Chikungunya IgG and IgM Rapid Test

Infectious Disease TestsTesting Kits

Chikungunya IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) is an in vitro immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies to Chikungunya virus (CHKV) in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of Chikungunya infections.

Description

Intended Use

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

 

Principle

Chikungunya IgG/IgM Rapid Test detects IgG and IgM antibodies to CHKV through visual interpretation of color development. Recombinant antigens, anti-human IgG and anti-human IgM antibodies are used to detect the specific antibodies in the human, serum or plasma samples. When a sample is added to the sample well on the test panel, specific IgG and/or IgM antibodies, if present, will bind to the recombinant antigens conjugated to colored particles on the sample pad. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by anti-human IgG and/or anti-human IgM antibodies immobilized at the detection zone. Excess colored particle are captured at the internal control zone.

The presence of a red band(s) in the test region indicates a positive result for the particular IgG and/or IgM antibodies, while its absence indicates a negative result. A red band at the control region (C) serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking is working

Materials

● Individually packed test devices

● Disposable droppers

● Package insert

● Buffer

Procedure

Allow the test device, specimen, buffer, and/or controls to reach room temperature (15 30°C) prior to testing.

1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.

2. Place the test device on a clean and level surface. Label the test with patient or control identification.

For Serum or Plasma Specimens:

Hold the dropper vertically, draw the specimen up to the Fill Line, and transfer all the serum/plasma (appr. 5 uL), onto the specimen well (S) of the test device, then add 3 drops of buffer and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S).

For Whole Blood Specimens:

Hold the dropper vertically, draw the specimen 0.5-1cm above the Fill Line, and transfer 1 drop of whole blood (appr. 10 µL) to the specimen well (S) of the test device, then add 3 drops of buffer and start the timer. See illustration below.

Note: Specimens can also be applied using a micropipette.

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

 

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How to Use