Rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
Reaction discs must be brought to 18-30°C for a minimum of 30 minutes, if stored refrigerated at 2-8°C, before beginning the assay. Specimens should be 18-30°C prior to use. Do not open foil pouches until ready to perform the assay.
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Remove the reaction disc from its foil pouch. Label with patient or control identifications. Place on a clean, flat, dry surface. |
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Draw specimen to the line marked on the transfer pipette. Dispense the entire contents drop wise into the sample well on the reaction disc. For each specimen, use a separate transfer pipette and reaction disc. |
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Wait for a pink/red colour in the End of Assay Window to appear (approximately 5 minutes). Read results. Ignore any results after this time. |
Refer to the Interpretation of Results and Performance Characteristics sections.
* On-Board Controls
TestPack hCG Urine provides the following integral control features :
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1. The Minus Sign
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A functional control showing that the sample has run through the test correctly. |
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2. The Positive Control
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Demonstrates the functionality of the antibodies that detect hCG. It will always be produced in a valid test whether or not hCG is present in the sample. |
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3. End of Assay
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Indicates the test is ready and must be read immediately ? no need for a timer. |
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4. The Negative Control
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Indicates a non-specific binding entity in the sample that could cause a false positive result |
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* Results
- The TESTPACK hCG URINE result format consists of one vertical line and one horizontal line that form a Plus Sign. The vertical line is the Patient Bar and the horizontal line is the Minus Sign.
- A positive result at end of assay is indicated by a plus sign (+) in the Result Window. Pink or red color (darker than the background) on the Patient Bar is interpreted as a positive result even if it has less color than the Minus Sign.
- A negative result at end of assay is indicated by the Minus Sign (-) in the Result Window. A negative result means that no hCG was detected, or that the levels of hCG in the specimen were below the detection limit of the assay.
- A valid TESTPACK hCG URINE with on board controls (OBC) test consists of all of the following:
• Appearance of the Minus Sign (-) in the Result Window on the reaction disc.
• Absence of NEG CTL (X) within the result window on the reaction disc.
• Appearance of POS CTL (v) within the designated POS CTL window on the reaction disc.
• Appearance of pink/red colour in the End of Assay window on the reaction disc.
1. Easy to use
2. Easy to interpret results (a simple '+' or '-')
3. Rapid results in approximately 5 minutes
4. Unique in-built controls give complete confidence throughout testing.
• Assay time - the test tells you when it is ready to read
• Sample migration - indicated by presence of the Minus Bar
• Antibody functionality - indicated by presence of the Positive On Board Control
• Non-specific binding - indicated by presence of the Negative On Board Control
5. Highly specific |
