BD ProbeTec Manual Del Usario página 22

(sample type/temperature/duration). The expected results were obtained with the CT Q
tested.
Pools of CT negative vaginal and endocervical swab specimen matrices in CT/GC Q
analytical experiments to support the storage stability claims for pre-warmed expressed vaginal, endocervical, and
male urethral swab specimens. For both types of matrix, pooled specimens were spiked with CT serovar H and GC
strain ATCC 19424 at 90 EB per mL and 300 cells per mL, respectively and aliquotted into 2 mL volumes in BD specimen
tubes. The tubes were pre-warmed at 114°C for 15 min and cooled for 15 min. After the pre-warm process, the
specimen tubes were stored either at 2 – 8°C for 3 or 7 days; or at 30°C for 3 or 7 days; or at -20°C for 30 or 180 days.
At each time point, samples were removed from storage and tested with the BD ProbeTec CT Q
System in extracted mode. Thirty-two assay replicates were generated for each condition (sample type/temperature/
duration). The expected results were obtained with the CT Q
Reproducibility
Reproducibility of the BD Viper System using the BD ProbeTec CT Q
BD Viper System per site. A panel of simulated specimens was tested that comprised CT and GC organisms seeded
into swab diluent for the BD ProbeTec CT Q
endocervical swab whereas the simulated urine and vaginal swab specimens did not. Uninoculated swab diluent for
the BD ProbeTec CT Q x
every day for five days on each BD Viper System. The data are summarized in Table 14.
Table 14: Summary of Reproducibility Data on the BD Viper System for the CT Q
Specimen CT
Type EB's/mL
0
30
Endocervical/
0
Urethral
30
75
0
30
Urine/Vaginal 0
30
75
A second study was conducted internally to characterize the reproducibility of test results (i.e., proportion positive or
negative) at target levels below the analytical Limit of Detection (LOD) of the BD ProbeTec CT Q
simulated specimens was tested that comprised CT and GC organisms seeded into swab diluent at two different levels
(1:10, 1:100) each of which was below the analytical LOD for the respective organism. These levels were selected to
fall within the dynamic range of the analytical LOD curve for this assay. Fifteen replicates of each panel member were
tested every day for five days across three BD Viper Systems. The data are summarized in Table 15.
Table 15: Characterization of System Reproducibility at Target Levels below the Analytical Limit of Detection for the
CT Q x Assay.
Dilution of
Specimen Type Analytical
Endocervical/
Urethral
Endocervical/
1:100
Urethral
Urine/Vaginal
Urine/Vaginal 1:100
x Assay. Simulated endocervical and urethral specimens contained a clean
Assay was used for the CT negative samples. Nine replicates of each panel member were tested
GC
Cells/mL % Correct
98.5%
0
(133/135)
100.0%
0 (97.3 – 100.0%) 2011.2
(135/135)
100.0%
100 (97.3 – 100.0%)
(135/135)
100.0%
250 (97.3 – 100.0%) 1991.9
(135/135)
100.0%
100 (97.3 – 100.0%) 1954.8
(135/135)
100.0%
0 (97.3 – 100.0%)
(135/135)
100.0%
0 (97.3 – 100.0%) 1999.8
(135/135)
100.0%
100 (97.3 – 100.0%)
(135/135)
100.0%
250 (97.3 – 100.0%) 1995.2
(135/135)
100.0%
100 (97.3 – 100.0%) 2014.4
(135/135)
% Positive
LOD
70.2
1:10
(158/225)
10.2
(23/225)
64.4
1:10
(145/225)
10.7
(24/225)
x assay under all conditions tested.
x Assay was evaluated at three clinical sites on one
MaxRFU
95% CI Mean
(94.8 – 99.8%) 29.9
1.4
0.9
0.8
MaxRFU
95% CI
Mean
(Positive)
(Positive)
(63.8, 76.1) 1794.2
(6.6,14.9) 1643.8
(57.8, 70.7) 1733.9
(7.0, 15.5) 1666.6
21
x assay under all conditions
x
Swab Diluent were used in
x
x
Assay
Between Runs
Within Run
Within Site
SD %CV SD
233.0 778.5 0.0
114.1 5.7 0.0
6.0 442.7 1.0
118.0 5.9 17.6
169.4 8.7 0.0
5.0 542.4 0.0
131.8 6.6 34.2
3.4 442.4 0.0
125.8 6.3 33.1
109.5 5.4 0.0
95% CI
% Negative
(Negative)
29.8 (67/225) (23.9, 36.2)
89.8
(85.1, 93.4)
(202/225)
35.6 (80/225) (29.3, 42.2)
89.3
(84.5, 93.0)
(201/225)
Assay on the BD Viper
Between Site
%CV SD %CV
0.0 33.9 113.4
0.0 14.8 0.7
76.9 0.0 0.0
0.9 10.4 0.5
0.0 0.0 0.0
0.0 0.0 0.0
1.7 0.0 0.0
0.0 0.0 0.0
1.7 52.9 2.7
0.0 0.0 0.0
x Assay. A panel of
MaxRFU
Mean
(Negative)
2.6
1.6
4.6
2.4