Zika IgG/IgM and Chikungunya IgG/IgM Combo Test

Intended Use:

Zika IgG/IgM and Chikungunya IgG/IgM Combo Test (Whole Blood/Serum/Plasma) is an in vitro immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies to Zika virus and Chikungunya virus (CHKV) in human whole blood, serum or plasma. Zika IgG/IgM and Chikungunya IgG/IgM Combo Test is intended to be used as a screening test and as an aid in the diagnosis of Zika and Chikungunya infections. The results obtained should be confirmed with alternative testing method(s).

Materials

● Individually packed test devices

● Disposable droppers

● Package insert

● Buffer

Test Procedure

Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results the assay should be performed within one hour.

2. For serum/plasma specimens:

Using the provided disposable dropper, draw the specimen up to the Fill Line, and transfer 1 drop of serum/plasma (approximately 5 uL), to the sample well (S), and then add 3 drops of buffer.

For whole blood specimens:

Using the provided disposable dropper, draw the specimen 0.5-1cm above the Fill Line, and transfer the whole blood (approximately 10 μL) to the sample well (S) of the test device, then add 3 drops of buffer

Note: Specimen application can also be performed with pipette.

Note: Avoid trapping air bubbles in the sample well (S), and do not add any solution to the result area.

3. As the test begins to work, sample will migrate across the membrane.

4. The result should be read at 15 minutes. Do not interpret the result after 20 minutes

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