Abstract
BackgroundUnchanged substrate in a negative rapid urease test may be reused to detect Helicobacter pylori (H. pylori). This could potentially reduce costs and wastage in low prevalence and resource-poor settings. We thus aimed to investigate the diagnostic accuracy of reused Pronto Dry® and CLOtest® kits, comparing this to the use of new Pronto Dry® test kits and histopathological evaluation of gastric mucosal biopsies.MethodsUsing a cross-sectional study design, subjects who presented for upper endoscopy due to various non-emergent causes had gastric biopsies obtained at three adjacent sites. Biopsy samples were tested for H. pylori using a reused Pronto Dry® test, a reused CLOtest®, a new Pronto Dry® test and histopathological examination. Concordance rates, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and diagnostic accuracy were then determined.ResultsA total of 410 subjects were recruited. The sensitivity and diagnostic accuracy of reused Pronto Dry® tests were 72.60 % (95 % CI, 61.44 – 81.51) and 94.15 % (95 % CI, 91.44 – 96.04) respectively. For reused CLOtests®, the sensitivity and diagnostic accuracy were 93.15 % (95 % CI 85.95 – 97.04) and 98.29 % (95 % CI 96.52 – 99.17) respectively. There were more true positives for new and reused Pronto Dry® pallets as compared to new and reused CLOtests® when comparing colour change within 30 min vs. 31–60 min (P < 0.001 and P = 0.7 respectively).ConclusionNegative Pronto Dry® and CLOtest® kits may be reused in a low prevalence setting where cost issues remain paramount. Reused CLOtest® kits have better accuracy than reused Pronto Dry® tests. Reused Pronto Dry® tests however have a more rapid colour change whilst maintaining diagnostic accuracy.
Highlights
Unchanged substrate in a negative rapid urease test may be reused to detect Helicobacter pylori (H. pylori)
The CLOtest® has a urea gel capsule that changes colour over time in the presence of specimens that contain H. pylori, whilst the Pronto Dry® kit consists of a dry filter paper that contains urea and an indicator that detects a rise in pH of specimens that are H. pylori positive
A total of 410 participants who presented between March 2008 and June 2010 for upper GI endoscopic assessment were recruited into this study
Summary
Unchanged substrate in a negative rapid urease test may be reused to detect Helicobacter pylori (H. pylori). We aimed to investigate the diagnostic accuracy of reused Pronto Dry® and CLOtest® kits, comparing this to the use of new Pronto Dry® test kits and histopathological evaluation of gastric mucosal biopsies. Unchanged substrate in a negative RUT may be used again to test for the presence of H. pylori in a new gastric biopsy sample. This has been shown to be true for CLOtest® pallets, where some studies have concluded that diagnostic accuracy is maintained despite being reused up to 6 months from the initial test application [10,11,12,13,14]. The main advantages of using Pronto Dry® over CLOtest® kits in the detection of H. pylori is the fact that Pronto Dry® kits may be stored at room temperature, with
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