TY - JOUR
T1 - Diagnosis of Clostridium difficile infection by toxin detection kits
T2 - a systematic review
AU - Planche, Tim
AU - Aghaizu, Adamma
AU - Holliman, Richard
AU - Riley, Peter
AU - Poloniecki, Jan
AU - Breathnach, Aodhán
AU - Krishna, Sanjeev
PY - 2008/12
Y1 - 2008/12
N2 - Clostridium difficile can be a fatal hospital-acquired infection and its prevalence has increased. Accurate diagnosis of C difficile is essential for patient management, infection control, and for defining its epidemiology. We did a systematic review of commonly used commercial assays for detection of C difficile toxin (CDT) A and B in stool samples. By comparison of detection of CDT in cell culture with or without selective culture for C difficile, the median sensitivities and specificities (IQR) were as follows: Meridian Premier 0·95 (0·86-0·97) and 0·97 (0·95-0·98), TechLab Tox A/B II 0·83 (0·82-0·85) and 0·99 (0·98-1·00), TechLab Tox A/B Quik Chek 0·84 (0·81-0·87) and 1·00 (0·99-1·00), Remel Xpect 0·82 (0·75-0·89) and 0·96 (0·95-0·98), Meridian Immunocard 0·90 (0·84-0·92) and 0·99 (0·98-1·00), and BioMérieux VIDAS 0·76 and 0·93. If the prevalence of CDT A and B in stool samples is relatively low (<10%), the positive predictive value of these assays is unacceptably low (eg, <50% in some circumstances) and will vary depending on the assay and number of samples tested. This low positive predictive value impinges on clinical management, outbreaks, and makes epidemiological data unreliable. To improve diagnosis, we suggest a two-stage testing strategy for C difficile toxin with an initial highly sensitive rapid screening test to identify positive samples that are then confirmed by a reference method.
AB - Clostridium difficile can be a fatal hospital-acquired infection and its prevalence has increased. Accurate diagnosis of C difficile is essential for patient management, infection control, and for defining its epidemiology. We did a systematic review of commonly used commercial assays for detection of C difficile toxin (CDT) A and B in stool samples. By comparison of detection of CDT in cell culture with or without selective culture for C difficile, the median sensitivities and specificities (IQR) were as follows: Meridian Premier 0·95 (0·86-0·97) and 0·97 (0·95-0·98), TechLab Tox A/B II 0·83 (0·82-0·85) and 0·99 (0·98-1·00), TechLab Tox A/B Quik Chek 0·84 (0·81-0·87) and 1·00 (0·99-1·00), Remel Xpect 0·82 (0·75-0·89) and 0·96 (0·95-0·98), Meridian Immunocard 0·90 (0·84-0·92) and 0·99 (0·98-1·00), and BioMérieux VIDAS 0·76 and 0·93. If the prevalence of CDT A and B in stool samples is relatively low (<10%), the positive predictive value of these assays is unacceptably low (eg, <50% in some circumstances) and will vary depending on the assay and number of samples tested. This low positive predictive value impinges on clinical management, outbreaks, and makes epidemiological data unreliable. To improve diagnosis, we suggest a two-stage testing strategy for C difficile toxin with an initial highly sensitive rapid screening test to identify positive samples that are then confirmed by a reference method.
UR - http://www.scopus.com/inward/record.url?scp=56149107841&partnerID=8YFLogxK
U2 - 10.1016/S1473-3099(08)70233-0
DO - 10.1016/S1473-3099(08)70233-0
M3 - Review article
C2 - 18977696
AN - SCOPUS:56149107841
SN - 1473-3099
VL - 8
SP - 777
EP - 784
JO - The Lancet Infectious Diseases
JF - The Lancet Infectious Diseases
IS - 12
ER -
