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LabCorp makes nationwide availability of CDC Zika MAC-ELISA test in US

MDBR Staff Writer Published 03 August 2016

Laboratory Corporation of America (LabCorp) announced the availability of the CDC Zika MAC-ELISA test.

The Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) test was developed by the Centers for Disease Control and Prevention (CDC). The US FDA issued Emergency Use Authorisation, initially in February 2016 and it was reissued in June, this year.

The FDA did not fully clear or approve the test. It has only been authorised by  FDA under an EUA to be used in authorised laboratories.

The test helps in qualitative detection of Zika virus and IgM antibodies in serum or cerebrospinal fluid and it is now available for commercial laboratories.

It will be used in the detection of Zika virus infection in individuals who meet clinical or epidemiological criteria established by CDC for Zika virus infection.

CDC’s established clinical criteria for Zika virus infection testing include a history of clinical signs and symptoms known for Zika virus infection. The epidemiological criteria for Zika virus includes a history of recent travel to a Zika virus active geographic region at the time of the travel and other epidemiologic criteria where Zika virus testing may be indicated as part of public health response.

The Zika MAC-ELISA test is effective in persons who exhibit the onset of symptoms after 12 weeks following infection. It will be useful in serum or cerebrospinal fluid when submitted with patient-matching serum sample.

This test, when compared to other tests such as RT-PCR tests for Zika virus and RealStar Zika Virus RT-PCR Kit U.S takes longer time.

Aedes aegypti mosquito bites are the primary cause of spread of Zika virus and it can also spread through sexual contact without a barrier method and from mother to fetus.

This was identified in over 1658 individuals in US in July 2016. In all cases except one, travel to areas with ongoing transmission of Zika virus or an epidemiological link in travel history was found.

Recently, in US, local mosquito-borne Zika virus transmission was confirmed in Miami, Florida. Public health officials have determined that Zika virus poses significant potential for health emergency.

In most cases, Zika virus infection are relatively minor and the infected may or may not exhibit symptoms or mild symptoms such as fever, joint pain, rash or redness of the eyes.

But, Zika virus during pregnancy can cause birth defects including fetal microcephaly and can also lead to poor pregnancy outcomes such as stillbirth or miscarriage.

LabCorp’s chairman and CEO David P. King said: “Zika virus continues to be a serious public health threat, and we are pleased to be among the first commercial laboratories to make the Zika MAC-ELISA test available to physicians for patients who meet CDC criteria for testing.

“This test enhances our offering in infectious diseases and can help to improve health and lives.”