TECHNICAL SUPPORT - Advice Line Further information can be obtained by contacting TECHLAB Technical Support 1-800-TECHLAB [email protected] C. DIFF QUIK CHEK COMPLETE  A Rapid Membrane Enzyme Immunoassay for the Simultaneous Detection of Clostridium difficile Glutamate Dehydrogenase Antigen and Toxins A and B in Fecal Specimens Catalog No. 30525C (25 Tests) or 30550C (50 Tests) IVD In Vitro Diagnostic Medical Device U.S. CLIA classification -– Moderate TECHLAB, Inc. 2001 Kraft Drive Blacksburg, VA 24060-6358 USA C. DIFF QUIK CHEK COMPLETE, the TECHLAB Logo, and TECHLAB are trademarks of TECHLAB, Inc. ProClin is a trademark of Rohm and Haas Company. All other trademarks referenced are trademarks of their respective owners. © 2021 TECHLAB, Inc. All rights reserved. TECHLAB, Inc. 2001 Kraft Drive Blacksburg, VA 24060-6358 USA

C. DIFF QUIK CHEK COMPLETE  INTENDED USE 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. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other...

MATERIALS PROVIDED MEM DEV Membrane Devices – each pouch contains 1 device DIL SPE Diluent (22 mL per bottle) – Buffered protein solution with graduated dropper assembly (contains 0.05% ProClin® 300) Signal Word: Warning H317:May cause an allergic skin reaction P261, P272, P280, P302, P352, P333, P313, P321, P362, P363, P364, P501 WASH REAG Wash Buffer (12 mL per bottle) – Buffered solution with graduated dropper assembly (contains 0.05% ProClin® 300) Signal Word: Warning H317:May cause an allergic skin reaction P261, P272, P280, P302, P352, P333, P313, P321, P362, P363, P364, P501 SUBS REAG...

9. Hold reagent bottles vertically to dispense reagents to ensure consistent drop size and correct volume. 10. Specimens and membrane devices should be handled and disposed of as potential biohazards after use. 11. Membrane devices cannot be reused. 12. The test has been optimized for sensitivity and specificity. Alterations of the specified procedure and/or test conditions may affect the sensitivity and specificity of the test. Do not deviate from the specified procedure. 13. Be attentive to the total assay time when testing more than one fecal specimen. Add Diluent first, and then add the Conjugate...

Antigen Positive Antigen Negative Toxin Positive Toxin Negative Sample 1 (95% negative results expected) Sample A (95% positive results expected) Specimens in transport media (Cary Blair, C&S) External Controls (positive and negative) Frozen Fecal Specimens (frozen undiluted) Fresh Fecal Specimens 4. Add one drop of Conjugate (red capped bottle) to each tube. 5. Obtain one disposable plastic transfer pipette (supplied with the kit) for each sample – the pipettes have raised graduations at 25 µL, 400 µL and 500 µL. Graduated Transfer Pipette: 6. Mix all specimens thoroughly regardless of consistency-...

11 TEST PROCEDURE 1. Obtain one Membrane Device per specimen, and one device per optional external positive or negative control as necessary. The foil bags containing the devices should be brought to room temperature before opening. Use the device immediately after opening. Label each device appropriately and orient it on a flat surface so the “C. DIFF COMPLETE” print is at the bottom of the device, and the small Sample Well is located in the top right corner of the device. Membrane Device Sample Well Reaction Window 2. Close each tube of diluted specimen and mix thoroughly. Proper mixing can...

Clinical evaluation of the toxin portion of the C. DIFF QUIK CHEK COMPLETE test The toxin portion of the C. DIFF QUIK CHEK COMPLETE test was compared to the tissue culture assay at two clinical laboratories and in-house at TECHLAB, Inc. Specimens included in the evaluation were submitted to the clinical laboratories for routine testing. The results are shown in Table 3. Table 3. Summary of clinical performance comparing C. DIFF QUIK CHEK COMPLETE  test to the tissue culture assay n = 1126 Tissue Culture positive Tissue Culture negative C. DIFF QUIK CHEK COMPLETE ® Toxin Line Positive C. DIFF...

QUALITY CONTROL Internal: A dotted blue line must be visible in the middle of the Reaction Window, below the “C” on every Membrane Device that is tested. The appearance of the blue control dots confirms that the sample and reagents were added correctly, that the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. It also confirms the reactivity of the other reagents associated with the assay. A uniform background in the result area is considered an internal negative control. If the test has been performed correctly and reagents...

Clinical evaluation of the antigen portion of the C. DIFF QUIK CHEK COMPLETE  test The antigen portion of the C. DIFF QUIK CHEK COMPLETE  test was compared to bacterial culture. Specimens included in the evaluation were submitted to the clinical laboratories for routine testing. The bacterial culture test was performed according to inhouse procedures. The results are shown in Table 1. Table 1. Summary of clinical performance comparing C. DIFF QUIK CHEK COMPLETE  test to bacterial culture Bacterial Culture negative C. DIFF QUIK CHEK COMPLETE ® Antigen Line Positive C. DIFF QUIK CHEK COMPLETE...

The antigen portion of the C. DIFF QUIK CHEK COMPLETE test was compared to the tissue culture assay for the detection of C. difficile toxin. Specimens included in the evaluation were submitted to the clinical laboratories for routine testing. The results are shown in Table 2. The antigen portion of the C. DIFF QUIK CHEK COMPLETE test detected 98.7% of the tissue culture-positive samples. Table 2. Summary of clinical performance comparing C. DIFF QUIK CHEK COMPLETE  test to the tissue culture assay Tissue Culture positive Tissue Culture negative C. DIFF QUIK CHEK COMPLETE ® Antigen Line Positive...