Safety Alert for ZIKV Detect IgM Capture ELISA

Safety alert

2016-12-28

2016-12-28

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20161228.html

Medical device safety alert: inbios international zikv detect igm capture elisa the united states food and drug administration (fda) has issued a medical device safety alert concerning zikv detect igm capture elisa, manufactured by inbios international, inc. the fda is alerting physicians who care for pregnant women meeting cdc zika virus clinical criteria and/or cdc zika virus epidemiological criteria, that the u.S. commercial testing facility, laboratory corporation of america (labcorp), has reported some false positive results from the zikv detect test. because confirmation tests may take a week to a month to complete, the fda is issuing this alert so that health care providers and patients know about a higher likelihood of false positive results. the fda urges health care providers to be aware that: positive igm zika virus results are only presumptive for the detection of antibodies to zika virus. confirmation of igm zika virus presumptive or possible positive results requires additional testing by cdc or by qualified laboratories. the confirmatory testing may take a week to a month to be performed, but can be prioritized if cdc is aware that the sample is from a pregnant woman. laboratories should be notified of the patient’s pregnancy status. the fda urges health care providers to: inform their patients that presumptive positive results need to be confirmed, so that pregnant women are not making health care decisions based on incomplete information. not rely on presumptive positive zika virus igm test results as the sole basis of significant patient management decisions. take the following into consideration before diagnosing zika virus infection in pregnant women: clinical observations, patient history, epidemiological information, and; results from other testing such as follow-up confirmatory testing. notify the laboratory of the patient’s pregnancy to facilitate prioritization of confirmatory testing by cdc or qualified laboratories. for details, please refer to the fda website: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm534538.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 december 2016.