Zika virus IgG/IgM Rapid Test

INTENDED USE

The Zika virus IgG/IgM Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Zika virus in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary Zika infections.

INTRODUCTION

Zika fever, also known as Zika virus disease or simply Zika, is an infectious disease caused by the Zika virus.1 Most cases have no symptoms, but when present they are usually mild and can resemble dengue fever.1-4 Symptoms may include fever, red eyes, joint pain, headache, and a maculopapular rash. Symptoms generally last less than seven days.2 It has not caused any reported deaths during the initial infection.4 Mother-to-child transmission during pregnancy can cause microcephaly and other brain malformations in some babies.5-6 Infections in adults have been linked to Guillain-Barre syndrome. Serology for the detection of specific IgM and IgG antibodies to Zika virus can be used. IgM antibodies can be detectable within 3 days of the onset of illness.7 Serological cross-reactions with closely related flaviviruses such as dengue and West Nile virus as well as vaccines to flaviviruses are possible.

The Zika virus IgG/IgM Rapid Test is a rapid test that utilizes a combination of Zika antigen coated colored particles for the detection of IgG and IgM Zika antibodies in human whole blood, serum, or plasma.

PROCEDURE

Allow the test device, specimen, buffer, and/or controls to reach room temperature (1530°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.

For Serum or Plasma Specimens: 

Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 10 uL), and transfer the specimen to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 mL) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S).

For Whole Blood (Venipuncture/Fingerstick) Specimens:

To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line, and transfer 2 drops of whole blood (approximately 20 µL) to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 uL) and start the timer. See illustration below.

To use a micropipette: Pipette and dispense 20 µL of whole blood to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 µL) and start the timer.

3. Wait for the colored line(s) to appear. Read results at 10 minutes.Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS