Principle of the Test
The assay is based on rapid chromatographic immunoassay technology. The strip contains:
T1 test line for detection of IgM.
T2 test line for detection of IgG.
C control line to ensure procedural validity.
Any visible line in the test region, along with the control line, is considered a positive result.
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Kit Components
Individually packaged test devices.
Plastic droppers.
Buffer solution.
Package insert.
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Storage and Stability
Store at 2–30°C.
Do not freeze.
Stable until the expiration date printed on the pouch.
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Materials Required but Not Provided
Sample collection containers.
Capillary tubes or centrifuge (for serum/plasma).
Timer.
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Warnings and Precautions
For professional in vitro diagnostic use only.
Do not use after the expiration date.
Handle all specimens as potentially infectious.
Wear gloves and protective clothing.
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Specimen Collection and Preparation
Whole blood, serum, or plasma can be used.
Test specimens immediately after collection.
If testing is delayed, store at 2–8°C (up to 48 hours) or below -20°C for long-term storage.
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Test Procedure
- Bring specimen and test components to room temperature.
- Open the pouch and place the device on a flat surface.
- Add 1 drop of specimen (10µl) into the sample well.
- Add 2 drops of buffer (80µl).
- Read the result at 15 minutes. Do not interpret after 20 minutes.
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Interpretation of Results
IgM Positive: Line at T1 + line at C → recent infection.
IgG Positive: Line at T2 + line at C → past or chronic infection.
IgG & IgM Positive: Lines at T1 and T2 + line at C → current or recurrent infection.
Negative: Line at C only.
Invalid: No line at C.
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Performance Characteristics
IgM: Sensitivity 90.24%, Specificity 100%.
IgG: Sensitivity 96.36%, Specificity 100%.
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Limitations
This is a qualitative test and does not measure antibody levels.
Should not be used as the sole diagnostic criterion.
Negative results may occur in early stages of infection.
