nal von minden NADAL C. Instructions D'utilisation page 5

ENGLISH
1. Intended Use
The NADAL® C. difficile Toxins A&B test is a rapid chro-
matographic immunoassay for the qualitative detection of
C. difficile Toxin A&B antigens in human stool specimens to aid
in the diagnosis of C. difficile infection.
2. Introduction and Clinical Significances
Clostridium difficile is an anaerobic, gram-positive, spore-
forming bacterium. The key feature that enables it to persist in
patients and physical environments for long periods of time
and facilitates its transmission is the ability of C. difficile to
form spores. C. difficile is transmitted through the fecal-oral
route.
Clostridium difficile is the principal pathogen related to
antibiotic associated diarrhea and/or pseudomembranous
colitis in hospitalized patients.
Mature colonic bacterial flora in a healthy adult is generally
resistant to C. difficile colonization. However, if the normal
colonic flora is altered, resistance to colonization is lost. Thus,
any factor associated with alteration of the normal enteric
flora increases the risk of C. difficile colonization after
exposure to antibiotics, especially those with broad-spectrum
activity such as penicillins, cephalosporins and clindamycin.
C. difficile can release two high-molecular-weight toxins, toxin
A and toxin B. These are responsible for the clinical
manifestations, which range from mild, self-limited watery
diarrhea to fulminant pseudomembranous colitis, toxic
megacolon, and death.
3. Principle of the Test
The NADAL® C. difficile Toxins A&B test is a qualitative
immunoassay for the detection of C. difficile Toxin A and Toxin
B antigens in human stool samples. The membrane is pre-
coated with antibodies against Toxin A and antibodies against
Toxin B antigens on the corresponding test line regions. During
testing, the sample binds to the anti-Toxin A and anti-Toxin B
antibodies on the conjugate pad. The mixture moves upward
on the membrane by capillary action. In the case of a positive
result the specific antibodies present in the test line regions
will react with the mixture conjugates and generate one or
two coloured test lines. A green coloured line (third line)
should always develop in the control line region. It serves as
an internal test control and as verification that sufficient
volume of specimen has been added and proper membrane
wicking has occurred.
4. Reagents and Materials Supplied
 10 NADAL® C. difficile Toxins A&B test cassettes
 10 specimen collection vials with buffer
 Package insert
5. Additional Required Materials
 Specimen collection container
 Disposable gloves
 Timer
6. Storage & Stability
Store as packaged in the sealed pouch either refrigerated or at
room temperature (2-30°C). The test is stable through to the
expiration date printed on the sealed pouch. The test must
remain in the sealed pouch until use. Do not freeze.
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • info@nal-vonminden.com • www.nal-vonminden.com
NADAL® C. difficile Toxins A&B Test
(Ref. 582008)
7. Warnings and Precautions
 For professional in-vitro diagnostic use only.
 Do not use after expiration date.
 The test should remain in the sealed pouch until use.
 Do not use the test if the pouch is damaged.
 All operations linked to the use of the test must be
performed in accordance with Good Laboratory Practices
(GLP).
 Wear protective clothing such as laboratory coats,
disposable gloves and eye protection when specimens are
assayed.
 Do not eat, drink or smoke in the area where the specimens
and kit reagents are handled.
 All the specimens should be considered potentially
hazardous and handled in the same manner as an infectious
agent.
 The test should be discarded in a proper biohazard
container after testing.
 The test must be carried out within 2 hours after opening
the sealed pouch.
8. Specimen Collection and Preparation
Collect sufficient quantity of feces (1-2 g or 1-2 mL for liquid
sample). Stool samples should be collected in clean and dry
containers (no preservatives or transport media). The samples
can be stored in the refrigerator (2-8°C) for 24-48 hours prior
to testing. For longer storage the specimen must be kept
frozen at –20°C. In this case, the sample should be completely
thawed, and brought to room temperature before testing.
9. Procedure of the Test
Specimen preparation:
Use a separate specimen
collection vial for each sample.
Unscrew the cap of the vial and
introduce the stick into three
different spots of the fecal
specimen to collect 125 mg of
sample.
Close the vial containing the
buffer and stool sample.
Shake the vial in order to
ensure good sample disper-
sion.
For liquid stool samples, aspirate the fecal specimen with a
dropper and add 125 μL into the specimen collection vial with
buffer.
Test Procedure
Bring the test cassettes, stool samples and buffer to room
temperature (15-30°C) prior to testing. Do not open pouches
until ready to perform the assay.
1. Remove the NADAL® C.
difficile Toxins A&B test
cassette from its sealed
pouch and use it as soon as
possible.
2. Shake the specimen collec-
5