BD ProbeTec Manual Del Usario página 14

D. Controls
During the clinical evaluation, there were no CT Q
Q x negative control, a failure was observed in 1 of 253 CT Q
MaxRFU values observed in the clinical trials are shown in Table 7.
Table 7: Distribution of MaxRFU Results for the CT Q
Control
x
CT Q Negative Control
CT Q x Positive Control
PERFORMANCE CHARACTERISTICS
Clinician-collected endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a
clinical setting), and male and female Q
and 479 male subjects attending OB/GYN, sexually transmitted disease (STD) and family planning clinics at seven
geographically diverse clinical sites in North America. Subjects were classified as symptomatic if they reported
symptoms such as dysuria, urethral discharge, coital pain/difficulty/bleeding, testicular or scrotum pain/swelling,
abnormal vaginal discharge, or pelvic/uterine/adnexal pain. Subjects were classified as asymptomatic if they did not
report symptoms. Sixty five female subjects and 7 male subjects were excluded from the data analysis due to age
requirement violations, antibiotic treatment in the last 21 days, opting to withdraw from the study after initially
consenting, failure to obtain paired swab and urine specimens, urine quantity less than 20 mL, or transport and
storage errors related to specimen collection. Therefore, the final data analysis included 994 compliant female subjects
and 472 compliant male subjects.
Five specimens were collected from each of the 994 eligible female subjects. A urine specimen was collected and split
x
into Q UPT, neat urine and the two reference urine specimen collection devices followed by a vaginal swab specimen
and three randomized endocervical swab specimens. Up to four specimens were collected from each of the 472
eligible male subjects. Up to three randomized urethral swab specimens were collected followed by a urine specimen
that was split into Q x UPT, neat urine and the two reference urine specimen collection devices. BD ProbeTec CT Q
assay results were generated from the Q
swab specimen and one male urethral swab specimen. The remaining two endocervical swab specimens, up to two
male urethral swab specimens, and the two reference urine specimens for each male and female subject were tested
using two reference methods: the BD ProbeTec ET CT/AC assay and another commercially available NAAT (Nucleic
Acid Amplification Test). Specimen testing was conducted either at the site of specimen collection or at a designated
BD Viper testing site.
All performance calculations were based on the total number of BD ProbeTec CT Q
vaginal and male urethral swab specimens, and male and female Q
a patient infected status (PIS) algorithm for each gender. In the algorithm, the designation of a subject as being
infected with CT or not was based on endocervical swab and urine specimen results from the commercially available
BD ProbeTec ET CT/AC assay and the other commercially available NAAT. Subjects were considered infected with
CT if two of the four endocervical swab and urine specimens (or two of the three or four urethral swab and urine
specimens) tested positive in the BD ProbeTec ET CT/AC assay and the other reference NAAT (one specimen testing
positive in each NAAT). Subjects were considered non-infected if less than two reference NAAT results were positive. A
total of 5388 BD ProbeTec CT Q
by specimen type and symptomatic status are presented in Table 8.
Performance of the assay with endocervical swabs, patient collected vaginal swab specimens (in a clinical setting),
female UPT and neat urine was assessed in the clinical study. Separate performance was calculated for specimens
collected from pregnant females. For the latter, sensitivity compared to patient infected status for FS was 62.5%
(5/8): the test and reference NAAT swab specimens were negative; the test and reference NAAT urine specimens were
positive yielding a PIS positive result. FV sensitivity was 75% (6/8): the test and reference NAAT swab specimens were
negative; the test and reference NAAT urine specimens were positive yielding a PIS positive result. FNU and FUPT
sensitivity were 100% (8/8). Specificity was 94.7% (18/19) for FS, FV, FNU, and FUPT separately.
Tables 10 and 11 summarize the number of results from symptomatic and asymptomatic subjects designated as
infected or non-infected with CT according to the PIS algorithm.
x
positive control failures from 253 CT Q
n Range
252 0 – 41
253 629 – 2378
x UPT and neat urine specimens were collected from 1059 female subjects
x UPT and neat urine specimens, the vaginal swab specimen, one endocervical
x assay results was used to calculate sensitivity and specificity. Sensitivity and specificity
x plate runs. The CT/GC Q
x Assay Positive and Negative Controls
MaxRFU
5th
Mean
Percentile
0.0 0.7
1597.7 1939.4
x UPT and neat urine specimens compared to
13
x
plate runs. For the CT
x positive and negative control
95th
Median
Percentile
0.0 4.3
1968.8 2184.0
x assays results for endocervical,
x