Effectiveness of a Two-Step Testing Algorithm for Reliable and Cost-Effective Detection of Clostridium difficile Infection in a Tertiary Care Hospital in Saudi Arabia.

Mohammed Qutub,Prasanth Govindan,Anupama Vattappillil

doi:10.3390/medsci7010006

Mohammed Qutub, Prasanth Govindan + Show 1 more

Open Access

https://doi.org/10.3390/medsci7010006

Copy DOI

Abstract

The aim of this study was to evaluate the effectiveness of a two-step algorithm for the detection of Clostridium difficile infection. Setting and Design: A two-step testing algorithm was evaluated for testing stool samples from patients suspected of Clostridium difficile infection (CDI). A total of 103 stool specimens were tested using the C. diff Quik Chek Complete enzyme immunoassay (EIA) test and the Xpert C. difficile PCR test. A two-step algorithm was implemented, and data from 3518 patient samples tested during a two-year period after implementation were analyzed to evaluate the effectiveness. The sensitivity, specificity, and positive and negative predictive values (PPV, NPV) of the Quik Chek Complete EIA test were calculated using the Xpert C. difficile PCR test as a reference method. The sensitivity, specificity, PPV, and NPV of the Quik Chek Complete EIA test for C. difficile toxin were 46.7%, 100%, 100%, and 91%, respectively. The two-step algorithm, which combined the Quik Chek Complete EIA with Xpert C. difficile PCR, improved the sensitivity and also provided rapid detection. When algorithm-based testing was performed daily, there was a 66% reduction in turnaround time compared to batch testing using a lengthy ELISA procedure. Postimplementation data analysis showed that almost 89% of the samples could be reported immediately by initial screening with Quik Chek Complete EIA. Only 11% of the samples gave discrepant results and required PCR confirmation. According to our results, the two-step algorithm is an effective tool for the rapid and reliable detection of toxigenic C. difficile from stool samples.

Highlights

Clostridium difficile infection (CDI) is considered the most common cause of hospital-acquired diarrhea [1,2,3]
Postimplementation data analysis showed that almost 89% of the samples could be reported immediately by initial screening with Quik Chek Complete enzyme immunoassay (EIA)
This study evaluated the effectiveness of a two-step testing algorithm for C. difficile detection at a tertiary care referral hospital with oncology and transplant facilities serving a patient population vulnerable to CDI

Summary

Introduction

Clostridium difficile infection (CDI) is considered the most common cause of hospital-acquired diarrhea [1,2,3]. The latest reports suggest that in the United states of America, CDI has replaced methicillin-resistant Staphylococcus aureus (MRSA) as the most common hospital-acquired infection overall [4,5]. The pathogenicity of C. difficile is attributed to two toxins: The enterotoxin A, coded by the tcd A gene, and the cytotoxin B, coded by the tcd B gene [6]. The combined activity of these toxins contributes to the damage caused to the intestinal mucosa and related pathologies. A variety of diagnostic techniques are available for C. difficile detection, which include cell culture neutralization, immunological methods, and molecular tests [8]. Culture-based techniques are time consuming, require specialized facilities, and may not be feasible in small and medium-sized laboratories

Objectives

Methods

Conclusion