BD ProbeTec Manual Del Usario página 21

Table 13: CT Q x Interfering Substances
Interpretation
No Interference Observed
May cause extraction control
(EC) failures
Neat and Q x UPT Urine Stability
Pools of CT negative male and female urine specimens were used in analytical experiments to support the urine
storage and transport stability claims. For neat urine, pools were co-spiked with CT serovar H and GC strain ATCC
19424 at 45 EB per mL and 150 cells per mL, respectively. Neat urine specimens were stored at either 2 – 8°C for 1, 3 or
7 days; or at 30°C for 8, 24 or 30 h; or at -20°C for 180 days. At each time point, samples were removed from storage
and tested with the BD ProbeTec CT Q
were generated for each condition (sample type/temperature/duration). The expected results were obtained with the
x
CT Q assay under all conditions tested.
For Q x UPT urine, pooled specimens were co-spiked with CT serovar H and GC strain ATCC 19424 at 45 EB per mL and
150 cells per mL, respectively. The spiked urine specimen pools were then stored at either 2 – 8°C for 24 h or 30°C for
8 h prior to transfer into Q
30 days; or at 30°C for 14, 21 or 30 days; or at -20°C for 180 days. At each time point Q
from storage and tested with the BD ProbeTec CT Q
replicates were generated for each condition (sample type/temperature/duration). The expected results were obtained
x
with the CT Q assay under all conditions tested.
Vaginal Dry and Expressed Swab Stability
Pools of CT negative vaginal swab matrix were used in analytical experiments to support the storage and transport
stability claims for dry vaginal swab specimens. Pools were co-spiked with CT serovar H and GC strain ATCC 19424 to
achieve 90 EB per mL and 300 cells per mL, respectively, when seeded onto swabs and expressed in CT/GC Q
Diluent. Seeded dry swabs were stored at 2 – 8°C for 3, 7, or 14 days; or at 30°C for 3, 7 or 14 days; or at -20°C for 30,
60 or 180 days. At each time point, dry swabs were removed from storage and expressed into 2 mL of CT/GC Q
Diluent and evaluated with the BD ProbeTec CT Q
replicates were generated for each condition (sample type/temperature/duration). The expected results were obtained
with the CT Q x assay under all conditions tested.
Pools of CT negative vaginal swab matrix were used in analytical experiments to support the storage and transport
stability claims for expressed vaginal swab specimens. Pools were spiked with CT serovar H and GC strain ATCC 19424
to achieve 90 EB per mL and 300 cells per mL, respectively. The spiked swab matrix was stored at 2 – 8°C for 7, 14 or 30
days; or at 30°C for 7, 14 or 30 days; or at -20°C for 30, 60 or 180 days. At each time point, samples were removed from
storage and tested with the BD ProbeTec CT Q
replicates were generated for each condition (sample type/temperature/duration). The expected results were obtained
with the CT Q x assay under all conditions tested.
Endocervical and Urethral Swab Specimen Stability
Pools of CT negative endocervical swab matrix were used in analytical experiments to support the storage and
transport stability claims for endocervical and urethral swab specimens. Pools of swab matrix were spiked with CT
serovar H and GC strain ATCC 19424 at 90 EB per mL and 300 cells per mL, respectively. The pools were dispensed in
2 mL volumes into BD sample tubes to simulate "wet" endocervical specimens and stored at either 2 – 8°C for 7, 14 or
30 days; or at 30°C for 7, 14 or 30 days; or at -20°C for 30, 60 or 180 days. At each time point, samples were removed
from storage and tested with the BD ProbeTec CT Q
replicates were generated for each condition (sample type/temperature/duration). The expected results were obtained
with the CT Q x assay under all conditions tested.
Post Pre-warm Specimen Stability
Pools of male and female CT negative neat urine were used in analytical experiments to support the storage stability
claims for pre-warmed neat and Q
GC strain ATCC 19424 at 45 EB per mL and 150 cells per mL, respectively and either added to Q
untreated as neat urine. Both specimen types were pre-warmed at 114°C for 15 min, and cooled for 15 min. After the
pre-warm process, specimen tubes were stored at either 2 – 8°C for 1, 3 or 7 days; or at 30°C for 1, 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 x Assay on the BD Viper System in extracted mode. Thirty-two assay replicates were generated for each condition
Swab
Blood (≤ 60%)
Seminal Fluid
Mucus
Over The Counter vaginal products
and contraceptives
Hemorrhoidal cream
Prescription vaginal treatments
Leukocytes (1x10
1x10 6 cells/mL Neisseria gonorrhoeae
Blood (> 60%)
x Assay on the BD Viper System in extracted mode. Thirty-two assay replicates
x UPT tubes. The Q x UPT specimen pools were then stored either at 2 – 8°C for 14, 21 or
x
x Assay on the BD Viper System in extracted mode. Thirty-two assay
x
UPT urine specimens. Pooled specimens were spiked with CT serovar H and
Blood (≤1%)
Seminal fluid
Mucus
Antibiotics
Analgesics
Over The Counter deodorant sprays and
6
cells/mL) Hormones
Leukocytes
Albumin <1 mg/mL
Glucose
Acidic urine (pH 4.0)
Alkaline urine (pH 9.0)
Bilirubin
1x10
Organisms associated with Urinary Tract
Not applicable
x Assay on the BD Viper System in extracted mode. Thirty-two assay
Assay on the BD Viper System in extracted mode. Thirty-two assay
x
Assay on the BD Viper System in extracted mode. Thirty-two assay
20
Urine
powders
6 cells/mL Neisseria gonorrhoeae
Infections
x UPT specimens were removed
x UPT tubes or left
x Swab
x Swab