Zika virus NS1 Rapid Test
INTENDED USE
The Zika virus NS1 Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Zika virus NS1 antigen in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary Zika infections.
INTRODUCTION
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. 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. While there is no specific treatment, paracetamol (acetaminophen) and rest may help with the symptoms. As of 2016, the illness cannot be prevented by medications or vaccines. 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.
The Zika virus NS1 Antigen Rapid Test is a rapid test that utilizes a combination of anti-Zika NS1 Ag coated colored particles for the detection of Zika NS1 antigen in human whole blood, serum, or plasma.
PROCEDURE
Bring tests, specimens, buffer and/or controls to room temperature (15 30°C) before use.
- 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.
- Using the provided disposable pipette, transfer 3 drops of specimen (approximately 75 µL) to the specimen well (S) of the device, then start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
As the test begins to work, color will migrate across the membrane.
- Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
