C. difficile Detection & Reflex Kits

EasyScreen™ Real-Time PCR assays are available for both toxigenic and hypervirulent C. difficile detection.

The advantages of the EasyScreen™ C. difficile Detection & Reflex Kits are:

  • Rapid Multiplexed Real-Time PCR assays
  • Simultaneous detection of both tcdA and tcdB genes
  • Three hypervirulence markers in the reflex kit
  • Simple & Automatable sample preparation method
    (via commonly available platforms)
  • Compatible with all major Real-Time PCR instruments
  • Extraction Control and Internal Control included

The EasyScreen™ C. difficile Detection and Reflex Kits are designed to be used in conjunction with EasyScreen™ Sample Processing Kits and include all reagents required for amplification.

Product#EasyScreen™ Kit Toxigenic C. difficile
(targets both tcdA and tcdB)
CDD001C. difficile Detection KitToxigenic C. difficile
(targets both tcdA and tcdB)
CDD002C. difficile Reflex KitHypervirulent C. difficile incl. 027 & 078 targeting:
(i) tcdC gene deletion at position 117
(ii) binary toxin gene (cdtA), and
(iii) gyrA gene mutation (fluroquinolone resistance)

All kits are sufficient for 100RXNs

“C. difficile continues to be a major nosocomial infection in many health-care institutions throughout the world. Strategies that reduce exposure to the organism or to antibiotics will have an impact on rates of C. difficile-associated diarrhoea.”[1]


EasyScreen™ C. difficile Detection Kit

The EasyScreen™ C. difficile Detection Kit is a real-time PCR kit for the detection of any toxigenic C. difficile bacteria.  The reaction uses three fluorescence channels as indicated below:

Detection_060112_All copy

Simultaneous detection of both tcdA and tcdB genes, in the FAM channel (in blue)
Detection of the Internal Control in the HEX channel (in green)
Detection of the Extraction Control in the Cy5 channel (in purple)


EasyScreen™ C. difficile Reflex Kit

The EasyScreen™ C. difficile Reflex Kit is a real-time PCR kit for the detection of hypervirulent C. difficile bacteria. The reaction uses four fluorescence channels for the detection of:

(i) The tcdC gene deletion at position 117 (in blue below)
(ii) The binary toxin gene (cdtA) (in purple below)
(iii) The gyrA gene mutation (fluroquinolone resistance) (in red below)
(iv) An internal positive control (IPC) (inhibition control) (in green below)

Reflex_060112_All copy

Control C.difficile bacteria (hypervirulent strain 027) were treated with the EasyScreen™ Sample Processing Kit (SP001) and DNA equivalent to 10,000 cfu, 1,000 cfu, 100 cfu, 50 cfu, 25 cfu and 12.5 cfu was seeded into the PCR.


Clinical Validation of EasyScreenC. difficile Kits

Table 1: Clinical performance of the EasyScreen™ C. difficile Detection Kit as compared to EIA.

Study #1 (n=70) 
C.difficile Culture+70 (100%)
EIA*43 (61.4%)
EasyScreen™ C.difficile* 53 (75.7%)

+ includes both toxigenic and non-toxigenic C. difficile

* toxigenic C. difficile results

Table 2: Comparison of C. difficile culture, EIA, Illumigene™ C. difficile DNA amplification assay, TechLab®  Quik Chek Complete™ and EasyScreen™ C. difficile Detection Kit on 73 stool samples.

Study #2 (n=73)  
Positive%
C. difficile Culture+63/7288
EIA*31/7243
Company B*56/7376.7
Quik Chek Complete*35/5267.3
EasyScreen™ C. difficile*56/7376.7

+ includes both toxigenic and non-toxigenic C. difficile
* toxigenic C. difficile results

Table 3: Clinical performance of the EasyScreenC. difficile Detection Kit compared to faecal toxin, the gold-standard of culture toxin and two independent molecular assays.

Study #3 (n=74) 
Culture Toxin +ve61/74 (82.4%)
EasyScreen™ +ve (1)65/74 (87.8%)
Company B +ve (2)65/74 (87.8%)
Company A +ve (3)36/69 (52.2%)
Faecal Toxin +ve (4)33/74 (44.6%)

(1) 61/61 Culture Toxin (CT) positive samples (100%)
(2) 59/61 CT positive samples (96.7%)
(3) 36/58 CT positive samples (62.1%)
(4) 33/74 CT positive samples (45.6%)


[1] Riley TV. Nosocomial diarrhoea due to Clostridium difficile. Curr Opin Infect Dis. 2004 Aug;17(4):323-7. Review.

 

Regulatory

The EasyScreen™ C. difficile Reflex Kit is for in vitro diagnostic use.