TECHLAB, Inc.

i) Rapid Test

DIFF QUIK CHEK COMPLETE®

The C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well.

DIFF QUIK CHEK®

The C. DIFF QUIK CHEK® test is a rapid membrane enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase (GDH), in fecal specimens from persons suspected of having C. difficile disease.

TOX A/B QUIK CHEK®

The TOX A/B QUIK CHEK® test is a rapid enzyme immunoassay that uses antibodies specific for toxins A and B of C. difficile.

ii) Microassay Plates

DIFF CHEK™ – 60

An enzyme immunoassay for the detection of glutamate dehydrogenase (GDH) produced by both toxigenic and non-toxigenic strains of Clostridium difficile.

The glutamate dehydrogenase (GDH) of C. difficile is a good antigen marker for the organism in feces because it is produced in high amounts by all strains, toxigenic or non-toxigenic. The antigen can be detected in fecal specimens by using the C. DIFF CHEK™ -60 test.

DIFFICILE TOX A/B II™

A second generation rapid ELISA for the detection of Clostridium difficile toxins A and B in fecal specimens. Clostridium difficile produces two toxins, A and B. Toxin A often is referred to as the enterotoxin and toxin B is referred to as the cytotoxin. Both toxins are detected by the C. DIFFICILE TOX A/B II™ test.

iii) Tissue Culture Assays

DIFFICILE TOXIN/ANTITOXIN KIT

A toxin/antitoxin kit for the detection of Clostridium difficile toxin in fecal specimens. Clostridium difficile produces two toxins, A and B. Toxin B, often referred to as the cytotoxin, is the toxin detected by the tissue culture assay. The C. DIFFICILE TOXIN/ANTITOXIN KIT uses a tissue culture format to detect the presence of cytotoxic activity (cell rounding) in fecal specimens and confirms the identification of C. difficile toxin by using specific antitoxin.

DIFFICILE TOX-B TEST

A tissue culture assay for the detection of Clostridium difficile toxin B in fecal specimens. The C. DIFFICILE TOX-B TEST uses a tissue culture format to detect the presence of cytotoxic activity (cell rounding) in fecal specimens and confirms the identification of C. difficile toxin by using specific antitoxin. Reagents in the kit include toxin control, specific antitoxin, Phosphate Buffered Saline, and diluent.