PTU-088 Simtomax® pre-endoscopy is a safe and cost-effective way to reduce the need for duodenal biopsies

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Abstract

Introduction

The demand for endoscopic investigation of anaemia is increasing. Pre-endoscopic screening for coeliac disease (CD) is rarely available at the time of endoscopy mandating duodenal biopsies and the associated costs.

Introduction

Simtomax is a point-of-care diagnostic test to rule out CD which can be performed in the immediate pre-endoscopy setting when CD serology is not available. This study investigates the safety and cost effectiveness of its use in clinical practice.

Methods

A Simtomax test was performed immediately prior to gastroscopy on patients referred for the investigation of anaemia or iron deficiency anaemia (IDA), figure 1. Results were blinded to the patient and investigating clinician. Endoscopy with duodenal biopsies were then performed following BSG guidelines.

Methods

Patient diagnosis, outcomes and Simtomax result were correlated after completion of investigations using the hospital electronic record.

Results

Data was analysed on 105 (36 male) adults, mean age 67 years (s.d. 15). Patients were followed up for mean 11 months (s.d. 5).

Results

No patient had CD serology (TTG-IgA) available at the time of endoscopy. Only 25% had CD serology recorded by study completion.

Results

5/105 (4.7%) patients were diagnosed with coeliac disease. 7/105 patients tested positive to Simtomax, 5 of which were confirmed CD with histology. 2 of 5 coeliac patients tested negative for TTG-IgA. The negative predictive value (NPV) for Simtomax is 100% compared to TTG-IgA 93%, table 1.

Results

Quality improvement 1: One patient diagnosed with CD following endoscopy tested negative to Simtomax. A review and further investigations revealed a normal TTG-IgA, IgA and negative HLA DQ2/DQ8. The histology result was overturned. The patient avoided a lifelong gluten free diet.

Results

Quality improvement 2: One patient initially TTG-IgA negative with minimal histological changes had been discharged. A positive Simtomax test prompted a histology review; CD was confirmed, avoiding a missed diagnosis.

Results

Cost of performing universal duodenal biopsies, 105 x £66.10 = £6940. £1388 per positive biopsy.

Results

Cost of performing Simtomax on each patient, 105 x £20 = £2100. Cost of performing duodenal biopsies only following positive Simtomax, 7 x £66.10 = £463. Total cost of Simtomax pathway = £2563.

Results

Total cost saving per 100 patients = £4169

Conclusions

Simtomax is a simple and safe point-of-care test with a 71% PPV and 100% NPV. Simtomax reduces the need to perform duodenal biopsies to investigate IDA or anaemia when TTG-IgA serology is not available. Simtomax performs better than TTG-IgA as a pre-endoscopic screening test for CD.

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