafta arasındaki 50 gebe dahil edildi. Hastalara önce Altest™ kiti verildi.. Sonra hasta muayene masasına yatırılarak spekulum uygulamaksızın Amnisure™ testi uygulandı. Sonuçları pozitif olanlara spekulum uygulanarak pooling değerlendirildi. Her hastanın amniyotik sıvı volumleri dört kadran ölçülerek kaydedildi. Bulgular: Altest™ in sensitivitesi %83.3, spesifısitesi %65.9 olarak hesaplandı. Altest™ in gerçek pozitiflik oranı %25, yalancı pozitiflik oranı ise %75 idi. Buna karşın Altest™ in gerçek negatiflik oranı %96.7, yalancı negatiflik oranı ise %0.3 olarak bulundu. Amnisure™ sensitivitesi %83.4, spesifısitesi %97.8 olarak hesaplandı. Amnisure™'un gerçek pozitiflik oranı %83, yalancı pozitiflik oranı ise %0.2 idi. Buna karşın Amnisure™'un gerçek negatiflik oranı %97.7, yalancı negatiflik oranı ise %0.2 olarak bulundu. Sonuçlar: Amnisure™ kiti erken membran rüptürü tanısında daha güvenilirdir.

Anahtar Kelimeler

• Fetal membranlar, prematür rüptür,Karşılaştırmalı çalışma,Gebelik komplikasyonları,Duyarlılık ve özgüllük

Kaynakça

1. 1. Cousins LM, SmokDP, Lovett SM, Poeltler SM. AmniSure Placental Alpha Microglobulin-1 Rapid Immunoassay versus Standard Diagnostic Methods for Detection of Rupture of Membranes. Am J Perinatal 2005;22(6):317-320
2. 2. Locwood CJ, WeinR, ChienD, Ghidini A, Alvarez M, Berkowitz RL. Fetal membrane rupture is presence of insülin-like growth factor binding protein-1 in vaginal secretions. Am J Obstet Gynecol 1994;71:146-150
3. 3. Rutanen EM, Karkkainen TH, Lehtovirta J, Uotia JT, Hinkula MK, Hartikainen AL. Evaluation of a rapid striptestfor insulin- like growth factor binding protein-1 in the diagnosis of ruptured fetal membranes. Clinica Chimica Acta 1996,253:91- 101
4. 4. Gorodeski IG, Haimowitz L, Bahari CM. Reevaluation of the pH, ferning and nile blue sulphate staining methods in pregnant women with premature rupture of the fetal membranes. J Perinat Med 1982;10:286-92
5. 5. McGregor J A, Johnson S. "Fig-Leaf" ferning and positive nitrazine testing: semen as a cause of misdiagnosis ofpremature rupture of membranes (letter to the editor). Am J Obstet Gynecol 1985;151:1142-1143
6. 6. Smith RP. A technique for the detection of rupture of the membranes: a review andpreliminary report. Obstet Gynecol 1976;48:172-176. 7. Recce EA, Chervenak FA, Moya FR, Hobbins JC. Amniotic fluid arborization: effect of blood, meconium, and pH alterations. Obstet Gynecol 1984;64:248-250
7. 8. de Haan HH, Offermans PM, Smits F, Schouten HJ, Peeters LL. Value of the fern test to confirm or reject the diagnosis of ruptured membranes in modest in nonlaboring women presenting with nonspecific vaginal fluid loss. Am J Perinatol 1994;11:46-50
8. 9. Gaucherand P, Salle B, Sergeant P, et al. Comparative study of three vaginal markers of the premature rupture of membranes. Insulin like growth factor binding protein, 1 diamine-oxidase, and PH. Acta Obstet Gynecol Scand 1997;76:536-540

9. 10. Lee SE, Park JS, Norwitz ER, Kim KW, Park HS, Jun JK. Measurement of placental a- microglobulin-1 in cervicovaginal discharge to diagnose rupture of membranes. Obstet Gynecol 2007;109:634-640
10. 11. Lee SM, Lee J, Seong HS, Lee SE, Park JS, Romero R, Yoon BH. The clinical significance of a positive Amnisure test in women with term labor with intact membranes. J Matern Fetal Neonatal Med. 2009 Apr;22(4):305-10
11. 12. Erdemoglu E,Mungan T. Significance of detecting insulin-like growth factor binding protein- 1 in cervicovaginal secretions: comparison with nitrazine test and amniotic fluid volume assessment. Acta Obstet Gynecol Scand 2004;83:622-626.