Table 1.
Enrollment criteria for participation in the clinical validation study, 2007–2011.
Table 2.
Demographic, clinical, and epidemiological characteristics of all participants enrolled in the clinical validation study (N = 868).
Table 3.
Laboratory diagnostic test results for all participants enrolled in the clinical validation study (N = 868).
Fig 1.
B. pertussis-positive laboratory test results by age group (N = 868).
Acute sera are collected ≤ 2 weeks after cough onset, and convalescent sera are collected > 2 weeks after cough onset.
Fig 2.
B. pertussis-positive laboratory test results by time of specimen collection.
Fig 3.
Comparison of log-transformed acute and convalescent serology results (n = 305).
Acute sera are collected ≤ 2 weeks after cough onset, and convalescent sera are collected > 2 weeks after cough onset. Open circles indicate participants with discordant results, and shaded circles indicate participants with concordant results at the acute and convalescent time periods. Dashed lines indicate the log-transformed diagnostic cutoff values. Log-transformed values ≥ 1.98 EU/mL were considered positive for pertussis, values 1.70–1.97 EU/mL were considered indeterminate, and values <1.96 EU/mL were considered negative.
Fig 4.
Log-transformed acute and convalescent antibody concentrations of nine B. pertussis culture-positive participants.
Acute sera are collected ≤ 2 weeks after cough onset, and convalescent sera are collected > 2 weeks after cough onset. Two participants had undetectable antibody concentrations at both the acute and convalescent time points. Dashed lines indicate the log-transformed diagnostic cutoff values. Log-transformed values ≥ 1.98 EU/mL were considered positive for pertussis, values 1.70–1.97 EU/mL were considered indeterminate, and values <1.96 EU/mL were considered negative.
Table 4.
Sensitivity and specificity estimates of B. pertussis culture, PCR, serology, and the clinical case definition.
Table 5.
Diagnostic measure result patterns and case classification of participants in Model 1 (n = 545).