ZIKA DETECT IgM

ZIKA Testing: ZIKV Detect™ IgM Capture ELISA

ZIKADetect IgM Capture ELISA Test Now Offered At UNILAB.

Updated: March 27, 2017

  • This test has been authorized by the FDA under an EUA (Emergency Use Authorization) for use by authorized laboratories.

  • This test has been authorized only for diagnosis of the Zika virus infection and not for any other viruses or pathogens.

  • This test is only authorized for the duration of the declaration that circumstance exit justifying the authorization of emergency use the in vitro diagnostic test for detection of the ZIKA virus and or diagnosis or Zika v virus infection under section 564(b) (1) of Act, 21 U.S.C. 360bbb-3 (b) (1), unless the authorization is terminated or revoked sooner.

  • This test has not been FDA cleared or approved. 

  • ALL patients must read, understand, and sign the Fact Sheet for Patients: Understanding Results from the Zika Detect IgM Capture ELISA.

  • UNILAB is requiring one SST and one lavender top be submitted for each patient

  • No advertising or promotional descriptive printed matter to the use of the authorized ZikaDetect IgM Capture ELISA may represent or suggest that this test is safe or effective for the diagnosis of the Zika virus infection.

What is the ZIKV Detect™ IgM Capture ELISA?


The ZIKV Detect™ IgM Capture ELISA is a laboratory test designed to detect proteins the human body makes to fight a Zika virus infection. These proteins, called antibodies, appear in the blood starting soon after the start of illness and last for up to 12 weeks. In some people, they are present for longer than 12 weeks. If the ZIKV Detect™ IgM Capture ELISA detects these antibodies, the test is positive. If the ZIKV Detect™ IgM Capture ELISA does not detect these antibodies, the test is negative. InBios International, Inc.




Why was my sample tested using the ZIKV Detect™ IgM Capture ELISA?


Your sample(s) were tested because you have signs and symptoms of Zika virus infection, because you live in or have recently traveled to a place where Zika virus infection is known to occur, and/or because you have another possible exposure to Zika virus. The sample(s) collected from you were tested using the ZIKV Detect™ IgM Capture ELISA to help find out whether you may have been infected with Zika virus.




What are the known and potential risks and benefits of the ZIKV Detect™ IgM Capture ELISA?


Besides possible discomfort or other complications that can happen when your sample(s) are collected, there is a risk that the test result is incorrect (see below for more information). The benefit of having this test is that the results of this test, along with other information, can help inform your healthcare providers when making recommendations about your care and, if you are pregnant, the care of your developing fetus. The results of this test may help limit the spread of Zika virus in your community. For more information, see.




If this test is positive for Zika virus, does it mean that I have Zika virus infection?


If you have a positive result, it is likely that you have had a recent Zika virus infection. It is possible that you may have had a recent Zika virus infection and not have any symptoms. There is a chance that this test can give a positive result that is wrong; this is called a “false positive” result. There are some other very closely related viruses (such as dengue virus) that can cause the human body to produce antibodies that may cause the test to be positive. If your result from this test is positive, your healthcare provider or health department will determine if your results should be evaluated with additional testing and/or with testing from other samples that may have been collected from you. It is important that you work with your healthcare provider or health department to help you understand the next steps you should take and, if you are pregnant, to monitor the health and development of your fetus. If you have a pregnant partner and you are positive for Zika virus infection, you should use condoms and/or other barriers (e.g., dental dams) consistently and correctly during sex, or abstain from sex with your partner, for the duration of the pregnancy, to lessen the risk that you may pass Zika virus infection to your partner. If you have a positive test result for Zika virus and you are considering becoming pregnant or have a partner who might become pregnant, then you should discuss risks with your healthcare provider.




If I am pregnant and my test is positive for Zika virus, does it mean that my child will have a birth defect?


No, not necessarily. Although evidence shows that Zika virus infection during pregnancy is a cause of birth defects and other poor pregnancy outcomes, not all Zika virus infections result in these problems. At this time, we do not know how likely it is that a baby will have microcephaly or other problems if his/her mother is infected with Zika virus while she is pregnant. A positive test result for Zika virus infection during pregnancy signals to your healthcare providers to watch your pregnancy more closely, meaning they might do more ultrasounds or other tests to check the growth and development of your fetus.




If this test is positive for “other flavivirus” (e.g., dengue virus or West Nile virus), does it mean that I have dengue virus infection or West Nile virus infection?


If you have a positive test result for “other flavivirus,” it is likely you have a dengue virus infection or a West Nile virus infection. If your result from this test is positive for other flavivirus, additional testing may be required and your health care provider or health department will work with you to help you understand the steps you should take to care for yourself.




If this test is negative, does it mean that I do not have Zika virus infection?


Even if you have a negative test, you may have been infected with Zika virus. If your sample was collected just after you became ill, it is possible that your body had not yet had enough time to make antibodies for the test to measure. If the sample was collected more than 12 weeks after your illness, it is possible that your body has already fought off the virus and the amount of antibodies is so low that they cannot be measured. Your healthcare provider will help you to interpret your test results and work with you to continue to monitor your health and, if you are pregnant, the health of your fetus.




Is this test FDA-approved or cleared?


The U.S. Food and Drug Administration (FDA) has not cleared or approved ZIKV Detect™ IgM Capture ELISA test or any other test to detect Zika virus infection. However, FDA has authorized the use of this test under an Emergency Use Authorization (EUA). An EUA is a tool that FDA can use to allow the use of certain medical products for emergencies based on scientific data. The U.S. Secretary of Health and Human Services (HHS) has declared that circumstances exist to allow the emergency use of diagnostic tests for Zika virus infection, such as the ZIKV Detect™ IgM Capture ELISA, under an EUA. FDA has authorized the emergency use of the ZIKV Detect™ IgM Capture ELISA to test for antibodies to Zika virus in your specimens only for the duration of the emergency, unless it is terminated or revoked by FDA sooner.




How can I learn more?


Information about Zika virus is available at the CDC website. Information about any significant new findings that are observed during the course of the emergency use of the ZIKV Detect™ IgM Capture ELISA will be made available at the InBios website.





Contact

Unilab of Dade

2145 W. Davie Blvd., Suite 106
Fort Lauderdale, Florida 33312

Toll Free Phone: (877) 522-5678  

Fax: (954) 797-9494

Email: lab@infertilitylab.com

Website: www.infertilitylab.com

About Unilab

Unilab is an FDA-registered medical laboratory specializing in infertility and reproductive testing. Unilab is trusted by fertility doctors everywhere to provide accurate and timely results.

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