|
Catalogue no.
|
505715 (20 tests)
505796 (40 tests)
|
|
Method
|
Lateral Flow
|
|
Time to Result
|
At appearance of End of Assay (approx. 5 minutes)
|
|
Storage
|
2 - 30oC
|
|
Shelf Life
|
24 months
|
|
Sensitivity
|
97.6%
|
|
Specificity
|
98.4%
|
|
Sample Type
|
Throat Swab
|
|
Kit Size
|
20 or 40 tests
|
|
Kit Contents
|
20 or 40 Reaction Discs
20 or 40 Throat Swabs
20 or 40 Extraction Tubes
1 workstation containing 1 bottle of each Reagent 1, 2 &
3
1 Package Insert
|
*in comparison to culture
Accuracy
Results were obtained from 369 patients, of which
125 were found to be positive by standard sheep blood agar (SBA)
culture and 244 were found to be negative. The sensitivity of
TestPack Strep A was 97.6% when compared to
standard SBA culture (95% confidence interval [CI]: 93.1-99.5%).
The specificity of TestPack Strep A was 98.4% when
compared to standard SBA culture (95% confidence interval [CI]:
95.9-99.6%).
Results compared to SBA culture
|
TestPack Strep
A
|
Sheep Blood
Agar
|
|
+
|
-
|
|
+
|
122
|
4
|
|
-
|
3
|
240
|
Results compared to SBA culture density
| Culture
density |
TestPack Strep
A |
|
1+
|
82% (9/11)
|
|
2+
|
96% (23/24)
|
|
3+
|
100% (39/39)
|
|
4+
|
100% (51/51)
|