|
Catalogue no.
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505805
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|
Method
|
Lateral Flow
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|
Time to Result
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5 minutes
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|
Storage
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2 - 30oC
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|
Shelf Life
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24 months
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|
Sensitivity
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25 mIU/ml
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|
Specificity
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> 99%*
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Sample Type
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Urine or Serum
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Kit Size
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20 tests
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Kit Contents
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20 Reaction Discs
20 transfer Pipettes
1 Package Insert
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*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
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Commercially available hCG
Combo test
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|
+
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-
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+
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126
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0
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|
-
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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
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|
+
|
-
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|
+
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110
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0
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|
-
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0
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76
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