Prolonged storage of frozen unbuffered rapid urease test

Abstract

Unbuffered rapid urease test (RUT) is an accurate, rapid, and inexpensive method of detecting Helicobacter pylori. However, it is generally recommended to prepare the reagent daily. This prospective study was undertaken to evaluate the shelf-life of our unbuffered RUT at -20°C. Two sets of antral biopsies (X2) and body biopsies (X1) were taken from all patients. They were subjected to histologic examination and RUT stored at -20°C. We studied 303 patients. One hundred seventy-nine (59%) were infected as defined by histologic examination. The reagent was classified according to the storage time (group I, 0-30 days [n = 109]; group II, 31-60 days [n = 63]; group III, 61-90 days [n = 80]; and group IV, τ91 days [n = 51]). There was an excellent agreement between the histologic examination and the RUT of the four groups (kappa coefficient: group I, 0.88; group II, 0.80; group III, 0.87; group IV, 0.88). The sensitivity of our RUT in groups I, II, III, and IV were 92%, 92%, 91%, and 89%, respectively. The corresponding specificity were 97%, 88%, 97%, and 100%. Our RUT remains highly sensitive and specific when it is stored at -20°C for 4 months.