Quality Control; Performance Characteristics - nal von minden NADAL C. Instructions D'utilisation

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tion vial to ensure good
sample dispersion. Break off
the tip of the vial.
3. Use a separate test cassette
for each sample. Dispense 4
drops of the sample into the
specimen well (S). Start the
timer.
4. Read the result at 10
minutes after dispensing the
sample.
10. Interpretation of the Results
Positive:
Toxin A positive:
In addition to the green line in the control
region (C), a red-coloured line will
develop in the test region (T1).
Toxin B positive:
In addition to the green line in the control
region (C), a red-coloured line will
develop in the test region (T2).
Toxin A/B positive:
In addition to the green line in the control
region (C), two red-coloured lines develop
in the test region (T1) and in test region
(T2).
The intensity of the red coloured test lines (T1 and T2) will
vary depending on the concentration of antigens in the
specimen. However, neither the quantitative value, nor the
rate of increase of antigens can be determined by this
qualitative test.
Negative:
Only one green line develops in the
control region C. No test lines
develop.
Invalid:
No line develops in the control region
(C). This indicates a possible error in
the performance of the test. A new
test should be performed.
Note: Insufficient specimen volume, incorrect procedural
techniques or reagent deterioration are the most likely
reasons for control line failure. Review the procedure and
repeat the test with a new test. If the problem persists,
discontinue using the test kit and contact your distributor.

11. Quality Control

An internal procedural control is included in
the test:
A green line developing in the control line
region (C) confirms sufficient specimen
volume and correct procedural technique.
12. Limitations
 The NADAL® C. difficile Toxins A&B test will only detect the
presence of parasites in the stool specimen (qualitative
detection) and should be used for the detection of Toxins A
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)
and/or B antigens in feces specimens only. Neither the
quantity nor the rate of increase in antigen concentration
can be determined by this test.
 An excess of sample may cause wrong results (brown bands
appear). Dilute the sample with the buffer and repeat the
test.
 Some stool samples can decrease the intensity of the
control bands.
 The test must be carried out within 2 hours after opening
the sealed pouch.
 If the test result is negative and clinical symptoms persist,
additional testing using other clinical methods
recommended. A negative result does not at any time
preclude the possibility of Clostridium difficile infection.
 The NADAL® C. difficile Toxins A&B test provides a
presumptive diagnosis of infection caused by Clostridium
difficile. All results must be interpreted together with other
clinical information and laboratory findings available to the
physician.
13. Expected values
Clostridium difficile is associated with 95-100% of the cases of
pseudomembranous colitis, 60-75% of the cases of antibiotic-
associated colitis and 35% of the cases of antibiotic-associated
diarrhea.

14. Performance Characteristics

Sensitivity and specificity
Stool samples from patients with diarrhea were studied. The
NADAL® C. difficile Toxins A&B test in comparison with other
commercial immunoassay tests showed:
Sensitivity >99%
Specificity >99%
Cross reactivity:
An evaluation was performed to determine the cross reactivity
of the NADAL® C. difficile Toxins A&B test. There is no cross
reactivity with common gastrointestinal microorganisms
occasionally present in feces.
Campylobacter Helicobacter pylori
spp.
E.Coli O157:H7 Shigella spp.
Listeria Staphilococcus
monocytogenes aureus
15. References
1. Wren, M.W.D, et al. "Laboratory diagnosis of Clostridium difficile infection. An
evaluation of tests for faecal toxin, glutamate dehydrogenase, lactoferrin and
toxigenic culture in the diagnostic laboratory". British Journal of Biomedical
Science, 66 (1), 2009.
2. Vaishnavi, Ch., "Clinical spectrum & pathogenesis of Clostridium difficile associated
diseases". Indican J. Med. Res. 131, April 2010, pp 487-499.
3. Poutanen, S. M. et al."Clostridium difficile-associated diarrhoea in adults", CMAJ,
171(1) July 2004, pp. 51-58.
is
Salmonella spp.
Yersinia spp.
Yersinia
enterolitica
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