Zika IgG/IgM and NS1 Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)

Zika IgG/IgM and NS1 Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)

A rapid test for the qualitative detection of IgG and IgM antibodies, NS1 antigen to Zika Virus in human whole blood, serum or plasma specimens. For professional in vitro diagnostic use only.

Applications:

The Zika IgG/IgM and NS1 Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies, NS1 antigen to Zika Virus in human whole blood, serum or plasma as an aid in the diagnosis of Zika infections.

Description:

Zika virus (ZIKV) is a member of the virus family Flaviviridae. It is spread by daytime- active Aedes mosquitoes, such as A.aegypti and A.albopictus. 1 Its name comes from the Zika Forest of Uganda, where the virus was first isolated in 1947. Zika virus is related to the dengue, yellow fever, Japanese encephalitis, and West Nile viruses. Since the 1950s, it has been known to occur within a narrow equatorial belt from Africa to Asia. From 2007 to 2016, the virus spread eastward, across the Pacific Ocean to the Americas, leading to the 2015–16 Zika virus epidemic.

The infection, known as Zika fever or Zika virus disease, often causes no or only mild symptoms, similar to a very mild form of dengue fever. 1 While there is no specific treatment, para/cetamol (ace/taminophen) and rest may help with the symptoms. 3 As of 2016, the illness, cannot be prevented by medications or vaccines. 3 Zika can also spread from a pregnant woman to her fetus. This can result in microcephaly, severe brain malformations, and other birth defects. Zika infections in adults may result rarely in Guillain–Barré syndrome. Zika fever, also known as Zika virus disease or simply Zika, is an infectious disease caused by the Zika virus. Most cases have no symptoms, but when present they are usually mild and can resemble dengue fever. Symptoms may include fever, red eyes, joint pain, headache, and a maculopapular rash. Symptoms generally last less than seven days.

It has not caused any reported deaths during the initial infection. 10 Mother-to-child transmission during pregnancy can cause microcephaly and other brain malformations in some babies.Infections in adults have been linked to Guillain–Barré syndrome (GBS). Serology for the detection of specific IgG and IgM antibodies to Zika virus can be used. IgM antibodies can be detectable within 3 days of the onset of illness. Serological cross- reactions with closely related flaviviruses such as dengue and West Nile virus as well as vaccines to flaviviruses are possible.

The Zika IgG/IgM and NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test that utilizes a combination of Zika IgG/IgM antigens and Zika NS1 antibody coated colored particles for the detection of Zika IgG/IgM antibodies and Zika NS1 antigen in human whole blood, serum, or plasma.

How to use?

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

1. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
 

2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
 

· For IgG/IgM:
Hold the dropper vertically and transfer 1 full drop of serum or plasma (approximately 10 ul) to the specimen well, then add 1 drop of buffer (approximately 40 ul), and start the timer. See illustration below.
 

· For NS1:
Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 ul) to the specimen area, then add 1 drop of buffer (approximately 40 ul), and start the timer. See illustration below.
For Whole Blood (Venipuncture/Fingerstick) specimen:
 

· For IgG/IgM:
 

· To use a dropper: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 20 μL) to the specimen area, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration below.
 

· To use a capillary tube: Fill the capillary tube and transfer approximately 20μL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration below.
 

· For NS1:
 

· To use a dropper: Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75 μL) to the specimen area, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration below.
 

· To use a capillary tube: Fill the capillary tube and transfer approximately 75μL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration below.

3. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the results after 20 minutes.
Note: It is suggested not to use the buffer, beyond 30 days after opening the vial.

 

INTERPRETATION OF RESULTS

IgG POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the IgG test line region.
 

IgM POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the IgM test line region.
 

IgG and IgM POSITIVE:* Three colored lines appear. One colored line should always appear in the control line region (C) and two test lines should be in the IgG test line region and IgM test line region.
 

NS1 POSITIVE:* Two colored lines appear. One colored line should be in the control region (C) and another colored line should be in the NS1 test line region (T).
*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of Zika NS1 antigen and Zika antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.
 

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test region(s).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

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