P. Mcnicol et al., EVALUATION AND VALIDATION OF A MONOCLONAL IMMUNOFLUORESCENT REAGENT FOR DIRECT-DETECTION OF BORDETELLA-PERTUSSIS, Journal of clinical microbiology, 33(11), 1995, pp. 2868-2871
An outbreak of pertussis in Manitoba, Canada, provided an opportunity
to evaluate the recently developed monoclonal antibody (MAb) BL-5 for
the direct detection of Bordetella pertussis. The MAb recognizes a lip
ooligosaccharide epitope, A total of 1,507 consecutive nasopharyngeal
swabs for culture and companion smears for direct fluorescent-antibody
(DFA) detection were evaluated at Cadham Provincial Laboratory betwee
n September and November 1994. The cutoff for DFA positivity was four
fluorescing organisms with morphology characteristic of B. pertussis.
PCR analysis for B. pertussis DNA was performed on a subset of 100 sme
ars by eluting material from the slides after DFA examination, In comp
arison with culture, the sensitivity, specificity, and positive and ne
gative predictive values of BL-5 were 65.1% (41 of 63 samples), 99.6%
(1,438 of 1,444 samples), 87.2% (41 of 47 samples), and 98.5% (1,338 o
f 1,460 samples), respectively, The sensitivity of culture compared wi
th PCR was 35.5% (10 of 22 samples) for the subset of 100 specimens te
sted by both procedures, An expanded ''gold standard'' of positivity b
y culture or PCR for these 100 specimens resulted in DFA sensitivity,
specificity, and positive and negative predictive values of 32.3, 97.1
, 83.3, and 76.1%, respectively, The utility of MAb BL-5 for direct de
tection of B. pertussis in a clinical laboratory setting has been demo
nstrated by this investigation.