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Aptima Zika Virus assay

At Hologic we are committed to the accurate detection of emerging pathogens. The Aptima® Zika Virus assay on the fully automated Panther® system is a transcription-mediated amplification test intended for the qualitative detection of Zika virus RNA in human serum, plasma and urine specimens. This assay has been issued Emergency Use Authorization (EUA) from the FDA. Results for the identification of Zika virus should be managed in consultation with public health or other authorities to whom reporting is required (reporting to the CDC is required in the U.S.)

About

The Aptima Zika Virus assay is used for the detection of Zika virus RNA in patients at risk of exposure to Zika or with signs and symptoms of the virus. This assay is designed to be used in individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated), by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories.

The Origins of Zika Virus

On February 1, 2016, the World Health Organization Director General declared a Public Health Emergency of International Concern for the Zika virus.1 The Zika virus is a member of family Flaviviridae, genus Flavivirus.2 It was first identified in 1947 in a rhesus macaque in the Zika Forest of Uganda, from which it was named.2 It was first reported in a human case in Uganda in 1952 and emerged in sporadic outbreaks until 2007, when the first outbreak outside of Asia or Africa occurred on a Pacific island in the Federated States of Micronesia.2

In 2013 and 2014, another major outbreak of Zika virus disease occurred in French Polynesia, and shortly after acquired cases were confirmed in Brazil and other South and Central American countries.2 Most recently, it has been identified in U.S. territories: Puerto Rico and the Virgin Islands, with recent cases diagnosed in the  U.S.2

Identifying Zika Virus

This assay was developed in response to Zika virus outbreaks and their association with serious clinical complications. This virus is transmitted to people primarily through the bite of an infected Aedes species mosquito, and can also be passed from mother to fetus during pregnancy.3 It can also be spread by unprotected sexual intercourse, and through blood during transfusion. 3

Research has shown Zika virus is a cause of microcephaly and other serious brain abnormalities in infants born to Zika-infected mothers.The World Health Organization has also noted that Zika virus is a cause of Guillain-Barré syndrome in a small proportion of infections.4

The Aptima Zika Virus assay uses transcription mediated amplification technology to detect Zika virus RNA in serum, plasma and urine specimens for the identification of Zika virus infection, to be managed in consultation with CDC and local state public health guidelines.

Features

Accurate Diagnosis

  • This assay provides excellent analytical sensitivity and the ability to detect viral RNA down to single-digit copies per mL.

Broader Capability

  • The use of the Aptima Zika Virus assay joins the ever-increasing Panther menu for broader testing capability per square foot of instrument footprint.

Fast Results

  • On the Panther system, the Aptima Zika Virus assay substantially reduces hands-on time and minimizes turnaround time to only 3.5 hours to first patient result and five minutes for subsequent results.

Volume Scalability

  • Flexibly adapt to high and low test volumes at any given time.
Performance

The table in this section can be found in the Aptima Zika Virus assay package insert.

 

 

CI = Confidence Interval.

a Includes two patient samples that were positive on initial reference testing and negative on re-testing by an alternate PCR method and was considered a false positive.

Regulatory

The Aptima Zika Virus assay:

  • This test has not been FDA cleared or approved;
  • This test has been authorized by FDA under an EUA for use by authorized laboratories;
  • This test has been authorized only for the detection of RNA from Zika virus and diagnosis of Zika virus infection, not for any other viruses or pathogens; and
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection undersection 564(b)(1) of the Act, 21 U.S.C.§ 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

For additional availability in other countries beyond the U.S., please contact your local sales representatives or distributor.

References

1. WHO statement on the first meeting of the International Health Regulations (2005) (IHR 2005) Emergency Committee on Zika virus and observed increase in neurological disorders and neonatal malformations [WHO statement]. World Health Organization; February 1, 2016.

2. CDC. About Zika Virus Disease. http://www.cdc.gov/zika/about/index.html. Updated June 3, 2016. Accessed June 9, 2016.

3. CDC. Zika Virus Transmission & Risks. http://www.cdc.gov/zika/transmission/. Updated May 12, 2016. Accessed June 1, 2016.

4. World Health Organization. Zika virus, Microcephaly and Guillan-Barré syndrome. http://who.int/emergencies/zika-virus/situation-report/12-may-2016/en/. Published May 12, 2016. Accessed August 10, 2016.