Performance Characteristics - Puritan Diagnostics UniTranz-RT Manual Del Usuario

PERFORMANCE CHARACTERISTICS

The survival and recovery of viruses, chlamydiae, mycoplasmas and ureaplasmas was tested to determine the performance
characteristics of Puritan UniTranz-RT. Neat stocks of the above microorganisms were prepared for testing. Two different
dilutions of the neat stock suspensions were prepared and, from these, 100 µL were directly inoculated onto swabs in
triplicate. The swabs were transferred into the transport medium and held at both 4
the required amount of time. At key time points following inoculation (0, 24 and 48h), each sample was vortexed after which
an aliquot of the suspension was inoculated into shell vials or suitable culture media. Viability of viruses and chlamydiae was
determined by shell vial assay followed by immunostaining and enumeration of fluorescent foci. The viability of mycoplasmas
and ureaplasmas was determined using direct culture methods onto appropriate growth media followed by enumeration
of colony forming units (CFU). Cultures were processed by standard laboratory techniques and examined following optimal
incubation periods. Test viruses used for evaluation of the transport medium were adenovirus, cytomegalovirus, echovirus
type 30, herpes simplex virus type 1, herpes simplex virus type 2, influenza A, parainfluenza 3, respiratory syncytial virus,
and varicella-zoster virus . Among bacteria, Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma pneumoniae,
Mycoplasma hominis, and Ureaplasma urealyticum were used for testing.
The results of the study are presented in Tables 1-3. The results demonstrate the ability of Puritan UniTranz-RT to sustain
the viability and recovery of test bacteria and viruses, namely adenovirus, cytomegalovirus, echovirus type 30, herpes
simplex virus type 1, herpes simplex virus type 2, influenza A, parainfluenza 3, respiratory syncytial virus, and varicella-
zoster virus, Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma pneumoniae, Mycoplasma hominis, and
Ureaplasma urealyticum for at least 48 h at 4
the Puritan UniTranz-RT transport system other than the ones tested here is not known and should be validated by the
user.
Table 1 – Recovery of Viruses
Dilution
Organism of Neat
Adenovirus
Cytomegalovirus
Echovirus
Type 30
Herpes Simplex
Type 1
Herpes Simplex
Type 2
Influenza A
4
C and room temperature (20-25
o
Percent
Infectivity of
Host Cells
Stock
a
(%) Infectivity)
1:100 2%
1:500 3%
1:10 100%
1:100 100%
1:100 64%
1:500 2.91%
1:10 6%
1:100 48%
1:10 47%
1:100 97%
1:50 10%
1:100 12%
C). Caution: Viability of microorganisms in
o
Incubation
Storage
Time Prior
Time
to Reading
(Hours) (Hours)
0
24 24
48
0
24 24
48
0
24 24
48
0
24 24
48
0
24 24
48
0
24 24
48
0
24 24
48
0
24 24
48
0
24 24
48
0
24 24
48
0
24 24
48
0
24 24
48
C and room temperature (20-25
o
Mean Viability of Test Organism
Using Test (Puritan) Device: Foci
Counts with SD
b
4°C
343 ± 72
550 ± 77
652 ± 143
118 ± 78
192 ± 37
145 ± 57
751 ± 71
209 ± 26
269 ± 58
242 ±7
134 ± 13
86 ± 35
95 ± 52
337 ± 178
454 ± 210
63 ± 48
194 ± 134
252 ± 31
207 ± 78
665 ± 189
609 ± 238
167 ± 101
89 ± 38
96 ± 14
126 ± 13
51 ± 21
108 ± 32
26 ± 6
25 ± 15
17 ± 6
298 ± 86
470 ± 96
173 ± 95
186 ± 130
109 ± 56
82 ± 36
C) for
o
RT
343 ± 72
434 ± 66
408 ± 89
118 ± 78
161 ± 28
47 ± 17
751 ± 71
47 ± 3
319 ± 34
242 ± 7
47 ± 5
207 ± 110
95 ± 52
332 ± 221
605 ± 194
63 ± 48
214 ± 108
151 ± 41
207 ± 78
325 ± 107
772 ± 243
167 ± 101
72 ± 17
107 ± 35
126 ± 13
85 ± 25
6 ± 3
26 ± 6
37 ± 13
8 ± 6
289 ± 86
250 ± 89
93 ± 41
186 ± 130
181 ± 117
30 ± 13