| Catalogue no. |
505805 |
| Method |
Lateral Flow |
| Time to Result |
5 minutes |
| Storage |
2 - 30oC |
| Shelf Life |
24 months |
| Sensitivity |
25 mIU/ml |
| Specificity |
> 99%* |
| Sample Type |
Urine or Serum |
| Kit Size |
20 tests |
| Kit Contents |
20 Reaction Discs
20 transfer Pipettes
1 Package Insert
|
*determined by comparison with a commercially available hCG
test.
Accuracy
In a study, 295 urine and 186 serum specimens
collected from women for the purpose of pregnancy testing, were
evaluated with TestPack hCG Combo and another
commercially available hCG serum / urine test.
Of the 295 urine specimens evaluated, 126 specimens tested positive
by both methods and 168 specimens tested negative by both methods.
One specimen, which tested less than 5 mIU hCG/ml on a quantitative
test, tested negative with TestPack hCG Combo test
but positive on the other test.
An agreement of over 99% was determined for these urine specimens.
The relative sensitivity and relative specificity were found to be
greater than 99% for these specimens.
Urine
|
TestPack hCG
Combo
|
Commercially available hCG
Combo test
|
|
+
|
-
|
|
+
|
126
|
0
|
|
-
|
1
|
168
|
Of the 186 serum specimens evaluated, 110 specimens tested positive
by both methods and 76 specimens tested negative by both methods.
An agreement of over 99% was determined for these serum specimens.
The relative sensitivity and relative specificity were found to be
greater than 99% for these specimens.
Serum
|
TestPack hCG
Combo
|
Commercially available hCG
Combo test
|
|
+
|
-
|
|
+
|
110
|
0
|
|
-
|
0
|
76
|