Filariasis IgG and IgM Rapid Test Device

Intended Use

Filariasis IgG and IgM Rapid Test Device (Serum/Plasma) is an in vitro diagnostic rapid immunochormatographic assay for the qualitative detection of specific IgG and IgM anti-lymphatic filarial parasites in human serum and plasma specimens. The product may be used as an aid in the diagnosis of filariasis. Testing results should be confirmed by other supplemental assay(s).

Materials

● Test devices

● Droppers

● Buffer

● Package insert

Specimen Collection and Preparation

● Filariasis IgG and IgM Rapid Test Device is intended for use with human whole blood, serum or plasma specimens only.

● Collect specimens according to safe phlebotomy procedure.

● Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.

● Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to one week. For long term storage, specimens should be kept below -20°C.

● Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 3 days of collection. Do not freeze whole blood specimens.

● Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Multiple freeze/ thaw cycles should be avoided.

● If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.

● Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.

Test Procedure

Bring the test device, buffer and specimen to room temperature (15-30°C) prior to testing.

1. Remove the test device from its sealed pouch and use it as soon as possible. For best results, the assay should be performed within one hour.

2. Place the test device on a clean, level surface. Label with specimen ID.

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

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

3. Wait for the colored band(s) to appear. Read results at 15 minutes.

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